WO2005032626A1 - Flush syringe having anti-reflux features - Google Patents

Flush syringe having anti-reflux features Download PDF

Info

Publication number
WO2005032626A1
WO2005032626A1 PCT/US2004/029280 US2004029280W WO2005032626A1 WO 2005032626 A1 WO2005032626 A1 WO 2005032626A1 US 2004029280 W US2004029280 W US 2004029280W WO 2005032626 A1 WO2005032626 A1 WO 2005032626A1
Authority
WO
WIPO (PCT)
Prior art keywords
stopper
barrel
distal
chamber
proximal end
Prior art date
Application number
PCT/US2004/029280
Other languages
French (fr)
Inventor
Eric Schiller
Tracy Ray Hottovy
Thomas A. Alheidt
Mitali Dutt
Original Assignee
Becton, Dickinson And Company
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Becton, Dickinson And Company filed Critical Becton, Dickinson And Company
Priority to DE602004022184T priority Critical patent/DE602004022184D1/en
Priority to DK04783506T priority patent/DK1673120T3/en
Priority to CA2539813A priority patent/CA2539813C/en
Priority to BRPI0414639A priority patent/BRPI0414639B8/en
Priority to KR1020067007646A priority patent/KR101124390B1/en
Priority to JP2006528033A priority patent/JP4672665B2/en
Priority to EP04783506A priority patent/EP1673120B1/en
Priority to MXPA06003235A priority patent/MXPA06003235A/en
Priority to AU2004277895A priority patent/AU2004277895B2/en
Publication of WO2005032626A1 publication Critical patent/WO2005032626A1/en
Priority to NO20061775A priority patent/NO337965B1/en

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/315Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31511Piston or piston-rod constructions, e.g. connection of piston with piston-rod
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M2005/1401Functional features
    • A61M2005/1403Flushing or purging
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M2005/3103Leak prevention means for distal end of syringes, i.e. syringe end for mounting a needle
    • A61M2005/3104Caps for syringes without needle
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/3129Syringe barrels
    • A61M2005/3132Syringe barrels having flow passages for injection agents at the distal end of the barrel to bypass a sealing stopper after its displacement to this end due to internal pressure increase
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/315Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31511Piston or piston-rod constructions, e.g. connection of piston with piston-rod
    • A61M2005/31523Piston or piston-rod constructions, e.g. connection of piston with piston-rod for reducing reflux

