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BR-112021015406-B1 - WASHING SYRINGE SET

BR112021015406B1BR 112021015406 B1BR112021015406 B1BR 112021015406B1BR-112021015406-B1

Abstract

SYRINGE WITH DISINFECTION FEATURE. Syringe sets comprising an absorbent pad containing disinfectant and a rotating cap to ensure adherence to aseptic techniques for use in flushing procedures for vascular access devices (VADs) are described. Methods for disinfecting vascular access devices are also described.

Inventors

  • Evan Leibowitz

Assignees

  • BECTON, DICKINSON AND COMPANY

Dates

Publication Date
20260310
Application Date
20200219
Priority Date
20190221

Claims (17)

  1. 1. Wash syringe assembly comprising: a cylinder (202) including a side wall (204) having an outer surface (206), an inner surface (208) defining a chamber (210) for retaining fluid, an open proximal end (212) and a distal end (214) including a distal wall (216) with a distal tip (218) extending distally therefrom, having a first passage (220) through thereto in fluid communication with said chamber (210); a removable seal (250) disposed on the peripheral distal surface (240); a cap (252) and an absorbent pad (254) containing disinfectant disposed between the removable seal (250) and the distal tip (218), the cap being rotatable from a first position in which the distal tip is covered by the cap (252) and a second position in which the distal tip (218) of the cylinder (202) is exposed through the open distal end (238) of an outer sleeve (232) slidingly engaged with the outer surface (206) of the cylinder (202), the cap (252) being rotatable between the distal tip (218) and the open distal end (238) of the outer sleeve (232), characterized in that the washing syringe further comprises a fixed seal (250b) located between the cap (252) and the removable seal (250a), wherein the rotation of the cap (252) causes the cap to pierce the fixed seal (250b) and move through the absorbent pad (254) to the second position.
  2. 2. Washing syringe assembly, according to claim 1, characterized in that the outer sleeve (232) comprising an inner surface (234), an outer surface (236) and an open distal end (238) comprising a peripheral distal surface (240), having the removable seal (250a) disposed therein, wherein the relative sliding motion of the outer sleeve (232) and the cylinder (202) to bring the distal tip (218) of the cylinder and the open distal end (238) of the outer sleeve causes the distal tip (218) to rotate the cap (252) from the first position to the second position.
  3. 3. Washing syringe assembly, according to claim 2, characterized in that the cylinder (202) further comprises a connecting collar (270) around the distal tip (218) and an alignment collar (272) coaxial with the connecting collar (270), the alignment collar (272) comprising a peripheral tab (274) that engages with the outer sleeve (232).
  4. 4. Washing syringe assembly, according to claim 3, characterized in that the outer sleeve (232) comprises a slit (235) that cooperates with the peripheral tab (174) to align the cap (152) with the open distal end (138) of the outer sleeve (232) and to guide the relative sliding movement between the cylinder (202) and the outer sleeve (232).
  5. 5. Washing syringe assembly, according to claim 4, characterized in that the slit (235) in the outer sleeve (232) comprises a retainer (237) to prevent unintentional relative movement of the syringe barrel (202) and the outer sleeve (232).
  6. 6. Washing syringe assembly, according to claim 3, characterized in that the absorbent pad (254) has a thickness and a cut pattern through the thickness.
  7. 7. Washing syringe assembly, according to claim 1, characterized in that the absorbent pad (254) is contained within the cap (252).
  8. 8. Washing syringe assembly, according to claim 7, characterized in that removal of the removable seal (250a) exposes the absorbent pad (254).
  9. 9. Wash syringe assembly, according to claim 8, characterized in that when the cap (252) is in the first position, the absorbent pad (254) is exposed through the open distal end (238) of the outer sleeve (232) and when the cap (252) is in the second position, the cap (252) is rotated through the open distal end (238) of the outer sleeve (232) to expose the distal tip (218) of the cylinder (202).
  10. 10. Washing syringe assembly, according to claim 4, characterized in that the absorbent pad (254) is contained within the cap (252).
  11. 11. Washing syringe assembly, according to claim 10, characterized in that removal of the removable seal (250a) exposes the absorbent pad (254).
  12. 12. Wash syringe assembly, according to claim 11, characterized in that when the cap (252) is in the first position, the absorbent pad (254) is exposed through the open distal end (238) of the outer sleeve (232) and when the cap (252) is in the second position, the cap (252) is rotated through the open distal end (238) of the outer sleeve (232) to expose the distal tip (218) of the cylinder (202).
  13. 13. Washing syringe assembly, according to claim 1, characterized in that the removable seal (250a) comprises a detachable aluminum or multilayer polymer film rear top.
  14. 14. Wash syringe assembly, according to claim 3, characterized in that the connecting collar (270) comprises a luer connector.
  15. 15. Wash syringe assembly, according to claim 1, characterized in that the outer sleeve (232) comprises a flange (239) at a proximal end and the cylinder comprises a cylinder flange (219) at the proximal end.
  16. 16. Wash syringe assembly comprising: a cylinder (102) including a side wall (104) having an outer surface (106), an inner surface (108) defining a chamber (110) for retaining fluid, an open proximal end (112) and a distal end (114) including a distal wall (116) with a distal tip (118) extending distally from thereto, having a first passage (120) through thereto in fluid communication with said chamber (110); an outer sleeve (132) slidingly engaged with the cylinder (102), the outer sleeve (132) including an open distal end (138), a peripheral distal surface (140), an inner surface (134), an outer surface (136) and an outer sleeve flange (139); a removable seal (150) disposed on the peripheral distal surface (140) of an outer sleeve (132); a cap (152) covering the distal tip (118), the cap (152) comprising a proximal side covering the distal tip (118) and a distal side (153) including an absorbent pad (115) mounted thereon, characterized in that the application of a force directed proximally to the flange of the outer sleeve (139) while applying a force directed distally to the flange of the cylinder (119) causes a relative sliding movement of the outer sleeve (132) and the cylinder (102) to bring the distal tip (118) closer to the cylinder (102) and the open distal end (138) to the outer sleeve (132), causing the distal tip (118) to articulately rotate the cap (152) from a first position (152a) in which the cap covers the distal tip to a second position (152b) in which the cap is moved away from the distal tip (118) and to a final position (152d) where the The cap (152) is in the uncovered position and the distal tip (118) is exposed, allowing the distal tip (118) to be connected to a vascular access device and the cap (152) to remain connected to the outer sleeve after moving to the second position.
  17. 17. Washing syringe assembly, according to claim 16, characterized in that removal of the removable seal exposes the absorbent pad.

