Blood sample collection system

Abstract

Provided herein is a blood sample collection system comprising: a container assembly having a cap and defining a reservoir; and a fluid passageway assembly having a housing defining an interior, the housing having a distal end and a proximal end, a fluid passageway component extending from the distal end of the housing into the interior of the housing, the fluid passageway component defining an interior cavity, and a fluid connector component defining an interior cavity, the fluid connector component defining an outer cavity, the fluid connector component is disposed on the distal end of the housing. A scrubbing cap is disposed at or adjacent a distal end of the fluid pathway assembly, where the scrubbing cap has a scrubbing insert and a housing defining a cavity configured to retain the scrubbing insert therein.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims priority to U.S. Provisional Application No. 63 / 461,712, filed on April 25, 2023, and entitled “Blood Sample Collection System with Integrated Scrubbing Cap and Method of Use Thereof,” the entire disclosure of which is incorporated herein by reference in its entirety. Technical Field

[0003] The present disclosure relates to a blood sample collection system with an integrated scrub cap and methods of using the same. Background Art

[0004] Catheters are commonly used to deliver fluids into and out of the body (i.e., blood), and in various situations, including in hospitals and home care, patients are able to receive such fluids or have blood withdrawn via a Vascular Access Device (VAD), which includes such a catheter inserted into the patient's vasculature. 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 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 specimens 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 include venipuncture using a blood collection set with an attached Luer-Lock Access Device (LLAD). During the insertion process, the venipuncture device may acquire microorganisms from the skin and during the insertion process, and subsequently transfer these microorganisms to the blood culture sample, resulting in a false positive test result for sepsis. In order to minimize the risk of false positives, it is usually necessary to discard the initial amount of blood that is most likely to contain microorganisms from the skin, such as discarding the initial 1 milliliter (ml) to 10 ml of blood drawn. However, this process also introduces some risks because discarding sample collection introduces additional non-sterile steps, techniques, and connections, which increases the risk of introducing microorganisms into subsequent blood culture samples.

[0006] In some prior art devices, such as the device described in U.S. Publication No. 2021 / 0196167 by Velano Vascular, Inc., the above complications are addressed by adding an adapter to the LLAD that holds the discarded sample in a pre-advanced position to allow sterilization of the entire assembly (including the discarded sample), thereby reducing the number of non-sterile steps and connections during the blood culture sample collection process. This reduces the overall risk of introducing microorganisms into the blood culture sample and therefore reduces the risk of false positives.

[0007] Although the LLAD as described above addresses some of the risks of false positive blood culture samples, it does not address the risk that the clinician fails to disinfect or ineffectively disinfects the access port or connector of the VAD before connecting the LLAD to the access port. That is, clinicians typically use alcohol wipes to scrub and disinfect the access port before connecting the LLAD to the access port, but the use of alcohol wipes to scrub and disinfect the access port is generally not completely effective in disinfecting all of the inner / outer surfaces of the access port (including (potentially) the complex threaded area around the Luer portion coupled to the LLAD). In addition, in some cases, the clinician may forget to wipe the access port before connecting the LLAD. If the disinfection of the access port is not performed correctly, false positive blood culture samples may occur.

[0008] Therefore, there is a need in the art for a means to ensure that a clinician has effectively sterilized the access port of a VAD before connecting a blood collection set to the port. Utility Model Content

[0009] A blood sample collection system is provided herein, the blood sample collection system comprising a container assembly having a cap and defining a reservoir, wherein the container assembly has a distal end and a proximal end, wherein the cap is disposed at the distal end of the container assembly. The blood sample collection system also comprises a fluid pathway assembly having a housing defining an interior, a fluid pathway component, and a fluid connector component, the housing having a distal end and a proximal end, the fluid pathway component extending from the distal end of the housing into the interior of the housing, the fluid pathway component defining an inner cavity, and the fluid connector component disposed on the distal end of the housing. The blood sample collection system also comprises a scrub cap disposed at or adjacent to the distal end of the fluid pathway assembly, wherein the scrub cap has a scrub insert and a housing, the housing defining a cavity, the cavity being configured to retain the scrub insert in the cavity.

[0010] In some embodiments, the fluid connector component includes a Luer connector configured to couple to an access port of a vascular access device, wherein the connector portion of the scrub cap engages the Luer connector to secure the scrub cap to the fluid access assembly.

[0011] In some embodiments, the Luer connector includes one of a sliding Luer, a threaded Luer, or a Luer lock with a collar.