Definitions

  • the present invention relates to syringe assemblies and particularly to syringe assemblies for use in IN. flush procedures.
  • An IN. catheter is a commonly used therapeutic device. Many patients, in accordance with their therapy, have an IN. catheter connected to a vein ready for use in various procedures or in fluid communication with an IN. system for infusing liquids and medication. Many IN. sets have IN. ports which are in fluid communication with a catheter and allow access for the purpose of injecting medication into the patient, and for use in flushing techniques to maintain catheter integrity. Healthcare facilities have flushing protocols which depend on the amount of time the catheter will remain in the patient and the type of catheter being used.
  • a peripherally inserted central catheter is a long flexible catheter, which is typically inserted into the central venous system (optimally with the tip terminating in the superior vena cava) via the superficial veins of the antecubital fossa.
  • PICC lines are designed for use when intermediate or long-term therapy is prescribed.
  • saline flush solution removes blood from the catheter and heparin helps prevent the formation of future blood clots.
  • the most common IN. ports are covered by pierceable septums or pre-slit septums and are known in the art and sometimes referred to as TRIM" from the Latin pro re nata meaning "as the need arises".
  • the septum is preferably made of rubber or another elastomeric material which permits insertion of a sharp needle cannula in order to infuse fluids into or to withdraw fluids from the catheter.
  • the septum Upon withdrawal of the needle cannula the septum seals itself. Ports having pre-slit septums are used with blunt cannula. Typically, the blunt cannula is attached to a syringe and the syringe is moved to place a gentle pressure on the pre-slit septum which is forced open by the blunt cannula to establish fluid communication. Also, some IN. sets have access valves which are responsive to the frusto-conically shaped tip of a syringe barrel for allowing fluid communication between the interior of the syringe and the catheter without the use of a cannula. [0004] Catheters are flushed using syringe assemblies filled with various fluids.
  • syringes used to flush IN. lines varies by various factors including the size and length of the catheter. Typically syringes of 1ml, 3ml, 5ml and 10ml volume are used.
  • reflux It is important in the flush procedure not to draw blood back into the catheter where it can clot and seal the catheter, commonly referred to as "reflux".
  • Reflux In order to prevent blood reflux into the catheter the user is encouraged to maintain a positive pressure in the line during the flush procedure. This may involve clamping the IV line and withdrawing the syringe and cannula from the IN.
  • the stopper When using a syringe with an elastomeric stopper, the stopper is often compressed when it contacts the distal end of the syringe barrel at the completion of the flush procedure. When a user relieves the pressure to the plunger after the flush procedure is completed, the stopper will expand back to its normal size drawing liquid from the catheter into the syringe barrel. This is undesirable, since it can cause blood to enter the catheter at the catheter distal end (reflux). Problems with reflux of blood into the catheter are on the rise because IV lines are now being flushed by a wide variety of health care workers not just those dedicated to catheter maintenance.
  • the present invention is directed to a syringe assembly for use in flush applications.
  • the syringe assembly reduces or eliminates reflux of blood into the catheter by providing a proximally facing annular boss on the inside surface of the distal wall of the syringe barrel.
  • the boss projects into the fluid containing chamber of the barrel and surrounds the passageway in the barrel tip through which flush solution is discharged.
  • the annular boss is positioned so that it contacts the distal surface of the stopper and seals the passageway before other portions of the inside surface of the distal wall of the barrel surrounding the boss contact the stopper. Further compression of the stopper will be independent of this seal so that reflux is reduced or eliminated.
  • An IN. flush syringe assembly comprises a barrel including a cylindrical sidewall having an inside surface defining a chamber for retaining fluid.
  • the barrel includes an open proximal end and a distal end having a distal wall with an elongate tip extending distally therefrom.
  • the tip includes a passageway therethrough in fluid communication with the chamber.
  • the plunger having an elongate body portion includes a proximal end, a distal end and a stopper slidably positioned in fluid-tight engagement with the inside surface of the barrel for drawing fluid into and driving fluid out of the chamber by movement of the stopper relative to the barrel.
  • the elongate body portion of the plunger extends outwardly from the open proximal end of the barrel.
  • the stopper has a distal surface.
  • Anti-reflux structure is provided for controlling stopper deflection when fluid has been delivered from the chamber and the stopper is in contact with the distal wall of the barrel.
  • Anti-reflux structure may include a stopper preferably having a conically shaped distal surface and a proximally-facing annular boss in the barrel for sealing the passageway in the distal tip of the barrel.
  • the syringe assembly may further include at least one projection on the distal surface of the stopper positioned mostly in the space between the distal surface of the stopper and the conically shaped inside surface of the distal wall of the barrel when the distal surface of the stopper first contacts the conically shaped inside surface, [oooio]
  • the syringe assembly may also include flush solution in the chamber and a tip cap releasably connected to the tip of the syringe barrel for sealing the passageway.
  • the flush solution may be selected from the group consisting of saline flush solution and heparin lock solution.
  • the syringe assembly may further include a needle assembly including a cannula having a proximal end, a distal end, and a lumen therethrough.
  • a hub having an open proximal end containing a cavity and a distal end attached to the proximal end of the cannula so that the lumen is in fluid communication with the cavity of the hub.
  • the needle assembly is removably attached to the tip of the barrel through engagement of the tip to the cavity of the hub so that the lumen is in fluid communication with the chamber of the barrel.
  • Another embodiment of the IN. flush syringe assembly of the present invention comprises a barrel including a cylindrical sidewall having an inside surface defining a chamber for retaining fluid.
  • the barrel includes an open proximal end and a distal end having a distal wall with an elongate tip extending distally therefrom having a passageway therethrough in fluid communication with the chamber.
  • a plunger includes an elongate body portion having a proximal end, a distal end and a stopper slidably positioned in fluid-tight engagement with the inside surface of the barrel for drawing fluid into and driving fluid out of the chamber by movement of the stopper relative to the barrel.
  • the elongate body of the plunger extends outwardly from the open proximal end of the barrel.
  • the stopper includes a distal surface.
  • a tip cap is releasably connected to the elongate tip of the barrel for sealing the passageway.
  • a quantity of flush solution is in the chamber between the stopper and the distal wall.
  • Anti-reflux structure for controlling stopper deflection when fluid has been delivered from the chamber and the stopper is in contact with the distal wall is provided.
  • the anti-reflux structure may include an annular boss on the inside surface of the distal wall of the barrel surrounding the passageway. The boss is positioned so that it contacts the distal surface of the stopper and seals the passageway before portions of the inside surface of the distal wall surrounding the boss contact the distal surface of the stopper.
  • the inside surface of the distal wall may be conically shaped and the annular boss raised from the conically shaped inside surface.
  • the distal surface of the stopper may be conically shaped and projecting toward the annular boss.
  • At least one projection on the distal surface of the stopper is provided.
  • the at least one projection is positioned and/or sized so that when the stopper contacts the annular boss in the barrel, any deflection of the projection will not store enough energy to move the stopper proximal ly to the extent the stopper is disengaged from the inside surface of the distal end of the barrel near the passageway.
  • a method of flushing a catheter of the present invention comprises the steps of providing a syringe assembly having a barrel including a cylindrical side wall having an inside surface defining a chamber for retaining fluid, an open proximal end and a distal end including a distal wall with an elongate tip extending distally therefrom having a passageway therethrough in fluid communication with the chamber, a plunger including an elongate body portion having a proximal end, a distal end and a stopper having a distal surface wherein the stopper is slidably positioned in fluid-tig ht engagement with the inside surface of the barrel for drawing fluid into and driving fluid out of the chamber by movement of the stopper relative to the barrel, the elongate body portion extending outwardly from the open proximal end of the barrel, a quantity of flush solution in said chamber, and anti-reflux means in the barrel for minimizing stopper deflection when the flush solution has been delivered from the chamber and the stopper is in
