System for line extraction irrigation and blood collection

Abstract

A system for line draw irrigation and blood collection is provided herein that includes a pre-filled syringe having a barrel defining a chamber containing a solution therein and a fluid connector member located at a distal end of the barrel. A plunger assembly including a plunger and a stop is movable within the barrel, the plunger including a channel extending along a length thereof. A passageway device is located at the proximal end of the plunger and includes a receiving lumen having an opening aligned with the passageway and a fluid passageway member located over the opening and extending into the receiving lumen. A sleeve is located within the barrel and extends through the stop, the sleeve making the fluid connector component in fluid communication with the channel. The closure assembly is secured to the fluid connector component and includes a sealing member configured to seal a lumen of the fluid connector component.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims priority to U.S. Provisional Application No. 63 / 461,671, filed on April 25, 2023, entitled “System for Line Draw Flushing and Blood Collection and Method of Use Thereof,” the entire disclosure of which is incorporated by reference. Technical Field

[0003] The present disclosure relates to a system for line draw flushing and blood collection and related methods of use. Background Art

[0004] Catheters are commonly used to inject fluids into the body and to extract fluids (i.e., blood) from the body, wherein, in various settings (including in hospitals and home care), patients administer these fluids or have blood extracted via a Vascular Access Device (VAD), which includes such a catheter inserted into the patient's vascular system. A common VAD includes a plastic catheter inserted into a patient's vein, wherein, as an example, the length of the catheter varies from a few centimeters when the VAD is a peripheral intravenous catheter (PIVC) to many centimeters 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 several 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. Current practices for collecting venous blood samples for blood culture testing involve venipuncture, which uses a blood collection 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 false positive test results for sepsis. In order to minimize the risk of false positives, a discarded sample is usually taken to remove the initial volume of blood that is more likely to contain microorganisms from the skin, such as discarding the initial 1 ml to 10 ml of blood drawn.

[0006] When obtaining a blood sample, such as when performing a blood culture, a workflow process is implemented that is intended to disinfect the connector components of the VAD and provide for the collection of a venous blood sample. The workflow typically begins with a clinician disinfecting the access port of the VAD (or the needleless connector on the VAD), such as by wiping the port using, for example, an alcohol wipe. After the access port is disinfected, a prefilled syringe (with a Luer connector on the syringe) is connected to the port to flush the indwelling VAD, and then the syringe is disconnected from the VAD access port and discarded after the flushing is completed. After disconnecting the syringe, the clinician disinfects the access port / needleless connector again, such as by using an alcohol wipe as described above. After the access port is disinfected, before subsequently drawing a blood culture sample (such as by, for example, connecting another vacuum tube to the LLAD), the LLAD is connected to the port, and a discarded volume of blood is first drawn through the port (e.g., by connecting a shunt syringe or vacuum tube to the LLAD).

[0007] While the above-described workflow process provides for efficient collection of blood samples (e.g., in connection with performing blood cultures), the workflow process is labor intensive and increases the risk of introducing microorganisms into the patient and / or blood collection sample due to the large number of steps and connections / disconnections performed during the workflow process. As an example, in some cases, a clinician may forget to wipe the access port of a VAD prior to connecting the LLAD to the access port of the VAD, and if disinfection of the access port is not properly performed, a false-positive blood culture sample may be generated.

[0008] Therefore, there is a need in the art for a system and method of use thereof that provides a simplified workflow process for VAD flushing and line draw blood sample collection. Utility Model Content

[0009] A system for line extraction flushing and blood collection is provided herein. The system includes a syringe assembly having a pre-filled syringe, the pre-filled syringe including a barrel and a fluid connector component, the barrel having a distal end and a proximal end, and the barrel defining a chamber in which a solution is contained, the fluid connector component being located at the distal end of the barrel. The syringe assembly also includes a plunger assembly, the plunger assembly including a plunger and a stopper, the plunger having a proximal end and a distal end, the stopper being located at the distal end of the plunger, the stopper being insertable into the proximal end of the barrel and being able to slide in the barrel, the plunger including a passage extending between the proximal end and the distal end along the length of the plunger. The syringe assembly also includes a passage device, the passage device being located at the proximal end of the plunger, the passage device including a receiving chamber and a fluid passage component, the receiving chamber having an opening aligned with the passage therein, and the fluid passage component being located on the opening and extending into the receiving chamber, the fluid passage component being in fluid communication with the passage. The syringe assembly also includes a cannula at least partially located within the barrel and extending through the stopper, wherein the cannula is configured to enable the fluid connector component to communicate with the passage fluid. The syringe assembly also includes a closure assembly fixed to the fluid connector component, the closure assembly including a sealing member configured to seal the lumen of the fluid connector component to contain the solution within the chamber of the syringe.

[0010] In some embodiments, the closure assembly includes an end cap configured to engage the fluid connector component, wherein the fluid path seal is located within the end cap, and wherein the proximal end of the end cap includes a Luer fitting configured to mate with an associated Luer fitting of the fluid connector component.

[0011] In some embodiments, the closure assembly further comprises a scrubbing cap secured to a distal end of the end cap, the scrubbing cap comprising: a shell secured to the end cap and defining a cavity; a scrubbing insert located within the cavity; and a seal attached to the cavity to seal the scrubbing insert within the cavity.

[0012] In some embodiments, the scrub insert comprises an elastomeric material comprising 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.

[0013] In some embodiments, the housing includes a connector portion including a threaded connector configured to engage with the end cap via a twist-on engagement.

[0014] In some embodiments, the closure assembly includes a peel plate directly coupled to the fluid path seal to facilitate removal of the fluid path seal from the fluid connector component.