[0012] In some embodiments, the blood sample collection system also includes an adapter, which includes a first engagement feature and a second engagement feature, the first engagement feature of the adapter being configured to releasably engage with a cap of the container assembly, and the second engagement feature of the adapter being configured to releasably engage with an engagement feature of the fluid pathway assembly, such that in a first configuration in which the first engagement feature of the adapter is engaged with the cap and the second engagement feature of the adapter is engaged with the engagement feature of the fluid pathway assembly, the cap of the container assembly is at least partially disposed within the interior of the housing of the fluid pathway assembly and is spaced apart from the fluid pathway component.

[0013] In some embodiments, the container assembly is configured to transition from a first configuration to a second configuration by translating the container assembly toward a first end of the fluid pathway assembly, such that the cap disengages from a first engagement feature of the adapter and the fluid pathway component pierces a resealable membrane of the cap such that the reservoir of the container assembly is in fluid communication with the fluid connector component and the connector portion via an inner cavity of the fluid pathway component.

[0014] In some embodiments, the blood sample collection system includes an extension member having a distal end and a proximal end, the proximal end of the extension member being coupled to a fluid connector component, wherein the extension member is configured to reduce hemolysis of a blood sample passing through the extension member, and wherein the connector portion of the scrub cap engages with the distal end of the extension member to secure the scrub cap to the extension member.

[0015] In some embodiments, the extension member includes: a connector interface disposed at a distal end of the extension member and configured to couple the extension member to an access port of a vascular access device; and a flexible tube fluidly coupled to the connector interface and configured to couple to a fluid connector component of the fluid pathway assembly, wherein the flexible tube is configured to reduce hemolysis of a blood sample passing through the flexible tube.

[0016] In some embodiments, the extension member includes a compact connector having: a proximal connector portion, which is configured to couple the compact connector to the fluid connector component; a distal connector portion, which is configured to couple the compact connector to an access port of a vascular access device; and a central portion, which is shaped and configured to reduce hemolysis of a blood sample passing through the central portion.

[0017] In some embodiments, the connector interface or the distal connector portion comprises one of: a threaded Luer, a sliding Luer, a threaded Luer lock with a collar, a blunt plastic cannula, a male Luer, a cannula for PRN access, a needleless connector, or a needle access cannula.

[0018] In some embodiments, the connector portion of the scrub cap secures the scrub cap via a twist-on engagement, wherein the scrub cap is removable to enable the blood sample collection system to be connected to an access port of a vascular access device.

[0019] 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 the access port of the vascular access device.

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

[0021] A method for using a blood sample collection system is also provided herein. The method includes: providing a blood sample collection system, the blood sample collection system including: a container assembly having a cap and defining a reservoir, the container assembly having a distal end and a proximal end, the cap being disposed at the distal end of the container assembly; a fluid pathway assembly including a housing defining an interior, a fluid pathway component, and a fluid connector component, the housing having a distal end and a proximal end, the fluid pathway component extending from the distal end of the housing into the interior of the housing, the fluid pathway component defining an inner cavity, the fluid pathway component being disposed on the distal end of the housing; and a scrub cap disposed on or adjacent to the distal end of the housing, the scrub cap including a scrub insert and a housing, the housing defining a cavity, the cavity being configured to retain the scrub insert in the cavity. The method also includes: positioning the scrub cap over an access port of a vascular access device so that the access port contacts the scrub insert, and cleaning the access port with the scrub insert.

[0022] In some embodiments, the fluid connector component includes a luer connector configured to couple to the access port, wherein the connector portion of the scrub cap engages the luer connector to secure the scrub cap to the fluid access assembly.

[0023] 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 fluidly connect the fluid access assembly with the vascular access device.

[0024] In some embodiments, the blood sample collection system includes an extension member having a distal end and a proximal end, the extension member being configured to reduce hemolysis of a blood sample passing through the extension member, wherein the connector portion of the scrub cap engages with the distal end of the extension member to secure the scrub cap to the extension member.

[0025] In some embodiments, the method further comprises: after cleaning the access port, removing the scrub cap from the distal end of the extension member; and coupling the distal end of the extension member to the access port to fluidly connect the fluid access assembly with the vascular access device.