  • the method further includes providing a catheter having a proximal end, a distal end and a passageway therethrough and a housing having a hollow interior in fluid communication with the passageway, the housing having an access valve capable of engaging the elongate tip of the barrel for allowing fluid communication with the hollow interior of the housing.
  • the method further includes the steps of placing the distal end of the catheter in a blood vessel; engaging the elongate tip of the barrel with the access valve so that the passageway in the tip is in fluid communication with the hollow interior of the housing; applying force to the plunger to move the plunger in a distal direction with respect to the barrel so that the flush solution in the chamber flows through the passageway into the hollow chamber of the housing and through the passageway of the catheter; continuing to apply force to the plunger until the stopper contacts and presses against the distal wall of the barrel; and disengaging said syringe assembly from said access valve.
  • An alternative method may include the step of attaching a needle assembly to the elongate tip of the barrel.
  • the needle assembly includes a cannula having a proximal end, a distal end and a lumen therethrough and a hub having an open proximal end containing a cavity and a distal end attached to the proximal end of the cannula so that the lumen is in fluid communication with the cavity.
  • the attachment of the needle assembly to the barrel is through frictional engagement between the cavity in the hub and the elongate tip.
  • This alternative method is used with a catheter having a proximal end, a distal end and a passageway therethrough and a housing having a hollow interior connected to the catheter and in fluid communication with the passageway of the catheter.
  • the housing further includes a septum for allowing fluid communication with the hollow interior. Fluid communication is established by forcing the distal end of the cannula through the septum so that the lumen of the cannula is in fluid communication with the hollow interior of the housing.
  • the cannula may be permanently attached to the barrel tip with or without the use of a hub. At completion of the flush procedure the cannula is withdrawn from the septum.
  • FIG. 1 is a perspective view of a syringe assembly according to one embodiment of the invention.
  • FIG. 2 is a partially cross-sectioned side elevational view of the syringe assembly of FIG. 1 with a needle assembly attached.
  • FIG. 3 is a cross-sectional view of the syringe assembly of FIG. 1 taken along line 3-3.
  • FIG. 4 is a partial perspective view of the stopper and distal end of the plunger of the syringe assembly of FIG. 1.
  • FIG. 5 is an enlarged partial cross-sectional side elevation view of the distal end of the syringe assembly of FIG. 2.
  • FIG. 6 is an enlarged partial, cross-sectional side elevational view of the distal end of the syringe assembly shown at the completion of a flush procedure.
  • FIG. 7 is a side-elevational view illustrating the syringe assembly in use with a catheter injection site.
  • a syringe 20 generally comprises a barrel 22, and a plunger 24.
  • the barrel 22 has a generally cylindrical side wall 23 including an open proximal end 28 having finger grips 29, a distal end 30 having a distal wall 31 and an inside surface 32 defining a chamber 33 for retaining fluid.
  • the inside surface of the barrel at the distal wall is preferably conically shaped and includes a proximally facing annular boss 35.
  • Distal end 30 further includes a tip 36 having a passageway 38 in fluid communication with the chamber.
  • the distal end of barrel 22 preferably, but not necessarily includes a locking luer type collar 40 concentrically surrounding tip 36.
  • a cannula 26 includes a proximal end 42, a distal end 44 and a lumen 46 therethrough.
  • the distal end may include a sharp tip or a blunt tip 48 as shown.
  • the cannula may be connected directly to the tip of the syringe barrel to establish fluid communication between the lumen and the chamber.
  • the cannula may be part of a needle assembly 27 including a hub 34 having an open proximal end 37 containing a cavity 41 and a distal end 39 attached to the proximal end of the cannula so that the lumen of the cannula is in fluid communication with the cavity.
  • Plunger 24 includes an elongate body portion 25, a proximal end 50 having a flange 51, and a distal end 52.
  • a stopper 54 is disposed on projection 53 at distal end 52 of the plunger, preferably via threading engagement.
  • Stopper 54 includes at least one rib and preferably a plurality of ribs 56 on its outside diameter. The stopper is slidably positioned in fluid-tight engagement with the inside surface of the barrel for drawing fluid into and drawing fluid out of the chamber, through the passageway, by movement of the stopper relative to the barrel.
  • Stopper 54 includes a proximal end 55 having a cavity 57 therein for engaging projection 53 on the distal end 52 of the plunger. Stopper 54 further includes a distal end 58 having a distal surface 59 thereon. Distal surface 59 is preferably conically shaped. [0018] Stopper 54 preferably includes at least one projection or lug 60 on distal surface 59. Projection 60 keeps the stoppers from nesting or sticking to each other during the assembly process. For example, the distal surface of one stopper may position itself in the cavity of another stopper while the stoppers are together before assembly. [0019] The stopper may be made of any material suitable for providing sealing characteristics while under compression.
  • the stopper may be made of thermoplastic elastomers, natural rubber, synthetic rubber or thermoplastic materials and combinations thereof.
  • the plunger in this embodiment is preferably made of material which is more rigid than the stopper such as polypropylene, polyethylene and the like.
  • syringe 20 is connected to a needle assembly and filled with flush solution using known methods.
  • the flush solution may be any solution intended for flushing. It is preferred that the flush solution be selected from the group consisting of saline flush solution and heparin lock flush solution. These solutions are known in the art and readily available.
  • An example of a saline flush solution is 0.9% Sodium Chloride USP.
  • An example of a heparin lock flush solution is 0.9% Sodium Chloride with 100 USP units of Heparin Sodium per ml or 10 USP units of Heparin Sodium per ml.
  • the syringe with needle assembly attached is used to pierce the pierceable septum or a blunt cannula may be inserted into a pre-split septum of a vial containing flush solution and the flush solution is drawn into the syringe barrel by pulling plunger rod flange 51 in the proximal direction while holding barrel 22, to draw fluid through the needle cannula into fluid chamber 33.
  • the syringe may be filled with flush solution during the manufacturing of the syringe via a sterile filling method.
  • Such prefilled syringes may be supplied with a tip cap, such as tip cap 45 releasably connected to tip 36 sealing passageway 38. It is preferred that the tip cap is formed of material selected from the group of thermoplastic materials and elastomeric materials such as natural and synthetic rubber and thermoplastic elastomers.
  • IN. set 64 comprises an IN. site 65 which includes a housing 67 having a hollow interior 68 and a septum 69 at its proximal end.
  • a catheter 70 having a conduit therethrough extends from the distal end of the housing.
  • septum 69 is pre-slit for use with blunt cannula.
  • Blunt tip 48 of cannula 26 may be inserted through pre-split septum 69 of IN. set 64.
  • a sharp tip of a needle cannula may be used to pierce a septum that is not pre-split, or the tip of the barrel may be engaged with a valve in the IN. site. This establishes fluid communication between the interior 68 of the IN. set and the chamber of the syringe barrel.
  • the syringe barrel 22 is preferably held via finger grips 29.
  • stopper deflection caused by additional unnecessary force applied to the plunger, at this time, which could cause reflux of blood into the catheter using prior art syringes, is minimized or eliminated with the syringe of the present invention.
  • the stopper may flex, however, this flexure will occur generally outside of the sealed area on the annular boss which surrounds the entrance to the passageway.
  • projection 60 is shaped so that upon further deflection of the stopper through forces applied to the plunger, the projection will not be able to force the stopper to move proximally. That is, the projection cannot create enough force to move the stopper proximally to create reflux.
  • the projection on the distal surface of the stopper be positioned mostly in space 61 between the distal surface of the stopper and the inside surface of the distal wall of the barrel as illustrated in FIG. 6.
  • the projection should be sized and positioned so that it cannot absorb enough energy during deflection to move the stopper proximally and break the seal between the stopper and the barrel at the annular boss.
  • the projection can have a variety of shapes including the raised rectangular shape illustrated.
  • the projection may also be angularly shaped having a distal surface at the same angle as the inside surface of the barrel.

