Blood sample collection system with a flow-distributing syringe with an integrated scrub cap.

Abstract

Provided herein is a blood collection system including a syringe assembly and a container. The syringe assembly includes a syringe having a chamber and a fluid connector component, and a plunger assembly including an adapter member, a receiving cavity, and a fluid access component. The adapter member includes a stopper that is slidable within the barrel and a channel extending between the stopper and the opening of the receiving cavity, and the fluid access component is positioned above the opening and extends into the receiving cavity. A cannula is fixed within the fluid connector component and extends proximal through the stopper to fluidly connect the fluid connector component to the channel. A scrub cap is fixed within the fluid connector component, which includes a housing that defines a cavity in which a scrub insert is placed. A container is configurable within the receiving cavity and can engage with the fluid access component.

Description

Technical Field

[0001] This application claims priority to U.S. Provisional Application No. 63 / 461,685, filed on April 25, 2023, entitled "Blood Sample Collection System with Diversion Syringe Having an Integrated Scrubbing Cap", the entire disclosure of which is incorporated herein by reference.

[0002] The present disclosure relates to a blood collection system that includes a diversion syringe with an integrated scrubbing cap.

Background Art

[0003] Catheters are generally used to administer fluid to a barrel and draw fluid (i.e., blood) from a barrel, and patients in various settings, including hospitals and home care, are administered such fluid or have blood drawn through a vascular access device (VAD) that includes such a catheter inserted into the patient's vasculature. A typical VAD includes a plastic catheter inserted into a patient's vein, and the length of the catheter can vary, for example, from a few centimeters if the VAD is a peripheral intravenous catheter (PIVC) to several tens of centimeters if the VAD is a central venous catheter (CVC). The VAD can be for short-term (days), moderate-term (weeks), or long-term (months to years) indwelling.

[0004] In some applications, VADs are used for collecting blood samples in connection with performing blood cultures. Blood cultures are often used as a tool to detect the presence of bacteria or fungi in a patient's blood sample, identify the types of bacteria or fungi present, and direct the patient's treatment. Current practice for collecting venous blood samples for blood culture testing involves venipuncture using a blood collection set equipped with an attached Luer Lock Access Device (LLAD). During the insertion process, the venipuncture device can pick up microorganisms from the skin and the insertion process, and later transfer such microorganisms to the blood culture sample, potentially leading to a false-positive test result for sepsis. To minimize the risk of false positives, a discard sample is typically taken to remove the initial volume of blood that is more likely to contain microorganisms from the skin, such as discarding the first 0.1–10 ml of collected blood.

[0005] Some conventional devices offer a syringe integrated with a Luer Adapter (LLAD) that allows for inline diversion of the initial blood volume by housing the syringe plunger. Once the initial blood volume is diverted and isolated, the blood culture sample collection container is connected to the LLAD, allowing the blood culture sample to flow into the container. While this addresses some of the risks of false-positive blood culture samples, it fails to address the risk that the clinician may not disinfect the VAD access port, or disinfect it ineffectively, before connecting the blood collection device to it. Specifically, clinicians often use alcohol wipes to scrub and disinfect the access port before connecting the LLAD to the access port, but the use of alcohol wipes to scrub and disinfect the access port is often not fully effective in disinfecting all internal / external surfaces of the access port, including the complex threaded area around its luer portion that (potentially) connects to the LLAD. Furthermore, in some cases, clinicians may forget to wipe the access port before connecting the LLAD. Inadequate disinfection of the access port can result in false-positive blood culture samples.

[0006] Therefore, in this field, there is a need for means to ensure that clinicians effectively disinfect the access port of the VAD before attaching a blood collection device thereto. [Overview of the Initiative]

[0007] Provided herein is a blood collection system comprising a syringe assembly and a container. The syringe assembly comprises a syringe having a distal end and a proximal end, the syringe defining a chamber and having a fluid connector component at the distal end. The syringe assembly also comprises a plunger assembly comprising an adapter member, a receiving cavity, and a fluid access component. The adapter member has a distal end that is insertable into the proximal end of the syringe and includes a stopper that is slidable within the barrel, and a channel that extends along its length between the stopper and the opening of the receiving cavity. The fluid access component is positioned above the opening and extends into the receiving cavity. The syringe assembly further comprises a cannula having a distal end and a proximal end, the distal end of which is fixed within the fluid connector component, the cannula extending proximal through the stopper and positioned to fluidly communicate the fluid connector component with the channel and the fluid access component. The syringe assembly further includes a scrub cap fixed to the fluid connector component of the syringe, the scrub cap including a housing fixed to the fluid connector component and defining a cavity, and a scrub insert positioned within the cavity. The container defines a reservoir and is positionable within the receiving cavity and is engageable with a fluid access component for transferring fluid to the reservoir.

[0008] In some embodiments, the scrub insert comprises an elastic material into which an antimicrobial solution or antimicrobial agent is absorbed, configured to disinfect the surface of the access port of a vascular access device.

