Patent Application
20050063857
The present invention relates to syringe assemblies and particularly to syringe assemblies for use in I.V. flush procedures.
An I.V. catheter is a commonly used therapeutic device. Many patients, in accordance with their therapy, have an I.V. catheter connected to a vein ready for use in various procedures or in fluid communication with an I.V. system for infusing liquids and medication. Many I.V. sets have I.V. 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.
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 I.V. ports are covered by pierceable septums or pre-slit septums and are known in the art and sometimes referred to as “PRN” 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 I.V. 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.
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 I.V. lines varies by various factors including the size and length of the catheter. Typically syringes of 1 ml, 3 ml; 5 ml and 10 ml volume are used.
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 slowly withdrawing the syringe and cannula from the I.V. 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.
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.
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 conically shaped stopper surface having a total included angle less than the angle of the conically shaped distal wall of the barrel so that the stopper seals the barrel first at its center near the passageway which discharges flush solution. Further compression of the stopper will be independent of this seal so that reflux is reduced or eliminated.
An I.V. 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. 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 includes the stopper having a conically shaped distal surface and the barrel having a conically shaped inside surface at its distal wall. The total included angle of the inside surface of the barrel at the distal wall is greater than the total included angle of the distal surface of the stopper by at least six degrees.
In one embodiment the total included angle of the distal surface of the stopper is about 110 degrees and the total included angle of the conically shaped inside surface of the distal wall of the barrel is about 120 degrees.
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.
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 I.V. 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. 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 the stopper having a conically shaped distal surface and the inside surface of the barrel at the distal wall being conically shaped wherein the total included angle of the inside surface of the barrel at the distal wall is greater than the total included angle of the distal surface of the stopper by at least six degrees and preferably at least about ten degrees. 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 inside surface of the barrel any deflection of the projection will not store enough energy to move the stopper proximally 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 them 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 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 extending outwardly from the open proximal end of the barrel, a quantity of flush solution in said chamber, and anti-reflux means 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.
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.
A method of making a flush syringe assembly having anti-reflux features comprises providing a plurality of barrels having 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 the chamber. The inside surface of the barrel at the distal wall is conically-shaped. The method further includes the step of providing a plurality of stoppers capable of being sealably positioned in fluid-tight engagement with the inside surface of said barrels for drawing fluid into and driving fluid out of the chamber by movement of the stopper relative to the barrel. The stoppers each have a conically-shaped distal surface. Another step involves selecting a stopper from the plurality of stoppers and selecting a barrel from the plurality of barrels wherein the total included angle of the inside surface of the selected barrel at the distal wall is greater than the total included angle of the selected stopper distal surface, and inserting the selected stopper in the chamber of the selected barrel so that the distal end of the selected stopper faces the distal wall of the selected-barrel. The method may also include providing a plunger having an elongate body portion including a proximal end and a distal end, and attaching the distal end of the plunger to the-proximal end of the stopper. The method can further include providing a tip cap configured for releasable connection to the tip of the barrel for sealing the passageway and, connecting the tip cap to the tip of the selected barrel. A further step may include placing a quantity of flush solution in the chamber of the selected barrel.
A flush syringe may be made by the method comprising providing a plurality of barrels having a chamber with an inside surface wherein the inside surface of the barrel at the distal wall of the barrel is conically-shaped and providing a plurality of stoppers having a conically-shaped distal surface. The method further includes providing a tip cap configured for releasable connection to the tip of a barrel for sealing the passageway and connecting the tip cap to the tip of a barrel selected from the plurality of barrels. A quantity of flush solution is then placed in the chamber of the selected barrel. A stopper is selected from the plurality of stoppers so that the total included angle of the selected barrel at its distal wall is greater than the total included angle of the selected stopper at its distal surface. The selected stopper is inserted in the chamber in the selected barrel so that the flush solution is contained generally between the distal wall of the selected barrel and the distal end of the selected stopper. The filled syringe may then be sterilized and placed in a protective package or placed in a protective package and then sterilized.
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 conically-shaped distal surface 59 thereon. Conically-shaped distal surface 59 has a total included angle B as illustrated in
Stopper 54 preferably includes at least one projection or lug 60 on conically shaped distal surface 59. Projection 60 keeps the stoppers from nesting or sticking to each other during the assembly process. For example, the conically-shaped distal surface of one stopper may position itself in the cavity of another stopper while the stoppers are together before assembly.
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.
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.
Alternatively, the syringe may be filled with flush solution during the manufacturing of the syringe via a sterile filling method. Such pre-filled 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.
The syringe is now ready for use in flushing a catheter of an I.V. set. I.V. 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 I.V. set 64 is illustrated in
Blunt tip 48 of cannula 26 maybe inserted through pre-split septum 69 of I.V. 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 IV site. This establishes fluid communication between the interior 68 of the I.V. 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 I.V. set and then through catheter 70.
Referring to
A plunger 124 includes an elongate body portion 125 having a distal end 152 and a resilient stopper 154 slidably positioned in fluid-tight engagement with the inside surface of the barrel. The stopper includes at least one rib 156 and a conically-shaped distal surface 159 at distal end 158. The total included angle of the conically-shaped inside surface A of distal wall 131 is greater than conically-shaped distal surface B on the stopper by at least eight degrees. In this embodiment the difference between angle A and angle B is about 20 degrees.
The distal surface of the stopper includes a plurality of projections or lugs 160 which are sized and positioned not to interfere with the sealing action of the conically shaped distal surface of the stopper as it contacts the conically shaped inside surface of the distal wall of the barrel. Further, the projections should be positioned such that and/or structured so that when they are in a partially compressed state they are not alone capable of forcing the stopper proximally in the barrel to disengage the seal between the conically-shaped distal surface of the stopper and the barrel near the passageway.
Referring to
The method may further include, in any workable order, the steps of providing a plunger 24 including an elongate body portion 25 having a proximal end 50 and a distal end 52, and attaching the distal end of the plunger to the proximal end of the selected stopper. The plunger may be attached to the stopper before the stopper is inserted in the selected barrel or after. A tip cap 45 configured for releasable connection to the tip of the barrel for sealing the passageway may be connected to the tip of the selected barrel. A quantity of flush solution may be placed in the chamber of the selected barrel.
A variation of the method of the present invention for making a flush syringe assembly includes the steps of providing a plurality of barrels 22 and providing a plurality of stoppers 54 as described hereinabove and selecting a stopper from the plurality of stoppers and a barrel from the plurality of barrels wherein the total included angle A of the inside surface of the selected barrel at the distal wall is greater than the total included angle B of the selected stopper distal surface. The method further includes providing a tip cap 45 configured for releasable connection to tip 36 of barrel 22 for sealing passageway 38 and connecting the tip cap to the selected barrel. The method further includes placing a quantity of flush solution 71 in the chamber of the selected barrel and inserting the selected stopper in the chamber of the selected barrel so that flush solution 71 is contained generally between distal wall 31 of selected barrel 22 and distal end 58 of the selected stopper. The method may further include a step of sterilizing the flush syringe assembly through a known method such as autoclaving, radiation sterilization and the like. The method may also include placing the syringe assembly in a protective package 73 and sealing the package.
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.
This application is a continuation-in-part of U.S. patent application Ser. No. 10/668,725 filed Sep. 23, 2003.
| Number | Date | Country | |
|---|---|---|---|
| Parent | 10668725 | Sep 2003 | US |
| Child | 10731827 | Dec 2003 | US |
