Systems for line-draw flushing and blood collection, and methods for using them.

Abstract

This disclosure provides a system comprising a pre-filled syringe having a barrel defining a chamber containing a solution, and a fluid coupling component at the distal end of the barrel. A plunger assembly, comprising a plunger and a stopper, is slidable within the barrel, and the plunger has a channel extending along its length. An access device is located at the proximal end of the plunger and comprises a receiving recess and a fluid access component, the receiving recess having an opening therein that coincides with the channel, and the fluid access component is located above the opening and extends into the receiving recess. A cannula is located within the barrel and extends through the stopper, and the cannula positions the fluid coupling component to communicate fluidly with the channel. A closure assembly comprises a sealing member fixed to the fluid coupling component and configured to seal its lumen.

Description

Technical Field

[0001] The present disclosure relates to systems for line draw flushing and blood collection, and related methods of use thereof.

[0002] Cross - Reference to Related Applications This application claims priority to U.S. Provisional Application No. 63 / 461,671, filed Apr. 25, 2023, entitled "Systems for Line Draw Flushing and Blood Collection, and Methods of Use Thereof", the entire disclosure of which is incorporated herein by reference.

Background Art

[0003] Catheters are used to inject fluids into and aspirate fluids (e.g., blood) from within a patient within a variety of settings, including hospitals and in - home settings, and such fluids are administered or blood is drawn through a vascular access device (VAD) that includes such a catheter inserted into the patient's vascular system. A typical VAD includes a plastic catheter inserted into a patient's vein, and the length of the catheter varies, for example, from a few centimeters in the case where the VAD is a peripheral intravenous catheter ("PIVC") to several tens of centimeters in the case where the VAD is a central venous catheter (CVC). The VAD can be indwelling for short periods (days), medium periods (weeks), or long periods (months - years).

[0004] In some applications, a VAD is used for collecting blood samples in connection with performing blood cultures. Blood cultures are commonly used as a tool to detect the presence of bacteria or fungi in a patient's blood sample, identify the type of bacteria or fungi, and direct the patient's treatment. Current practice for collecting venous blood samples for blood culture testing involves venipuncture with a blood collection set equipped with a Luer lock access device (LLAD). During the insertion process, the venipuncture device takes in microorganisms from the skin and the insertion process, and subsequently transfers such microorganisms into the blood culture sample, leading to a false-positive test result against Sepsis. To minimize the risk of false positives, a discard sample is typically taken to remove the initial volume of blood that would contain more microorganisms from the skin, such as discarding the first 1-10 ml of blood collected.

[0005] When obtaining a blood sample, such as when performing a blood culture, the workflow process is performed with the intention of sterilizing the VAD's connecting components and then providing them for the collection of the venous blood sample. The workflow process typically involves a healthcare worker disinfecting the VAD's access port (or the needleless connector on it) by, for example, wiping the port with an alcohol wipe. Disinfecting the access port allows a filled syringe (with a Luer connector on it) to be connected to the port and used to flush the indwelling VAD. After flushing is complete, the syringe is then disconnected from the VAD access port and discarded. After disconnecting the syringe, the healthcare worker disinfects the access port / needleless connector again by using an alcohol wipe as described above. Disinfection of the access port allows the LLAD to be connected to the port via the initial aspiration of the amount of blood to be discarded (e.g., via a repurposed syringe or connection of a vacuum tube to the LLAD) before any blood culture samples are subsequently aspirationed (e.g., via the connection of another vacuum tube to the LLAD).

[0006] While the workflow process described above enables the effective collection of blood samples (such as those related to performing blood cultures), the workflow process is labor-intensive and, due to the numerous steps and connection / disconnection performed during the workflow process, increases the risk of microbial contamination of patients and / or collected blood samples. One specific example is when a physician forgets to wipe the access port of a VAD before connecting it to an LLAD, and if the access port is not properly disinfected, a false-positive blood culture sample may result.

[0007] Therefore, there is a need in the art for systems and methods for using them that provide a simplified workflow process for VAD flushing and line draw (aspiration) blood sample collection. [Overview of the Initiative]

[0008] This specification provides a system for line draw flushing and blood collection. The system comprises a syringe assembly having a pre-filled syringe having a barrel having a proximal and distal end and defining a chamber therein containing a solution, and a fluid connecting component at the distal end of the barrel. The syringe assembly comprises a plunger assembly having a plunger having a proximal and distal end, and a stopper positioned at the distal end of the plunger which is insertable into and slidable within the proximal end of the barrel, the plunger having a channel extending along its length between the proximal and distal ends. The syringe assembly also comprises an access device positioned at the proximal end of the plunger, the access device comprising a receiving recess and a fluid access component, the receiving recess having an opening therein which coincides with the channel, and the fluid access component positioned above the opening and extending into the receiving recess to fluidize the channel. The syringe assembly comprises a cannula positioned at least partially within the barrel and extending through a stopper, the cannula also configured to position a fluid coupling component to communicate with a channel and fluid. The syringe assembly also comprises a closure assembly fixed to the fluid coupling component, the closure assembly comprising a sealing member configured to seal the lumen of the fluid coupling component and contain the solution within the syringe chamber.

[0009] In some embodiments, the closure assembly comprises an end cap configured to engage with a fluid coupling component, a fluid path seal located within the end cap, and the proximal end of the end cap comprises a Luer fitting configured to engage with an associated Luer fitting of the fluid coupling component.

[0010] In some embodiments, the closure assembly further comprises a scrubbing cap fixed to the distal end of the end cap, the scrubbing cap being fixed to the end cap and comprising a housing defining a recess, a scrubbing insert positioned within the recess, and a seal mounted on the recess for sealing the scrubbing insert within the recess.

[0011] In some embodiments, the scrubbing insert comprises an elastic material containing an antimicrobial solution or antimicrobial agent absorbed therein, configured to disinfect the surface of the access port of a vascular access device.

[0012] In some embodiments, the housing includes a connecting portion that includes a screw connection configured to engage with an end cap via a twist-type engagement.

[0013] In some embodiments, the closure assembly includes a peeling web directly connected to the fluid path seal to assist in the removal of the fluid path seal from the fluid coupling component.

[0014] In some embodiments, the system further comprises a container defining a reservoir, the container being positioned in a receiving recess and being able to engage with a fluid coupling component to move fluid into the reservoir.