Landscapes

  • Health & Medical Sciences (AREA)
  • Vascular Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
  • Road Signs Or Road Markings (AREA)

Abstract

An IN. flush syringe assembly includes a barrel having an inside surface defining a chamber for retaining fluid, an open proximal end and a distal end including a distal wall with an elongate tip extending distally therefrom having a passageway therethrough in fluid communication with the chamber. A plunger (24) having an elongate body portion and a stopper (54) slidably positioned in fluid-tight engagement with the inside surface of the barrel is provided. Anti-reflux structure (35) in said barrel is provided for controlling stopper deflection when fluid has been delivered from the chamber and the stopper is in contact with structure on the distal wall.

Description

FLUSH SYRINGE HAVING ANTI-REFLUX FEATURES
BACKGROUND OF THE INVENTION
[00 ol] The present invention relates to syringe assemblies and particularly to syringe assemblies for use in IN. flush procedures.
[0002] An IN. catheter is a commonly used therapeutic device. Many patients, in accordance with their therapy, have an IN. catheter connected to a vein ready for use in various procedures or in fluid communication with an IN. system for infusing liquids and medication. Many IN. sets have IN. ports which are in fluid communication with a catheter and allow access for the purpose of injecting medication into the patient, and for use in flushing techniques to maintain catheter integrity. Healthcare facilities have flushing protocols which depend on the amount of time the catheter will remain in the patient and the type of catheter being used. For example, a peripherally inserted central catheter (PICC) is a long flexible catheter, which is typically inserted into the central venous system (optimally with the tip terminating in the superior vena cava) via the superficial veins of the antecubital fossa. PICC lines are designed for use when intermediate or long-term therapy is prescribed.
[00 θ3] These catheter lines must be periodically flushed with saline flush solution and/or heparin lock flush solution depending on the protocol. Among other things, flushing saline solution removes blood from the catheter and heparin helps prevent the formation of future blood clots. The most common IN. ports are covered by pierceable septums or pre-slit septums and are known in the art and sometimes referred to as TRIM" from the Latin pro re nata meaning "as the need arises". The septum is preferably made of rubber or another elastomeric material which permits insertion of a sharp needle cannula in order to infuse fluids into or to withdraw fluids from the catheter. Upon withdrawal of the needle cannula the septum seals itself. Ports having pre-slit septums are used with blunt cannula. Typically, the blunt cannula is attached to a syringe and the syringe is moved to place a gentle pressure on the pre-slit septum which is forced open by the blunt cannula to establish fluid communication. Also, some IN. sets have access valves which are responsive to the frusto-conically shaped tip of a syringe barrel for allowing fluid communication between the interior of the syringe and the catheter without the use of a cannula. [0004] Catheters are flushed using syringe assemblies filled with various fluids. In some cases, different fluids are injected sequentially in accordance with the protocol. For example, a saline solution followed by an anticoagulant such as heparin. The size of the syringe used to flush IN. lines varies by various factors including the size and length of the catheter. Typically syringes of 1ml, 3ml, 5ml and 10ml volume are used. [0005] It is important in the flush 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 reflux into the catheter the user is encouraged to maintain a positive pressure in the line during the flush procedure. This may involve clamping the IV line and withdrawing the syringe and cannula from the IN. port while still applying pressure to the syringe plunger rod during the flush procedure. When using a syringe with an elastomeric stopper, the stopper is often compressed when it contacts the distal end of the syringe barrel at the completion of the flush procedure. When a user relieves the pressure to the plunger after the flush procedure is completed, the stopper will expand back to its normal size drawing liquid from the catheter into the syringe barrel. This is undesirable, since it can cause blood to enter the catheter at the catheter distal end (reflux). Problems with reflux of blood into the catheter are on the rise because IV lines are now being flushed by a wide variety of health care workers not just those dedicated to catheter maintenance. These other health care workers, as a result of having many other aspects of patient care to be responsible for and who spend much less time flushing IV lines, are not as efficient as those dedicated to catheter maintenance. [0006] Therefore there is a need for simple, straight forward easy-to-manufacture syringe assemblies which helps reduce or eliminate reflux of blood into the catheter during and after the flushing procedure has occurred even if flush protocols and procedures are not precisely followed. For example, prematurely releasing the compressive force on the stopper, which may cause reflux of blood into the catheter. SUMMARY OF THE INVENTION
[0007] The present invention is directed to a syringe assembly for use in flush applications. The syringe assembly reduces or eliminates reflux of blood into the catheter by providing a proximally facing annular boss on the inside surface of the distal wall of the syringe barrel. The boss projects into the fluid containing chamber of the barrel and surrounds the passageway in the barrel tip through which flush solution is discharged. The annular boss is positioned so that it contacts the distal surface of the stopper and seals the passageway before other portions of the inside surface of the distal wall of the barrel surrounding the boss contact the stopper. Further compression of the stopper will be independent of this seal so that reflux is reduced or eliminated.
[0008] An IN. flush syringe assembly comprises a barrel including a cylindrical sidewall having an inside surface defining a chamber for retaining fluid. The barrel includes an open proximal end and a distal end having a distal wall with an elongate tip extending distally therefrom. The tip includes a passageway therethrough in fluid communication with the chamber. The plunger having an elongate body portion includes a proximal end, a distal end and a stopper slidably positioned in fluid-tight engagement with the inside surface of the barrel for drawing fluid into and driving fluid out of the chamber by movement of the stopper relative to the barrel. The elongate body portion of the plunger extends outwardly from the open proximal end of the barrel. The stopper has a distal surface. Anti-reflux structure is provided for controlling stopper deflection when fluid has been delivered from the chamber and the stopper is in contact with the distal wall of the barrel. Anti-reflux structure may include a stopper preferably having a conically shaped distal surface and a proximally-facing annular boss in the barrel for sealing the passageway in the distal tip of the barrel. [0009] The syringe assembly may further include at least one projection on the distal surface of the stopper positioned mostly in the space between the distal surface of the stopper and the conically shaped inside surface of the distal wall of the barrel when the distal surface of the stopper first contacts the conically shaped inside surface, [oooio] The syringe assembly may also include flush solution in the chamber and a tip cap releasably connected to the tip of the syringe barrel for sealing the passageway. The flush solution may be selected from the group consisting of saline flush solution and heparin lock solution. [oooil] The syringe assembly may further include a needle assembly including a cannula having a proximal end, a distal end, and a lumen therethrough. A hub having an open proximal end containing a cavity and a distal end attached to the proximal end of the cannula so that the lumen is in fluid communication with the cavity of the hub. The needle assembly is removably attached to the tip of the barrel through engagement of the tip to the cavity of the hub so that the lumen is in fluid communication with the chamber of the barrel. [00012] Another embodiment of the IN. flush syringe assembly of the present invention comprises a barrel including a cylindrical sidewall having an inside surface defining a chamber for retaining fluid. The barrel includes an open proximal end and a distal end having a distal wall with an elongate tip extending distally therefrom having a passageway therethrough in fluid communication with the chamber. A plunger includes an elongate body portion having a proximal end, a distal end and a stopper slidably positioned in fluid-tight engagement with the inside surface of the barrel for drawing fluid into and driving fluid out of the chamber by movement of the stopper relative to the barrel. The elongate body of the plunger extends outwardly from the open proximal end of the barrel. The stopper includes a distal surface. A tip cap is releasably connected to the elongate tip of the barrel for sealing the passageway. A quantity of flush solution is in the chamber between the stopper and the distal wall. Anti-reflux structure for controlling stopper deflection when fluid has been delivered from the chamber and the stopper is in contact with the distal wall is provided. The anti-reflux structure may include an annular boss on the inside surface of the distal wall of the barrel surrounding the passageway. The boss is positioned so that it contacts the distal surface of the stopper and seals the passageway before portions of the inside surface of the distal wall surrounding the boss contact the distal surface of the stopper. The inside surface of the distal wall may be conically shaped and the annular boss raised from the conically shaped inside surface. The distal surface of the stopper may be conically shaped and projecting toward the annular boss. At least one projection on the distal surface of the stopper is provided. The at least one projection is positioned and/or sized so that when the stopper contacts the annular boss in the barrel, any deflection of the projection will not store enough energy to move the stopper proximal ly to the extent the stopper is disengaged from the inside surface of the distal end of the barrel near the passageway. [00013] A method of flushing a catheter of the present invention comprises the steps of providing a syringe assembly having a barrel including a cylindrical side wall having an inside surface defining a chamber for retaining fluid, an open proximal end and a distal end including a distal wall with an elongate tip extending distally therefrom having a passageway therethrough in fluid communication with the chamber, a plunger including an elongate body portion having a proximal end, a distal end and a stopper having a distal surface wherein the stopper is slidably positioned in fluid-tig ht engagement with the inside surface of the barrel for drawing fluid into and driving fluid out of the chamber by movement of the stopper relative to the barrel, the elongate body portion extending outwardly from the open proximal end of the barrel, a quantity of flush solution in said chamber, and anti-reflux means in the barrel for minimizing stopper deflection when the flush solution has been delivered from the chamber and the stopper is in contact with and pressed against the distal wall. The method further includes providing a catheter having a proximal end, a distal end and a passageway therethrough and a housing having a hollow interior in fluid communication with the passageway, the housing having an access valve capable of engaging the elongate tip of the barrel for allowing fluid communication with the hollow interior of the housing. The method further includes the steps of placing the distal end of the catheter in a blood vessel; engaging the elongate tip of the barrel with the access valve so that the passageway in the tip is in fluid communication with the hollow interior of the housing; applying force to the plunger to move the plunger in a distal direction with respect to the barrel so that the flush solution in the chamber flows through the passageway into the hollow chamber of the housing and through the passageway of the catheter; continuing to apply force to the plunger until the stopper contacts and presses against the distal wall of the barrel; and disengaging said syringe assembly from said access valve.