[0015] In some embodiments, the system further includes a container defining a reservoir, the container being positionable within the receiving cavity and engageable with the fluid pathway component to transfer fluid to the reservoir.

[0016] In some embodiments, the fluid pathway component comprises a needle having a lumen defined therein, and wherein the container comprises a cap pierceable by the needle to place the reservoir in fluid communication with the channel of the plunger.

[0017] In some embodiments, wherein each of the receiving cavity and the proximal end of the plunger includes a Luer connector, the Luer connector of the receiving cavity engages with the Luer connector of the plunger to secure the access device to the plunger assembly, and wherein a removable sleeve extending through the Luer connection connects the channel to the fluid of the fluid access component.

[0018] In some embodiments, the plunger and the barrel include locking features positioned and configured to lock the plunger relative to the barrel when the plunger assembly is in the distal advanced position.

[0019] In some embodiments, the plunger and the barrel include a locking feature positioned to lock the plunger relative to the barrel when the plunger assembly is in the proximally retracted position.

[0020] In some embodiments, the sleeve is coupled to the barrel and remains stationary during use of the syringe assembly.

[0021] In some embodiments, the sleeve is coupled to the plunger such that the sleeve is movable in response to advancement or retraction of the plunger within the barrel.

[0022] A method for using a system for line extraction flushing and blood collection is also provided herein. The method includes: providing a syringe assembly, the syringe assembly including a prefilled syringe, the prefilled syringe including a barrel and a fluid connector component, the barrel having a distal end and a proximal end, and the barrel defining a chamber in which a solution is contained, the fluid connector component being located at the distal end of the barrel. The syringe assembly also includes a plunger assembly, the plunger assembly including a plunger and a stopper, the plunger having a proximal end and a distal end, the stopper being located at the distal end of the plunger, the stopper being insertable into the proximal end of the barrel and being able to slide in the barrel, the plunger including a channel extending between the proximal end and the distal end along the length of the plunger. The syringe assembly also includes a passage device, the passage device being located at the proximal end of the plunger, the passage device including a receiving chamber and a fluid passage component, the receiving chamber having an opening therein aligned with the passage, and the fluid passage component being located on the opening and extending into the receiving chamber, the fluid passage component being in fluid communication with the passage. The syringe assembly also includes a sleeve that is at least partially located within the barrel and extends through the stopper, wherein the sleeve is configured to enable the fluid connector component to communicate with the channel fluid. The syringe assembly also includes a closure assembly that is fixed to the fluid connector component, the closure assembly including a sealing member that is configured to seal the lumen of the fluid connector component to contain the solution within the chamber of the syringe. The method also includes: removing the closure assembly from the fluid connector component; coupling the fluid connector component to the access port of the vascular access device to fluidly connect the syringe assembly to the vascular access device; advancing the plunger assembly distally to flush the vascular access device with the solution; obtaining a diverted or discarded blood volume via operating the syringe assembly; and obtaining a sample blood volume via operating the syringe assembly after obtaining the diverted or discarded blood volume.

[0023] In some embodiments, the closure assembly further comprises: an end cap configured to engage the fluid connector component, wherein a fluid channel seal is located within the end cap; and a scrub cap secured to a distal end of the end cap, the scrub cap comprising: a housing secured to the end cap and defining a cavity; a scrub insert located within the cavity; and a seal attached to the cavity to seal the scrub insert within the cavity. The method further comprises: prior to removing the closure assembly from the fluid connector component, positioning the scrub cap on the access port of the vascular access device so that the scrub insert contacts the access port, and cleaning the access port with the scrub insert.

[0024] In some embodiments, obtaining the diverted or discarded blood volume includes: retracting the plunger assembly proximally into the barrel to draw the diverted or discarded blood volume into the chamber of the barrel.

[0025] In some embodiments, the method further comprises locking the plunger in position relative to the barrel after proximally retracting the plunger assembly to draw the diverted or discarded blood volume into the chamber of the barrel.

[0026] In some embodiments, obtaining the diverted or discarded blood volume includes: positioning a container within the receiving chamber, the container defining a vacuum reservoir within the container; engaging the container with the fluid pathway component to draw the diverted or discarded blood volume into the vacuum reservoir; and removing the container from the receiving chamber.

[0027] In some embodiments, obtaining the sample blood volume includes positioning a container within the receiving cavity, the container defining a vacuum reservoir therein, engaging the container with the fluid pathway component to draw the sample blood volume into the vacuum reservoir.

[0028] In some embodiments, the fluid pathway component includes a needle having a lumen therein, and wherein engaging the container with the fluid pathway component includes piercing a cover of the container with the needle to partially position the needle within the reservoir.

[0029] In some embodiments, the method further comprises locking the plunger in place relative to the barrel after distally advancing the plunger assembly to flush the vascular access device with the solution. BRIEF DESCRIPTION OF THE DRAWINGS

[0030] Figure 1 is a perspective view of a system for line draw flushing and blood collection according to an embodiment, the system including a syringe assembly and a collection container;

[0031] Figure 2 yes Figure 1 A side cross-sectional view of a system;

[0032] Figure 3 yes Figure 1 Exploded view of the system;

[0033] 4A to 4H The use of the embodiment is shown Figure 1 The system includes a process step of cleaning the via connector and connecting to the via connector;

[0034] Figure 5 is a side view of a syringe assembly according to an embodiment;

[0035] Figure 6 yes Figure 5 An exploded view of the syringe assembly;

[0036] Figure 7 is a side view of a syringe assembly according to an embodiment;

[0037] Figure 8 yes Figure 7 An exploded view of the syringe assembly;

[0038] Fig. 9 is a side view of a syringe assembly according to an embodiment;

[0039] Fig.10 yes Fig. 9 An exploded view of the syringe assembly;

[0040] Fig.11 is a side view of a syringe assembly according to an embodiment;

[0041] Fig.12 yes Fig.11 An exploded view of the syringe assembly;

[0042] Fig.13 is a side view of a syringe assembly according to an embodiment;

[0043] Fig.14 yes Fig.13 An exploded view of the syringe assembly;

[0044] Fig.15 is a side view of a syringe assembly according to an embodiment; and

[0045] Fig.16 yes Fig.15 Exploded view of the syringe assembly. DETAILED DESCRIPTION

[0046] The following description is provided to enable those skilled in the art to make and use the various aspects described 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.