[0015] In some embodiments, the fluid access component includes a needle that defines a lumen, and the container includes a cover that is perforated by the needle, thereby positioning the reservoir in fluid communication with the channel of the plunger.

[0016] In some embodiments, each of the receiving recesses and the proximal end of the plunger are provided with a Luer connector, the Luer connector of the receiving recess engaging with the Luer connector of the plunger to secure the access device to the plunger assembly, and a folding sleeve extending through the Luer connector to position the channel in fluid communication with the fluid coupling component.

[0017] In some embodiments, the plunger and barrel are configured to lock the plunger relative to the barrel when the plunger assembly is in a distally advanced position, and include a locking feature.

[0018] In some embodiments, the plunger and barrel include a locking feature positioned to lock the plunger relative to the barrel when the plunger assembly is in a proximal retracted position.

[0019] In some embodiments, the cannula remains connected to the barrel and stationary during the use of the syringe assembly.

[0020] In some embodiments, the cannula is connected to a plunger, and the cannula is movable within the barrel in response to the forward or retraction of the plunger.

[0021] This specification also provides a method for using a system for line draw flushing and blood collection. The method comprises a syringe assembly having a pre-filled syringe having a barrel having a proximal and distal end and defining a chamber therein containing a solution, and a fluid connecting component at the distal end of the barrel. The syringe assembly comprises a plunger assembly having a plunger having a proximal and distal end, and a stopper positioned at the distal end of the plunger which is insertable into and slidable therein in the proximal end of the barrel, the plunger having a channel extending along its length between the proximal and distal ends. The syringe assembly also comprises an access device positioned at the proximal end of the plunger, the access device comprising a receiving recess and a fluid access component, the receiving recess having an opening therein which coincides with the channel, and the fluid access component positioned above the opening and extending into the receiving recess, the fluid access component being in fluid communication with the channel. The syringe assembly comprises a cannula positioned at least partially within the barrel and extending through a stopper, the cannula also configured to position a fluid coupling component to fluidize a channel. The syringe assembly also comprises a closure assembly fixed to the fluid coupling component, the closure assembly comprising a sealing member configured to seal the lumen of the fluid coupling component and contain the solution within the syringe chamber. The method further includes removing the closure assembly from the fluid coupling component, connecting the fluid coupling component to an access port of a vascular access device to fluidize the syringe assembly to the vascular access device, advancing the plunger assembly distally to flush the vascular access device with the solution, obtaining a volume of diverted or discarded blood via manipulation of the syringe assembly, and obtaining a volume of sampled blood via manipulation of the syringe assembly following obtaining a volume of diverted or discarded blood.

[0022] In some embodiments, the closure assembly comprises a terminal cap configured to engage with a fluid coupling component, a fluid path seal located within the terminal cap, and a scrubbing cap fixed to the distal end of the terminal cap, the scrubbing cap being fixed to the terminal cap and comprising a housing defining a recess, a scrubbing insert located within the recess, and a seal mounted on the recess for sealing the scrubbing insert within the recess. The method further involves positioning the scrubbing cap over the access port of the vascular access device so that the scrubbing insert contacts the access port before removing the closure assembly from the fluid coupling component, and cleaning the access port with the scrubbing insert.

[0023] In some embodiments, obtaining the amount of blood to be diverted or discarded involves housing a plunger assembly proximal to the barrel and drawing the amount of blood to be diverted or discarded into the chamber of the barrel.

[0024] In some embodiments, the method comprises retracting the plunger assembly proximal to aspirate a volume of blood to be diverted or discarded into the barrel chamber, followed by locking the plunger in place relative to the barrel.

[0025] In some embodiments, the step of obtaining the amount of blood to be diverted or discarded comprises placing a container in a receiving recess, the container defining an empty storage container therein, engaging the container with a fluid access component to draw the amount of blood to be diverted or discarded into the empty storage container, and removing the container from the receiving recess.

[0026] In some embodiments, the step of obtaining a sample blood volume comprises placing a container in a receiving recess, the container defining an empty storage container therein, and engaging the container with a fluid access component to draw the reusable or discarded blood volume into the empty storage container.

[0027] In some embodiments, the fluid access component comprises a needle having a lumen therein, and engaging the container with the fluid access component comprises piercing a hole in the container's cover with the needle and disposing the needle partially within the reservoir.

[0028] In some embodiments, the method comprises advancing the plunger assembly distally to flush the vascular access device with solution, and subsequently locking the plunger in a predetermined position relative to the barrel.

Brief Description of the Drawings

[0029] [Figure 1] FIG. 1 is a perspective view of a system for line drawing flushing and blood collection, including a syringe assembly and a collection container, according to one embodiment. [Figure 2] FIG. 2 is a side cross-sectional view of the system of FIG. 1. [Figure 3] FIG. 3 is an enlarged view of the system of FIG. 1. [Figure 4A] FIG. 4A shows the process steps of using the system of FIG. 1, including cleaning and connecting to an access connector, according to one embodiment. [Figure 4B] FIG. 4B shows the process steps of using the system of FIG. 1, including cleaning and connecting to an access connector, according to one embodiment. [Figure 4C] FIG. 4C shows the process steps of using the system of FIG. 1, including cleaning and connecting to an access connector, according to one embodiment. [Figure 4D] FIG. 4D shows the process steps of using the system of FIG. 1, including cleaning and connecting to an access connector, according to one embodiment. [Figure 4E] FIG. 4E shows the process steps of using the system of FIG. 1, including cleaning and connecting to an access connector, according to one embodiment. [Figure 4F]Figure 4F shows a process step using the system of Figure 1, including cleaning and connection to the access connector, according to one embodiment. [Figure 4G] Figure 4G shows a process step using the system of Figure 1, including cleaning and connection to the access connector, according to one embodiment. [Figure 4H] Figure 4H shows a process step using the system of Figure 1, including cleaning and connection to the access connector, according to one embodiment. [Figure 5] Figure 5 is a side view of a syringe assembly according to one embodiment. [Figure 6] Figure 6 is a magnified view of the syringe assembly shown in Figure 5. [Figure 7] Figure 7 is a side view of a syringe assembly according to one embodiment. [Figure 8] Figure 8 is a magnified view of the syringe assembly shown in Figure 7. [Figure 9] Figure 9 is a side view of a syringe assembly according to one embodiment. [Figure 10] Figure 10 is a magnified view of the syringe assembly shown in Figure 9. [Figure 11] Figure 11 is a side view of a syringe assembly according to one embodiment. [Figure 12] Figure 12 is a magnified view of the syringe assembly shown in Figure 11. [Figure 13] Figure 13 is a side view of a syringe assembly according to one embodiment. [Figure 14] Figure 14 is a magnified view of the syringe assembly shown in Figure 13. [Figure 15] Figure 15 is a side view of a syringe assembly according to one embodiment. [Figure 16] Figure 16 is a magnified view of the syringe assembly shown in Figure 15. [Modes for carrying out the invention]

