Methods and apparatus for disinfecting and reflux prevention flush syringe assembly

Patent metadata

Field	Value
Publication number	US-9943676-B2
Application number	US-201514973872-A
Country	US
Kind code	B2
Filing date	Dec 18, 2015
Priority date	Nov 29, 2012
Publication date	Apr 17, 2018
Grant date	Apr 17, 2018

Abstract

Embodiments of the invention are directed to flush syringe assemblies comprising an integrated contamination-prevention device integrated with device connector flushing positioned so that the practitioner cannot forget to apply disinfectant. The flush syringe assemblies comprise a barrel with an elongate plunger rod disposed therein and a cap comprising a passageway. The plunger rod includes a stopper of which at least a portion can be embedded in the passageway of the cap to form a plug in the cap.

First claim

What is claimed is:

1. A method of flushing a vascular access device (VAD) comprising the steps of:
(a) providing a flush syringe assembly comprising
a barrel,
a sleeve external to the barrel having a distal end and a proximal end, and an inside surface and an outside surface, wherein the sleeve retracts from distal to proximal positions in relationship to a distal movement of the barrel,
a disinfecting system comprising a disinfectant contained in a hub, the hub connected to the distal end of the sleeve, the disinfecting system comprising a protective cover on a distal end of the flush syringe assembly, and
a cap, the cap comprising a proximal end for releasably attaching the cap to a distal end of the barrel and a distal end for releasably attaching the cap to the VAD;

(b) using one hand to remove the protective cover from the distal end of the flush syringe assembly thereby exposing the disinfectant contained in the hub;
(c) using one hand to apply the disinfectant to a connector on the VAD;
(d) using the same hand as in (c) to eject the disinfecting system upon proximal motion of the sleeve;
(e) coupling the distal end of the cap of the flush syringe assembly to the VAD;
(f) using one hand to hold the flush syringe assembly and depress a plunger rod disposed within the barrel to flush the VAD with a flush solution that is contained in a chamber of the barrel;
(g) using the same hand to continue to depress the plunger rod after the barrel is empty to embed a stopper tip of the plunger rod into the VAD and retract the sleeve to expose the cap; and
(h) separating the cap including the embedded stopper tip from the barrel of the flush syringe assembly.

2. The method of claim 1 further comprising:
(i) removing the cap including the embedded stopper tip; and
(j) repeating steps (a) through (h).

3. The method of claim 1 , wherein the barrel of the flush syringe assembly comprises a side wall having an inside surface defining a chamber for retaining fluid, an outside surface, an open proximal end, a distal end including a distal wall having a passageway therethrough in fluid communication with the chamber.

4. The method of claim 1 , wherein the plunger rod is disposed within the barrel, the plunger rod comprising a distal end including a stopper slidably positioned in fluid-tight contact with an inside surface of the barrel for driving fluid out of the chamber by movement of the stopper relative to the barrel, wherein the stopper comprises a stopper body and a detachable stopper tip.

5. The method of claim 4 , wherein the stopper tip has threads which engage with complementary threads on the stopper body.

6. The method of claim 4 , wherein the stopper tip is secured to the stopper body using an interference fit.

7. The method of claim 4 , wherein the stopper body is made of material selected from the list consisting of thermoplastic elastomers, natural rubber, synthetic rubber, thermoplastic materials and combinations thereof.

8. The method of claim 4 , wherein the stopper tip is made of material selected from the list consisting of thermoplastic elastomers, natural rubber, synthetic rubber, thermoplastic materials and combinations thereof.

9. The method of claim 1 , wherein the cap comprises an outer wall surrounding a threaded connection, wherein the cap comprising a passageway for fluid communication therethrough, wherein the passageway is undercut to receive and retain the stopper tip when the plunger rod is fully depressed, the cap further comprises a distal end for releasably attaching the cap to a vascular access device (VAD) and a proximal end for releasably attaching the cap to the barrel.

10. The method of claim 9 , wherein the undercut of the passageway of the cap creates a tight interference fit sufficient for retaining the stopper tip within the cap upon movement of the plunger rod away from the cap after emptying the fluid from the syringe.

11. The method of claim 9 , wherein coupling the flush syringe assembly to the VAD comprises engaging complementary threads on the cap with the VAD.

12. The method of claim 9 , wherein coupling the flush syringe assembly to the VAD comprises engaging the cap to the VAD with an interference fit.

13. The method of claim 1 , wherein the sleeve further comprises one or more cutouts to provide visibility to the flush solution of the barrel.

14. The method of claim 1 , wherein an outside surface of the barrel further comprises two annular positioning ridges, a distal annular positioning ridge and a proximal annular positioning ridge.

15. The method of claim 14 , wherein the inside surface of the sleeve further comprises at least one annular positioning groove for controlling the position of the sleeve relative to the barrel by engaging with the annular positioning ridges on the outside surface of the barrel.

16. The method of claim 15 , wherein the outside surface of the barrel comprises one or more ridges that extend along a length of the barrel and engage with a corresponding groove on the inside surface of the sleeve.

17. The method of claim 1 , wherein the disinfectant is made of material selected from the list consisting of alcohol, an antiseptic gel and combinations thereof.

18. The method of claim 9 , wherein the passageway of the cap is coated with an antimicrobial agent.

19. The method of claim 1 , further comprising leaving the cap with the embedded stopper tip connected to the VAD connector.

Assignees

• Becton Dickinson Co

Inventors

• Tekeste Girum Yemane

Classifications

• A61M2202/0468

  non-physiological · CPC title

• A61M39/0247 Primary

  Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body (peritoneal dialysis catheters A61M1/285; tracheostomy devices A61M16/0465; measuring pressure within the body A61B5/03; colostomy devices A61F5/445; gastrotomy feeding tubes A61J15/0015; means for fixing a feeding tube outside of the body A61J15/0053) · CPC title

• A61M5/31515

  Connection of piston with piston rod · CPC title

• A61M2039/0285

  with sterilisation means, e.g. antibacterial coatings, disinfecting pads, UV radiation LEDs or heating means in the port · CPC title

• A61M5/345

  Adaptors positioned between needle hub and syringe nozzle · CPC title