[0047] 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.

[0048] In the present disclosure, the distal end of a component or device refers to 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 refers to 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 connector portion.

[0049] Although not shown or described herein, it should be understood that the system described below may be used to draw blood from any suitable vascular access device (VAD), such as the BD NEXIVA TM Closed IV catheter system (BDNEXIVA TM Closed IV Catheter system), BD CATHENA TM Catheter system (BD CATHENA TM Cathetersystem), BD VENFLON TM Pro Safety Protection IV Catheter System (BD VENFLON TM Pro Safely Shielded IVCatheter system), BD NEOFLON TM IV cannula system (BD NEOFLON TM IV Cannula system), BDINSYTE TM AUTOGUARD TM BC Protective IV Catheter System (BD INSYTE TM AUTOGUARD TM BC Shielded IV Catheter system) or other suitable vascular access device.

[0050] Embodiments of the present disclosure will be described primarily in the context of devices for flushing and blood sample collection for use with a PIVC. However, embodiments of the present disclosure extend equally to use with other catheter devices.

[0051] Reference Figures 1 to 3 , Figures 1 to 3 A system 10 for line draw flushing and blood collection (hereinafter "system 10") according to one aspect of the present disclosure is shown. System 10 includes a syringe assembly 12 and a blood collection container 14 that can be used with syringe assembly 12. As described in further detail below, a user (e.g., a clinician) can use system 10 to first flush a line draw vascular access device (VAD), then obtain an initial discarded blood sample in syringe assembly 12 (or discarded collection container), and finally obtain a blood culture sample in collection container 14 that can be analyzed to detect the presence of bacteria or fungi.

[0052] like Figures 1 to 3 As shown, the syringe assembly 12 may generally be characterized as including a syringe 16 , a plunger assembly 18 , a access device 20 , a cannula 22 , and a closure assembly 24 .

[0053] The syringe 16 can be configured as a generally cylindrical barrel 26, which includes a distal end 28 and a proximal end 30, with a fluid connector component 32 at the distal end 28 and a finger grip 34 at the proximal end 30. According to an embodiment, the fluid connector component 32 can be integrated with the distal end 28 of the barrel 26 or removably coupled to the distal end 28 of the barrel 26. According to various embodiments, the fluid connector component 32 may include any suitable component configured to couple the barrel 26 to a connector (e.g., a needleless connector) or an access port of a vascular access device (VAD). For example, in some embodiments, the fluid connector component 32 may be a Luer connector. The Luer connector may be in the form of, for example, a sliding Luer, a threaded Luer, a Luer lock with a collar, etc. In some embodiments, the fluid connector component 32 provides an outlet for the barrel 26 via a lumen 36 formed therein.

[0054] The plunger assembly 18 includes a plunger 38 and a stopper 40. Figures 1 to 3 As shown, the plunger 38 is formed as a generally elongated member that can be inserted into the chamber 42 defined by the barrel 26 of the syringe 16, and the plunger 38 has a distal end 44 and a proximal end 46. A passage 48 is formed in the plunger 38 that extends its length. In one embodiment, the passage 48 tapers along its length—the diameter of the passage 48 increases as the passage 48 extends from the distal end 44 to the proximal end 46.

[0055] The stopper 40 of the plunger assembly 18 is located at the distal end 44 of the plunger 38 so as to be movable with the plunger 38 within the chamber 42 of the syringe barrel 26. The stopper 40 may be made of a material that is different from the material of the plunger 38 and that is capable of forming a tight seal with the syringe barrel 26 when the stopper 40 is advanced therein. In some embodiments, the stopper 40 includes a receptacle (not shown) formed therein that is sized and configured to receive a threaded connection 49 formed on the distal end 44 of the plunger 38, the threaded connection 49 being coupled to the receptacle, for example, via a threaded / twist-type connection, to secure the stopper 40 to the plunger 38, although it will be appreciated that the stopper 40 may be secured to the distal end 44 of the plunger 38 by other techniques known in the art.

[0056] The access device 20 is located at the distal end 44 of the plunger 38 and includes a receiving cavity 50, a fluid access component 52, and a finger grip 54. In the illustrated embodiment, the plunger 38, the receiving cavity 50, and the finger grip 54 are a single, unitary component. For example, the plunger 38, the receiving cavity 50, and the finger grip 54 can be formed as a molded component.

[0057] The receiving cavity 50 is generally shaped as a receiver into which the container 14 can be placed, and has an open proximal end 56 for receiving the container 14. The distal end 58 of the receiving cavity 50 is connected to the plunger 38 (e.g., formed by the plunger 38) and includes an opening 60 formed therein that is aligned with the passage 48. A plunger seal 62 is located within the opening 60 to separate the passage 48 from the receptacle of the receiving cavity 50, and the fluid pathway component 52 is located within the opening 60 and extends through the plunger seal 62. The fluid pathway component 52 can be fixed within the plunger seal 62 and extend from the plunger seal to the interior of the receiving cavity 50. In one embodiment, the fluid pathway component 52 can include a needle 64 defining a lumen therein. In some embodiments, a flexible needle sheath 66 can be disposed on the needle 64, the flexible needle sheath being configured to be able to translate relative to the needle 64 so that the proximal end of the needle 64 can be selectively exposed.