[0030] The following description is provided so that those skilled in the art may create and use the described embodiments that are conceivable for carrying out the invention. Various modifications, equivalents, substitutions, and alternatives will, however, be obvious to those skilled in the art. Such modifications, equivalents, substitutions, and alternatives are intended to fall within the spirit and scope of the invention.

[0031] For the purposes of the following description, the terms “top,” “bottom,” “right,” “left,” “vertical,” “horizontal,” “top,” “bottom,” “lateral,” “longitudinal,” and their derivatives will be relevant to the present invention as they are oriented in the drawings. However, it should be understood that the present invention may envision various alternative modifications unless explicitly specified otherwise. Furthermore, it should be understood that the particular apparatus shown in the accompanying drawings and described in the following specification is merely an illustrative embodiment of the present invention. Accordingly, the specific dimensions and other physical characteristics relating to the embodiments disclosed herein should not be understood as limiting.

[0032] In this disclosure, when a component or device is in a position for use, i.e., when a user is holding the blood collection device for preparation or during use, the distal end of the component of the device means the end furthest from the user's hand, and the proximal end means the end closest to the user's hand. Similarly, in this application, the terms “distal direction” and “distal” mean the direction toward the access connection portion of the fluid transfer device, and the terms “proximal direction” and “proximal” mean the direction opposite to the direction of the connection.

[0033] Although not shown or described herein, it will be understood that the systems described below may be used for blood collection from any suitable vascular access device (VAD), such as the BD NEXIVA® Closed IV Catheter System, BD CATHENA® Catheter System, BD VENFLON® ProSafety Shield IV Catheter System, BD NEOFLON® IV Cannula System, BD INSYTE® AUTOGUARD® BC Shield IV Catheter System, or other suitable vascular access devices.

[0034] Embodiments of this disclosure will primarily be described in the context of devices for flushing and blood sample collection used in conjunction with PIVC. However, embodiments of this disclosure can be similarly extended to use in conjunction with other catheter devices.

[0035] Referring to Figures 1-3, a line draw flushing and blood collection system 10 (hereinafter referred to as "System 10") is shown as one embodiment of the present disclosure. System 10 comprises a syringe assembly 12 and a blood collection container 14 that can be used with the syringe assembly 12. As will be described in more detail below, System 10 is performed by a user (e.g., a physician) to first flush a line draw vascular access device (VAD), then obtain an initial waste sample of blood in the syringe assembly 12 (or waste collection container), and finally obtain a blood culture sample in the blood collection container 14 that can be analyzed to detect the presence of microorganisms or fungi.

[0036] As shown in Figures 1-3, the syringe assembly 12 can generally be characterized by comprising a syringe 16, a plunger assembly 18, an access device 20, a cannula 22, and a closure assembly 24.

[0037] The syringe 16 may be configured as a generally cylindrical barrel 26, comprising a distal end 28 and a proximal end 30, a fluid coupling component 32 on the distal end 28, and a finger grip 34 on the proximal end 30. According to the embodiment, the fluid coupling component 32 may be integrated with the distal end 28 of the barrel 26 or may be detachably coupled. According to the embodiment, the fluid coupling component 32 may comprise any suitable component configured to connect the barrel 26 to a connector (e.g., a needleless connector) or an accelerator port of a vascular access device (VAD). For example, in some embodiments, the fluid coupling component 32 may be a Luer connector. The Luer connector may take the form of, for example, a slip Luer, a screw Luer, or a collared Luer. In some embodiments, the fluid coupling component 32 provides an outlet for the barrel 26 through a lumen 36 formed therein.

[0038] The plunger assembly 18 comprises a plunger 38 and a stopper 40. As shown in Figures 1-3, the plunger 38 is formed as a generally elongated member that can be inserted into a chamber 46 defined by the barrel 26 of the syringe 16, and the plunger 38 has a distal end 44 and a proximal end 46. A channel 48 is formed extending along its length within the plunger 38. In one embodiment, as the channel 48 extends from the distal end 44 to the proximal end 46, the diameter of the channel 48 increases, and the channel 48 tapers along its length.

[0039] The stopper 40 of the plunger assembly 18 is positioned at the distal end 44 of the plunger 38 so as to be movable along the plunger 38 within the chamber 42 of the syringe barrel 26. The stopper 40 may be made of a different material from the material of the plunger 38 and may form a tight seal in the syringe barrel 26 as it advances through them. In some embodiments, it may be understood that the stopper 40 can be fixed to the distal end 44 of the plunger 38 by another known technique, wherein the stopper 40 comprises a container (not shown) formed therein, which is sized and configured to receive a threaded connector 49 formed at the distal end 44 of the plunger 38, and the threaded connector 49 is connected to the container, for example, via a screw / twist connector, thereby fixing the stopper 40 to the plunger 38.

[0040] The access device 20 is positioned at the distal end 44 of the plunger 38 and comprises a receiving recess 50, a fluid access component 52, and a finger grip 54. As shown in the embodiment, the plunger 38, the receiving recess 50, and the finger grip 54 are a single integrated component. For example, the plunger 38, the receiving recess 50, and the finger grip 54 may be formed as molded parts.

