Methods and apparatus for disinfecting and reflux prevention flush syringe assembly

Patent metadata

Field	Value
Publication number	US-10022530-B2
Application number	US-201514973863-A
Country	US
Kind code	B2
Filing date	Dec 18, 2015
Priority date	Nov 29, 2012
Publication date	Jul 17, 2018
Grant date	Jul 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 flush syringe assembly comprising:
a barrel including 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 with a tip extending distally therefrom having a passageway therethrough in fluid communication with the chamber, the barrel further comprising an outside surface having one or more annular positioning discontinuity;
a cap comprising a distal end and a proximal end defining a length, an irregularly shaped outer wall, a profiled center passageway providing fluid communication from the chamber to a patient's vascular access device (VAD), further comprising a distal end annular channel that releasably attaches the cap to the VAD, and a proximal end annular channel that releasably attaches the cap to the barrel;
a releasable disinfecting system comprising a disinfectant;
an elongate plunger rod disposed within the barrel, the plunger rod comprising a distal portion and a proximal portion, the plunger rod further comprising a distal end including a stopper slidably positioned in fluid-tight contact with the inside surface of the barrel for expelling fluid from the chamber by movement of the stopper relative to the barrel, the stopper having a distal face and a proximal end, the distal face of the stopper further comprising a profiled stopper tip that is detachable from the stopper and seatable in the cap when the plunger rod is fully depressed; and
a sleeve external to the barrel having an inside surface and an outside surface, an open proximal end containing at least one flange, and an open distal end defining a recess with an irregular inner surface to contain and prevent rotation of the cap relative to the sleeve, the distal end further connected to the releasable disinfecting system, the sleeve further comprising one or more annular positioning discontinuity complementary to the one or more annular positioning discontinuity on the barrel which together control distal motion of the barrel relative to the sleeve.

2. The flush syringe assembly of claim 1 , wherein the distal end annular channel of the cap further comprises a straight inner wall and an outer wall that is threaded to complement the VAD, and the distal end annular channel extends less than the length of the cap.

3. The flush syringe assembly of claim 1 , wherein the proximal end annular channel of the cap further comprises a straight outer wall and an inner wall that is releasably attached to the barrel, and the proximal end annular channel extends less than the length of the cap.

4. The flush syringe assembly of claim 1 , wherein the proximal end annular channel of the cap is attached to the barrel by one or more of an interference fit and a threaded connector.

5. The flush syringe assembly of claim 1 , wherein the profiled center passageway of the cap extends the entire length of the cap to establish fluid connection between the barrel and the VAD, and the profile of the center passageway is undercut near the proximal end to complement the profile of an external surface of stopper tip.

6. The flush syringe assembly of claim 5 , wherein the profiled center passageway of the cap is coated with an antimicrobial agent.

7. The flush syringe assembly of claim 1 , wherein the stopper or any portion of the stopper is detachable and capable of being embedded into the VAD.

8. The flush syringe assembly of claim 1 , wherein the stopper has a cavity to hold a stopper tip by one or more of a threaded connection and an interference fit.

9. The flush syringe assembly of claim 1 , wherein the profile of the distal end of the stopper tip is configured to complement the profile of the center passageway of the cap and create an interference fit therewith sufficient to retain the stopper tip within the VAD after the flush syringe assembly is removed.

10. The flush syringe assembly of claim 1 , wherein stopper tip is threadably attached to stopper using threads on the stopper tip that complement those on the VAD allowing both to be removed in one motion by the practitioner.

11. The flush syringe assembly of claim 1 , wherein the annular positioning discontinuities on the barrel comprise two annular positioning ridges: a distal annular positioning ridge and a proximal annular positioning ridge and the discontinuity on the sleeve comprises a groove configured to interact with the annular positioning ridges on the barrel.

12. The flush syringe assembly of claim 1 , wherein the outside surface of the barrel further comprises one or more linear discontinuity spaced around the barrel that run along a length of the barrel and engage with a corresponding discontinuity on the inside surface of the sleeve.

13. The flush syringe assembly of claim 1 , further comprising a quantity of flush solution in the chamber between the stopper and distal wall of the barrel.

14. The flush syringe assembly of claim 1 , wherein the stopper body and stopper tip are independently made of a material selected from the group consisting of thermoplastic elastomers, natural rubber, synthetic rubber, thermoplastic materials and combinations thereof.

15. The flush syringe assembly of claim 1 , wherein the sleeve further comprises one or more cutouts to provide visibility to contents of the barrel.

16. The flush syringe assembly of claim 1 , wherein the plunger is of sufficient length relative to the sleeve and the barrel that when plunger is fully depressed after all flushing solution has been expelled from the syringe, the sleeve retracts to expose the cap.

17. The flush syringe assembly of claim 1 , wherein the distal end of the sleeve is threaded to engage complementary threads on the disinfecting system.

18. The flush syringe assembly of claim 1 , wherein the distal end of the sleeve is attached to the disinfecting system using an interference fit.

19. The flush syringe assembly of claim 1 , wherein the disinfecting system further comprises a removable cover to protect the disinfecting system prior to use and a disinfectant carrier.

20. The flush syringe assembly of claim 1 , wherein the disinfectant is made of material selected from the group consisting of: an alcohol, an antiseptic gel, and combinations thereof.

21. The flush syringe assembly of claim 1 , wherein the barrel does not include a flange for providing opposing force to the direction of movement of an elongate plunger rod.

22. The flush syringe assembly of claim 1 , wherein the sleeve slidably engages the barrel from a distal position to a proximal position, and the flange is effective to provide a region that can be gripped by the user to aide in the movement of the sleeve relative to the barrel.

Assignees

• Becton Dickinson Co

Inventors

• Tekeste Girum Yemane

Classifications

• A61M39/16

  having provision for disinfection or sterilisation {(A61M39/143 takes precedence)} · CPC title

• A61M2039/0258

  for vascular access, e.g. blood stream access · CPC title

• A61M2039/1077

  Adapters, e.g. couplings adapting a connector to one or several other connectors · CPC title

• A61M2005/3104

  Caps for syringes without needle · CPC title

• A61M5/345

  Adaptors positioned between needle hub and syringe nozzle · CPC title