[0058] Still refer to Figures 1 to 3 , which shows the inclusion of the cannula 22 into the syringe assembly 12 by positioning the cannula 22 within the syringe 16 and the plunger assembly 18. In one embodiment, the cannula 22 is disposed in the syringe assembly 12 so as to be secured to the barrel 26 and such that its distal end 68 is positioned substantially flush with the opening 70 in the fluid connector component 32 of the syringe 16, the cannula 22 extending from the proximal side of the fluid connector component 32, through a portion of the chamber 42 of the barrel 26 and through the hole formed in the stopper 40, and into the passage 48 formed in the plunger 38, as shown. Figure 2In some embodiments, the cannula 22 can be recessed behind the opening 70 in the fluid connector component 32, and this recessed arrangement provides the syringe assembly 12 with compatibility with needleless connectors, luer-activated valves, and / or IV connectors, which can have internal prongs or similar protrusions that are intended to be inserted into the fluid connector component 32 to function.

[0059] According to aspects of the present disclosure, the sleeve 22 has a smaller cross-section at the tip of the fluid connector component 32 than the opening 70, thereby allowing fluid to flow through the gap between the outer surface of the sleeve 22 and the inner surface of the opening 70. According to an embodiment, the sleeve 22 is fixed to the fluid connector component 32 so as not to hinder the flow of fluid between the gaps. In one embodiment, the sleeve 22 is fixed to the fluid connector component 32 via one or more retaining features of the fluid connector component 32, which may include flanges, struts, wings, beveled flanges, or other mechanical structures (not shown) extending between the inner surface of the fluid connector component 32 and the outer surface of the sleeve 22. In other embodiments, the sleeve 22 may be fixed to the fluid connector component 32 using adhesives, thermal bonding, or other suitable means.

[0060] With the cannula 22 sized and positioned as described above 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 is formed by the gap between the outer surface of the cannula 22 and the inner surface of the opening 70, and through which fluid (i.e., blood) can flow from the fluid connector component 32 and enter a portion of the chamber 42 within the barrel 26—i.e., the fluid chamber defined by the distal surface of the stopper 40 and the inner surface of the distal end 28 of the barrel 26. A (second) fluid path is provided by the cannula 22, through which fluid (i.e., blood) can flow from the fluid connector component 32 and enter the passage 48 of the plunger 38, and then the fluid can be removed from the passage 48 and enter the container 14 through the fluid pathway component 52.

[0061] Refer again Figure 1 , the container 14 may have any of a variety of structures that enable the container 14 to be inserted into the receiving cavity 50 (defined by the cylindrical wall structure), Figure 1 The container 14 is shown as a tube such as the BD As a non-limiting example, it is recognized that the container 14 can be configured as a bottle body with a neck or other suitable receptacle. The container 14 includes a cap 72 and a fluid reservoir 74, and the cap 72 is disposed at the distal end of the container 14. In some embodiments, the cap 72 can include a sealable membrane configured so that a fluid pathway component (e.g., a needle 64 of the fluid pathway component 52) ​​can pierce the sealable membrane to achieve fluid communication with the reservoir 74. The sealable membrane of the cap 72 can be configured to reseal when the fluid pathway component 52 is separated from the cap 72, so that the reservoir 74 is fluidly isolated from the area outside the container 14. The reservoir 74 can be a vacuum reservoir, so that when the reservoir 74 is configured (e.g., via piercing the sealable membrane of the cap 72 using a needle 64 that is fluidically coupled to the patient's vascular system) to communicate with a fluid source, the fluid (e.g., blood) can be drawn into the reservoir 74 due to the pressure difference between the reservoir 74 and the fluid source.

[0062] like Figures 1 to 3 As shown, the closure assembly 24 is secured to the fluid connector component 32 of the syringe assembly 12. The closure assembly 24 includes an end cap 76 that is configured to engage with the fluid connector component 32 so as to cover the fluid connector component 32 when the syringe assembly 12 is not in use. In one embodiment, the proximal end of the end cap 76 is configured as a Luer fitting that is configured to mate with an associated Luer fitting of the fluid connector component 32 to secure the end cap 76 to the syringe 16. The closure assembly 24 also includes a sealing member 78 that is configured to seal the lumen 36 of the fluid connector component 32. As shown in FIG. Figure 2 As best shown in FIG. 1 , the sealing member 78 can be positioned / secured within the interior cavity of the end cap 76 such that when the end cap 76 is secured to the fluid connector component 32 , the sealing member 78 is inserted into the opening 70 at the tip of the fluid connector component 32 , thereby sealing the lumen 36 .

[0063] According to aspects of the present disclosure, it should be appreciated that when the system 10 is initially connected to the VAD access port, for example, by coupling the fluid connector component 32 to the access port, it is desirable to disinfect the access port prior to connecting the system 10 to the access port. That is, it is desirable to clean and disinfect the access port prior to the fluid connector component 32 (e.g., by mating a male Luer connection with a female Luer connection) engaging the access port to prevent microbial entry and possible catheter-related blood stream infection (CRBSI).

[0064] Therefore, some embodiments of the syringe assembly 12 include a scrub cap 80 that is integrated into the closure assembly 24 so that the syringe assembly 12 provides cleaning and disinfection of the access port before the system 10 is engaged with the access port. The scrub cap 80 is fixed to the distal end of the end cap 76 and is configured to engage with the VAD access port to achieve cleaning and disinfection of the inner and / or outer surfaces of the access port, such as by twisting and scrubbing motions between the scrub cap 80 and the access port. After the cleaning and disinfection of the access port is completed, the closure assembly 24 can be removed from the fluid connector component 32, so that the fluid connector component 32 can be subsequently coupled to the access port and blood draws can be performed through the operation of the system 10, as described above.