[0041] The receiving recess 50 is molded to generally form a container in which the container 14 may be placed, and the receiving recess 50 has a proximal opening 56 for receiving the container 14. The distal end 58 of the receiving recess 50 is attached to (e.g., formed together with) the plunger 28 and has an opening 60 formed therein to coincide with the channel 48. A plunger seal 62 is positioned within the opening 60 to separate the channel 48 from the container of the receiving recess 50, and a fluid access component 52 is positioned within the opening 60 and extends through the plunger seal 62. The fluid access component 52 is fixed within the plunger seal 62 and may extend outward into the interior of the receiving recess 50. In one embodiment, the fluid access component 52 may include a needle 64 therein that defines a lumen. In some embodiments, the flexible needle sheath 66 may be provided on the needle 64, configured to move relative to the needle 64, so that the proximal end of the needle 64 is selectively exposed.

[0042] Referring to Figures 1-3, it is shown that the cannula 22 is inserted into the syringe assembly 12 via the syringe 16 and their arrangement within the plunger assembly 18. In one embodiment, as best shown in Figure 2, the cannula 22 is provided in the syringe assembly 12 to secure the barrel 26 and is positioned so that its distal end 68 is substantially flushed at the opening 70 in the fluid coupling component 32 of the syringe 16, and the cannula 22 extends proximal to the fluid coupling component 32, through a portion of the chamber 42 of the barrel 26, through a hole formed in the stopper 40, and into a channel 48 formed in the plunger 38. In some embodiments, the cannula 22 may be recessed in the fluid coupling component 32 behind the opening 70, and this recessed arrangement provides compatibility with needleless connectors, Luer activation valves and / or IV connectors, which may have an internal spike or similar projection intended to be inserted into the fluid coupling component 32 for functionality in the syringe assembly 12.

[0043] In embodiments of this disclosure, the cannula 22 has a cross-section smaller than the opening 70 at the tip of the fluid coupling component 32, allowing fluid to flow through the gap between the outer surface of the cannula 22 and the inner surface of the opening 56. According to the embodiment, the cannula 22 is fixed to the fluid coupling component 32 so as not to obstruct the flow of fluid between the gaps. In one embodiment, the cannula 22 is fixed to the fluid coupling component 32 via one or more retaining features of the fluid coupling component 32, which may include a flange, strut, wing, bevel flange, or another mechanical structure (not shown) extending between the inner surface of the fluid coupling component 32 and the outer surface of the cannula 22. In another embodiment, the cannula 22 may be fixed to the fluid coupling component 32 using an adhesive, heat bonding, or another preferred means.

[0044] The cannula 22 is sized as described above and positioned relative to the syringe 16 and plunger assembly 18, providing separate fluid pathways into the syringe assembly 12 via which blood may be aspirated into the system 10. The (first) fluid pathway is formed through a gap between the outer surface of the cannula 22 and the inner surface of the opening 70, through which the fluid (e.g., blood) flows from the fluid coupling component 32 into a portion of the chamber 42 in the barrel 26, i.e., into the fluid chamber defined by the distal surface of the stopper 40 and the inner surface of the distal end 28 of the barrel 26. The (second) fluid pathway is provided through the cannula 22, through which the fluid (e.g., blood) flows from the fluid coupling component 32 into the channel 48 of the plunger 38, and the fluid may then exit the channel 48 and flow through the fluid access component 52 into the container 14.

[0045] Referring to Figure 1, the container 14 may have any number of structures that allow the container 14 to be inserted into a receiving recess 50 (defined by a cylindrical wall structure 64). Figure 1 shows the container 14 as a tube, such as Becton Dickinson & Co.'s VACUTAINER®, as a non-limiting specific example, but the container 14 may be provided as a necked vial or another container. The container 14 comprises a cover 72 and a reservoir 74, the cover 72 being located at the distal end of the container 14. In some embodiments, the cover 72 may have a release membrane configured such that a fluid access component, such as a needle 64 of a fluid access component 52, punctures the release membrane to achieve fluid communication with the reservoir 74. The release membrane of the cover 72 may be configured to reseal so that the fluid access component 52 is detached from the cover 72, allowing the reservoir 74 to be fluidly separated from the external area to the container 14. The storage container 74 may be an empty container, arranged so as to be in fluid communication with a fluid source (for example, by puncturing the peelable membrane of the cover 72 with a needle that is fluidly in communication with the patient's blood vessel), and a fluid (for example, blood) can be drawn into the storage container 74 due to the pressure difference between the storage container 74 and the fluid source.

[0046] As shown in Figures 1-3, the closure assembly 24 is fixed to the fluid coupling component 32 of the syringe assembly 12. The syringe assembly 12 includes a terminal cap 76 configured to engage with the syringe assembly 12, covering the fluid coupling component 32 when the syringe assembly 12 is not in use. In one embodiment, the proximal end of the terminal cap 76 is configured as a Luer fitting configured to engage with the associated Luer fitting of the fluid coupling component 32, thereby fixing the terminal cap 76 to the syringe 16. The closure assembly 24 also includes a sealing member 78 configured to peel off the lumen 36 of the fluid coupling component 52. As best shown in Figure 2, the sealing member 78 may be positioned / fixed within an inward recess of the terminal cap 76, and when the terminal cap 76 is fixed to the fluid coupling component 32, the sealing member 78 is inserted into the opening 70 at the tip of the fluid coupling component 32, thereby sealing the lumen 36.

[0047] In accordance with embodiments of this disclosure, when the system 10 is initially connected to the VAD access port, such as by connecting the fluid coupling component 32 to the access port, it is preferable to disinfect the access port before connecting the system 10 thereto. That is, it is desirable to clean and sterilize the access port before engaging the fluid coupling component 32 thereto (for example, by combining it with a female and male Luer connector) to prevent microbial intrusion and potential catheter-associated bloodstream infection (CRBI).

[0048] Accordingly, some embodiments of the syringe assembly 12 include a scrubbing cap 80 integrated into a closure assembly 24, which provides cleaning and sterilization of the access port before engagement with the system 10. The scrubbing cap 80 is fixed on the distal end of the end cap 76 and is configured to engage with the VAD access port to clean and sterilize their inner and / or outer surfaces via a twisting and scrubbing motion between the scrubbing cap 80 and the access port. The closure assembly 24, having completed cleaning and sterilization of the access port, is removed from the fluid coupling component 32, thereby subsequently coupling the fluid coupling component 32 to the access port and allowing blood collection to be performed via the operation of the system 10 as previously described.