Description

TECHNICAL FIELD [001] This disclosure relates to syringe sets and, in particular, to syringe sets comprising a disinfection cap for use in flushing procedures for vascular access devices (VADs). FUNDAMENTALS OF THE INVENTION [002] VADs are commonly used therapeutic devices and include intravenous (IV) catheters. There are two general classifications of VADs: peripheral catheters and central venous catheters. To ensure that VADs are used and maintained correctly, standards of practice have been developed, which include a cleaning procedure, commonly referred to as flushing a catheter. [003] VAD practice standards generally recommend that flushing procedures be performed after catheter placement, before fluid infusion, and before and after drug administration, blood sampling, transfusions, and parenteral nutrition. The purpose of these flushing procedures is to confirm catheter patency, avoid drug mismatches, ensure complete drug dose administration, prevent thrombus formation, and minimize the risk of bloodstream infections. Flushing procedures require different types and amounts of flushing solutions. The most commonly used flushing solutions are saline solution and/or heparin solution. The type of flushing solution and the amount vary depending on the specific type of catheter. Flushing solution volumes between 5 and 10 ml are the most common, but can range from 1 ml to 20 ml. [004] For lavage procedures, an IV line refers to a system that may include a VAD, a set of clamped tubing, and a VAD connector as termination. Common types of VAD connectors are covered by pierceable septa or pre-cut septa made of rubber or other elastomeric material, which allows the insertion of a sharp needle cannula to infuse fluids or withdraw fluids from the catheter. After the needle cannula is withdrawn, the septum closes. Ports with pre-cut septa are used with a blunt plastic cannula or the frustoconical tip of a syringe barrel. The syringe tip or blunt plastic cannula (which is usually connected to a syringe) is gently pushed through the pre-cut septum to establish fluid communication. [005] IV valves, which are another type of VAD connector that do not require a needle with a sharp tip, are activated by the frustoconical tip of a syringe barrel to allow fluid communication between the inside of the syringe and the catheter. These valves may contain features to distribute fluid from a storage compartment in the valve to the catheter and are referred to in the art as positive displacement valves. An example of such a valve is disclosed in U.S. Pat. No. 6,206,861. [006] Bacteria and other microorganisms can gain entry into a patient's vascular system from access cannulas and ports/valves upon connection to the venous catheter (VC) to deliver fluid or pharmaceuticals. Each access cannula (or port/valve or connection) is associated with some risk of transmitting a catheter-related bloodstream infection (CRBSI), which can be costly and potentially lethal. Contamination can occur during medication mixing, cannula placement, and insertion into the access cannula. Currently, the risk to hospitals and patients is a substantial function of the diligence of the clinician performing the connection, and this diligence is largely uncontrollable. [007] A currently available product aimed at combating the problems associated with contaminated VAD connectors is the SwabCap®. This device disinfects a VAD connector by covering the connector and protecting it from touch and airborne contamination after the cap is applied. As the SwabCap® is twisted onto a VAD connector, a foam pad inside the cap is compressed, releasing isopropyl alcohol that passively disinfects the top and threads of the VAD connector while the cap is in place. Because the SwabCap® is a separate component, there is room for error, so the cap cannot be used after each step of the flushing process. Thus, the cap does not guarantee compliance with aseptic technique. [008] There is therefore a need for a washing syringe set that promotes compliance with aseptic technique by eliminating the additional steps of swabbing and disinfection. SUMMARY [009] Aspects of the present disclosure are directed to a syringe assembly for use in syringe flushing applications and methods of disinfecting syringes. Syringe assemblies, for example, a flushing syringe assembly according to a first aspect of the present disclosure comprises a cylinder including a side wall having an outer surface, an inner surface defining a chamber for retaining fluid, an open proximal end and a distal end including a distal wall with a distal tip extending distally therefrom having a first passage through therefrom in fluid communication with said chamber; a removable seal disposed on the peripheral distal surface; and a cap and an absorbent pad containing disinfectant disposed between the removable seal and the distal tip, the cap rotating from a first position in which the distal tip is covered by the cap and a se