[0065] like Figure 2 and Figure 3 As best shown in the figure, the scrub cap 80 includes a cap housing 82, a scrub insert 84 and a peelable seal 86. The housing 82 can be made by injection molding and can be made of an alcohol-compatible material (e.g., polypropylene or polyethylene). The housing 82 can have a cup shape that defines an open cavity 88 that is configured to accommodate the insert 84 therein. In some embodiments, the cavity 88 can have a cylindrical cross-sectional shape and can have a depth suitable for accommodating the insert 84 therein in a recessed manner. However, it should be understood that the housing 82 and the cavity 88 defined thereby can adopt other shapes, including squares, hexagons, etc., and the housing 82, its cavity 88 and the insert 84 disposed therein can be configured in shape and size so that the scrub cap 80 can clean a medical device (i.e., a catheter connector of a catheter assembly) of a specific size and configuration to be used with the scrub cap 80.

[0066] The dimensions of the housing 82 can be set so that when the insert 84 is installed in the cavity 88, the cavity 88 compresses the insert 84 so as to retain the insert 84 therein. The insert 84 can also be adhered to the bottom (i.e., base 83) of the housing 82 using a suitable hot melt glue or other suitable adhesive, although it is recognized that other suitable methods (including, for example, mechanical fixation) can also be used to fix the insert 84 to the housing 82. An annular lip 90 can be formed on the housing 82 to define a platform for receiving a seal 86, wherein the seal 86 cooperates with the annular lip 90 to seal the cavity 88 and retain the insert 84 therein. The seal 86 seals the cavity 88 of the housing 82 and the insert 84 therein to prevent contamination from the external environment, and the seal 86 provides a leak-proof barrier to protect the contents of the insert 84 and maintain a sealed, sterile environment. The seal 86 provides sufficient sealing under a certain range of temperature, pressure and humidity levels, and according to the embodiment, can be formed as a peelable top member of aluminum or a multi-layer polymer film. In some embodiments, seal 86 is heat or induction sealed to the open end of scrub cap 80. Seal 86 may include tabs 92 to facilitate handling of seal 86 and removal of seal 86 from scrub cap 80.

[0067] The insert 84 is made of a foam material such as an injection molded structure, or the insert 84 can be die-cut from a foam sheet. The insert includes a cleaning substance impregnated therein (while in the housing 82), such as a solution of a suitable bactericide or sterilant. The cleaning substance may include any suitable type and any suitable content of an antimicrobial disinfectant, the content depending on the size of the insert of the foam material. 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), the aqueous solution including about two percent (2%) of chlorhexidine gluconate (Chlorhexidine Solution, CHG) by volume. Alternatively, a solution including about 0.50cc is used. In another embodiment, the cleaning substance includes a solution including about seventy percent (70%) of isopropyl alcohol (IPA) in an aqueous solution. In yet another embodiment, the cleaning substance includes a solution comprising about seventy percent (70%) IPA and about two percent (2%) CHG in an aqueous solution having a content of about 0.2 ml. In the latter solution, it is recognized that, in one embodiment, the concentration of IPA can vary from about sixty percent (60%) to about ninety percent (90%), and the concentration of CHG can 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, the cleaning substance can include povidone iodine or a hydrogen peroxide solution.

[0068] According to aspects of the present disclosure, the insert 84 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 thereby. The insert 84 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 that enable the insert 84 to better deform / conform to the inner and outer surfaces of the port / connector.

[0069] The housing 82 of the scrub cap 80 has a proximal end configured to mate with the end cap 76 to secure the scrub cap 80 thereto. According to an embodiment, the housing 82 can be connected to the end cap 76 by inserting the housing into a receptacle 94 disposed on the distal end of the end cap 76, wherein the scrub cap 80 is secured to the end cap 76 by a press-fit connection between the housing 82 and the receptacle 94, a threaded engagement between the housing 82 and the receptacle 94, or any other suitable engagement means that secures the housing 82 relative to the end cap 76.

[0070] As shown below, and as 4A to 4H As shown, the use of the system 10 for line draw flushing and blood collection is described according to one aspect of the present disclosure. The use of the system 10 begins with the syringe assembly 12 being in a position such as Figure 4A , and the like. The syringe assembly 12 is configured as a prefilled syringe that, in the initial configuration, contains a solution therein (i.e., contained in the barrel 26) that is used to flush the fluid path / line of the VAD to which the syringe assembly 12 is to be connected. When in the initial configuration, the plunger 38 is disposed in an intermediate position that is neither fully advanced nor fully retracted, such that a fluid chamber is defined within the barrel 26 (by the inner surface of the distal end 28 of the barrel 26 and the distal surface of the stopper 40) to maintain a desired volume of flushing solution. As is known in the art, the flushing solution may be, by way of non-limiting example, a 0.9% sodium chloride injection solution, a physiological saline solution, or a heparin solution. Also as shown in the drawings, the syringe assembly 12 is provided with a prefilled syringe having a prefilled syringe assembly. Figure 4A As shown in , when in the initial configuration, the closure assembly 24 is secured to the fluid connector component 32 of the syringe 16—the end cap 76 and the wipe cap 80 are secured to the fluid connector component 32 and the wipe cap 80 of the syringe 16 in a sealed state (i.e., the seal 86 is secured to the housing 82 so as to seal the wipe insert 84).

