Blood collection system and syringe assembly

Abstract

A blood collection system and a syringe assembly are provided herein. The blood collection system includes 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 containment cavity, and a fluid pathway component. The adapter member includes a stop slidable within the chamber and a channel extending between the stop and an opening of the receiving cavity, where the fluid passage component is positioned over the opening and extends into the receiving cavity. A cannula is secured within the fluid connector component and extends proximally through the stop to fluidly connect the fluid connector component with the channel. The scrubbing cap is secured to the fluid connector component, the fluid connector component including a housing defining a cavity within which the scrubbing insert is positioned. A container is positionable within the containment cavity and may be engaged with the fluid pathway member.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims priority to U.S. Provisional Application No. 63 / 461,685, filed on April 25, 2023, and entitled “Blood Sample Collection System with Diversion Syringe Having an Integrated Scrubbing Cap,” the entire disclosure of which is incorporated herein by reference. Technical Field

[0003] The present disclosure relates to a blood collection system including a transfer syringe with an integrated scrub cap. Background Art

[0004] Catheters are typically used to deliver fluids into and draw fluids (i.e., blood) from a barrel, where patients in various settings, including in hospitals and home care, receive these fluids or have blood drawn via a Vascular Access Device (VAD), which includes such a catheter inserted into the patient's vasculature. Common VADs include a plastic catheter inserted into a patient's vein, where, as an example, the length of the catheter varies from a few centimeters long when the VAD is a Peripheral Intravenous Catheter (PIVC) to many centimeters long when the VAD is a Central Venous Catheter (CVC). VADs can be indwelled for a short period (several days), a medium period (several weeks), or a long period (several months to years).

[0005] In some applications, VADs are used to collect blood samples associated with performing blood cultures. Blood cultures are often used as a means of detecting the presence of bacteria or fungi in a patient's blood sample to identify the type of bacteria or fungi present and to guide the patient's treatment. The current practice of collecting venous blood samples for blood culture testing involves venipuncture, which uses a blood collection kit (set) with an attached Luer-Lock Access Device (LLAD). During the insertion process, the venipuncture device may be contaminated with microorganisms from the skin and during the insertion process, which are then transferred to the blood culture sample, resulting in a false positive test result for sepsis. In order to minimize the risk of false positives, discarded samples are usually taken to remove the initial volume of blood that is more likely to contain microorganisms from the skin, such as discarding the initial 0.1 ml to 10 ml of blood drawn.

[0006] In some prior art devices, a syringe integrated with the LLAD is provided, which helps to transfer the initial blood volume in-line by retracting the syringe plunger. Once the initial blood volume is transferred and isolated, the blood culture sample collection container is connected to the LLAD, thereby allowing the blood culture sample to flow into the container. Although this solves some risks of false positive blood culture samples, it does not solve the risk of clinicians failing to disinfect the VAD access port or performing ineffective disinfection before connecting the blood collection device to the VAD access port. That is, before connecting the LLAD to the access port, clinicians usually use alcohol wipes to scrub and disinfect the access port, but using alcohol wipes to scrub and disinfect the access port is often not completely effective in disinfecting all inner / outer surfaces of the access port (including (potentially) the complex threaded area around the Luer portion of the access port coupled to the LLAD). In addition, in some instances, clinicians may forget to wipe the access port before connecting the LLAD. If the access port is not properly disinfected, false positive blood culture samples may occur.

[0007] Therefore, there is a need in the art for a device for ensuring that a clinician effectively sterilizes an access port of a VAD prior to attaching a blood collection set to the access port. Utility Model Content

[0008] A blood collection system is provided herein, which includes a syringe assembly and a container. The syringe assembly includes 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, which includes an adapter component, a receiving chamber, and a fluid pathway component. The adapter component has: a distal end, the distal end includes a stopper, the stopper can be inserted into the proximal end of the syringe and can slide in the chamber; and a channel, the channel extends along the length of the adapter component between the stopper and the opening of the receiving chamber. The fluid pathway component is positioned on the opening and extends into the receiving chamber. The syringe assembly also includes a sleeve, the sleeve having a distal end and a proximal end, the distal end of the sleeve is fixed in the fluid connector component, wherein the sleeve extends proximally through the stopper to allow the fluid connector component to be in fluid communication with the channel and the fluid pathway component. The syringe assembly still further includes a scrub cap fixed to the fluid connector component of the syringe, the scrub cap comprising: a housing fixed to the fluid connector component and defining a cavity; and a scrub insert positioned within the cavity. A container defines a reservoir, the container being positionable within the receiving cavity and being engageable with the fluid pathway component to transfer fluid into the reservoir.

