Flush syringe having anti-reflux features

Abstract

An I.V. flush syringe assembly includes a barrel having an inside surface defining a chamber for retaining fluid, an open proximal end and a distal end with a passageway therethrough in fluid communication with the chamber. An elongate plunger having a proximal end, a distal end and a flexible stopper is slidably positioned in fluid-tight engagement with the inside surface of the barrel for drawing fluid into and out of the chamber by movement of the stopper relative to the barrel. The barrel includes anti-reflux structure for holding said stopper in a partially deflected position after fluid has been delivered from the chamber and the stopper is being force against the distal end of the chamber.

Claims

1. A method of preventing or minimizing reflux after flushing a catheter comprising the steps of: (a) providing an I.V. flush syringe assembly which comprises i) 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 said chamber, said inside surface having a contact area at the distal end of said barrel, said contact area being a roughened portion of said inside surface wherein the roughened portion comprises a plurality of annular deformations, and wherein said contact area has a higher coefficient of friction than said inside surface outside of said contact area for frictionally engaging a flexible stopper when said stopper is in contact with and compressed against said distal wall of said barrel to frictionally hold said stopper in a partially deflected position and prevent reflux of the fluid back into the chamber after fluid has been delivered from said chamber, (ii) a plunger including an elongate body portion having a proximal end, a distal end, and the flexible 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, and (iii) a quantity of flush solution in said chamber; (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 of said catheter; (c) placing said distal end of said catheter in a blood vessel; (d) establishing fluid communication between said passageway of said barrel and with-said hollow interior of said housing; (e) applying force to said plunger to move said stopper in a distal direction with respect to said barrel so that said flush solution in said chamber flows through said passageway of said barrel into said hollow interior of said housing and through said passageway of said catheter; (f) continuing to apply force to the plunger until said stopper contacts, and is compressed against, said distal wall of said barrel within said contact area, such that said stopper is restrained from moving in a proximal direction and is frictionally held in a compressed state by said plurality of annular deformations after the stopper contacts said distal wall.

2. The method of claim 1, wherein said annular deformations are annular projections on said inside surface of said barrel.

3. The method of claim 1, wherein said syringe assembly further comprises a tip cap releasably connected to said tip of said barrel for sealing said passageway of said barrel.

4. The method of claim 1, wherein said flush solution is selected from the group consisting of saline flush solution and heparin lock flush solution.

5. The method of claim 1, wherein said stopper is made from material selected from the group consisting of thermoplastic elastomers, natural rubber, synthetic rubber and combinations thereof.

6. The method of claim 1, wherein said stopper is removed from said contact area after said stopper has contacted said distal wall of said barrel.

7. A method of preventing or minimizing reflux after flushing a catheter comprising the steps of: (a) providing an I.V. flush syringe assembly which comprises i) 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 said chamber, said inside surface having a contact area at the distal end of said barrel, said contact area being a roughened portion of said inside surface wherein the roughened portion comprises a plurality of annular deformations, and wherein said contact area has a higher coefficient of friction than said inside surface outside of said contact area for frictionally engaging a flexible stopper when said stopper is in contact with, and compressed against, said distal wall of said barrel to frictionally hold said stopper in a partially deflected position and prevent reflux of the fluid back into the chamber after fluid has been delivered from said chamber, (ii) a plunger including an elongate body portion having a proximal end, a distal end, the flexible 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, (iii) a quantity of flush solution in said chamber; (iv) 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 is in fluid communication with said chamber, (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 of said catheter, 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 of said barrel into said hollow interior of said housing and through said passageway of said catheter; (f) continuing to apply force to the plunger until said stopper contacts, and is compressed against, said distal wall of said barrel within said contact area, such that said stopper is restrained from moving in a proximal direction and is held in a compressed state by said plurality of annular deformations after said stopper contacts said distal wall.

8. The method of claim 7, wherein said annular deformations are annular projections on said inside surface of said barrel.

9. The method of claim 7, wherein said syringe assembly further comprises a tip cap releasably connected to said tip of said barrel for sealing said passageway of said barrel.

10. The method of claim 7, wherein said flush solution is selected from the group consisting of saline flush solution and heparin lock flush solution.

11. The method of claim 7, wherein said stopper is made from material selected from the group consisting of thermoplastic elastomers, natural rubber, synthetic rubber and combinations thereof.

12. The method of claim 7, wherein said stopper is removed from said contact area after said stopper has contacted said distal wall of said barrel.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

(1) FIG. 1 is a perspective view of a syringe assembly according to one embodiment of the invention.

(2) FIG. 2 is a partially cross-sectioned side-elevational view of the syringe of FIG. 1 with a needle assembly attached.