[0009] In some embodiments, the scrub cap includes a seal mounted on top of the cavity to seal the scrub insert inside the cavity.

[0010] In some embodiments, the fluid connector component includes a Luer connector configured to connect to an access port or needleless connector of a vascular access device, and the housing includes a connector portion configured to engage with the Luer connector to secure the scrub cap to the syringe assembly.

[0011] In some embodiments, the luer connector comprises one of a slip luer, a screw-in luer, or a luer lock with a collar.

[0012] In some embodiments, the housing includes a connector portion configured to secure a scrub cap to a fluid connector component via a torsion-type engagement, and the scrub cap is removable so that the syringe assembly can be connected to an access port or needleless connector of a vascular access device.

[0013] In some embodiments, the fluid access component comprises a needle defining a lumen therein, and the container comprises a cover that can be pierced by the needle to position the reservoir so as to be in fluid communication with the channel of the plunger assembly.

[0014] In some embodiments, the fluid access component includes a female Luer connector, and the vessel includes a male Luer connector that can engage with the female Luer connector, with the reservoir positioned to communicate fluidly with the channel of the plunger assembly.

[0015] In some embodiments, the fluid connector component includes an opening formed therein, the cannula is placed within the opening, and the cannula has a cross-section smaller than the opening.

[0016] In some embodiments, the gap between the outer diameter of the opening and the cannula forms a first fluid path from the fluid connector component to the fluid chamber defined by the distal end of the stopper and the inner surface of the distal end of the syringe, and the cannula forms a second fluid path from the fluid connector component to the fluid access component.

[0017] Furthermore, this specification provides a syringe assembly including a syringe having a distal end and a proximal end, the syringe defining a chamber and having a fluid connector component at the distal end. The syringe assembly also includes a plunger assembly including an adapter member, a receiving cavity, and a fluid access component. The adapter member is insertable into the proximal end of the syringe and has a distal end including a stopper that is slidable within the barrel and a channel that extends along its length between the stopper and the opening of the receiving cavity. The fluid access component is positioned above the opening and extends into the receiving cavity. The syringe assembly further includes a cannula having a distal end and a proximal end, the distal end of the cannula fixed within the fluid connector component, the cannula extending proximal through the stopper and positioned to fluidly communicate the fluid connector component with the channel and the fluid access component. The syringe assembly further includes a scrub cap fixed to the fluid connector component of the syringe, the scrub cap being fixed to the fluid connector component and including a housing that defines a cavity and a scrub insert positioned within the cavity.

[0018] In some embodiments, the scrub insert includes an elastic material containing an antimicrobial solution or antimicrobial agent that is absorbed therein.

[0019] In some embodiments, the scrub cap includes a seal mounted on top of the cavity to seal the scrub insert inside the cavity.

[0020] In some embodiments, the fluid connector component includes a Luer connector configured to connect to an access port or needleless connector of a vascular access device, and the housing includes a connector portion configured to engage with the Luer connector to secure the scrub cap to the syringe assembly.

[0021] In some embodiments, the connector portion of the housing secures the scrub cap via a twist-type engagement, and the scrub cap is removable so that the syringe assembly can be connected to an access port or needleless connector of a vascular access device.

[0022] Furthermore, a method for using a blood sample collection system is provided herein. This method comprises providing a syringe assembly comprising a syringe having a distal end and a proximal end, the syringe defining a chamber and having a fluid connector component at the distal end. The syringe assembly also comprises a plunger assembly comprising an adapter member, a receiving cavity, and a fluid access component. The adapter member has a distal end that is insertable into the proximal end of the syringe and includes a stopper that is slidable within the barrel, and a channel that extends along its length between the stopper and the opening of the receiving cavity. The fluid access component is positioned above the opening and extends into the receiving cavity. The syringe assembly further comprises a cannula having a distal end and a proximal end, the distal end of the cannula fixed within the fluid connector component, the cannula extending proximal through the stopper and positioned to fluidly communicate the fluid connector component with the channel and the fluid access component. The syringe assembly further includes a scrub cap fixed to the fluid connector component of the syringe, the scrub cap including a housing fixed to the fluid connector component and defining a cavity, and a scrub insert positioned within the cavity. The method also includes the steps of positioning the scrub cap over the access port of a vascular access device so that the proximal connector contacts the scrub insert, and cleaning the access port with the scrub insert.

[0023] In some embodiments, the fluid connector component includes a Luer connector configured to couple with an access port, and the scrub cap includes a connector portion that engages with the Luer connector to secure the scrub cap to the syringe.

[0024] In some embodiments, the method further includes removing the scrub cap from the luer connector after cleaning the access port and coupling the luer connector to the access port to fluidly connect the syringe assembly to the vascular access device.

[0025] In some embodiments, the scrub cap includes a seal attached over the cavity to seal a scrub insert within the cavity, and the method further includes removing the seal from the scrub cap, placing the scrub cap over the access port of the vascular access device, and bringing the scrub insert into contact with the access port.