[0009] In some embodiments, the scrub insert comprises an elastomeric material comprising an antimicrobial solution or agent absorbed therein, the antimicrobial solution or agent being configured to disinfect a surface of an access port of a vascular access device.

[0010] In some embodiments, the scrub cap includes a seal attached to the cavity to seal the scrub insert within the cavity.

[0011] In some embodiments, the fluid connector component includes a Luer connector configured to couple to an access port or a needleless connector of a vascular access device, wherein the housing includes a connector portion configured to engage with the Luer connector to secure the scrub cap to the syringe assembly.

[0012] In some embodiments, the Luer connector includes one of a sliding Luer, a threaded Luer, or a Luer lock with a collar.

[0013] In some embodiments, the housing includes a connector portion configured to secure the scrub cap to the fluid connector component via a twist-type engagement, and the scrub cap is removable to enable the syringe assembly to be connected to an access port or needleless connector of a vascular access device.

[0014] In some embodiments, the fluid pathway component comprises a needle having a lumen defined therein, wherein the container comprises a cap pierceable by the needle to place the reservoir in fluid communication with the passageway of the plunger assembly.

[0015] In some embodiments, the fluid pathway component comprises a female Luer connector, wherein the container comprises a male Luer connector engageable with the female Luer connector to place the reservoir in fluid communication with the channel of the plunger assembly.

[0016] In some embodiments, the fluid connector component includes an opening formed therein, wherein the sleeve is positioned within the opening, the sleeve having a smaller cross-section than the opening.

[0017] In some embodiments, the gap between the outer diameter of the opening and the sleeve 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, wherein the sleeve forms a second fluid path from the fluid connector component to the fluid pathway component.

[0018] The present invention also provides a syringe assembly, which includes: 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, which includes an adapter component, a receiving chamber and a fluid pathway component. The adapter component has: a distal end, the distal end includes a stopper, the stopper can be inserted into the proximal end of the syringe and can slide in the chamber; and a channel, the channel extends along the length of the adapter component between the stopper and the opening of the receiving chamber. The fluid pathway component is positioned on the opening and extends into the receiving chamber. The syringe assembly also includes a sleeve, the sleeve having a distal end and a proximal end, the distal end of the sleeve is fixed in the fluid connector component, wherein the sleeve extends proximally through the stopper to connect the fluid connector component to the channel and the fluid pathway component fluid. The syringe assembly still further includes a scrub cap secured to the fluid connector component of the syringe, the scrub cap comprising: a housing secured to the fluid connector component and defining a cavity; and a scrub insert positioned within the cavity.

[0019] In some embodiments, the scrub insert comprises an elastic material including an antimicrobial solution or agent absorbed in the elastic material.

[0020] In some embodiments, the scrub cap includes a seal attached to the cavity to seal the scrub insert within the cavity.

[0021] In some embodiments, the fluid connector component includes a Luer connector configured to couple to an access port or a needleless connector of a vascular access device, wherein the housing includes a connector portion configured to engage with the Luer connector to secure the scrub cap to the syringe assembly.

[0022] In some embodiments, the connector portion of the housing secures the scrub cap via a twist-type engagement, wherein the scrub cap is removable to enable the syringe assembly to be connected to the access port or needleless connector of the vascular access device.

[0023] A method for using a blood sample collection system is also provided herein. The method includes providing a syringe assembly, the 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, the plunger assembly including an adapter component, a receiving chamber, and a fluid pathway component. The adapter component has: a distal end, the distal end including a stopper, the stopper being insertable into the proximal end of the syringe and being able to slide within the chamber; and a channel extending along the length of the adapter component between the stopper and the opening of the receiving chamber. The fluid pathway component is positioned on the opening and extends into the receiving chamber. The syringe assembly also includes a sleeve having a distal end and a proximal end, the distal end of the sleeve being fixed in the fluid connector component, wherein the sleeve extends proximally through the stopper so that the fluid connector component is in fluid communication with the channel and the fluid pathway component. The syringe assembly still further includes a scrub cap secured to the fluid connector component of the syringe, the scrub cap comprising: a housing secured to the fluid connector component and defining a cavity; and a scrub insert positioned within the cavity. The method further includes: positioning the scrub cap over an access port of a vascular access device such that a proximal connector contacts the scrub insert; and cleaning the access port using the scrub insert.

[0024] In some embodiments, the fluid connector component includes a luer connector configured to couple to the access port, and the scrub cap includes a connector portion that engages the luer connector to secure the scrub cap to the syringe.

[0025] In some embodiments, the method further comprises: after cleaning the access port, removing the scrub cap from the luer connector; and coupling the luer connector to the access port to place the syringe assembly in fluid communication with the vascular access device.