(3) FIG. 3 is an enlarged partial cross-sectional side elevation view of the distal end of the syringe assembly of FIG. 2.

(4) FIG. 4 is an enlarged partial cross-sectional side-elevational view of the distal end of the syringe assembly of FIG. 2 with the stopper positioned in its distal-most position after flush solution has been delivered.

(5) FIG. 5 is a side-elevational view illustrating the syringe assembly in use with a catheter injection site.

(6) FIG. 6 is a perspective view of a syringe assembly according to another embodiment of the invention.

(7) FIG. 7 is a partially cross-sectioned side-elevational view of the syringe assembly of FIG. 6.

(8) FIG. 8 is an enlarged cross-sectional side elevation view of the distal end of the syringe assembly of FIG. 7.

(9) FIG. 9 is an enlarged cross-sectional side elevational view of the distal end of the syringe assembly of FIG. 7 with the stopper positioned in its distalmost position after flush solution has been delivered.

DETAILED DESCRIPTION

(10) FIGS. 1-4 show a syringe 20 according to the present invention generally comprising a barrel 22, a plunger 24. Barrel 22 has a generally elongate body including an open proximal end 28 having finger grips 29, a distal end 30 and an inside surface 32 defining a fluid chamber 34. Inside surface 32 includes a generally annular recess 35 towards distal end 30. Distal end 30 further includes a tip 36 having a passageway 38 in fluid communication with the chamber 34. The distal end of barrel 22 preferably, but does not necessarily include a locking luer type collar 40 concentrically surrounding tip 36. The inside surface of the collar includes at least one thread 41. 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 37 having an open proximal end 39 containing a cavity 43 and a distal end 45 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. 2-4.

(11) Plunger 24 includes a proximal end 50 having a flange 51 and a distal end 52. A flexible stopper 54 is disposed on the distal end of plunger 24. Stopper 54 includes at least one annular rib and in this embodiment includes a proximal rib 56, a middle rib 58 and a distal rib 60. The stopper comprises any flexible resilient material suitable for providing sealing characteristics while under compression. For example, the stopper may be made of thermoplastic elastomers, natural rubber, synthetic rubber and the like.

(12) In operation, the syringe 20 is connected to a hypodermic 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 the fluid chamber 34.

(13) 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 23 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.

(14) 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 FIG. 5. I.V. set 64 comprises an I.V. 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 I.V. set, septum 69 is pre-slit for use with blunt cannula. The I.V. site may have a pierceable septum or a valve having structure for accepting the syringe barrel tip and being activated by the insertion of the tip to establish fluid communication with the catheter, such as the valve taught in U.S. Pat. No. 6,171,287.

(15) Blunt tip 48 of cannula 26 may be 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 it 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 35 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.

(16) Referring to FIG. 4, the position of the plunger and stopper at the completion of the flush procedure is shown. As shown, the flange 51 does not contact the proximal end of the barrel at the completion of the flush procedure. Stopper 54 is now compressed. Distal rib 60 of the stopper is received within recess 35 of the barrel. Distal rib 60 fits within the recess 35 preferably via a friction fit or an interference fit. Thus, the stopper 54 is held in position at the distal end of the barrel 22. This, in turn, holds the plunger 24 within the barrel. Therefore, reflux of liquid, including blood, into the catheter is prevented or minimized since the stopper is held in a compressed form and will not withdraw into the proximal direction.

(17) It is within the purview of the present invention to include additional recesses at the distal end of the barrel to receive the middle rib and the proximal rib. In such an embodiment, the recesses would be spaced apart in order to receive the ribs when the stopper is in a compressed form, typical at the end of the flush procedure.

(18) FIGS. 6-9 shown another embodiment of the invention where like elements are similarly numbered. In this embodiment of the invention, syringe assembly 120 includes plunger 24 and barrel 122. A needle assembly 127 includes cannula 126 having a sharp distal end and hub 137 attached to distal end 130 of the barrel. Inside surface 132 of syringe barrel 122 includes a contact area 162. The contact area may be, for example, one or more discontinuities, and/or a roughened portion of the inside surface. In operation, after the flush procedure has occurred, the stopper 54 is compressed at the distal end of the barrel within contact area 162 of the barrel. The contact area restrains the stopper from moving in the proximal direction. Therefore, stopper 54 is frictionally restrained by the contact area 162, holding stopper 54 and plunger 24 within the barrel. The force required to overcome the friction between the stopper 54 and contact area 162 is more than the force required to overcome the friction between the stopper and the inside surface the barrel outside of the contact area. The force between the stopper and the contact area is sufficient to hold the stopper in a partially compressed state after the stopper contacts the distal end of the chamber. Thus, the stopper 54 is restrained from expanding out of its compressed form thereby preventing or minimizing reflux.

(19) 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.