[0049] As shown in Figures 2 and 3, the scrubbing cap 80 comprises a cap housing 82, a scrubbing insert 84, and a peelable seal 86. The housing 82 may be manufactured by injection molding and may be made from an alcohol-compatible material such as polypropylene or polyethylene. The housing 82 may have a cap shape that defines an opening recess 88 configured to receive the insert 84 therein. In some embodiments, the recess 88 may have a cylindrical cross-sectional shape and may have a recessed shape with a depth suitable for receiving the insert 84 therein. However, the housing 82 and the defined recess 88 can be inferred to be of other shapes, including square, hexagonal, etc., and when a scrubbing cap 80 is performed (for example, on the catheter connector 20 of a catheter assembly 12), the housing 82, its recess 88, and the insert 84 placed therein can be molded and configured to determine the size so that the scrubbing cap 80 cleans to a specific size and position of the medical device.

[0050] The housing 82 may be sized such that the recess 88 accommodates the insert 84 to hold it in place when the insert 84 is fitted into the recess 88. It is understood that the insert 84 may also be bonded to the housing 82 using other preferred methods, including mechanical fastening, but a preferred hot melt glue or another preferred adhesive may be used to bond the insert 84 to the bottom of the housing 82 (e.g., to the base 82). An annular lip 90 is formed on the housing 82 to define a portion for receiving a seal 86, and the seal 86, in cooperation with the annular lip 90, seals the recess 88 and holds the insert 84 therein. The seal 86 seals the recess 88 of the housing 82 and the insert 84 therein from contamination of the external environment, provides a leak-proof barrier, thereby protecting the contents of the insert 84 and maintaining a sealed, sterile environment. The seal 86 may, according to the embodiment, provide sufficient sealing within a range of temperature, pressure, and humidity levels and may be formed as aluminum or a multi-layer film with a peelable top surface. In some embodiments, the seal 86 may be heat-sealed or induction-sealed at the opening of the scrubbing cap 80. The seal 86 may be provided with a tab 92 to facilitate the operation and removal of the seal 86 from the scrubbing cap 80.

[0051] The insert 84 is composed of, for example, a foam material of an injection-molded structure, and the insert 84 may be die-cut from a foam sheet. The insert comprises a cleansing substance integrated therein (while in the housing 82), such as a solution of a suitable disinfectant. The cleansing substance is of any preferred type and contains a suitable amount of antimicrobial disinfectant depending on the size of the foam material insert. For example, in one embodiment, the product is made in an amount of about 0.20 cc to about 0.75 cc from an aqueous solution containing about 2 percent (2%) chlorhexidine gluconate (chlorhexidine solution, "CHG") by volume. Optionally, a solution containing about 0.50 cc is implemented. In another embodiment, the cleansing substance contains a solution containing about 70 percent (70%) isopropyl alcohol ("IPA") in an aqueous solution. Furthermore, in yet another embodiment, the cleansing substance contains a solution containing about 70 percent (70%) IPA and about 2 percent (2%) CHG in an aqueous solution in an amount of about 0.2 ml. In this latter solution, in one embodiment, the concentration of IPA may vary from about 60 percent to about 90 percent, and the concentration of CHG may vary from about 1 percent to about 5 percent. Other suitable solution compositions and concentrations are also possible. In one embodiment, for example, povidone-iodine or hydrogen peroxide solution may be included as the cleansing substance.

[0052] In accordance with embodiments of the present disclosure, the insert 84 may be configured (molded) to have a predetermined shape to conform to the unique shape of the VAD access port or the connector to be cleaned thereby. The insert 84 may further have any number of structures provided to effectively clean the port / connector, including patterned or rough surfaces and / or gaps or slits formed in a foam material that allow the insert 84 to deform / fit well with the approximately inner and outer surfaces of the port / connector.

[0053] The housing 82 of the scrubbing cap 80 has a proximal end configured to be coupled with the end cap 76, to which the scrubbing cap 80 is fixed. According to the embodiment, the housing 82 may also be connected to the end cap 76 by the housing being inserted into a container 94 provided on the distal end of the end cap 76, and the scrubbing cap 80 is fixed to the end cap 76 by a press-fit connection between the housing 82 and the container 94, a screw engagement between the housing 82 and the container 94, or any other preferred engagement that fixes the housing 82 in a fixed position relative to the end cap 76.

[0054] As follows, and as shown in Figures 4A-4H, a system 10 for line draw flushing and blood collection is described according to one embodiment of the present disclosure. Use of the system 10 together with the syringe assembly 12 begins with the initial setup shown in Figure 4A. In the initial setup, the syringe assembly 12 is provided as a pre-filled syringe containing a solution (e.g., contained in the barrel 26) for flushing the fluid pathway / line of the VAD. When in the initial setup, the plunger 38 is provided in an intermediate position, either fully advanced or not fully retracted, so that a fluid chamber is defined within the barrel 26 (by the inner surface of the distal end 28 of the barrel 26 and the distal surface of the stopper 40) that holds the desired amount of flushing solution. As is known, the flushing solution may be, but is not limited to, a 0.9% sodium chloride injection solution, saline solution, or heparin solution. As shown in Figure 4A, in the initial configuration, the closure assembly is fixed onto the fluid coupling component 32 of the syringe 16 under sealed conditions (for example, the seal 86 is fixed to the housing 82 to remove the scrubbing insert 84), and the end cap 76 and the scrubbing cap 80 are fixed to the fluid coupling component 32 and the scrubbing cap 80 of the syringe 16.