[00014] An alternative method may include the step of attaching a needle assembly to the elongate tip of the barrel. The needle assembly includes a cannula having a proximal end, a distal end and a lumen therethrough and a hub having an open proximal end containing a cavity and a distal end attached to the proximal end of the cannula so that the lumen is in fluid communication with the cavity. The attachment of the needle assembly to the barrel is through frictional engagement between the cavity in the hub and the elongate tip. This alternative method is used with a catheter having a proximal end, a distal end and a passageway therethrough and a housing having a hollow interior connected to the catheter and in fluid communication with the passageway of the catheter. The housing further includes a septum for allowing fluid communication with the hollow interior. Fluid communication is established by forcing the distal end of the cannula through the septum so that the lumen of the cannula is in fluid communication with the hollow interior of the housing. Also, the cannula may be permanently attached to the barrel tip with or without the use of a hub. At completion of the flush procedure the cannula is withdrawn from the septum.
BRIEF DESCRIPTION OF THE DRAWINGS [00015] FIG. 1 is a perspective view of a syringe assembly according to one embodiment of the invention.
[0010] FIG. 2 is a partially cross-sectioned side elevational view of the syringe assembly of FIG. 1 with a needle assembly attached. [ooii] FIG. 3 is a cross-sectional view of the syringe assembly of FIG. 1 taken along line 3-3. [0012] FIG. 4 is a partial perspective view of the stopper and distal end of the plunger of the syringe assembly of FIG. 1. [0013] FIG. 5 is an enlarged partial cross-sectional side elevation view of the distal end of the syringe assembly of FIG. 2. [0014] FIG. 6 is an enlarged partial, cross-sectional side elevational view of the distal end of the syringe assembly shown at the completion of a flush procedure. [0015] FIG. 7 is a side-elevational view illustrating the syringe assembly in use with a catheter injection site.
DETAILED DESCRIPTION [ooiβ] Referring to FIGS. 1-6, a syringe 20 according to the present invention generally comprises a barrel 22, and a plunger 24. The barrel 22 has a generally cylindrical side wall 23 including an open proximal end 28 having finger grips 29, a distal end 30 having a distal wall 31 and an inside surface 32 defining a chamber 33 for retaining fluid. The inside surface of the barrel at the distal wall is preferably conically shaped and includes a proximally facing annular boss 35. Distal end 30 further includes a tip 36 having a passageway 38 in fluid communication with the chamber. The distal end of barrel 22 preferably, but not necessarily includes a locking luer type collar 40 concentrically surrounding tip 36. The inside surface of the collar includes at least one thread 43. A cannula 26 includes a proximal end 42, a distal end 44 and a lumen 46 therethrough. The distal end may include a sharp tip or a blunt tip 48 as shown. The cannula may be connected directly to the tip of the syringe barrel to establish fluid communication between the lumen and the chamber. Also, the cannula may be part of a needle assembly 27 including a hub 34 having an open proximal end 37 containing a cavity 41 and a distal end 39 attached to the proximal end of the cannula so that the lumen of the cannula is in fluid communication with the cavity. The cavity of the hub can be removably frictionally engaged to the tip of the barrel as illustrated in Figs. 2, 5 and 6. [0017] Plunger 24 includes an elongate body portion 25, a proximal end 50 having a flange 51, and a distal end 52. A stopper 54 is disposed on projection 53 at distal end 52 of the plunger, preferably via threading engagement. Stopper 54 includes at least one rib and preferably a plurality of ribs 56 on its outside diameter. The stopper is slidably positioned in fluid-tight engagement with the inside surface of the barrel for drawing fluid into and drawing fluid out of the chamber, through the passageway, by movement of the stopper relative to the barrel. Stopper 54 includes a proximal end 55 having a cavity 57 therein for engaging projection 53 on the distal end 52 of the plunger. Stopper 54 further includes a distal end 58 having a distal surface 59 thereon. Distal surface 59 is preferably conically shaped. [0018] Stopper 54 preferably includes at least one projection or lug 60 on distal surface 59. Projection 60 keeps the stoppers from nesting or sticking to each other during the assembly process. For example, the distal surface of one stopper may position itself in the cavity of another stopper while the stoppers are together before assembly. [0019] The stopper may be made of any material suitable for providing sealing characteristics while under compression. For example, the stopper may be made of thermoplastic elastomers, natural rubber, synthetic rubber or thermoplastic materials and combinations thereof. The plunger in this embodiment is preferably made of material which is more rigid than the stopper such as polypropylene, polyethylene and the like.
[0020] In operation, syringe 20 is connected to a needle assembly and filled with flush solution using known methods. The flush solution may be any solution intended for flushing. It is preferred that the flush solution be selected from the group consisting of saline flush solution and heparin lock flush solution. These solutions are known in the art and readily available. An example of a saline flush solution is 0.9% Sodium Chloride USP. An example of a heparin lock flush solution is 0.9% Sodium Chloride with 100 USP units of Heparin Sodium per ml or 10 USP units of Heparin Sodium per ml. The syringe with needle assembly attached is used to pierce the pierceable septum or a blunt cannula may be inserted into a pre-split septum of a vial containing flush solution and the flush solution is drawn into the syringe barrel by pulling plunger rod flange 51 in the proximal direction while holding barrel 22, to draw fluid through the needle cannula into fluid chamber 33. [0021] Alternatively, the syringe may be filled with flush solution during the manufacturing of the syringe via a sterile filling method. Such prefilled syringes may be supplied with a tip cap, such as tip cap 45 releasably connected to tip 36 sealing passageway 38. It is preferred that the tip cap is formed of material selected from the group of thermoplastic materials and elastomeric materials such as natural and synthetic rubber and thermoplastic elastomers.
[0022] The syringe is now ready for use in flushing a catheter of an IN. set. IN. sets can be very complicated and may include multiple injection ports, a valve and/or other components. For the purpose of illustrating the present invention a simplified IN. set 64 is illustrated in Fig. 7. IN. set 64 comprises an IN. site 65 which includes a housing 67 having a hollow interior 68 and a septum 69 at its proximal end. A catheter 70 having a conduit therethrough extends from the distal end of the housing. For this IN. set septum 69 is pre-slit for use with blunt cannula. The IN. site may be a valve having structure for accepting the syringe barrel tip and being activated by the insertion of the barrel tip to establish fluid communication with the catheter, such as the valve taught in U.S. Patent No. 6,171,287. [0023] Blunt tip 48 of cannula 26 may be inserted through pre-split septum 69 of IN. set 64. Alternatively, a sharp tip of a needle cannula may be used to pierce a septum that is not pre-split, or the tip of the barrel may be engaged with a valve in the IN. site. This establishes fluid communication between the interior 68 of the IN. set and the chamber of the syringe barrel. The syringe barrel 22 is preferably held via finger grips 29. Pressure is then applied to flange 51 of the plunger, for example by a thumb, in the distal direction. This moves the plunger 24 having the stopper 54 on its distal end forcing the liquid such as flush solution 71 in the chamber 34 out of the chamber, through cannula 26 and into interior 68 of the IN. set and then through catheter 70. [0024] Referring to FIG. 6, the position of the plunger and stopper at the completion of the flush procedure is shown. At the completion of the flush procedure distal surface 59 of the stopper contacts annular boss 35, inside the area of the stopper projection, sealing the passageway so that further deflection of the stopper will have little or no effect on liquid in the passageway and the catheter. Accordingly, stopper deflection caused by additional unnecessary force applied to the plunger, at this time, which could cause reflux of blood into the catheter using prior art syringes, is minimized or eliminated with the syringe of the present invention. The stopper may flex, however, this flexure will occur generally outside of the sealed area on the annular boss which surrounds the entrance to the passageway. In addition, projection 60 is shaped so that upon further deflection of the stopper through forces applied to the plunger, the projection will not be able to force the stopper to move proximally. That is, the projection cannot create enough force to move the stopper proximally to create reflux. It is preferred that the projection on the distal surface of the stopper be positioned mostly in space 61 between the distal surface of the stopper and the inside surface of the distal wall of the barrel as illustrated in FIG. 6. The projection should be sized and positioned so that it cannot absorb enough energy during deflection to move the stopper proximally and break the seal between the stopper and the barrel at the annular boss. The projection can have a variety of shapes including the raised rectangular shape illustrated. The projection may also be angularly shaped having a distal surface at the same angle as the inside surface of the barrel. [0025] Although the invention 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 may be made to the illustrative embodiments and that other arrangements may be devised without departing from the spirit and scope of the present invention as disclosed.

