System for Line Draw Flushing and Blood Collection and Method of Use Thereof

Patent metadata

Field	Value
Publication number	US-2024358300-A1
Application number	US-202418644799-A
Country	US
Kind code	A1
Filing date	Apr 24, 2024
Priority date	Apr 25, 2023
Publication date	Oct 31, 2024
Grant date	—

Abstract

Provided herein is a system including a pre-filled syringe with a barrel defining a chamber containing a solution therein and a fluid connector component at the distal end of the barrel. A plunger assembly including a plunger and a stopper is movable within the barrel, with the plunger including a channel extending along a length thereof. An access device is positioned at the proximal end of the plunger and includes a receiving cavity and a fluid access component, the receiving cavity having an opening aligned with the channel and the fluid access component positioned over the opening and extending into the receiving cavity. A cannula is positioned within the barrel and extends through the stopper, the cannula placing the fluid connector component in fluid communication with the channel. A closure assembly is secured to the fluid connector component and includes a seal member configured to seal off a lumen thereof.

First claim

The invention claimed is:

1 . A system for line draw flushing and blood collection, the system comprising:
a syringe assembly including:
a pre-filled syringe including a barrel having a distal end and a proximal end and that defines a chamber containing a solution therein, and a fluid connector component at the distal end of the barrel;
a plunger assembly including a plunger having a proximal end and a distal end, and a stopper positioned at the distal end of the plunger that is insertable into the proximal end of the barrel and slidable therein, the plunger including a channel extending along a length thereof between the proximal end and the distal end;
an access device positioned at the proximal end of the plunger, the access device comprising a receiving cavity and a fluid access component, the receiving cavity having an opening therein aligned with the channel, and the fluid access component positioned over the opening and extending into the receiving cavity, the fluid access component in fluid communication with the channel;
a cannula positioned at least partially within the barrel and extending through the stopper, with the cannula configured to place the fluid connector component in fluid communication with the channel; and
a closure assembly secured to the fluid connector component, the closure assembly comprising a seal member configured to seal off a lumen of the fluid connector component to contain the solution within the chamber of the syringe.

2 . The system of claim 1 , wherein the closure assembly comprises an end cap configured to engage the fluid connector component, wherein the fluid path seal is positioned within end cap, and wherein a proximal end of the end cap comprises a luer fitting configured to mate with an associated luer fitting of the fluid connector component.

3 . The system of claim 2 , wherein the closure assembly further comprises a scrubbing cap secured to a distal end of the end cap, the scrubbing cap comprising:
a housing secured to the end cap and defining a cavity; a scrubbing insert positioned within the cavity; and a seal attached over the cavity to seal the scrubbing insert within the cavity.

4 . The system of claim 3 , wherein the scrubbing insert comprises a resilient material including an antimicrobial solution or agent absorbed therein configured to disinfect a surface of the access port of the vascular access device.

5 . The system of claim 4 , wherein the housing comprises a connector portion including a threaded connection configured to engage with the end cap via a twist-type engagement.

6 . The system of claim 1 , wherein the closure assembly comprises a peel-off web coupled directly to the fluid path seal, to aid in removal of the fluid path seal from the fluid connector component.

7 . The system of claim 1 , further comprising a container defining a reservoir, the container positionable within the receiving cavity and engageable with the fluid access component to transfer fluid into the reservoir.

8 . The system of claim 7 , wherein the fluid access component comprises a needle defining a lumen therein, and wherein the container comprises a cover pierceable by the needle to place the reservoir in fluid communication with the channel of the plunger.

9 . The system of claim 7 , wherein each of the receiving cavity and the proximal end of the plunger includes a luer connection, the luer connection of the receiving cavity engaging the luer connection of the plunger to secure the access device to the plunger assembly, and wherein a collapsible sleeve extending through the luer connections places the channel in fluid communication with the fluid access component.

10 . The system of claim 1 , wherein the plunger and barrel comprise a locking feature positioned and configured to lock the plunger relative to the barrel when the plunger assembly is in a distally advanced position.

11 . The system of claim 1 , wherein the plunger and barrel comprise a locking feature positioned to lock the plunger relative to the barrel when the plunger assembly is in a proximally retracted position.

12 . The system of claim 1 , wherein the cannula is coupled to the barrel and remains stationary during use of the syringe assembly.

13 . The system of claim 1 , wherein the cannula is coupled to the plunger, such that the cannula is movable responsive to advancing or retracting of the plunger within the barrel.

14 . A method of using a system for line draw flushing and blood collection, the method comprising:
providing a syringe assembly including:
a pre-filled syringe including a barrel having a distal end and a proximal end and that defines a chamber containing a solution therein, and a fluid connector component at the distal end of the barrel;
a plunger assembly including a plunger having a proximal end and a distal end, and a stopper positioned at the distal end of the plunger that is insertable into the proximal end of the barrel and slidable therein, the plunger including a channel extending along a length thereof between the proximal end and the distal end;
an access device positioned at the proximal end of the plunger, the access device comprising a receiving cavity and a fluid access component, the receiving cavity having an opening therein aligned with the channel, and the fluid access component positioned over the opening and extending into the receiving cavity, the fluid access component in fluid communication with the channel;
a cannula positioned at least partially within the barrel and extending through the stopper, with the cannula configured to place the fluid connector component in fluid communication with the channel; and
a closure assembly secured to the fluid connector component, the closure assembly comprising a seal member configured to seal off a lumen of the fluid connector component to contain the solution within the chamber of the syringe;
removing the closure assembly from the fluid connector component; coupling the fluid connector component to an access port of a vascular access device, to place the syringe assembly in fluid connection with the vascular access device; distally advancing the plunger assembly to flush the vascular access device with the solution; obtaining a diversion or discard blood volume via operation of the syringe assembly; and subsequent to obtaining the diversion or discard blood volume, obtaining a sample blood volume via operation of the syringe assembly.

15 . The method of claim 14 , wherein the closure assembly further comprises:
an end cap configured to engage the fluid connector component, wherein the fluid path seal is positioned within end cap; and a scrubbing cap secured to a distal end of the end cap, the scrubbing cap comprising:
a housing secured to the end cap and defining a cavity;
a scrubbing insert positioned within the cavity; and
a seal attached over the cavity to seal the scrubbing insert within the cavity;
wherein, prior to removing the closure assembly from the fluid connector component, the method further comprises:
positioning the scrubbing cap over the access port of the vascular access device, such that the scrubbing insert contacts the access port; and
cleaning the access port with the scrubbing insert.

16 . The method of claim 14 , wherein obtaining the diversion or discard blood volume comprises proximally retracting the plunger assembly within the barrel, to draw the diversion or discard blood volume into the chamber of the barrel.

17 . The method of claim 14 , further comprising locking the plunger in place r

Assignees

• Becton Dickinson Co

Inventors

• Burkholz Jonathan Karl
• Nalawade Praveen
• Timmers Richard Bradley

Classifications

• A61B5/150236

  Pistons, i.e. cylindrical bodies that sit inside the syringe barrel, typically with an air tight seal, and slide in the barrel to create a vacuum or to expel blood · CPC title

• A61B5/150312

  Sterilisation of piercing elements, piercing devices or sampling devices (piercing element stocking means, e.g. cartridges, A61B5/15176) · CPC title

• A61B5/150328

  by aseptic fluid · CPC title

• A61B5/150206

  Construction or design features not otherwise provided for; manufacturing or production; packages; sterilisation of piercing element, piercing device or sampling device · CPC title

• A61B5/153 Primary

  {Devices} specially adapted for taking samples of venous or arterial blood, e.g. with syringes · CPC title