[0026] In some embodiments, the blood sample collection system includes an adapter, which includes a first engagement feature and a second engagement feature, the first engagement feature of the adapter being configured to releasably engage with a cap of the container assembly, and the second engagement feature of the adapter being configured to releasably engage with an engagement feature of the fluid pathway assembly, such that in a first configuration in which the first engagement feature of the adapter is engaged with the cap and the second engagement feature of the adapter is engaged with the engagement feature of the fluid pathway assembly, the cap of the container assembly is at least partially disposed within an interior of a housing of the fluid pathway assembly and is spaced apart from the fluid pathway component.

[0027] In some embodiments, the method further includes: translating the container assembly relative to the adapter toward the first end of the fluid pathway assembly so that the cap disengages from the first engagement feature of the adapter and the fluid pathway component pierces the resealable membrane of the cap so that the reservoir of the container assembly is in fluid communication with the fluid connector component via the inner cavity of the fluid pathway component; separating the second engagement feature of the adapter from the engagement feature of the fluid pathway assembly; and translating the container assembly away from the first end of the fluid pathway assembly and out of the interior of the fluid pathway assembly so that the container assembly and the adapter are separated from the fluid pathway assembly.

[0028] In some embodiments, the scrub cap includes a seal attached to the cavity to seal the scrub insert within the cavity, wherein the method further comprises removing the seal from the scrub cap so that the scrub cap can be positioned over an access port of a vascular access device and bring the scrub insert into contact with the access port.

[0029] In some embodiments, cleaning the access port includes applying a twisting motion to the blood sample collection system. BRIEF DESCRIPTION OF THE DRAWINGS

[0030] Figure 1 is a schematic diagram of a blood sample collection system according to an embodiment;

[0031] Figure 2 is a side view of a blood sample collection system according to an embodiment;

[0032] Figure 3A yes Figure 2 A rear perspective view of a blood sample collection system in a first configuration;

[0033] Figure 3B yes Figure 2 A rear perspective view of the blood sample collection system in a second configuration;

[0034] Figure 4 According to an embodiment, the Figure 2An exploded view of a scrub cap in a blood sample collection system;

[0035] Figure 5 It shows Figure 4 A cross-sectional view of a scrub cap engaged with an access port of a vascular access device;

[0036] Figure 6 is a side view of a blood sample collection system according to another embodiment;

[0037] Figure 7 is a side view of a blood sample collection system according to another embodiment; and

[0038] Figure 8 is a side view of a blood sample collection system according to another embodiment. DETAILED DESCRIPTION

[0039] 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.

[0040] 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.

[0041] 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" refer to the direction toward the pathway connector portion of the fluid transfer device, and the terms "in the proximal direction" and "proximally" refer to the direction opposite to the direction of the pathway connector portion.

[0042] 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, for example, 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.

[0043] Embodiments of the present disclosure will be described primarily in the context of a blood sample collection system for use with a PIVC. However, embodiments of the present disclosure extend to use with other catheter devices as well.

[0044] Reference Figures 1 to 3B , Figures 1 to 3B A blood sample collection system 50 is shown in accordance with an aspect of the present disclosure. Figure 1 is a schematic diagram of a blood sample collection system (or, hereinafter, may also be referred to as a system) 50 according to an embodiment. The system 50 includes a container assembly 210, an adapter 230, a fluid path assembly 220, and a scrub cap 60.

[0045] Although described in detail below, it should be appreciated that, according to one non-limiting example, the container assembly 210 may be any suitable standard vacuum tube and the fluid path assembly 220 may be any suitable standard holder, wherein the container assembly 210 is provided as a BD Vacuum ... The fluid path assembly 220 is provided as a BD Retainer Device More generally, container assembly 210 may include cap 212 and may define reservoir 211 , while fluid pathway assembly 220 may include housing 228 defining an interior, engagement feature 222 , fluid pathway component 224 , and fluid connector component 226 .