[0026] In some embodiments, cleaning the access port includes applying a torsional movement to the blood sample collection system. BRIEF DESCRIPTION OF THE DRAWINGS

[0027] [Figure 1] FIG. 1 is a side view of a blood sample collection system including a syringe assembly and a blood collection container, according to one embodiment. [Figure 2] FIG. 2 is a detailed view of notch "A" of the syringe assembly of FIG. 1, according to one embodiment. [Figure 3] FIG. 3 is a front view of the syringe assembly of FIG. 1 with the scrub cap removed therefrom. [Figure 4] FIG. 4 is an exploded view of the scrub cap included in the blood sample collection system of FIG. 1, according to one embodiment. [Figure 5] FIG. 5 is a side view of the blood sample collection system of FIG. 1 showing process steps for using the system with an associated catheter assembly, according to one embodiment. [Figure 6] FIG. 6 is a side view of the blood sample collection system of FIG. 1 showing process steps for using the system with an associated catheter assembly, according to one embodiment. [Figure 7]Figure 7 is a side view of the blood sample collection system of Figure 1, showing process steps for using the system with an associated catheter assembly according to one embodiment. [Figure 8] Figure 8 is a side view of the blood sample collection system of Figure 1, showing process steps for using the system with an associated catheter assembly according to one embodiment. [Figure 9] Figure 9 is a detailed view of the notch "B" of the syringe assembly and catheter assembly in Figure 8, according to one embodiment. [Figure 10] Figure 10 is a side view of a syringe assembly according to another embodiment. [Modes for carrying out the invention]

[0028] The following description is provided to enable those skilled in the art to create and use the described embodiments intended for carrying out the invention. However, various modifications, equivalents, variations, and substitutions will remain immediately obvious to those skilled in the art. Any and all such modifications, variations, equivalents, and substitutions are intended to fall within the spirit and scope of this disclosure.

[0029] Hereinafter, for explanatory purposes, “top,” “bottom,” “right,” “left,” “vertical,” “horizontal,” “top,” “bottom,” “horizontal,” “vertical,” and their derivatives shall be considered as relating to the present invention as oriented in the drawings. However, it will be understood that the present invention may presuppose various alternative modifications unless explicitly specified otherwise. It should also be understood that the specific devices shown in the accompanying drawings and described below are merely exemplary embodiments of the present invention. Therefore, specific dimensions and other physical features relating to the embodiments disclosed herein should not be considered limiting.

[0030] In this disclosure, the distal end of a component or device means the end furthest from the user's hand when the component or device is in use, i.e., when the user is holding the blood collection device while preparing for or using it, 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 connector portion of the fluid transfer device, and the terms “proximal direction” and “proximal” mean the direction opposite to the direction of the connector.

[0031] It should be understood that, although not shown or described herein, the blood sample collection 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® Pro Safely Shielded IV Catheter System, BD NEOFLON® IV Cannula System, BD INSYTE® AUTOGUARD® BC Shielded IV Catheter System, or any other suitable vascular access device.

[0032] Embodiments of this disclosure are primarily described in the context of blood sample collection systems for use with peripheral IV catheters (PIVCs), midline, PICC, and centralline catheters. However, embodiments of this disclosure are equally extendable to use with other catheter devices.

[0033] Referring to Figures 1-3, the blood sample collection system 10 is shown in accordance with aspects of this disclosure. The system 10 includes 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, the blood sample collection system 10 may be used by a user (e.g., a clinician) to first obtain an initial waste sample of blood in the syringe assembly 12 and then obtain a blood culture sample in the blood collection container 14 that can be analyzed to detect the presence of bacteria or fungi.

[0034] As shown in Figure 1, the syringe assembly 12 may generally be characterized to include a syringe 16, a plunger assembly 18, and a cannula 20. The syringe 16 may be configured as a generally cylindrical barrel 22, including a distal end 24 and a proximal end 26, having a fluid connector component 28 at the distal end 24 and a finger grip 30 at the proximal end 26. According to embodiments, the fluid connector component 28 may be integrated with the distal end 24 of the barrel 22 or may be detachably coupled to the distal end 24 of the barrel 22. According to embodiments, the fluid connector component 28 may include any suitable component configured to connect the barrel 22 to a connector or access port of a vascular access device (VAD). For example, in some embodiments, the fluid connector component 28 may be a Luer connector. The Luer connector may take the form of, for example, a slip Luer, a threaded Luer, or a Luer lock with a collar. In some embodiments, the fluid connector component 28 may be the outlet of the barrel 22 defining a lumen.

[0035] The plunger assembly 18 includes an adapter member 32, a stopper 34, a receiving cavity 36, a fluid access component 38, and a finger grip 40. In one embodiment, the adapter member 32, the receiving cavity 34, and the finger grip 40 are a single, integrated component. For example, the adapter member 32, the receiving cavity 34, and the finger grip 40 may be formed as a molded part. Alternatively, the adapter member 32, the receiving cavity 34, and the finger grip 40 may be manufactured individually and then connected to each other.