[0055] To access the scrubbing insert 84, the system 10 can continue to be used as shown in Figures 4B and 4C by removing the seal 86 from the scrubbing cap 80 of the syringe assembly 12. Upon removal of the seal 86, the syringe assembly 12 is brought close to a VAD (not shown) for cleaning and sterilization of the VAD's access port or connector 96, as shown in Figures 4B and 4C, which illustrate a needleless connector according to a non-limiting specific example. By bringing the syringe assembly 12 proximal to the connector 96, the scrubbing cap 80 is positioned on the portion of the connector 96 (i.e., a female luer with an external threaded linkage 98 defining a tapered lumen or recess 100, according to a non-limiting specific example), and the foam insert 84 is pushed onto the connector 96 by the user. At this point, the portion of the insert 84 is fitted and / or receptacled into the connector 96 (i.e., approximately within the external threaded linkage 98 and lumen 100). Once the connector 96 is inserted into the foam insert 84 of the scrubbing cap 80, the scrubbing cap 80 rotates relative to the connector 96. For example, the user may hold the connector 96 stationary while rotating the syringe assembly 12. The scrubbing cap 80 is fixed in place relative to the syringe 16 via the connection of the end cap 76 and the fluid coupling component 32 to the scrubbing cap 80, and the rotation of the syringe assembly 12 rotates the corresponding scrubbing cap 80. The rotation of the scrubbing cap 80 relative to the connector 96 may be entirely in one direction or a twisting motion back and forth. The scrubbing cap 80 is rotated relative to the connector 96 for a sufficient length of time to thoroughly kill any microorganisms so that the solution-impregnated foam insert 84 makes sufficient contact and / or removes any bacterial film from the outer peripheral surface, the outer threaded connection 98 of the connector 96, and the inner surface of the lumen 100 of the connector 96. In this way, both the outer surface and the inner lumen surface of the connector 96 are scrubbed by the insert 84, cleaning the material inside, disinfecting the surface, and removing any bacterial film present thereon.

[0056] Upon completion of cleaning and sterilization of the VAD connector 96 via the scrubbing cap 80, the scrubbing cap 80 is separated from the connector 96. The closure assembly 24 (scrubbing cap 80, end cap 76, and sealing member 78) may then be removed from the fluid coupling component 32 of the syringe assembly 12. After drying the connector 96, the syringe assembly 12 is then connected to the VAD by connecting the fluid coupling component 32 to the connector 96, as shown in Figure 4D, thereby fluidly connecting the syringe assembly 12 to the catheter assembly 100.

[0057] In accordance with embodiments of the present disclosure, the connection of the syringe assembly 12 to the connector 96 may flush the connector 96 and the fluid path of the VAD with a flushing solution provided in a pre-filled syringe 16. As shown in Figure 4E, the plunger assembly 18 (i.e., the plunger 38 and stopper 40) advances distally, pushing the flushing solution from the barrel 26 through the lumen 36 of the fluid connector 32 and into the VAD fluid path. The plunger 38 and stopper 40 may be actuated to their fully advanced positions to empty the flushing solution from the syringe 16.

[0058] Following flushing of the VAD fluid pathway, the syringe assembly 12 may then be operated to collect the first waste sample of blood. As shown in Figure 4F, the plunger assembly 18 (i.e., the plunger 38 and stopper 40) is housed to draw the first waste sample of blood proximal. By housing the plunger 38 and stopper 40 proximal within the syringe barrel 26, the amount of waste (or repurposed) blood is drawn into a portion of the chamber 42, i.e., into a fluid chamber defined by the distal surface of the stopper 40 and the proximal surface of the distal end 28 of the barrel 26, and the blood flows from the fluid coupling component 32 and along the first fluid pathway into the portion of the chamber 42.

[0059] After sufficient aspiration of blood waste sample, the system 10 can then be operated to subsequently obtain a desired blood culture sample in a collection container 14, as shown in Figure 4G. To obtain such a sample, the collection container 14 is engaged with the syringe assembly 12, and the collection container 14 (e.g., a vacuum) is placed in a receiving recess 50 and engaged with a fluid access component 52, thereby positioning the container 14 in fluid communication with the plunger assembly 18. That is, by positioning / connecting the collection container 14 in the receiving recess 50 and onto the fluid access component 52, a second fluid path is formed from the fluid connecting component 32 to the collection container 14, the cannula 22 moves the blood from the fluid connecting component 32 into the channel 48 in the plunger 38, and the blood then enters the container 14 through the fluid access component 52 from the channel 48. As described above, in some embodiments, the fluid access component 52 is provided as a needle 64 having a lumen formed therein, and the needle punctures the cover 72 of the container 14 so that blood is drawn into a vacuum reservoir 74 within the container 14.

[0060] As shown in Figure 4H, upon acquisition of the blood culture sample in the collection container 14, the collection container 14 may be removed from the syringe assembly 12. Furthermore, in some embodiments, the syringe assembly 12 may then be operated to return the waste blood sample to the patient. That is, as shown in Figure 4H, the plunger assembly 18 (i.e., the plunger 38 and stopper 40) advance distally to push the waste blood sample out of the barrel 26 through the lumen 36 of the fluid coupling component 32 and into the VAD fluid path. The plunger 38 and stopper 40 may be actuated to their fully advanced positions to empty the waste blood sample from the syringe 16.

[0061] While the systems 10 and their usage are shown and described in Figures 1-4 according to specific embodiments, the systems 10 (and their syringe assemblies 12) may have other preferred arrangements. Figures 5-16 show additional embodiments of syringe assemblies that may be used for line draw flushing and blood collection, according to further embodiments of the present disclosure.

[0062] Now, with reference to Figures 5 and 6, a syringe assembly 12 is shown according to another embodiment of the present disclosure. The syringe assembly 12 comprises all the components of the syringe assembly 12 shown and described above in Figures 1 to 4, except that the closure assembly 102 provided within the syringe assembly 12 does not have a scrubbing cap 80 on it. Instead, the closure assembly 102 comprises only an end cap 76 and a sealing member 78. As described above, the end cap 76 is configured to engage with the fluid coupling component 32 to cover the fluid coupling component 32 when the syringe assembly 12 is not in use, and one embodiment has an end cap 76 configured to have a Luer fitting at its proximal end so as to be together with the associated Luer fitting of the fluid coupling component 32. When the end cap 76 is fixed to the fluid coupling component 32, the sealing member 78 is inserted into the opening 70 at the tip of the fluid coupling component 32, and is positioned / fixed within an inner recess of the end cap 76 to seal the lumen 36. In the closure assembly 102, the distal end of the end cap 76 may be a flat surface or a recessed recess, and it is understood that the end cap 76 covers and closes the fluid coupling component 32, keeping the inside clean.