[0071] like Figure 4B and Figure 4CAs shown, use of the system 10 continues by removing the seal 86 from the scrub cap 80 of the syringe assembly 12 to provide access to the scrub insert 84. Upon removal of the seal 86, the syringe assembly 12 begins to access the VAD (not shown) to provide cleaning and disinfection of the access port or connector 96 of the VAD. Figure 4B and Figure 4C A needleless connector according to a non-limiting example is shown. When the syringe assembly 12 approaches the connector 96, the scrub cap 80 is positioned on a portion of the connector 96 (i.e., a female Luer connection having a threaded outer connector 98 defining a tapered lumen or cavity 100 according to a non-limiting embodiment), wherein the foam insert 84 is pushed onto the connector 96 by the user. At this point, portions of the insert 84 conform to and / or are inserted into the connector 96 (i.e., approximately in the threaded outer connector 98 and the lumen 100). Once the portion of the connector 96 has been inserted into the foam insert 84 of the scrub cap 80, the scrub cap 80 is rotated relative to the connector 96. For example, the user can keep the connector 96 stationary while rotating the syringe assembly 12. When the scrub cap 80 is fixed in place relative to the syringe 16—through the connection of the fluid connector component 32 to the end cap 76 and the scrub cap 80—the rotation of the syringe assembly 12 causes a corresponding rotation of the scrub cap 80. The rotation of the scrub cap 80 relative to the connector 96 may be done entirely in one direction, or may be a back and forth twisting motion. The scrub cap 80 is rotated relative to the connector 96 a sufficient number of times to adequately kill any bacteria that the solution-impregnated foam insert 84 contacts, and / or remove any biofilm from the outer peripheral surface of the connector 96 and the threaded outer connector 98 and the inner surface of the lumen 100 of the connector 96. In this manner, both the outer and inner lumen surfaces of the connector 96 are scrubbed by the insert 84, causing the cleaning material therein to disinfect these surfaces and remove any biofilm disposed thereon.

[0072] After the cleaning and disinfection of the connector 96 of the VAD is completed by the scrub cap 80, the scrub cap 80 is separated from the connector 96. Then, the closure assembly 24 (scrub cap 80, end cap 76 and sealing member 78) can be removed from the fluid connector component 32 of the syringe assembly 12. Figure 4D As shown, after allowing connector 96 to dry, syringe assembly 12 may then be connected to the VAD by coupling fluid connector component 32 to connector 96, thereby fluidly connecting syringe assembly 12 to the catheter assembly.

[0073] According to one aspect of the present disclosure, when syringe assembly 12 is connected to connector 96, connector 96 and the fluid path of the VAD may be flushed with a flushing solution provided in a prefilled syringe 16. Figure 4EAs shown, the plunger assembly 18 (i.e., the plunger 38 and the stopper 40) is advanced distally to force the flushing solution out of the barrel 26 and into the VAD fluid path through the lumen 36 of the fluid connector component 32. The plunger 38 and the stopper 40 can be driven to their fully advanced positions to empty the flushing solution from the syringe 16.

[0074] After flushing of the VAD fluid path is complete, syringe assembly 12 may then be operated to collect an initially discarded blood sample. Figure 4F As shown, the plunger assembly 18 (i.e., the plunger 38 and the stopper 40) are proximally retracted to draw an initially discarded blood sample into the syringe assembly 12. As the plunger 38 and the stopper 40 are proximally retracted within the syringe barrel 26, a discarded (or bypassed) 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 40 and the inner surface of the distal end 28 of the barrel 26—and the blood flows from the fluid connector component 32 along the first fluid path and into the portion of the chamber 42.

[0075] like Figure 4G As shown, after a sufficient waste blood sample is drawn, the 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—the collection container 14 (e.g., a vacuum blood collection tube) is positioned within the receiving chamber 50 and engaged with the fluid pathway component 52 to place the container 14 in fluid communication with the plunger assembly 18. That is, when the collection container 14 is positioned / connected within the receiving chamber 50 and positioned / connected to the fluid pathway component 52, a second fluid path is formed from the fluid connector component 32 to the collection container 14—wherein the cannula 22 delivers blood from the connector component 32 to the channel 48 within the plunger 38, and then the blood enters the container 14 from the channel 48 through the fluid pathway component 52. As described above, in some embodiments, the fluid pathway component 52 is configured as a needle 64 having a lumen formed therein, wherein the needle 64 pierces the cover 72 of the container 14 so that blood is drawn into the vacuum reservoir 74 within the container 14.

[0076] like Figure 4H As shown, when the blood culture sample in the collection container 14 is obtained, the collection container 14 can be removed from the syringe assembly 12. In addition, in some embodiments, the syringe assembly 12 can then be operated to return the discarded blood sample to the patient. Figure 4H As shown, the plunger assembly 18 (i.e., the plunger 38 and the stopper 40) is advanced distally to force the discarded blood sample out of the barrel 26 and into the VAD fluid path through the lumen 36 of the fluid connector component 32. The plunger 38 and the stopper 40 can be driven to their fully advanced positions to empty the discarded blood sample from the syringe 16.

[0077] Although according to the specific embodiment Figures 1 to 4H Although the system 10 and method of use thereof are shown and described in detail in FIG. 1 , it should be appreciated that the system 10 (and its syringe assembly 12 ) may have other suitable configurations. Figures 5 to 16 Additional embodiments of syringe assemblies that may be used for line draw flushing and blood collection according to other aspects of the present disclosure are shown.