[0026] In some embodiments, the scrub cap includes a seal attached to the cavity to seal the scrub insert within the cavity, and the method further includes removing the seal from the scrub cap to enable the scrub cap to be positioned on the access port of the vascular access device and to enable the scrub insert to contact the access port.

[0027] In some embodiments, cleaning the access port includes applying a twisting motion to the blood sample collection system. BRIEF DESCRIPTION OF THE DRAWINGS

[0028] Figure 1 is a side view of a blood sample collection system according to an embodiment, the blood sample collection system including a syringe assembly and a collection container;

[0029] Figure 2 According to the embodiment Figure 1 A detailed view of a cut section "A" of a syringe assembly;

[0030] Figure 3 yes Figure 1 A front view of a syringe assembly with a scrub cap removed from the syringe assembly;

[0031] Figure 4 is included in the embodiment Figure 1 An exploded view of a scrub cap in a blood sample collection system;

[0032] Figures 5 to 8 According to the embodiment Figure 1 A side view of a blood sample collection system illustrating procedural steps for using the system with an associated catheter assembly;

[0033] Fig. 9 According to the embodiment Figure 8 a detailed view of a cut section "B" of the syringe assembly and the catheter assembly; and

[0034] Fig.10 is a side view of a syringe assembly according to another embodiment. DETAILED DESCRIPTION

[0035] The following description is provided to enable those skilled in the art to make and use the various aspects conceived for implementing the present invention. However, various modifications, equivalents, variations and substitutes will still be apparent to those skilled in the art. Any and all such modifications, variations, equivalents and substitutes are intended to fall within the spirit and scope of the present disclosure.

[0036] Hereinafter, for the purpose of description, the terms "upper", "lower", "right", "left", "vertical", "horizontal", "top", "bottom", "lateral", "longitudinal" and their derivatives shall be related to the present invention as oriented in the accompanying drawings. However, it should be understood that the present invention may adopt various alternative variations unless otherwise expressly stated. It should also be understood that the specific devices shown in the drawings and described in the following specification are merely exemplary aspects of the present invention. Therefore, the specific dimensions and other physical characteristics associated with the various aspects disclosed herein should not be considered limiting.

[0037] In the present disclosure, the distal end of a component or device means the end farthest from the user's hand when the component or device is in the use position, i.e., when the user holds the blood drawing device in preparation for use or during use, and the proximal end means the end closest to the user's hand when the component or device is in the use position, i.e., when the user holds the blood drawing device in preparation for use or during use. Similarly, in the present application, the terms "in the distal direction" and "distally" mean in the direction toward the pathway connector portion of the fluid transfer device, and the terms "in the proximal direction" and "proximally" mean in the direction opposite to the direction of the pathway connector portion.

[0038] Although not shown or described herein, it should be understood that the blood sample collection system described below may be used to draw blood from any suitable vascular access device (VAD), such as a BD NEXIVA TM Closed IV catheter system (BD NEXIVA TM Closed IV Catheter system), BD CATHENA TM Catheter system (BDCATHENA TM Catheter system), BD VENFLON TM Pro Safety Protection IV Catheter System (BD VENFLON TM ProSafely Shielded IV Catheter system), BD NEOFLON TM IV cannula system (BD NEOFLON TM IVCannula system), BD INSYTE TM AUTOGUARD TM BC Protective IV Catheter System (BDINSYTE TM AUTOGUARD TM BC Shielded IV Catheter system) or other suitable vascular access device.

[0039] Embodiments of the present disclosure will be described primarily in the context of a blood sample collection system for use with a peripheral IV catheter (PIVC), a midline catheter, a PICC catheter, or a central line catheter. However, embodiments of the present disclosure are equally extended to use with other catheter devices.

[0040] refer to Figures 1 to 3 , Figures 1 to 3 A blood sample collection system (or, also referred to hereinafter as a system) 10 according to aspects of the present disclosure is shown. The system 10 includes a syringe assembly 12 and a blood collection container (or, also referred to hereinafter as a collection container) 14 that can be used with the syringe assembly 12. As described in further detail below, a user (e.g., a clinician) can employ the blood sample collection system 10 to first obtain an initial discarded blood sample in the syringe assembly 12 and then, subsequently, obtain a blood culture sample in the collection container 14 that can be analyzed to detect the presence of bacteria or fungi.