Claims

WHAT IS CLAIMED IS:
1. An IN. flush syringe assembly comprising: a barrel including a cylindrical sidewall having an inside surface defining a chamber for retaining fluid, an open proximal end and a distal end including a distal wall with an elongate tip extending distally therefrom having a passageway therethrough in fluid communication with said chamber; a plunger including an elongate body portion having a proximal end, a distal end and a stopper slidably positioned in fluid-tight engagement with said inside surface of said barrel for drawing fluid into and driving fluid out of said chamber by movement of said stopper relative to said barrel, said elongate body portion extending outwardly from said open proximal end of said barrel, said stopper having a distal surface; and anti-reflux means in said barrel for controlling stopper deflection when fluid has been delivered from said chamber and said stopper is in contact with said distal wall.
2. The syringe assembly of claim 1 wherein said anti-reflux means includes an annular boss on said inside surface of said distal wall surrounding said passageway, said boss being positioned so that it contacts said distal surface of said stopper and seals said passageway before portions of said inside surface of said distal wall surrounding said boss contact said distal surface of said stopper.
3. The syringe assembly of claim 2 wherein said inside surface of said distal wall is conically shaped and said annular boss is raised from said inside surface.
4. The syringe assembly of claim 2 wherein said anti-reflux means includes said distal surface of said stopper being conically shaped and projecting toward said annular boss.
5. The syringe assembly of claim 2 further including at least one projection on said distal surface of said stopper positioned mostly in a space between said distal surface and said inside surface of said distal wall when said distal surface of said stopper first contacts said annular boss.
6. The syringe assembly of claim 1 including flush solution in said chamber.
7. The syringe assembly of claim 6 further including a tip cap releasably connected to said tip of said syringe barrel for sealing said passageway.
8. The syringe assembly of claim 6 wherein said flush solution is selected from the group consisting of saline flush solution and heparin lock flush solution.
9. The syringe assembly of claim 1 wherein said stopper is made of material selected from the list consisting of thermoplastic elastomers, natural rubber, synthetic rubber, thermoplastic materials and combinations thereof.
10. The syringe assembly of claim 1 further comprising a needle assembly including a cannula having a proximal end, a distal end and a lumen therethrough, and a hub having an open proximal end containing a cavity and a distal end attached to said proximal end of said cannula so that said lumen is in fluid communication with said cavity, said needle assembly being removably attached to said tip of said barrel through engagement of said tip to said cavity so that said lumen is in fluid communication with said chamber.
11. An IN. flush syringe assembly comprising: a barrel including a cylindrical sidewall having an inside surface defining a chamber for retaining fluid, an open proximal end and a distal end including a distal wall with an elongate tip extending distally therefrom having a passageway therethrough in fluid communication with said chamber; a plunger including an elongate body portion having a proximal end, a distal end and a stopper slidably positioned in fluid-tight engagement with said inside surface of said barrel for drawing fluid into and driving fluid out of said chamber by movement of said stopper relative to said barrel, said elongate body portion extending outwardly from said open proximal end of said barrel, said stopper having a distal surface; and a tip cap releasably connected to said tip of said syringe barrel for sealing said passageway; a quantity of flush solution in said chamber between said stopper and said distal wall; anti-reflux means for controlling stopper deflection when fluid has been delivered from said chamber and said stopper is in contact with said distal wall, said anti-reflux means including an annular boss on said inside surface of said of said distal wall surrounding said passageway, said boss being positioned so that it contacts said distal surface of said stopper and seals said passageway before portions of said inside surface of said distal wall surrounding said boss contact said distal surface of said stopper.
12. The syringe assembly of claim 11 further including at least one projection on said distal surface of said stopper positioned mostly in a space between said distal surface and said inside surface of said distal wall when said distal surface of said stopper first contacts said annular boss.
13. A method of flushing a catheter comprising the steps of: (a) providing a syringe assembly having a barrel including a cylindrical sidewall having an inside surface defining a chamber for retaining fluid, an open proximal end and a distal end including a distal wall with an elongate tip extending distally therefrom having a passageway therethrough in fluid communication with said chamber, a plunger including an elongate body portion having a proximal end, a distal end, and a stopper having a distal surface, said stopper being slidably positioned in fluid-tight engagement with said inside surface of said barrel for drawing fluid into and driving fluid out of said chamber by movement of said stopper relative to said barrel, said elongate body portion extending outwardly from said open proximal end of said barrel, a quantity of flush solution in said chamber, and anti-reflux means in said barrel for controlling stopper deflection when said flush solution has been delivered from said chamber and said stopper is in contact with said distal wall; (b) providing a catheter having a proximal end, a distal end and a passageway therethrough and a housing having a hollow interior connected to said catheter and in fluid communication with said passageway, said housing having an access valve for allowing fluid communication with said hollow interior; (c) placing said distal end of said catheter in a blood vessel; (d) engaging said elongate tip of said barrel with said access valve so that said passageway of said syringe barrel is in fluid communication with said hollow interior of said housing; (e) applying force to said plunger to move said plunger in a distal direction with respect to said barrel so that said flush solution in said chamber flows through said passageway into said hollow chamber of said housing and through said passageway of said catheter; (f) continue applying force to the plunger until said stopper contacts and presses against said distal wall of said barrel; and (g) disengaging said elongate tip from said access valve.
14. A method of flushing a catheter comprising the steps of: (a) providing a syringe assembly having a barrel including a cylindrical sidewall including an inside surface defining a chamber for retaining fluid, an open proximal end and a distal end including a distal wall with an elongate tip extending distally therefrom having a passageway therethrough in fluid communication with said chamber, a plunger including an elongate body portion having a proximal end, a distal end, and a stopper having a distal surface, said stopper being slidably positioned in fluid-tight engagement with said inside surface of said barrel for drawing fluid into and driving fluid out of said chamber by movement of the stopper relative to said barrel, said elongate body portion extending outwardly from said open proximal end of said barrel, a quantity of flush solution in said chamber, a needle assembly including a cannula having a proximal end, a distal end and a lumen therethrough and a hub having an open proximal end containing a cavity and a distal end attached to said proximal end of said cannula so that said lumen is in fluid communication with said cavity, said needle assembly being attached to said tip of said barrel so that said lumen ins in fluid communication with said chamber, and anti-reflux means in said barrel for controlling stopper deflection when said flush solution has been delivered from said chamber and said stopper is in contact with said distal wall; (b) providing a catheter having a proximal end, a distal end and a passageway therethrough and a housing having a hollow interior connected to said catheter and in fluid communication with said passageway, said housing having a septum for allowing fluid communication with said hollow interior; (c) placing said distal end of said catheter in a blood vessel; (d) forcing said distal end of said cannula through said septum so that said lumen is in fluid communication with said hollow interior of said housing; (e) applying force to said plunger to move said plunger in a distal direction with respect to said barrel so that said flush solution in said chamber flows through said passageway into said hollow chamber of said housing and through said passageway of said catheter; (f) continue applying force to the plunger until said stopper contacts and presses against said distal wall of said barrel; and (g) withdrawing said cannula from said septum.
PCT/US2004/029280 2003-09-23 2004-09-03 Flush syringe having anti-reflux features WO2005032626A1 (en)

Priority Applications (10)

Application Number Priority Date Filing Date Title
DE602004022184T DE602004022184D1 (en) 2003-09-23 2004-09-03 FLUSHING SYRINGE WITH REFLUX-RESISTANT CHARACTERISTICS
DK04783506T DK1673120T3 (en) 2003-09-23 2004-09-03 Flushing sprayer with measures to counteract backflow
CA2539813A CA2539813C (en) 2003-09-23 2004-09-03 Flush syringe having anti-reflux features
BRPI0414639A BRPI0414639B8 (en) 2003-09-23 2004-09-03 i.v. wash syringe set
KR1020067007646A KR101124390B1 (en) 2003-09-23 2004-09-03 Flush syringe having anti-reflux features
JP2006528033A JP4672665B2 (en) 2003-09-23 2004-09-03 Washing syringe with backflow prevention feature
EP04783506A EP1673120B1 (en) 2003-09-23 2004-09-03 Flush syringe having anti-reflux features
MXPA06003235A MXPA06003235A (en) 2003-09-23 2004-09-03 Flush syringe having anti-reflux features.
AU2004277895A AU2004277895B2 (en) 2003-09-23 2004-09-03 Flush syringe having anti-reflux features
NO20061775A NO337965B1 (en) 2003-09-23 2006-04-21 Flush sprayer with anti-backflow feature