[0036] As shown in Figure 1, the adapter member 32 is formed as a generally elongated member that can be inserted into a chamber 42 defined by the barrel 22 of the syringe 16, and the adapter member 32 has a distal end 44 and a proximal end 46. The channel 48 is formed within the adapter member 32, extending its length. In one embodiment, the channel 48 tapers along its length, and the diameter of the channel 48 increases as the channel 48 extends from the distal end 44 to the proximal end 46. The proximal end 46 of the channel 48 includes an opening 50 that transitions into a receiving cavity 36.

[0037] According to aspects of the present disclosure, the fluid access component 38 is positioned within the opening 50 at the proximal end 46 of the channel 48. The fluid access component 38 is fixed within the opening 50 and may extend from the proximal end 46 of the channel 48 into the interior of the receiving cavity 36. In one embodiment, the fluid access component 38 may include a needle 52 that defines a lumen. In some embodiments, the fluid access component 38 may include a flexible needle sheath (not shown) that substantially surrounds the needle 52 and is configured to translate relative to the needle 52, so that the proximal end of the needle 52 can be selectively exposed.

[0038] The stopper 34 of the plunger assembly 18 is positioned at the distal end 44 of the adapter member 32 so as to be movable together with the adapter member 32 within the chamber 42 of the syringe barrel 22. The stopper 34 may be made of a different material from the material of the adapter member 32 and may form a seal with the syringe barrel 22 as the syringe barrel 22 moves forward through it. In some embodiments, the stopper 34 includes a receptacle (not shown) formed therein, sized and configured to receive a flanged extension member 50 formed at the distal end 44 of the adapter member 32, the flanged extension member may be coupled to the receptacle, for example, via a press-fit connection, thereby fixing the stopper 34 to the adapter member 32; however, by other techniques known in the art, it may be understood that the stopper 34 may be fixed at the distal end 44 of the adapter member 32.

[0039] Referring further to Figures 1-3, it is shown that the cannula 20 is incorporated into the syringe assembly 12 by being positioned within the syringe 16 and plunger assembly 18. The cannula 20 is provided in the syringe assembly 12 such that its distal end 54 is positioned substantially at the same height as the opening 56 in the fluid connector component 28 of the syringe 16, as best shown in Figure 2, and the cannula 20 extends proximal from the fluid connector component 28, passing through a portion of the chamber 42 of the barrel 22, through a hole formed in the stopper 34, and into a channel 48 formed in the adapter member 32. In some embodiments, the cannula 20 may be recessed behind the opening 56 of the fluid connector component 28, and this recessed configuration provides the syringe assembly 12 with compatibility with needleless connectors, Luer-operated valves, and / or IV connectors, which may have internal spikes or similar protrusions intended for insertion into the fluid connector component 28 for function.

[0040] As shown in Figure 3, the cannula 20 has a cross-section smaller than the opening 56 at the tip of the fluid connector component 28, allowing fluid to flow through the gap 58 between the outer surface of the cannula 20 and the inner surface of the opening 56. According to one embodiment, the cannula 20 is fixed to the fluid connector component 28 so as not to obstruct the flow of fluid through the gap 58. In one embodiment, the cannula 20 is fixed to the fluid connector component 28 via one or more retaining features of the fluid connector component 28, which may include a flange, strut, wing, inclined flange, or other mechanical structure (not shown) extending between the inner surface of the fluid connector component 28 and the outer surface of the cannula 20. In another embodiment, the cannula 20 may be fixed to the fluid connector component 28 using adhesive, heat bonding, or other suitable means.

[0041] Once the cannula 20 is sized and positioned relative to the syringe 16 and plunger assembly 18 as described above, a separate fluid path is provided to the syringe assembly 12 through which blood can be drawn into the system 10. The (first) fluid path 60 is formed through a gap 58 between the outer surface of the cannula 20 and the inner surface of the opening 56, through which the fluid (i.e., blood) can flow from the fluid connector component 28 into a portion of the chamber 42 in the barrel 22, i.e., the fluid chamber defined by the distal surface of the stopper 34 and the inner surface of the distal end 24 of the barrel 22. The (second) fluid path 62 is provided through the cannula 20 through which the fluid (i.e., blood) can flow from the fluid connector component 28 into a channel 48 of the adapter member 32, through which the fluid is then transportable from the channel 48 and transportable through the fluid access component 38 to the container 14.