[0078] Now refer to Figure 5 and Figure 6 , which shows a syringe assembly 12 according to another aspect of the present disclosure. The syringe assembly 12 includes the previously described Figures 1 to 4H 1 and 2, except that the closure assembly 102 included in the syringe assembly 12 does not include the scrub cap 80 thereon. Instead, the closure assembly 102 includes only the end cap 76 and the sealing member 78. As previously described, the end cap 76 is configured to engage with the fluid connector component 32 so as to cover the fluid connector component 32 when the syringe assembly 12 is not in use, with one embodiment having the end cap 76 configured to include a Luer fitting at its proximal end that is configured to mate with an associated Luer fitting of the fluid connector component 32. The sealing member 78 is positioned / secured within the interior cavity of the end cap 76 such that when the end cap 76 is secured to the fluid connector component 32, the sealing member 78 is inserted into the opening 70 at the tip of the fluid connector component 32, thereby sealing the lumen 36. In the closure assembly 102, the distal end of the end cap 76 may present a flat surface or a recessed cavity, it being understood that the end cap 76 covers and encloses the fluid connector component 32 to maintain its cleanliness.

[0079] Now refer to Figures 7 to 10 , a syringe assembly 12 is shown according to other aspects of the present disclosure. In each of the illustrated embodiments, the syringe assembly 12 includes the syringe assembly 12 previously described. Figures 1 to 4H 78, except that the closure assembly 104 included in the syringe assembly 12 does not include the wipe cap 80 or the end cap 76 thereon. Alternatively, the closure assembly 104 includes only the sealing member 78 and the peelable top plate 106. The peelable top plate 106 is fixed to the fluid connector component 32 and is fixed to the distal surface of the sealing member 78—fixed to the (flat) portion extending from the opening 70 (and the lumen 36) at the tip of the fluid connector component 32. The peelable top plate 106 can be heat-sealed to the distal surface of the sealing member 78. When it is desired to engage the syringe assembly 12 with the connector of the VAD, the user can peel off the top plate 106, and the removal of the top plate 106 also removes the sealing member 78 from the fluid connector component 32 (through the attachment of the top plate 106 to the sealing member 78), or allows the sealing member 78 to be subsequently removed from the fluid connector component 32.

[0080] exist Figure 7 and Figure 8 In the illustrated syringe assembly 12, the sleeve 22 is disposed in the syringe assembly 12 so as to be secured to the barrel 26 of the syringe. With the sleeve 22 coupled to the barrel 26, the sleeve 22 thus remains stationary during use of the syringe assembly 12, i.e., during advancement and / or retraction of the plunger assembly 18. Fig. 9 and Fig.10 In the illustrated syringe assembly 12, the sleeve 22 is disposed in the syringe assembly 12 so as to be fixed / coupled to the plunger 38. With the sleeve 22 coupled to the plunger, the sleeve 22 thus moves with the plunger 38 during use of the syringe assembly 12, i.e., during advancement and / or retraction of the plunger assembly 18.

[0081] Now refer to Figures 11 to 14 , Figures 11 to 14 1 and 2 show syringe assemblies 12 according to other aspects of the present disclosure. In each of the illustrated embodiments, the syringe assembly 12 includes the syringe assembly 12 previously described. Figure 5 and Figure 6 All elements of the syringe assembly 12 shown and described in the drawings include a closure assembly 102 consisting of the end cap 76 and the sealing member 78 (without the wipe cap 80 thereon). However, Figures 11 to 14 Each of the syringe assemblies 12 also includes features therein that provide for locking the plunger assembly 18 (ie, the plunger 38) relative to the syringe 16 (ie, the barrel 26 of the syringe).

[0082] exist Fig.11 and Fig.12In the illustrated syringe assembly 12, the syringe assembly 12 is configured to lock the plunger 38 relative to the barrel 26 of the syringe when the plunger assembly 18 is in the distally advanced position. To achieve such locking of the plunger 38, the barrel 26 includes a retaining ring 108 formed on an inner surface 110 thereof, which extends radially inward from the remainder of the inner surface 110 - the retaining ring 108 of the barrel is located at the proximal end 30 of the barrel 26. The plunger 38 includes a corresponding retaining ring 112 formed thereon, which protrudes radially outward from an outer surface 114 of the plunger 38. The retaining ring 112 is formed on the plunger 38 adjacent to the proximal end 46 of the plunger 38. With the retaining rings 108, 112 so positioned, the retaining ring 112 on the plunger 38 can be advanced distally through the retaining ring 108 of the barrel 26 when the syringe assembly 12 is fully advanced distally relative to the syringe 16 (e.g., the retaining ring 112 slides through the retaining ring 108). When the retaining ring 112 on the plunger 38 is advanced distally through the retaining ring 108 of the barrel 26, such as when a flushing solution is dispensed / injected from the syringe assembly 12 into the VAD fluid line, the plunger 38 is subsequently locked within the barrel 26 and prevented from being retracted proximally from the barrel 26.

[0083] exist Fig.13 and Fig.14 In the illustrated syringe assembly 12, the syringe assembly 12 is configured to lock the plunger 38 relative to the syringe barrel 26 when the plunger assembly 18 is in the proximal retracted position. To achieve such locking of the plunger 38, the barrel 26 includes a retaining ring 108 formed on an inner surface 110 thereof, which extends radially inward from the remainder of the inner surface 110—the barrel retaining ring 108 is located at the proximal end 30 of the barrel 26. The plunger 38 includes a corresponding pair of retaining rings 112, 116 formed thereon, which project radially outward from an outer surface 114 of the plunger 38. The retaining rings 112, 116 are formed on the plunger 38 in a spaced-apart manner, and these retaining rings are adjacent to the distal end 44 of the plunger (e.g., just proximal to the stopper 40). With the retaining rings 108, 112, 116 so positioned, the plunger 38 can be fully advanced distally into the barrel 26 and then retracted proximally through the barrel 26 until the retaining rings 112, 116 on the plunger 38 contact the retaining ring 108 of the barrel 26 (i.e., the retaining rings 112, 116 are in place on opposite sides of the retaining ring 108). When the retaining rings 112, 116 on the plunger 38 are located on both sides of the retaining ring 108 of the barrel 26, such as when the plunger assembly 18 has been retracted to draw a waste volume of blood into the chamber 42 of the barrel 26, the plunger 38 is then locked relative to the barrel 26 and the plunger 38 is prevented from being further retracted proximally or advanced distally.