[0046] The adapter 230 may include a first engagement feature 231 and a second engagement feature 232. The first engagement feature 231 of the adapter 230 may be configured to releasably engage with the cap 212 of the container assembly 210, and the second engagement feature 232 of the adapter 230 may be configured to releasably engage with the engagement feature 222 of the fluid path assembly 220. The first engagement feature 231 of the adapter 230 may be or may include any suitable engagement mechanism that is configured to temporarily or releasably hold the cap 212 in a position relative to the adapter 230 and release the cap 212 when the cap 212 moves relative to the first engagement feature 231. The movement may include, for example, translational movement, rotational movement, and / or helical movement. The second engagement feature 232 of the adapter 230 and the engagement feature 222 of the fluid pathway assembly 220 may be or may include any suitable engagement mechanism that is configured to temporarily or releasably engage with each other to temporarily hold the adapter 230 in a position relative to the fluid pathway assembly 220 or a component of the fluid pathway assembly 220 (e.g., the housing 228), and to release the adapter 230 from the fluid pathway assembly 220 (e.g., via deformation of the adapter 230 such that the cap 212 is released from the adapter 230 and / or via deformation and / or movement (e.g., rotation, spiraling and / or translation) of the second engagement feature 232 and / or the engagement feature 222 relative to the second engagement feature 232 or the other of the engagement features 222 such that the second engagement feature 232 can be separated from the engagement feature 222).

[0047] Container assembly 210 may include a distal end and a proximal end. Cap 212 may be disposed at the distal end of container assembly 210. In some embodiments, container assembly 210 may include a tube having an open end and a closed end opposite to the open end. Cap 212 may be coupled to the open end so that cap 212 and the tube define reservoir 211. In some embodiments, cap 212 may include a resealable membrane. The resealable membrane may be configured so that a fluid pathway component (e.g., fluid pathway component 224) may pierce the resealable membrane to achieve fluid communication with reservoir 211. The resealable membrane of cap 212 may be configured to reseal when fluid pathway component 224 is separated from cap 212 so that reservoir 211 is fluidically isolated from an area outside container assembly 210. In some embodiments, cap 212 may include a ridge and / or one or more flanges disposed on its outer surface. Reservoir 211 may be a vacuum reservoir, such that when reservoir 211 is placed in fluid communication with a fluid source (e.g., via piercing a resealable membrane of cap 212 using a fluid passage component fluidically coupled to the patient's vascular system), fluid (e.g., blood) may be drawn into reservoir 211 due to a pressure differential between reservoir 211 and the fluid source. In some embodiments, container assembly 210 may be a vacuum tube, and cap 212 may be formed of any suitable material (e.g., rubber). The tube may be formed of, for example, plastic.

[0048] Fluid pathway assembly 220 may also have a distal end and a proximal end. Fluid pathway component 224 may be disposed within the interior of housing 228 and may extend from the distal end of housing 228 into the interior of housing 228. For example, in some embodiments, fluid pathway component 224 may have a distal end and a proximal end opposite the distal end. The distal end of fluid pathway component 224 may be coupled to the distal end of housing 228, and the proximal end may be disposed within the interior of housing 228. In some embodiments, fluid pathway component 224 may include a needle defining a lumen. In some embodiments, fluid pathway assembly 220 may include a flexible needle sheath configured to substantially surround the needle and be capable of translating relative to the needle so that the proximal end of the needle may be selectively exposed.

[0049] The fluid connector component 226 can be integrated with the distal end of the housing 228 or removably coupled to the distal end of the housing. For example, the housing 228 can define an outlet that is fluidically coupled to the inner cavity of the fluid pathway component 224, wherein the fluid connector component 226 can be coupled to the inner cavity. In some embodiments, the fluid connector component 226 can include any suitable component configured to couple the housing 228 to the access port of a connector or patient access tube. For example, in some embodiments, the fluid connector component 226 can be a Luer connector. The Luer connector can be in the form of, for example, a sliding Luer piece, a threaded Luer piece, a Luer lock with a collar, etc. In some embodiments, the fluid connector component 226 can be an outlet of the housing 228 that defines the inner cavity.

[0050] like Figures 1 to 3B As shown, the engagement feature 222 of the fluid pathway assembly 220 may include a flange that extends perpendicularly from the central axis of the housing 228. In some embodiments, the flange may be extended so that the flange extends further in a first direction than in a second direction from the central axis of the housing 228. For example, the flange may form an extended surface of the fluid pathway assembly 220 disposed in a plane containing the proximal end of the housing 228.

[0051] The first engagement feature 231 of the adapter 230 can be any suitable feature configured to releasably engage with the cap 212 of the container assembly 210. In some embodiments, the first engagement feature 231 of the adapter 230 can be an inner surface of the adapter 230 that defines a through hole. The inner surface of the adapter 230 can include a diameter that is sufficiently small relative to the outermost diameter of the cap 212 so that the inner surface and the cap 212 can engage via a friction fit. In some embodiments, the first engagement feature 231 can include a feature that corresponds to a feature on the cap 212 so that the adapter 230 and the cap 212 can releasably engage.