[0042] Referring again to Figure 1, the container 14 may have one of several structures that allow the container 14 to be inserted into the receiving cavity 36 (defined by a cylindrical wall structure 64). While Figure 1 shows the container 14 as a necked vial, it should be noted that the container 14 may, in non-limiting examples, be supplied as a tube or other suitable receptacle, such as the BD Vacutainer® from Becton, Dickinson and Co. The container 14 includes a cover 66 and a fluid reservoir 68, the cover 66 being located at the distal end of the container 14. In some embodiments, the cover 66 may include a resealable membrane configured to allow a fluid access component, such as a fluid access component 38, to penetrate the resealable membrane to achieve fluid communication with the reservoir 68. The resealable membrane of the cover 66 may be configured to reseal when the fluid access component 38 is detached from the cover 66 so that the reservoir 68 is fluidly isolated from areas outside the container 14. The reservoir 68 can be a vacuum reservoir 68, such that when the reservoir 68 is positioned to be in fluid communication with a fluid source (for example, by penetrating a resealable membrane of the cover 66 using a fluid access component fluidly coupled to the patient's vascular system), the pressure difference between the reservoir 68 and the fluid source can draw fluid (e.g., blood) into the reservoir 68.

[0043] According to aspects of this disclosure, when the blood sample collection system 10 is first connected to the VAD access port, such as via the coupling of the fluid connector component 28 to the access port, it is recognized that it is desirable to disinfect the access port before connecting the blood sample collection system 10 thereto. That is, it is desirable to clean and sterilize the access port before engaging the fluid connector component 28 (for example, via the mating of the female and male Luer connectors) to prevent microbial intrusion and the possibility of catheter-associated bloodstream infection (CRBSI).

[0044] According to aspects of this disclosure, a scrubbing cap 70 is integrated with the syringe assembly 12 to provide cleaning and sterilization of the access port before the system 10 engages with the access port. The scrubbing cap 70 is fixed to a fluid connector component 28 and is configured to engage with the access port to allow cleaning and sterilization of its internal and / or external surfaces via twisting and scrubbing motion between the scrubbing cap 70 and the access port. The scrubbing cap 70 may be removed from the fluid connector component 28 upon completion of cleaning and sterilization of the access port, thereby enabling subsequent coupling of the fluid connector component 28 to the access port and the execution of blood collection via the operation of the system 10 as described above.

[0045] As shown in Figures 1 and 2 and further in Figures 4 and 5, the scrub cap 70 includes a cap housing 72, a scrub insert 74, and a peelable seal 76. The housing 72 may be a structure manufactured by integrally forming by injection molding and may be made of an alcohol-compatible material such as polypropylene or polyethylene. The housing 72 can generally be described as including a holder portion 78 that holds the insert 74 therein and a connector portion 80 configured to mate with a fluid connector component 28 of the blood sample collection system 10.

[0046] The holder portion 78 may have a cup shape formed by a base 82 and a side wall structure 84 defining an opening 86 at one end thereof. The side wall structure 84 is integrally formed with the base 82 to define a cavity 88 configured to receive an insert 74 therein. In some embodiments, the cavity 88 may have a cylindrical cross-sectional shape and may have a depth suitable for receiving the insert 74 into a recess. However, the holder portion 78 and the cavity 88 defined therein can be other shapes, including square, hexagon, etc., and it is understood that the holder portion 78, its cavity 88, and the insert 74 placed therein can be configured in shape and size so that the scrub cap 70 can be configured in shape and size so as to enable cleaning of a particular size and configuration of a medical device (i.e., the catheter connector 20 of the catheter assembly 12) in which the scrub cap 70 is used.

[0047] The holder portion 78 may be sized such that when the insert 74 is fitted into the cavity 88, the cavity 88 defined by the side wall structure 84 compresses the insert 74 and holds it therein. The insert 74 may also be bonded to the bottom of the holder portion 78 (i.e., to the base 82) using a suitable hot melt adhesive or other suitable adhesive, but it is recognized that other suitable methods, including mechanical fastening, may also be used to secure the insert 74 to the holder portion 78. An annular lip 90 may be formed in the holder portion 78 (i.e., on the side wall structure 84) around the opening 86 to define a land for receiving a seal 76, which, in cooperation with the annular lip 90, seals the opening 86 of the cavity 88 and holds the insert 74 therein. The seal 76 seals the cavity 88 of the holder portion 78 and the insert 74 therein from contamination from the external environment, providing a leak-proof barrier, thereby protecting the contents of the insert 74 and maintaining a sealed, sterile environment. The seal 76 provides sufficient sealing over a range of temperature, pressure, and humidity levels and, according to the embodiment, may be formed as an aluminum or multilayer polymer film peel-back top. In some embodiments, the seal 76 is heat-sealed or induction-sealed to the open end of the scrub cap 70. The seal 76 may include a tab 92 to facilitate the operation and removal of the seal 76 from the scrub cap 70.