[0041] like Figure 1 As shown, the general features of the syringe assembly 12 may include a syringe 16, a plunger assembly 18, and a cannula 20. The syringe 16 may be configured as a generally cylindrical barrel 22, the barrel including a distal end 24 and a proximal end 26, wherein a fluid connector component 28 is provided at the distal end 24, and a finger grip 30 is provided at the proximal end 26. According to some embodiments, the fluid connector component 28 may be integrated with the distal end 24 of the barrel 22, or may be removably coupled to the distal end of the barrel. According to some embodiments, the fluid connector component 28 may include any suitable component configured to couple 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 be in the form of, for example, a sliding Luer piece, a threaded Luer piece, a Luer lock with a collar, and the like. In some embodiments, the fluid connector component 28 may be an outlet of the barrel 22 defining an inner cavity.

[0042] The plunger assembly 18 includes an adapter member 32, a stopper 34, a receiving chamber 36, a fluid passage component 38, and a finger grip 40. In one embodiment, the adapter member 32, the receiving chamber 36, and the finger grip 40 are a single integrated component. For example, the adapter member 32, the receiving chamber 36, and the finger grip 40 can be formed as a molded component. Alternatively, the adapter member 32, the receiving chamber 36, and the finger grip 40 can be manufactured separately and then connected to each other.

[0043] like Figure 1As shown, the adapter member 32 is formed as a generally elongated member that is insertable into the chamber 42 defined by the barrel 22 of the syringe 16, wherein the adapter member 32 has a distal end 44 and a proximal end 46. A passage 48 is formed in the adapter member 32 in a manner extending along the length of the adapter member 32. In one embodiment, the passage 48 tapers along its length, wherein the diameter of the passage 48 increases as the passage 48 extends from the distal end 44 to the proximal end 46. The proximal end 46 of the passage 48 includes an opening 50 that transitions into the receiving cavity 36 at the proximal end.

[0044] According to aspects of the present disclosure, fluid pathway component 38 is positioned within opening 50 at proximal end 46 of channel 48. Fluid pathway component 38 may be secured within opening 50 and extend from proximal end 46 of channel 48 to the interior of receiving cavity 36. In one embodiment, fluid pathway component 38 may include needle 52 having a lumen defined therein. In some embodiments, fluid pathway component 38 may include a flexible needle guard (not shown) configured to substantially surround needle 52 and be translatable relative to the needle such that the proximal end of needle 52 may be selectively exposed.

[0045] The stopper 34 of the plunger assembly 18 is positioned at the distal end 44 of the adapter member 32 so that the stopper 34 can move with the adapter member 32 within the chamber 42 of the barrel 22 of the syringe. The stopper 34 can be made of a material different from the material of the adapter member 32, and the material can form a tight seal with the barrel 22 of the syringe when the stopper is advanced in the barrel of the syringe. In some embodiments, the stopper 34 includes a receiver (not shown) formed in the stopper, the size of the receiver being designed and the receiver being configured to receive a flange extension member formed on the distal end 44 of the adapter member 32, wherein the flange extension member is coupled to the receiver via a press-fit connection, for example, to secure the stopper 34 to the adapter member 32, but it is understood that the stopper 34 can be secured to the distal end 44 of the adapter member 32 by other techniques known in the art.

[0046] Still refer to Figures 1 to 3 , Figures 1 to 3 The cannula 20 is shown coupled to the syringe assembly 12 via its positioning within the syringe 16 and the plunger assembly 18. Figure 2As best shown, the cannula 20 is disposed in the syringe assembly 12 such that the distal end 54 of the cannula 20 is positioned generally flush with the opening 56 in the fluid connector component 28 of the syringe 16, wherein the cannula 20 extends proximally from the fluid connector component 28, through a portion of the chamber 42 of the barrel 22 and through the hole formed in the stopper 34, and into the passage 48 formed in the adapter member 32. In some embodiments, the cannula 20 may be recessed rearwardly of the opening 56 in the fluid connector component 28, and such recessed arrangement provides compatibility of the syringe assembly 12 with needleless connectors, luer-activated valves, and / or IV connectors, which may have internal prongs or similar protrusions that are intended to be inserted into the fluid connector component 28 to function.

[0047] like Figure 3 As shown, the cross-section of the sleeve 20 is smaller than the opening 56 at the end of the fluid connector component 28, thereby allowing fluid to flow through the gap 58 between the outer surface of the sleeve 20 and the inner surface of the opening 56. According to an embodiment, the sleeve 20 is fixed to the fluid connector component 28 in a manner that does not hinder the flow of fluid between the gap 58. In one embodiment, the sleeve 20 is fixed to the fluid connector component 28 via one or more retention features of the fluid connector component 28, which may include flanges, struts, wings, beveled flanges, or other mechanical structures (not shown) extending between the inner surface of the fluid connector component 28 and the outer surface of the sleeve 20. In other embodiments, the sleeve 20 can be fixed to the fluid connector component 28 using adhesives, thermal bonding, or other suitable means.