[0052] The second engagement feature 232 of the adapter 230 can be any suitable feature configured to releasably engage with the engagement feature 222 of the fluid pathway component 220. For example, the second engagement feature 232 can include two oppositely disposed lugs. A latch can be disposed on the end of each lug. The shape and size of each latch can be designed to accommodate a portion of a flange of the engagement feature 222 of the fluid pathway component 220. In some embodiments, the adapter 230 can be rotated relative to the fluid pathway component 220 so that the second engagement feature 232 (e.g., latch) can be rotated out of engagement with the engagement feature 222 (e.g., flange) of the fluid pathway component 220. In some embodiments, the second engagement feature 232 can include a plurality of arms (e.g., two), each of the plurality of arms having a distal end that is coupled to the base of the adapter 230 via a flexible joint and a latch disposed on an opposite end of the arm. In some embodiments, each of the plurality of arms can be curved and can form a portion of the outer edge of the adapter 230. Such an adapter can be separated from the engagement feature 222 of the fluid path assembly 220 via, for example, rotation and / or deformation (e.g., bending). In some embodiments, the second engagement feature 232 may include a plurality of tabs including a latch configured to snap onto a flange of the engagement feature 222. For example, the second engagement feature 232 may include two or three latching tabs. To separate such an adapter 230 from the housing 228, a user may separate each latching tab from the flange of the engagement feature 222 by pulling the latch away from the flange of the engagement feature 222, so that the latching tab is released from engagement with the flange of the engagement feature 222.

[0053] According to various embodiments, the adapter 230 allows container assemblies 210 of various sizes and shapes to be used with (e.g., disposed within and stabilized by) the fluid pathway assembly 220. As described above, the adapter 230 can be configured (e.g., shaped and dimensioned to) engage with the engagement feature 222 of the fluid pathway assembly 220, wherein the second engagement feature 232 of the adapter 230 receives a portion of the engagement feature 222 when the second engagement feature 232 of the adapter 230 engages with the engagement feature 222 of the fluid pathway assembly 220.

[0054] Reference Figure 3A, the system 50 has a first configuration (e.g., an initial configuration) in which the first engagement feature 231 of the adapter 230 engages with the cap 212 and the second engagement feature 232 engages with the engagement feature 222 of the fluid pathway assembly 220. When the first engagement feature 231 of the adapter 230 engages with the cap 212 and the second engagement feature 232 engages with the engagement feature 222 of the fluid pathway assembly 220, the cap 212 is spaced apart from the fluid pathway component 224 such that the reservoir 211 is fluidly isolated from the external environment of the container assembly 210. In the first configuration, the cap 212 can be at least partially disposed within the adapter 230 and / or the housing 228. For example, the distal end of the cap 212 can be disposed within the interior of the housing 228 (either protruding from the adapter 230 or located within the adapter 230). In some embodiments, the distal end of the cap 212 can be disposed and maintained within the adapter 230 in the first configuration, but proximate to the housing 228. In some embodiments, the entire system 50 can be sterilized in the first configuration and packaged for sterile shipment to a user (eg, a healthcare provider).

[0055] Next, refer to Figure 3B , system 50 also has a second configuration in which the lumen of fluid pathway component 224 is in fluid communication with reservoir 211. To convert system 50 from the first configuration to the second configuration, container assembly 210 can be translated distally toward the distal end of fluid pathway component 220 such that cap 212 engages with fluid pathway component 224 (e.g., fluid pathway component 224 pierces cap 212) and a portion of fluid pathway component 224 is disposed within reservoir 211. For example, in embodiments in which container assembly 210 engages first engagement feature 231 via a friction fit, a force can be applied to container assembly 210 to overcome the force applied by first engagement feature 231 on container assembly 210 (e.g., cap 212) and translate container assembly 210 into engagement with fluid pathway component 224. In a second configuration, when the fluid connector component 226 is fluidly coupled to the patient's vasculature (via connection of the blood sample collection system 50 to the VAD, for example, via coupling of the fluid connector component 226 to the VAD access port), fluid (e.g., blood) can be drawn through the fluid connector component 226, through the fluid pathway component 224 and into the reservoir 211 of the container assembly 210.