[0084] Now refer to Fig.15 and Fig.16, shows a syringe assembly 12 according to another aspect of the present disclosure. The syringe assembly 12 includes the previously described Figure 5 and Figure 6 All elements of the syringe assembly 12 shown and described in the drawings, including the closure assembly 102 consisting of the end cap 76 and the sealing member 78 (without the wipe cap 80 thereon). Fig.15 and Fig.16 In the syringe assembly 12 of the embodiment, rather than forming the plunger 38, receiving cavity 50 and finger grip 54 of the access device 20 as a single integral component, the receiving cavity 50 and finger grip 54 may be manufactured separately from the plunger 38 and then connected to the plunger 38. In the illustrated embodiment, the plunger 38 includes a female Luer connection 118 at its proximal end 46, and the access device 20 (i.e., its receiving cavity 50) includes a corresponding male Luer connection 120 thereon, which is configured to cooperate with the female Luer connection 118 to secure the access device 20 to the plunger assembly 18 and fluidly connect the passage 48 of the plunger 38 to the receiving cavity 50. A collapsible sleeve 122 extending through the Luer connections 118, 120 may be provided, the collapsible sleeve 122 providing a leak-proof fluid path between the passage 48 and the fluid access component 52 (i.e., the needle 64) of the access device 20. Needle 64 of access device 20 is inserted into male Luer connection 120 to engage removable sleeve 122 .

[0085] Although several embodiments of systems configured for line extraction flushing and blood collection are described in the above specific embodiments, those skilled in the art may modify and change these embodiments without departing from the scope and spirit of the present invention. That is, it is recognized that the features of each system of each embodiment can be incorporated into the systems of other embodiments. Therefore, the above description is intended to be illustrative rather than restrictive. The utility model described above is defined by the appended claims, and all changes to the utility model that fall within the equivalent meaning and equivalent range of the claims are included in the scope of the claims.

Claims

1. A system for line extraction, flushing and blood collection, characterized in that: The system comprises: A syringe assembly, the syringe assembly comprising: a prefilled syringe comprising a barrel having a distal end and a proximal end and defining a chamber for containing a solution therein, and a fluid connector component located at the distal end of the barrel; a plunger assembly including a plunger and a stopper, the plunger having a proximal end and a distal end, the stopper being located at the distal end of the plunger, the stopper being insertable into and slidable within the proximal end of the barrel, the plunger including a passage extending along the length of the plunger between the proximal end and the distal end; a passage device located at the proximal end of the plunger, the passage device comprising a receiving cavity having an opening therein aligned with the passage and a fluid passage component located over the opening and extending into the receiving cavity, the fluid passage component being in fluid communication with the passage; a sleeve at least partially disposed within the barrel and extending through the stopper, wherein the sleeve is configured to enable fluid communication between the fluid connector component and the passageway; and A closure assembly is secured to the fluid connector component, the closure assembly including a sealing member configured to seal the lumen of the fluid connector component to contain the solution within the chamber of the syringe.

2. The system according to claim 1, characterized in that The closure assembly includes an end cap configured to engage the fluid connector component, wherein a fluid path seal is located within the end cap, and wherein a proximal end of the end cap includes a Luer fitting configured to mate with an associated Luer fitting of the fluid connector component.

3. The system according to claim 2, characterized in that The closure assembly further includes a scrubbing cap secured to a distal end of the end cap, the scrubbing cap comprising: a housing secured to the end cap and defining a cavity; a scrub insert positioned within the cavity; and A seal is attached to the cavity to seal the scrub insert within the cavity.

4. The system according to claim 3, characterized in that 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.

5. The system according to claim 4, characterized in that The housing includes a connector portion including a threaded connection configured to engage with the end cap via a twist-on engagement.

6. The system according to claim 1, characterized in that The closure assembly includes a peel plate directly coupled to a fluid path seal to facilitate removal of the fluid path seal from the fluid connector component.

7. The system according to claim 1, characterized in that The system also includes a container defining a reservoir, the container being positionable within the receiving cavity and engageable with the fluid pathway component to transfer fluid into the reservoir.

8. The system according to claim 7, characterized in that The fluid pathway component includes a needle having a lumen defined therein, and wherein the container includes a cap pierceable by the needle to place the reservoir in fluid communication with the passageway of the plunger.

9. The system according to claim 7, characterized in that Each of the receiving cavity and the proximal end of the plunger includes a Luer connector, the Luer connector of the receiving cavity engages with the Luer connector of the plunger to secure the access device to the plunger assembly, and wherein a removable sleeve extending through the Luer connector places the channel in fluid communication with the fluid access component.

10. The system according to claim 1, characterized in that The plunger and barrel include locking features positioned and configured to lock the plunger relative to the barrel when the plunger assembly is in a distally advanced position.

11. The system according to claim 1, characterized in that The plunger and barrel include locking features positioned to lock the plunger relative to the barrel when the plunger assembly is in a proximally retracted position.

12. The system according to claim 1, characterized in that The sleeve is coupled to the barrel and remains stationary during use of the syringe assembly.

13. The system according to claim 1, characterized in that The cannula is coupled to the plunger such that the cannula is movable in response to advancement or retraction of the plunger within the barrel.

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