[0048] As described above, with the cannula 20 sized and positioned relative to the syringe 16 and plunger assembly 18, a separate fluid path is provided in the syringe assembly 12 through which blood can be drawn into the system 10. A (first) fluid path 60 is formed through the gap 58 between the outer surface of the cannula 20 and the inner surface of the opening 56 through which fluid (i.e., blood) can flow from the fluid connector component 28 and into a portion of the chamber 42 within 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). A (second) fluid path 62 is provided through the cannula 20 through which fluid (i.e., blood) can flow from the fluid connector component 28 and into the channel 48 of the adapter member 32, whereupon the fluid can be delivered out of the channel 48 and into the container 14 through the fluid pathway component 38.

[0049] Reference again Figure 1The container 14 may have any of a variety of structures that enable the container 14 to be inserted into the receiving cavity 36 (defined by the cylindrical wall structure 64), Figure 1 The container 14 is shown as a bottle with a neck, but it will be appreciated that the container 14 may be provided as a tube or other suitable receptacle (such as, by way of non-limiting example, the BD 1000 from Becton, Dickinson and Co.). ). The container 14 includes a cover 66 and a fluid reservoir (or, hereinafter also referred to as a reservoir) 68, wherein the cover 66 is disposed at the distal end of the container 14. In some embodiments, the cover 66 may include a resealable membrane configured such that a fluid pathway component (e.g., fluid pathway component 38) may pierce 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 pathway component 38 is separated from the cover 66, so that the reservoir 68 is fluidically isolated from the area outside the container 14. The reservoir 68 may be an evacuated reservoir, so that when the reservoir 68 is placed in fluid communication with a fluid source (e.g., by piercing the resealable membrane of the cover 66 with a fluid pathway component that is fluidically coupled to the patient's vascular system), a fluid (e.g., blood) may be drawn into the reservoir 68 due to a pressure difference between the reservoir 68 and the fluid source.

[0050] According to aspects of the present disclosure, it can be appreciated that when initially connecting the blood sample collection system 10 to the VAD access port (such as via coupling of the fluid connector component 28 to the access port), it is desirable to disinfect the access port prior to connecting the blood sample collection system 10 to the access port. That is, it is desirable to clean and disinfect the access port prior to engaging the fluid connector component 28 with the access port (e.g., via mating of a female Luer connector and a male Luer connector) to prevent microbial entry and possible catheter-related bloodstream infection (CRBSI).

[0051] According to aspects of the present disclosure, a scrub cap 70 is integrated with the syringe assembly 12 to provide cleaning and disinfection of the access port before the system 10 is engaged with the access port. The scrub cap 70 is secured to the fluid connector component 28 and is configured to engage with the access port to achieve cleaning and disinfection of the interior and / or exterior surfaces of the access port (such as via a twisting and scrubbing motion between the scrub cap 70 and the access port). After the cleaning and disinfection of the access port is completed, the scrub cap 70 can be removed from the fluid connector component 28, thereby enabling the fluid connector component 28 to be subsequently coupled to the access port and blood extraction to be performed via operation of the system 10 as previously described.

[0052] like Figure 1 and Figure 2 As shown, now also Figure 4 and Figure 5 , the scrub cap 70 includes a cap housing (or also referred to as housing hereinafter) 72, a scrub insert (or also referred to as insert hereinafter) 74, and a peelable seal 76. For example, the housing 72 can be an integrally formed structure made by injection molding and can be made of an alcohol compatible material (e.g., polypropylene or polyethylene). The housing 72 can generally be described as including a retainer portion 78 and a connector portion 80, the retainer portion 78 retaining the insert 74 therein, the connector portion 80 being configured to mate with the fluid connector component 28 of the blood sample collection system 10.

[0053] The holder portion 78 may have a cup shape formed by a base 82 and a sidewall structure 84, the cup shape defining an opening 86 at one end thereof. The sidewall structure 84 is integrally formed with the base 82 to define a cavity 88 configured to accommodate the insert 74 therein. In some embodiments, the cavity 88 may have a cylindrical cross-sectional shape and may have a depth suitable for accommodating the insert 74 therein in a recessed manner. However, it is understood that the holder portion 78 and the cavity 88 defined thereby may have other shapes (including square, hexagonal, etc.), and the shape and size of the holder portion 78, the cavity 88 of the holder portion, and the insert 74 disposed therein may be configured to enable the scrub cap 70 to clean a medical device of a specific size and configuration (i.e., a catheter connector of the catheter assembly 100) to be used with the scrub cap 70.