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US10/668,863 US7534233B2 (en) 2003-09-23 2003-09-23 Flush syringe having anti-reflux features
US10/668,863 2003-09-23

Publications (1)

Publication Number Publication Date
WO2005032626A1 true WO2005032626A1 (en) 2005-04-14

Family

ID=34313598

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2004/029280 WO2005032626A1 (en) 2003-09-23 2004-09-03 Flush syringe having anti-reflux features

Country Status (14)

Country Link
US (1) US7534233B2 (en)
EP (1) EP1673120B1 (en)
JP (1) JP4672665B2 (en)
KR (1) KR101124390B1 (en)
CN (1) CN100540076C (en)
AU (1) AU2004277895B2 (en)
BR (1) BRPI0414639B8 (en)
CA (1) CA2539813C (en)
DE (1) DE602004022184D1 (en)
DK (1) DK1673120T3 (en)
ES (1) ES2330114T3 (en)
MX (1) MXPA06003235A (en)
NO (1) NO337965B1 (en)
WO (1) WO2005032626A1 (en)

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2007019164A1 (en) 2005-08-03 2007-02-15 Becton Dickinson And Company Splatter prevention mechanism for a syringe
US7798993B2 (en) 1998-07-29 2010-09-21 Becton, Dickinson And Company Single use syringe
US8202257B2 (en) 1998-07-29 2012-06-19 Becton, Dickinson And Company Splatter prevention mechanism for a syringe
EP3156090A1 (en) * 2005-08-03 2017-04-19 Becton, Dickinson and Company Splatter prevention mechanism for a syringe

Families Citing this family (39)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8936577B2 (en) 2005-05-02 2015-01-20 Shi Zi Technology, Ltd. Methods and devices for autoflush syringes
US8529517B2 (en) * 2005-05-02 2013-09-10 Shi Zi Technology, Ltd. Autoflush syringe
US8075533B2 (en) * 2005-05-02 2011-12-13 Preventiv, Inc. Autoflush syringe
CN101175519A (en) * 2005-05-16 2008-05-07 马林克罗特公司 Multi-stage syringe and methods of using the same
US11229746B2 (en) 2006-06-22 2022-01-25 Excelsior Medical Corporation Antiseptic cap
US9259535B2 (en) 2006-06-22 2016-02-16 Excelsior Medical Corporation Antiseptic cap equipped syringe
US8167847B2 (en) 2006-06-22 2012-05-01 Excelsior Medical Corporation Antiseptic cap and antiseptic cap equipped plunger and syringe barrel assembly
US9700710B2 (en) 2006-06-22 2017-07-11 Excelsior Medical Corporation Antiseptic cap equipped syringe
US8038656B2 (en) * 2006-09-29 2011-10-18 Tyco Healthcare Group Lp Detachable plunger rod syringe
US8226770B2 (en) 2007-05-04 2012-07-24 Applied Materials, Inc. Susceptor with backside area of constant emissivity
CA2689922C (en) * 2007-06-04 2012-05-08 Becton, Dickinson And Company Stopper and plunger rod for a pre-filled syringe
US8740856B2 (en) 2007-06-04 2014-06-03 Becton, Dickinson And Company Stoppers used in pre-filled syringes
US9078992B2 (en) 2008-10-27 2015-07-14 Pursuit Vascular, Inc. Medical device for applying antimicrobial to proximal end of catheter
CN102905751B (en) * 2009-10-29 2015-12-16 罗伯特·E·海尔姆 The conduit dressing of sealed, sterile
US10682507B2 (en) 2009-10-29 2020-06-16 One Iv Solutions, Llc Catheter extension with integrated circumferentially sealing securement dressing
WO2012106088A2 (en) 2011-01-31 2012-08-09 Helm Robert E Jr Snap-seal sterile intravascular catheter-dressing system
US9295788B2 (en) 2011-03-04 2016-03-29 Anestaweb, Inc. Syringe with integrated cannula
WO2012145760A1 (en) * 2011-04-21 2012-10-26 Lcaip, Llc Malleable stopper for a syringe
US10016587B2 (en) 2011-05-20 2018-07-10 Excelsior Medical Corporation Caps for needleless connectors
US9867975B2 (en) 2011-05-23 2018-01-16 Excelsior Medical Corporation Antiseptic line cap
US10166381B2 (en) 2011-05-23 2019-01-01 Excelsior Medical Corporation Antiseptic cap
CA2841832C (en) 2011-07-12 2019-06-04 Pursuit Vascular, Inc. Device for delivery of antimicrobial agent into a trans-dermal catheter
WO2013040154A1 (en) * 2011-09-15 2013-03-21 Helm Robert E Jr Catheter-dressing systems with integrated flushing mechanisms
US9302049B2 (en) * 2012-08-20 2016-04-05 Becton, Dickinson And Company Medical devices for blood reflux prevention and methods of use
WO2015150646A1 (en) * 2014-04-02 2015-10-08 Aptar Stelmi Sas Anti-reflux syringe assembly
JP6546988B2 (en) 2014-05-02 2019-07-17 エクセルシオール・メディカル・コーポレイションExcelsior Medical Corporation Strip package for preservative cap
WO2016182822A1 (en) 2015-05-08 2016-11-17 Icu Medical, Inc. Medical connectors configured to receive emitters of therapeutic agents
AU2017341782B2 (en) 2016-10-14 2023-03-16 Icu Medical, Inc. Sanitizing caps for medical connectors
WO2018204206A2 (en) 2017-05-01 2018-11-08 Icu Medical, Inc. Medical fluid connectors and methods for providing additives in medical fluid lines
KR102051207B1 (en) 2018-01-30 2019-12-03 이준석 Piston for centriguation
US11406327B2 (en) 2018-04-17 2022-08-09 Canon U.S.A., Inc. Imaging catheter assembly
US11517732B2 (en) 2018-11-07 2022-12-06 Icu Medical, Inc. Syringe with antimicrobial properties
US11541221B2 (en) 2018-11-07 2023-01-03 Icu Medical, Inc. Tubing set with antimicrobial properties
US11541220B2 (en) 2018-11-07 2023-01-03 Icu Medical, Inc. Needleless connector with antimicrobial properties
US11400195B2 (en) 2018-11-07 2022-08-02 Icu Medical, Inc. Peritoneal dialysis transfer set with antimicrobial properties
US11534595B2 (en) 2018-11-07 2022-12-27 Icu Medical, Inc. Device for delivering an antimicrobial composition into an infusion device
JP2022513096A (en) 2018-11-21 2022-02-07 アイシーユー・メディカル・インコーポレーテッド Antibacterial device with cap with ring and insert
CA3204371A1 (en) 2020-12-07 2022-06-16 Icu Medical, Inc. Peritoneal dialysis caps, systems and methods
US11612692B1 (en) 2021-10-29 2023-03-28 Thomas C. Kuracina Method and apparatus to reduce the deadspace in syringes and small-bore devices

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5836919A (en) * 1996-05-23 1998-11-17 Solopak Pharmaceuticals, Inc. Cap assembly
US20040010235A1 (en) * 2002-07-11 2004-01-15 Weilbacher Eugene E. Anti-reflux syringe
WO2004033006A2 (en) * 2002-10-11 2004-04-22 Becton Dickinson And Company Flush syringe having compressible plunger
WO2004033018A1 (en) * 2002-10-11 2004-04-22 Becton Dickinson And Company Flush syringe having anti-reflux features