[0048] The insert 74 is composed of, for example, a foamed material in an injection-molded structure, or the insert 74 may be die-cut from a foamed sheet. The insert contains a cleaning substance impregnated therein (while inside the holder portion 78), such as a solution of a suitable bactericide (microbiocide) or disinfectant (germicide). The cleaning substance may contain any suitable type and amount of antimicrobial disinfectant depending on the size of the foam material insert. For example, in one embodiment, an aqueous solution containing about 0.20 cc to about 0.75 cc of about 2 volume percent (2%) chlorhexidine gluconate (chlorhexidine solution, "CHG") is used. Optionally, a solution containing about 0.50 cc is used. In another embodiment, the cleaning substance contains a solution containing about 70 percent (70%) isopropyl alcohol ("IPA") in an aqueous solution. In yet another embodiment, the cleaning 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 the latter solution, it is recognized that in one embodiment, the concentration of IPA may be in the range of about 60 percent to about 90 percent, and the concentration of CHG may be in the range of about 1 percent to about 5 percent. Other suitable solution compositions and concentrations are also possible. For example, in one embodiment, a povidone-iodine or hydrogen peroxide solution may be included as the cleansing substance.

[0049] According to aspects of the present disclosure, the insert 74 may be configured (e.g., molded) to have a predetermined shape that conforms to the unique shape of the VAD access port or connector to be cleaned by it. The insert 74 may further have any of several structures that provide effective cleaning of the port / connector, for example, a patterned or rough top surface and / or gaps or slits formed in its foam material that allow the insert 74 to better deform / conform to the inner and outer surfaces of the port / connector.

[0050] The connector portion 80 of the scrub cap 70 extends proximal to the holder portion 78 and is configured to mate with the fluid connector component 28 to secure the scrub cap 70 therein. According to one embodiment, the connector portion 80 may be configured as a Luer connection (e.g., a male Luer connection or a female Luer connection) that allows the connector portion 80 to mate with a corresponding Luer connection provided by the fluid connector component 28 so that the connector portion 80 is secured in place relative to the fluid connector component 28.

[0051] The use of System 10 will be described according to one aspect of the present disclosure, as shown in Figures 5-8. The use of System 10 begins with a syringe assembly 12 in an initial configuration as shown in Figure 5, where the scrub cap 70 is fixed to the fluid connector component 28 of the syringe 16, and the scrub cap 70 is in a sealed state (i.e., the seal 76 is fixed to the housing 72 to seal off the scrub insert 74). The use of System 10 continues by removing the seal 76 from the scrub cap 70 of the syringe assembly 12 to provide access to the scrub insert 74, as shown in Figure 6. After removing the seal 76, the syringe assembly 12 is brought close to the catheter assembly 100 to provide cleaning and sterilization of the access port thereto. In the non-limiting embodiments shown in Figure 7, the catheter assembly 100 includes a catheter adapter 102 and an associated catheter 104 (which can be inserted into the patient's vascular system), as well as a connector 106 coupled (e.g., via a fluid conduit 110) to an adapter port 108 on the catheter adapter 102. The connector 106 may be a t-connector (e.g., one lateral port positioned at a 90-degree angle to the longitudinal axis of the connector 106), a y-connector (e.g., one lateral port positioned at a 25-degree, 60-degree, or 75-degree angle to the longitudinal axis of the connector 106), or any other type of connector known in the art. In some embodiments or aspects, the connector 106 may have a Luer connector or a needle-free access connector 112 coupled to its proximal end, the needle-free access connector 112 providing the catheter assembly 100 with a patient-closed access port.

[0052] As shown in Figure 7, as the syringe assembly 12 approaches the catheter assembly 100, the scrub cap 70 is positioned on the connector 112 (see Figure 9, which may be configured as a female Luer connector with a threaded outer connection 114 defining a tapered lumen or cavity 116, in a non-limiting embodiment), and the foam insert 74 is pushed onto the connector 112 by the user. At this time, a portion of the insert 74 fits around the connector 112 (i.e., around the threaded outer connection 114 and in the lumen 116) and / or is inserted into the connector 112. Once a portion of the connector 112 is inserted into the foam insert 74 of the scrub cap 70, the scrub cap 70 rotates relative to the connector 112. For example, the user may rotate the blood sample collection system 10 while keeping the connector 112 stationary. Once the scrub cap 70 is secured in place relative to the blood sample collection system 10 via the connection of the fluid connector component 28 to the scrub cap 70, rotation of the blood sample collection system 10 causes a corresponding rotation of the scrub cap 70. The rotation of the scrub cap 70 relative to the connector 112 may be entirely in one direction, or it may be a back-and-forth twisting motion. The scrub cap 70 is rotated a sufficient number of times relative to the connector 112 to sufficiently kill any bacteria that the solution-impregnated foam insert 74 comes into contact with, and / or to remove any biofilm from the outer surface of the connector 112 and the threaded outer connection 114, as well as the inner surface of the lumen 116 of the connector 112. In this way, both the outer surface and the lumen surface of the connector 112 are scrubbed by the insert 74, and the cleaning substance within it disinfects the surface and removes any biofilm that has settled thereon.