[0054] The dimensions of the retainer portion 78 can be designed so that: when the insert 74 is assembled into the cavity 88, the cavity 88 defined by the sidewall structure 84 compresses the insert 74 to retain the insert 74 in the cavity. The insert 74 can also be adhered to the bottom of the retainer portion 78 (i.e., the base 82) using a suitable hot melt glue or other suitable adhesive, but it can be appreciated that other suitable methods can also be used to secure the insert 74 to the retainer portion 78 (including, for example, mechanically secure). An annular lip 90 can be formed on the retainer portion 78 (i.e., on the sidewall structure 84) around the opening 86 to define a platform for receiving the seal 76, wherein the seal 76 cooperates with the annular lip 90 to seal the opening 86 of the cavity 88 and retain the insert 74 in the cavity. The seal 76 seals the cavity 88 of the holder portion 78 and the insert 74 therein to resist contamination from the external environment and provides a leak-proof barrier to protect the contents of the insert 74 and maintain a sealed, sterile environment. The seal 76 provides adequate sealing under a range of temperature levels, pressure levels, and humidity levels, and, depending on the embodiment, can be formed as a peelable top piece of aluminum or a multilayer polymer film. In some embodiments, the seal 76 is heat sealed or induction sealed to the open end of the scrub cap 70. The seal 76 can include tabs 92 to facilitate manipulation of the seal 76 and removal of the seal 76 from the scrub cap 70.

[0055] The insert 74 is made of a foam material such as an injection molded structure, or the insert 74 can be die-cut from a foam sheet. The insert includes a cleaning substance impregnated therein (while in the retaining member portion 78), such as a solution of a suitable microbicide or bactericide. Depending on the size of the insert of the foam material, the cleaning substance can include any suitable type and amount of antibacterial disinfectant. For example, in one embodiment, an aqueous solution is used in an amount of about 0.20cc (cubic centimeters) to about 0.75cc (cubic centimeters), and the aqueous solution includes about two percent (2%) of chlorhexidine gluconate (Chlorhexidine Solution, CHG) by volume. Optionally, a solution including about 0.50cc is used. In another embodiment, the cleaning substance includes a solution including about 70 percent (70%) isopropyl alcohol (Isopropyl Alcohol, "IPA") in an aqueous solution. In yet another embodiment, the cleaning substance includes a solution comprising 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 will be appreciated that in one embodiment, the concentration of IPA may vary from about 60 percent (60%) to about 90 percent (90%), and the concentration of CHG may vary from about one percent (1%) to about five percent (5%). Other suitable solution compositions and concentrations are also possible. For example, in one embodiment, a povidone iodine solution or a hydrogen peroxide solution may be included in the cleaning substance.

[0056] According to aspects of the present disclosure, the insert 74 can be constructed (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 can also have any of a variety of structures that provide effective cleaning of the port / connector, such as including a patterned or roughened top surface and / or gaps or slits formed in its foam material so that the insert 74 can better deform / conform to the inner and outer surfaces of the port / connector.

[0057] The connector portion 80 of the scrub cap 70 extends proximally away from the retainer portion 78 and is configured to mate with the fluid connector component 28 to secure the scrub cap 70 to the fluid connector component. According to some embodiments, the connector portion 80 can be configured as a Luer connector (e.g., a male Luer connector or a female Luer connector) that enables the connector portion to mate with a corresponding Luer connector provided by the fluid connector component 28, such that the connector portion 80 is fixed in place relative to the fluid connector component 28.

[0058] As described below, Figures 5 to 8As shown, the use of the system 10 is described according to one aspect of the present disclosure. The use of the system 10 begins as follows Figure 5 The initial configuration of the syringe assembly 12 is shown in which the scrub cap 70 is secured 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 secured to the housing 72 so as to seal the scrub insert 74). Figure 6 As shown, the system 10 is continued to be used by removing the seal 76 from the scrub cap 70 of the syringe assembly 12 to provide access to the scrub insert 74. After removing the seal 76, the syringe assembly 12 is brought into proximity with the catheter assembly 100 to provide cleaning and disinfection of the access port of the catheter assembly 100. Figure 7 In the non-limiting embodiment shown, catheter assembly 100 comprises catheter adapter 102 and relevant catheter 104 (this catheter can be inserted in the vascular system of patient) and connector 106, and this connector 106 is coupled to adapter port 108 (for example via fluid pipeline 110) on catheter adapter 102.Connector 106 can be t-type connector (for example, a side port is arranged at 90 degrees of angles with respect to the longitudinal axis of connector 106), y-type connector (for example, a side port is arranged at 25 degrees, 60 degrees of angles or 75 degrees of angles with respect to the longitudinal axis of connector 106) or any other type of connector known in the art.In some embodiments or aspect, connector 106 can have Luer connector or needleless access connector (or hereinafter referred to as connector) 112 that is coupled to the proximal end of this connector, and wherein, this needleless access connector 112 provides the access port of patient's near side (near-patient) to catheter assembly 100.