[0063] Now, with reference to Figure 7-10, a syringe assembly 12 is further shown according to embodiments of the present disclosure. In each of the shown embodiments, the syringe assembly 12 comprises all the components of the syringe assembly 12 shown and described above in Figures 1-4, except that the closure assembly 104 provided within the syringe assembly 12 does not have a scrubbing cap 80 or end cap 76 on it. Instead, the closure assembly 104 comprises only a sealing member 78 and a peelable top web 106. The peelable top web 106 is fixed on the fluid coupling component 32 to its (flat) portions that extend outward from the opening 70 (and Luer 36) at the tip of the fluid coupling component 32, and on the distal surface of the sealing member 78. The peelable top web 106 may be heat-sealed to the distal surface of the sealing member 78. When it is desired to engage the syringe assembly 12 with the VAD connector, the user peels off the top web 106, and the removal of the top web 106 allows for the removal of the seal member 78 from the fluid coupling component 32 (via adhesion between the top layer 98 and the seal member 78) or subsequent removal of the seal member 78 from the fluid coupling component 32.

[0064] In the syringe assembly 12 shown in Figures 7 and 8, the cannula 22 is provided within the syringe assembly 12 to be fixed to the syringe barrel 26. With the cannula 22 connected to the barrel 26, the cannula 22 remains stationary during use of the syringe assembly 12, i.e., during the forward and / or retraction of the plunger assembly 18. In the syringe assembly 12 shown in Figures 9 and 10, the cannula 22 is provided within the syringe assembly 12 to be fixed / connected to the plunger 38. With the cannula 22 connected to the plunger 38, the cannula 22 moves along the plunger 18 during use of the syringe assembly 12, i.e., during the forward and / or retraction of the plunger assembly 18.

[0065] Now, with reference to Figures 11-14, syringe assemblies 12 are further shown according to embodiments of the present disclosure. In each of the shown embodiments, the syringe assembly 12 comprises all the components of the syringe assembly 12 shown and described above, including a closure assembly 102 comprising an end cap 76 and a sealing member 78 (without having a scrubbing cap 80 on it). However, each of the syringe assemblies 12 in Figures 11-14 includes a feature therein that provides locking of a plunger assembly 18 (i.e., a plunger 38) to a syringe 16 (i.e., a syringe barrel 26).

[0066] In the syringe assembly 12 shown in Figures 11 and 12, the syringe assembly 12 is configured to lock the plunger 38 against the syringe barrel 26 when the plunger assembly 18 is in a distally advanced position. To provide such locking of the plunger 38, the barrel 26 has a retaining ring 108 formed on its inner surface 110, extending radially inward from the remainder of the inner surface 110, and the retaining ring 108 of the barrel is located at the proximal end 30 of the barrel 26. The plunger 38 has a corresponding retaining ring 112 formed thereon, projecting radially outward from the outer surface 114 of the plunger 38. The retaining ring 112 is formed on the plunger 38 adjacent to its proximal end 46. With the retaining rings 108, 112 positioned in this manner, when the syringe assembly 18 is fully advanced distally relative to the syringe 16 (e.g., with retaining ring 112 and slide past retaining ring 108), the retaining ring 112 on the plunger 38 can advance distally beyond the retaining ring 108 on the barrel 26. When the retaining ring 112 on the plunger 38 advances distally beyond the retaining ring 108 on the barrel 26, such as when distributing / injecting flushing solution from the syringe assembly 12 into the VAD fluid line, the plunger 38 is then prevented from locking in the barrel 26 and retracting proximal from there.

[0067] In the syringe assembly 12 shown in Figures 13 and 14, the syringe assembly 12 is configured to lock the plunger 38 against the syringe barrel 26 when the plunger assembly 18 is in a proximal retracted position. To provide such locking of the plunger 38, the barrel 26 includes a retaining ring 108 formed on its inner surface 110, extending radially inward from the remainder of the inner surface 110, the retaining ring 108 of the barrel being located at the proximal end 30 of the barrel 26. The plunger 38 includes a corresponding pair of retaining rings 112, 116 formed thereon, projecting radially outward from the outer surface 114 of the plunger 38. The retaining rings 112, 116 are formed on the plunger 38 with space between them, adjacent to their distal ends 44 (e.g., the end immediately proximal to the stopper 40). With the retaining rings 108, 112, 116 positioned in this manner, the plunger 38 advances fully distally within the barrel 26 and then retracts proximally through the barrel 26 to the retaining rings 112, 116 on the plunger 38 (for example, the retaining rings 112, 116 are carried into a position above the opposite side of the retaining ring 108) so as to contact the retaining ring 108 of the barrel. When the retaining rings 112, 116 on the plunger 38 are positioned on either side of the retaining ring 108 of the barrel 26, such as when drawing a waste blood volume into the chamber 42 of the barrel 26 with the retracted plunger assembly 18, the plunger 38 is then locked against the barrel 26 and further prevented from being retracted proximally or advanced distally.

[0068] Now, with reference to Figures 15 and 16, a syringe assembly 12 is shown according to another embodiment of the present disclosure. The syringe assembly 12 comprises all the components of the syringe assembly 12 shown and described above, including a closure assembly 102 (without a scrubbing cap 80 on it) consisting of an end cap 76 and a sealing member 78. However, in the syringe assembly 12 of Figures 15 and 16, rather than the plunger 38, the receiving recess 50 and the finger grip 54 of the access device 20 being formed as a single integrated part, the receiving recess 50 and the finger grip 54 may be made separately from the plunger 38 and then connected to the plunger 38. In the embodiment shown, the plunger 38 is provided with a female Luer connector 118 at its proximal end, while the access device 20 (e.g., its receiving recess 50) is provided with a corresponding male Luer connector 120 above it, which together with the female Luer connector 118 secures the access device 20 to the plunger assembly 18 and provides fluid communication between the channel 48 of the plunger 38 and the receiving recess 50. A folding sleeve 122 is provided extending through the Luer connectors 118 and 120, and the folding sleeve 122 provides a leak-proof fluid path between the channel 48 of the access device 20 and the fluid access component 52 (i.e., the needle 64). The needle 64 of the access device 20 is inserted through the male Luer connector 120 and engages with the folding sleeve 122.

[0069] Multiple embodiments of the system configured for line draw flushing and blood collection have been described in the following detailed description, and those skilled in the art can modify or change these embodiments without departing from the claims and the spirit of the invention. That is, each feature of each system in each embodiment can be included in another embodiment. Accordingly, the following description is intended to be illustrative and not restrictive. The present invention as described above may be considered to be defined by the appended claims and all modifications that are included in the same meaning and scope as the claims.