[0053] Once the cleaning and sterilization of the connector 112 of the catheter assembly 100 via the scrub cap 70 is complete, the scrub cap 70 is separated from the connector 112. The scrub cap 70 may then be removed from the fluid connector component 28 of the system 10. After drying the connector 112, the blood sample collection system 10 may then be connected to the catheter assembly 100 by coupling the fluid connector component 28 to the connector 112, as shown in Figure 8, thereby connecting the system 10 to the catheter assembly 100.

[0054] According to one aspect of the present disclosure, when the blood sample collection system 10 is connected to the catheter assembly 100, the first waste blood sample may be drawn into the syringe assembly 12. That is, the syringe assembly 12 may be actuated from an initial configuration to a diversion or waste configuration such that the plunger assembly 18 is pulled back proximal to the syringe 16 and the stopper 34 moves proximal within the syringe barrel 22. As shown in Figure 8, when the stopper 34 moves proximal within the syringe barrel 22, the waste (or diversion) amount of blood is drawn into a portion of the chamber 42, i.e., the fluid chamber defined by the distal surface of the stopper 34 and the inner surface of the distal end 24 of the barrel 22, and the blood flows into the portion of the chamber 42 along a first fluid path (through the gap 58) from the fluid connector component 28.

[0055] Once a sufficient amount of waste blood sample has been collected, the blood sample collection system 10 can then be operated to obtain a desired blood culture sample in the blood collection container 14. To obtain such a sample, the blood collection container 14 engages with the syringe assembly 12, and the blood collection container 14 (e.g., a vacuuminer) is placed in the receiving cavity 36 and engages with the fluid access component 38 to position the container 14 in fluid communication with the plunger assembly 18. That is, once the blood collection container 14 is positioned / connected with the receiving cavity 36 and the fluid access component 38, a second fluid path is formed from the connector component 28 to the blood collection container 14, and the cannula 20 transfers the blood from the connector component 28 to the channel 48 in the adapter member 32, and the blood passes from the channel 48 through the fluid access component 38 to the container 14. As described above, in some embodiments, the fluid access component 38 is provided as a needle 52 in which a lumen is formed, and the needle 52 penetrates the cover 66 of the container 14 so that blood is drawn into a vacuum reservoir 68 in the container 14.

[0056] The blood sample collection system 10 is shown and described in Figures 1–8 according to a particular embodiment, but it is recognized that the system 10 (and its syringe assembly 12) may have other suitable configurations. Figure 10 shows a syringe assembly 94 according to another aspect of the present disclosure. The syringe assembly 94 is substantially the same as the syringe assembly 12 previously shown and described in Figures 1–8, except that the fluid access component 38 is provided as a closure connector 96, such as a closure system female Luer connector as provided in Figure 10, rather than as a needle 52. The closure system female Luer connector 96 is configured to accept and mate with the associated male Luer connector of a blood collection container to provide collection of a blood sample in the blood collection container when the container (not shown) is connected to the syringe assembly 94.

[0057] Several embodiments of blood sample collection systems configured to collect blood while a catheter is in place are described in the detailed description above, but those skilled in the art can modify and change these embodiments without departing from the scope and spirit of the invention. Therefore, the description above is intended to be illustrative rather than restrictive. The invention as described above is defined by the appended claims, and all modifications to the invention that fall within the meaning and equivalence of the claims are encompassed within those scopes.

Claims

1. Syringe assembly, A syringe having a distal end and a proximal end, wherein the syringe defines a chamber and a fluid connector component at the distal end, A plunger assembly comprising an adapter member, a receiving cavity, and a fluid access component, wherein the adapter member is insertable into the proximal end of the syringe and has a distal end including a stopper slidable within its barrel, the adapter member includes a channel extending along its length between the stopper and the opening of the receiving cavity, and the fluid access component is positioned above the opening and extends into the receiving cavity, A cannula having a distal end and a proximal end, wherein the distal end of the cannula is fixed within the fluid connector component, and the cannula extends proximal through the stopper, positioning the fluid connector component to be in fluid communication with the channel and the fluid access component, A scrub cap fixed to the fluid connector component of the syringe, wherein the scrub cap is A housing fixed to the aforementioned fluid connector component and defining a cavity, A scrub insert is placed within the cavity, Includes a scrub cap, A container defining a reservoir, wherein the container is capable of being positioned within the receiving cavity and is capable of engaging with the fluid access component for transferring fluid into the reservoir, A blood collection system, including a blood collection system.

2. The system according to claim 1, wherein the scrub insert comprises an elastic material containing an antimicrobial solution or an antimicrobial agent absorbed therein, configured to disinfect the surface of the access port of a vascular access device.

3. The system according to claim 2, wherein the scrub cap comprises a seal mounted on the cavity to seal the scrub insert within the cavity.

4. The system according to any one of claims 1 to 3, wherein the fluid connector component includes a Luer connector configured to be coupled to an access port or needleless connector of a vascular access device, and the housing includes a connector portion configured to engage with the Luer connector to secure the scrub cap to the syringe assembly.