[0059] When the syringe assembly 12 is brought near the catheter assembly 100, as shown in FIG. Figure 7 As shown, the scrub cap 70 is positioned on the connector 112 (according to a non-limiting embodiment, the connector can be configured as a female Luer connector having a threaded outer connector 114 defining a tapered inner cavity or cavity 116, see Fig. 9), wherein the foam insert 74 is pushed onto the connector 112 by the user. At this point, some portion of the insert 74 conforms to and / or is inserted into the connector 112 (i.e., around the threaded outer connector 114 and into the inner cavity 116). Once a portion of the connector 112 has been inserted into the foam insert 74 of the scrub cap 70, the scrub cap 70 is rotated relative to the connector 112. For example, the user can hold the connector 112 stationary while rotating the blood sample collection system 10. When the scrub cap 70 is fixed in place relative to the blood sample collection system 10 (via the connection of the fluid connector component 28 to the scrub cap 70), the 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 can be done entirely in one direction, or can be a back-and-forth twisting motion. The scrub cap 70 is rotated relative to the connector 112 a sufficient number of times to adequately kill any bacteria contacted by the solution-impregnated foam insert 74 and / or remove any biofilm from the outer peripheral surface of the connector 112 and the threaded outer connector 114 and the inner surface of the lumen 116 of the connector 112. In this manner, both the outer surface and the inner lumen surface of the connector 112 are scrubbed by the insert 74, so that the cleaning substance in the insert disinfects the surfaces and removes any biofilm disposed thereon.

[0060] After the cleaning and disinfection of the connector 112 of the catheter assembly 100 is completed via the scrub cap 70, the scrub cap 70 is separated from the connector 112. The scrub cap 70 can then be removed from the fluid connector component 28 of the system 10. After allowing the connector 112 to dry, the blood sample collection system 10 can then be connected to the catheter assembly 100 by coupling the fluid connector component 28 to the connector 112, as shown in FIG. Figure 8 As shown, the system 10 is thereby connected to the catheter assembly 100.

[0061] According to aspects of the present invention, after the blood sample collection system 10 is connected to the catheter assembly 100, an initially discarded blood sample can be drawn into the syringe assembly 12. That is, the syringe assembly 12 can be actuated from an initial configuration to a transfer or discard configuration, wherein the plunger assembly 18 is pulled back proximally relative to the syringe 16, causing the stopper 34 to move proximally within the syringe barrel 22. Figure 8 As shown, when the stopper 34 moves proximally within the syringe barrel 22, a discarded (or transferred) volume of blood is drawn into a portion of the chamber 42 (i.e., a fluid chamber defined by the distal surface of the stopper 34 and the inner surface of the distal end 24 of the barrel 22), wherein the blood flows (through the gap 58) along the first fluid path from the fluid connector component 28 and into that portion of the chamber 42.

[0062] After a sufficient discarded blood sample is drawn, the blood sample collection system 10 can then be operated to obtain a desired blood culture sample within the collection container 14. To obtain such a sample, the collection container 14 is engaged with the syringe assembly 12, wherein the collection container 14 (e.g., a vacutainer) is positioned within the receiving chamber 36 and engaged with the fluid pathway component 38 to place the container 14 in fluid communication with the plunger assembly 18. That is, upon positioning / connection of the collection container 14 with the receiving chamber 36 and the fluid pathway component 38, a second fluid path is formed from the connector component 28 to the collection container 14, wherein the cannula 20 delivers blood from the connector component 28 to the channel 48 within the adapter member 32, and then the blood passes from the channel 48 through the fluid pathway component 38 into the container 14. As described above, in some embodiments, the fluid pathway component 38 is configured as a needle 52 having an inner lumen formed therein, which pierces the cover 66 of the container 14 so that blood is drawn into the evacuated reservoir 68 within the container 14.

[0063] Although Figures 1 to 8 The blood sample collection system 10 is shown and described according to a particular embodiment, but it will be appreciated that the system 10 (and its syringe assembly 12 ) may have other suitable configurations. Fig.10 A syringe assembly 94 according to another aspect of the present disclosure is shown. The syringe assembly 94 is similar to the syringe assembly previously described in Figures 1 to 8 The syringe assembly 12 shown and described in FIG. 1 is substantially the same, except that rather than the fluid pathway component 38 being provided as a needle 52, the fluid pathway component 38 is provided as a closed connector 96, such as Fig.10 The closed system female Luer connector 96 is configured to receive and mate with an associated male Luer connector of a collection container (not shown) to provide for collection of a blood sample within the collection container when the container is connected to the syringe assembly 94.