Claims

1. A system for line draw flushing and blood collection, The system includes a syringe assembly, The syringe assembly is A pre-filled syringe comprising a barrel having a proximal and distal end and defining a chamber containing a solution, and a fluid coupling component at the distal end of the barrel; A plunger assembly comprising a plunger having a proximal and distal end, and a stopper positioned at the distal end of the plunger that is insertable into and slidable within the proximal end of a barrel, wherein the plunger has a channel extending along its length between the proximal and distal ends; An access device positioned at the proximal end of a plunger, the access device comprising a receiving recess and a fluid access component, the receiving recess having an opening therein that coincides with a channel, and the fluid access component positioned above the opening and extending into the receiving recess to fluidly communicate with the channel; A cannula that is at least partially positioned within a barrel and extends through a stopper, and is configured to have a fluid coupling component positioned to communicate fluidly with a channel; and, A system comprising: a closure assembly fixed to a fluid coupling component, the closure assembly comprising a sealing member configured to seal the lumen of the fluid coupling component so as to contain a solution in the chamber of a syringe;

2. The system according to claim 1, wherein the closure assembly comprises an end cap configured to engage with a fluid coupling component, a fluid path seal is located within the end cap, and the proximal end of the end cap comprises a lure fitting configured to engage with an associated lure fitting of the fluid coupling component.

3. The closure assembly further includes a scrubbing cap fixed to the distal end of the terminal cap, the scrubbing cap is A housing that is fixed to the end cap and defines the recess; Scrubbing inserts placed in recesses: and, The system according to claim 2, further comprising a seal mounted on a recess for sealing a scrubbing insert within the recess.

4. The system according to claim 3, wherein the scrubbing insert comprises an elastic material containing an antimicrobial solution or antimicrobial agent that is absorbed therein, configured to disinfect the surface of the access port of the vascular access device.

5. The system according to claim 4, wherein the housing comprises a connecting portion including a screw connection configured to engage with an end cap via a twist-type engagement.

6. The system according to claim 1, wherein the closure assembly comprises a peeling web directly connected to the fluid path seal, which assists in the removal of the fluid path seal from the fluid coupling component.

7. The system according to claim 1, further comprising a container defining a storage vessel, the container being able to be placed in a receiving recess, and being able to engage with a fluid coupling component to move fluid into the storage vessel.

8. The system according to claim 7, wherein the fluid access component comprises a needle that defines a lumen, and the container comprises a cover that is perforated by the needle, thereby arranging the reservoir to be in fluid communication with the channel of the plunger.

9. The system according to claim 7, wherein each of the receiving recesses and the proximal end of the plunger are provided with a Luer connector, the Luer connectors of the receiving recesses engage with the Luer connectors of the plunger to secure the access device to the plunger assembly, and a folding sleeve extends through the Luer connectors to position the channel in fluid communication with a fluid coupling component.

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

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

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

13. The system according to claim 1, wherein the cannula is connected to a plunger and the cannula is movable within the barrel in response to the forward or retraction of the plunger.

14. A method using a line-draw flushing and blood collection system, The aforementioned method, A pre-filled syringe comprising a barrel having a proximal and distal end and defining a chamber containing a solution, and a fluid coupling component at the distal end of the barrel; A plunger assembly comprising a plunger having a proximal and distal end, and a stopper positioned at the distal end of the plunger that is insertable into and slidable within the proximal end of a barrel, wherein the plunger has a channel extending along its length between the proximal and distal ends; An access device positioned at the proximal end of a plunger, the access device comprising a receiving recess and a fluid access component, the receiving recess having an opening therein that coincides with a channel, and the fluid access component positioned above the opening and extending into the receiving recess to fluidly communicate with the channel; A cannula that is at least partially positioned within a barrel and extends through a stopper, and is configured to have a fluid coupling component positioned to communicate fluidly with a channel; and, To provide a syringe assembly comprising a closure assembly fixed to a fluid coupling component, the closure assembly comprising a sealing member configured to seal the lumen of the fluid coupling component and contain a solution within the syringe chamber; Removing the closure assembly from the fluid coupling component; Connecting the fluid coupling component to the access port of the vascular access device to establish fluid communication between the syringe assembly and the vascular access device; Advance the plunger assembly distally to flush the vascular access device with the solution; Obtaining the amount of blood to be diverted or discarded through the operation of the syringe assembly; and, A method comprising obtaining a sample blood volume through the operation of a syringe assembly, following obtaining a volume of blood to be reused or discarded.

15. The closure assembly further comprises an end cap configured to engage with a fluid coupling component, and a scrubbing cap fixed to the distal end of the end cap. The fluid path seal is located inside the end cap. The aforementioned scrubbing cap is A housing fixed to the distal end and defining the recess; Scrubbing inserts placed in recesses; and, A seal mounted on a recess for sealing a scrubbing insert within the recess; Before removing the closure assembly from the fluid coupling component, Furthermore, position the scrubbing cap on the access port of the vascular access device so that the scrubbing insert is in contact with the access port; and, Includes cleaning the access port with a scrubbing insert; The method according to claim 14.

16. The method according to claim 14, wherein obtaining the amount of blood to be diverted or discarded is further comprising housing the plunger assembly proximal within the barrel and aspirating the amount of blood to be diverted or discarded into the chamber of the barrel.

17. The method according to claim 14, comprising: retracting the plunger assembly in the proximal direction, aspirating a volume of blood to be diverted or discarded into the barrel chamber, and then locking the plunger in a predetermined position relative to the barrel.

18. Obtaining the aforementioned amount of blood to be diverted or discarded is, To place a container within a receiving recess, and for the container to define an empty storage container within it; Engaging the container with a fluid access component to draw the amount of blood to be diverted or discarded into an empty storage container; and, The method according to claim 14, further comprising removing the container from the receiving recess.

19. Obtaining the aforementioned sample blood volume is, To place a container within a receiving recess, and for the container to define the empty storage container within it; The method according to claim 14, further comprising engaging a container with a fluid access component to draw a volume of diverted or discarded blood into an empty storage container.

20. The method according to claim 14, wherein the fluid access component comprises a needle having a lumen therein, and engaging the container with the fluid access component comprises puncturing the cover of the container with the needle and partially positioning the needle inside the storage container.

21. The method according to claim 14, further comprising advancing the plunger assembly distally to flush the vascular access device with a solution, and then locking the plunger in place relative to the barrel.

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