5. The system according to claim 4, wherein the lure connector comprises one of a slip lure, a threaded lure, or a collared lure lock.

6. The system according to claim 1, wherein the housing includes a connector portion configured to secure the scrub cap to the fluid connector component via a torsion-type engagement, and the scrub cap is removable so that the syringe assembly can be connected to an access port or needleless connector of a vascular access device.

7. The system according to claim 1, wherein the fluid access component includes a needle defining a lumen therein, and the container comprises a cover that can be penetrated by the needle to position the reservoir in fluid communication with the channel of the plunger assembly.

8. The system according to claim 1, wherein the fluid access component includes a female Luer connector, and the vessel includes a male Luer connector that engages with the female Luer connector to position the reservoir in fluid communication with the channel of the plunger assembly.

9. The system according to claim 1, wherein the fluid connector component includes an opening formed therein, the cannula is positioned within the opening, and the cannula has a cross-section smaller than the opening.

10. The system according to claim 9, wherein the gap between the outer diameter of the opening and the cannula forms a first fluid path from the fluid connector component to a fluid chamber defined by the distal end of the stopper and the inner surface of the distal end of the syringe, and the cannula forms a second fluid path from the fluid connector component to the fluid access component.

11. Syringe assembly, A syringe having a distal end and a proximal end, wherein the syringe defines a chamber and a fluid connector component at the distal end, A plunger assembly comprising an adapter member, a receiving cavity, and a fluid access component, wherein the adapter member is insertable into the proximal end of the syringe and has a distal end including a stopper slidable within its barrel, the adapter member includes a channel extending along its length between the stopper and the opening of the receiving cavity, and the fluid access component is positioned above the opening and extends into the receiving cavity, A cannula having a distal end and a proximal end, wherein the distal end of the cannula is fixed within the fluid connector component, the cannula extends proximal through the stopper and into the channel, and the fluid connector component is positioned to be in fluid communication with the fluid access component, A scrub cap fixed to the fluid connector component of the syringe, wherein the scrub cap is A housing fixed to the aforementioned fluid connector component and defining a cavity, A scrub insert is placed within the cavity, Syringe assembly, including

12. The syringe assembly according to claim 11, wherein the scrub insert comprises an elastic material in which an antimicrobial solution or antimicrobial agent is absorbed.

13. The syringe assembly according to claim 11, wherein the scrub cap comprises a seal mounted on the cavity to seal the scrub insert within the cavity.

14. The syringe assembly according to claim 11, wherein the fluid connector component includes a Luer connector configured to connect to an access port or needleless connector of a vascular access device, and the housing includes a connector portion configured to engage with the Luer connector to secure the scrub cap to the syringe assembly.

15. The syringe assembly according to claim 14, wherein the connector portion of the housing secures the scrub cap via a twist-type engagement, the scrub cap is removable, and the syringe assembly is connected to the access port or needleless connector of the vascular access device.

16. A step of providing a syringe assembly, A syringe having a distal end and a proximal end, wherein the syringe defines a chamber and a fluid connector component at the distal end, A plunger assembly comprising an adapter member, a receiving cavity, and a fluid access component, wherein the adapter member is insertable into the proximal end of the syringe and has a distal end including a stopper slidable within its barrel, the adapter member includes a channel extending along its length between the stopper and the opening of the receiving cavity, and the fluid access component is positioned above the opening and extends into the receiving cavity, A cannula having a distal end and a proximal end, wherein the distal end of the cannula is fixed within the fluid connector component, the cannula extends proximal through the stopper and into the channel, and the fluid connector component is positioned to be in fluid communication with the fluid access component, A scrub cap fixed to the fluid connector component of the syringe, wherein the scrub cap is A housing fixed to the aforementioned fluid connector component and defining a cavity, A scrub insert is placed within the cavity, Includes a scrub cap, The steps include providing a syringe assembly, The steps include positioning the scrub cap over the access port of the vascular access device such that its proximal connector contacts the scrub insert, The steps include cleaning the access port with the scrub insert, A method of using a blood sample collection system, including [details omitted].

17. The method according to claim 16, wherein the fluid connector component includes a luer connector configured to be coupled to the access port, and the scrub cap includes a connector portion that engages with the luer connector to secure the scrub cap to the syringe.

18. After cleaning the access port, the scrub cap is removed from the lure connector. The steps include connecting the Luer connector to the access port and positioning the syringe assembly in a fluid connection with the vascular access device, The method according to claim 17, including the method described in claim 17.

19. The method according to claim 16, wherein the scrub cap includes a seal that is mounted over the cavity and seals the scrub insert within the cavity, and the method further includes the step of removing the seal from the scrub cap and positioning the scrub cap over the access port of the vascular access device, thereby allowing the scrub insert to come into contact with the access port.

20. The method according to claim 16, wherein the step of cleaning the access port includes the step of applying a twisting motion to the blood sample collection system.

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