[0064] Although several embodiments of a blood sample collection system configured for drawing blood during catheter indwelling are described in the above detailed description, those skilled in the art may modify and change these embodiments without departing from the scope and spirit of the present invention. Therefore, the above description is intended to be illustrative rather than restrictive. The present invention described above is defined by the appended claims, and all changes to the present invention that fall within the equivalent meaning and equivalent range of the claims are included within the scope of the claims.

Claims

1. A blood collection system, characterized in that: The blood collection system comprises: A syringe assembly, the 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; a plunger assembly comprising an adapter member, a receiving chamber, and a fluid pathway component, the adapter member having a distal end, the distal end comprising a stopper insertable into the proximal end of the syringe and slidable within the chamber, the adapter member comprising a passage extending along a length of the adapter member between the stopper and an opening of the receiving chamber, wherein the fluid pathway component is positioned over the opening and extends into the receiving chamber; a cannula having a distal end and a proximal end, the distal end of the cannula being secured within the fluid connector component, wherein the cannula extends proximally through the stopper to place the fluid connector component in fluid communication with the passageway and the fluid pathway component; and a scrub cap secured to the fluid connector component of the syringe, the scrub cap comprising: a housing secured to the fluid connector component and defining a cavity; a scrub insert positioned within the cavity; and A container defines a reservoir, the container being positionable within the receiving cavity and engageable with the fluid pathway component to transfer fluid into the reservoir.

2. The blood collection system according to claim 1, wherein: The scrubbing insert includes an elastomeric material including an antimicrobial solution or agent absorbed therein, the antimicrobial solution or agent configured to disinfect a surface of an access port of a vascular access device.

3. The blood collection system according to claim 2, wherein: The scrub cap includes a seal attached to the cavity to seal the scrub insert within the cavity.

4. The blood collection system according to claim 1, wherein: The fluid connector component includes a Luer connector configured to couple to an access port of a vascular access device or a needleless connector, wherein the housing includes a connector portion configured to engage with the Luer connector to secure the scrub cap to the syringe assembly.

5. The blood collection system according to claim 4, wherein: The Luer connector includes one of a sliding Luer, a threaded Luer, or a Luer lock with a collar.

6. The blood collection 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 twist-type engagement, wherein the scrub cap is removable to enable the syringe assembly to be connected to an access port or a needleless connector of a vascular access device.

7. The blood collection system according to claim 1, wherein: The fluid pathway component includes a needle having a lumen defined therein, wherein the container includes a cap pierceable by the needle to place the reservoir in fluid communication with the passageway of the plunger assembly.

8. The blood collection system according to claim 1, wherein: The fluid pathway component includes a female Luer connector, wherein the container includes a male Luer connector engageable with the female Luer connector to place the reservoir in fluid communication with the passageway of the plunger assembly.

9. The blood collection system according to claim 1, wherein: The fluid connector component includes an opening formed therein, wherein the sleeve is positioned within the opening, the sleeve having a smaller cross-section than the opening.

10. The blood collection system according to claim 9, wherein: The gap between the outer diameter of the opening and the sleeve 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, wherein the sleeve forms a second fluid path from the fluid connector component to the fluid pathway component.

11. A syringe assembly, characterized in that: 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; a plunger assembly comprising an adapter member, a receiving chamber, and a fluid pathway component, the adapter member having a distal end, the distal end comprising a stopper insertable into the proximal end of the syringe and slidable within the chamber, the adapter member comprising a passage extending along a length of the adapter member between the stopper and an opening of the receiving chamber, wherein the fluid pathway component is positioned over the opening and extends into the receiving chamber; a cannula having a distal end and a proximal end, the distal end of the cannula being secured within the fluid connector component, wherein the cannula extends proximally through the stopper and into the passageway to place the fluid connector component in fluid communication with the fluid pathway component; and a scrub cap secured to the fluid connector component of the syringe, the scrub cap comprising: a housing secured to the fluid connector component and defining a cavity; and A scrub insert is positioned within the cavity.

12. The syringe assembly of claim 11, wherein: The scrub insert includes an elastic material including an antimicrobial solution or agent absorbed in the elastic material.

13. The syringe assembly of claim 11, wherein: The scrub cap includes a seal attached to the cavity to seal the scrub insert within the cavity.

14. The syringe assembly of claim 11, wherein: The fluid connector component includes a Luer connector configured to couple to an access port of a vascular access device or a needleless connector, wherein 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 of claim 14, wherein: The connector portion of the housing secures the scrub cap via a twist-type engagement, wherein the scrub cap is removable to enable the syringe assembly to be connected to the access port or needleless connector of the vascular access device.

Images