Family Cites Families (19)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3050059A (en) * 1959-05-25 1962-08-21 Baxter Don Inc Hypodermic syringe
US3331538A (en) * 1963-07-17 1967-07-18 Roehr Products Company Inc Syringe
US3331537A (en) * 1965-08-13 1967-07-18 Elmer M Benedict Ring type finger supported defensive spray dispenser
AT367301B (en) * 1975-02-12 1982-06-25 Buender Glas Gmbh INJECTION SYRINGE
US4057052A (en) * 1976-10-26 1977-11-08 Becton, Dickinson And Company Blood-gas syringe
EP0341281B1 (en) * 1987-11-06 1993-03-24 ELLGASS, Louis Paul Non-reusable syringe
US5135489A (en) * 1988-01-25 1992-08-04 Baxter International Inc. Pre-slit injection site and tapered cannula
US5098402A (en) * 1990-05-23 1992-03-24 Davis Lynn E Retractable hypodermic syringe
US5120314A (en) * 1991-03-22 1992-06-09 Greenwood Eugene C Single use hypodermic syringe
DE4339528C2 (en) * 1993-11-19 1995-09-07 Freudenberg Carl Fa Disposable syringe
US5795337A (en) * 1994-02-14 1998-08-18 Becton Dickinson And Company Syringe assembly and syringe stopper
US5865798A (en) * 1996-06-28 1999-02-02 Becton Dickinson France, S.A. Stopper assembly having bypass features for use in a multi-chamber syringe barrel
US5782803A (en) * 1996-11-26 1998-07-21 Jentzen; S. William Low dead space, interchangeable needle syringe
US5807374A (en) * 1997-08-14 1998-09-15 Becton, Dickinson And Company Syringe filling and delivery device
US6361524B1 (en) * 1998-04-14 2002-03-26 Becton, Dickinson And Company Syringe assembly
CN100471535C (en) * 1998-05-29 2009-03-25 劳伦斯A·林恩 Luer receiver and method for fluid transfer
US6752784B2 (en) * 2002-07-30 2004-06-22 Hsi-Chin Tsai Labor efficient safety syringe
US20040127859A1 (en) * 2002-12-26 2004-07-01 Ward Michael Terrance Anti-reflux syringe
TWM249672U (en) * 2003-05-15 2004-11-11 Huei-Hung Chen Airtight safe syringe with double elastic structure

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5836919A (en) * 1996-05-23 1998-11-17 Solopak Pharmaceuticals, Inc. Cap assembly
US20040010235A1 (en) * 2002-07-11 2004-01-15 Weilbacher Eugene E. Anti-reflux syringe
WO2004033006A2 (en) * 2002-10-11 2004-04-22 Becton Dickinson And Company Flush syringe having compressible plunger
WO2004033018A1 (en) * 2002-10-11 2004-04-22 Becton Dickinson And Company Flush syringe having anti-reflux features

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7798993B2 (en) 1998-07-29 2010-09-21 Becton, Dickinson And Company Single use syringe
US8202257B2 (en) 1998-07-29 2012-06-19 Becton, Dickinson And Company Splatter prevention mechanism for a syringe
US9308331B2 (en) 1998-07-29 2016-04-12 Becton, Dickinson And Company Splatter prevention mechanism for a syringe
WO2007019164A1 (en) 2005-08-03 2007-02-15 Becton Dickinson And Company Splatter prevention mechanism for a syringe
EP3156090A1 (en) * 2005-08-03 2017-04-19 Becton, Dickinson and Company Splatter prevention mechanism for a syringe

Also Published As

Publication number Publication date
NO20061775L (en) 2006-06-21
DK1673120T3 (en) 2009-09-21
JP4672665B2 (en) 2011-04-20
US7534233B2 (en) 2009-05-19
KR101124390B1 (en) 2012-03-22
BRPI0414639A (en) 2006-11-21
CA2539813A1 (en) 2005-04-14
DE602004022184D1 (en) 2009-09-03
US20050065479A1 (en) 2005-03-24
BRPI0414639B1 (en) 2016-01-12
AU2004277895A1 (en) 2005-04-14
AU2004277895B2 (en) 2010-04-01
CN100540076C (en) 2009-09-16
EP1673120B1 (en) 2009-07-22
MXPA06003235A (en) 2006-06-08
EP1673120A1 (en) 2006-06-28
KR20060113670A (en) 2006-11-02
CN1874814A (en) 2006-12-06
NO337965B1 (en) 2016-07-18
ES2330114T3 (en) 2009-12-04
BRPI0414639B8 (en) 2021-06-22
CA2539813C (en) 2012-04-03
JP2007506511A (en) 2007-03-22

Similar Documents

Publication Publication Date Title
US7534233B2 (en) Flush syringe having anti-reflux features
AU2011202396B2 (en) Flush syringe having anti-reflux stopper
US11083848B2 (en) Flush syringe having anti-reflux features
EP1549367B1 (en) Flush syringe having compressible plunger
US20050063857A1 (en) Flush syringe having anti-reflux stopper

Legal Events

Date Code Title Description
WWE Wipo information: entry into national phase

Ref document number: 200480031951.X

Country of ref document: CN

AK Designated states

Kind code of ref document: A1

Designated state(s): AE AG AL AM AT AU AZ BA BB BG BR BW BY BZ CA CH CN CO CR CU CZ DE DK DM DZ EC EE EG ES FI GB GD GE GH GM HR HU ID IL IN IS JP KE KG KP KR KZ LC LK LR LS LT LU LV MA MD MG MK MN MW MX MZ NA NI NO NZ OM PG PH PL PT RO RU SC SD SE SG SK SL SY TJ TM TN TR TT TZ UA UG US UZ VC VN YU ZA ZM ZW

AL Designated countries for regional patents

Kind code of ref document: A1

Designated state(s): BW GH GM KE LS MW MZ NA SD SL SZ TZ UG ZM ZW AM AZ BY KG KZ MD RU TJ TM AT BE BG CH CY CZ DE DK EE ES FI FR GB GR HU IE IT LU MC NL PL PT RO SE SI SK TR BF BJ CF CG CI CM GA GN GQ GW ML MR NE SN TD TG

121 Ep: the epo has been informed by wipo that ep was designated in this application
WWE Wipo information: entry into national phase

Ref document number: 2539813

Country of ref document: CA

WWE Wipo information: entry into national phase

Ref document number: 2006528033

Country of ref document: JP

Ref document number: 2004277895

Country of ref document: AU

Ref document number: PA/a/2006/003235

Country of ref document: MX

Ref document number: 1583/DELNP/2006

Country of ref document: IN

WWE Wipo information: entry into national phase

Ref document number: 2004783506

Country of ref document: EP

ENP Entry into the national phase

Ref document number: 2004277895

Country of ref document: AU

Date of ref document: 20040903

Kind code of ref document: A

WWP Wipo information: published in national office

Ref document number: 2004277895

Country of ref document: AU

WWE Wipo information: entry into national phase

Ref document number: 1020067007646

Country of ref document: KR

WWP Wipo information: published in national office

Ref document number: 2004783506

Country of ref document: EP

WWP Wipo information: published in national office

Ref document number: 1020067007646

Country of ref document: KR

ENP Entry into the national phase

Ref document number: PI0414639

Country of ref document: BR