[0056] After sufficient blood has been drawn into the reservoir 211, the system 50 can be converted from the second configuration to a third configuration (not shown) in which the container assembly 210 and the adapter 230 are separated from the fluid pathway assembly 220. For example, the container assembly 210 can be translated relative to the fluid pathway assembly 220 so that the cap 212 is disposed near the proximal end of the housing 228. In response to the cap 212 being disengaged from the fluid pathway component 224, the reservoir 211 can be fluidly isolated from the environment outside the container assembly 210 due to the cap 212 having a resealable membrane. The adapter 230 can then be separated from the fluid pathway assembly 220 by separating the second engagement feature 232 from the engagement feature 222 (e.g., by rotating, disengaging, or deforming one or more portions of the second engagement feature 232 from the engagement feature 222 of the fluid pathway assembly 220). The adapter 230 and the container assembly 210 can then optionally be discarded, particularly when this initial blood sample may be considered a "discarded sample."

[0057] After the adapter 230 and the container assembly 210 are removed from the fluid pathway assembly 220, the second container assembly can be inserted into the interior of the housing and the second container assembly can be engaged with the fluid pathway component 224 so that the second container assembly can draw blood into the reservoir of the second container assembly via the fluid connector component 226 and the fluid pathway component 224. In some embodiments, the second container assembly can include a culture medium (e.g., soybean casein digest broth) in the reservoir of the second container assembly, which is configured to be used for blood culture when combined with the patient's blood sample in the reservoir. Any suitable number of container assemblies can be engaged with the fluid pathway component 224 (and then disengaged) to extract fluid from the patient for various tests. In addition, because many of the main components of the system 50 do not need to be removed between two blood draws, the workflow of the healthcare provider is improved. In addition, compared with traditional blood drawing methods, the overall reduction in connections can reduce the risk of sample contamination during blood drawing. This, combined with the ability to provide the entire system 50 in a sterile package, reduces the total risk of blood culture sample contamination.

[0058] According to aspects of the present disclosure, it should be appreciated that when the blood sample collection system 50 is initially connected to the VAD access port (e.g., via the coupling of the fluid connector component 226 to the access port), it is desirable to disinfect the access port prior to connecting the blood sample collection system 50 to the access port. That is, it is desirable to clean and disinfect the access port prior to the fluid connector component 226 being engaged with the access port (e.g., via the mating of a female Luer connector and a male Luer connector) to prevent microbial entry and possible catheter-related bloodstream infection (CRBSI).

[0059] According to aspects of the present disclosure, a scrub cap 60 is integrated with the blood sample collection system 50 at the distal end 52 of the blood sample collection system 50 to provide cleaning and disinfection of the access port before the system 50 is engaged with the scrub cap. The scrub cap 60 is fixed to the fluid connector component 226 and is configured to engage with the access port to achieve cleaning and disinfection of the inner and / or outer surfaces of the access port, such as cleaning and disinfection via a twisting and scrubbing motion between the scrub cap 60 and the access port. After the cleaning and disinfection of the access port is completed, the scrub cap 60 can be removed from the fluid connector component 226, so that the fluid connector component 226 can be subsequently coupled to the access port and blood draws can be performed via operation of the system 50 as previously described.

[0060] like Figure 1 and Figure 2 As shown and still Figure 4 and Figure 5 As shown, the scrub cap 60 includes a cap housing (or, hereinafter referred to as a housing) 62, a scrub insert (or, hereinafter referred to as an insert) 64, and a peelable seal 66. The housing 62 can be an integrally formed structure made by injection molding, and can be made of an alcohol-compatible material, for example, the alcohol-compatible material is such as polypropylene or polyethylene. The housing 62 can be generally described as including a retainer portion 68 and a connector portion 70, the retainer portion retaining the insert 64 therein, and the connector portion is configured to cooperate with the fluid connector component 226 of the blood sample collection system 50.

[0061] The retainer portion 68 may have a cup shape formed by a base 72 and a sidewall structure 74, the cup shape defining an opening 76 at one end thereof. The sidewall structure 74 is integrally formed with the base 72 to define a cavity 78 configured to accommodate the insert 64 therein. In some embodiments, the cavity 78 may have a cylindrical cross-sectional shape and may have a depth suitable for accommodating the insert 64 therein in a recessed manner. However, it is understood that the retainer portion 68 and the cavity 78 defined thereby may take other shapes, including square, hexagonal, etc., and the shape and size of the retainer portion 68, the cavity 78 of the retainer portion, and the insert 64 disposed therein may be configured to enable the scrub cap 60 to 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 60.

[0062] The dimensions of the retainer portion 68 can be designed so that when the insert 64 is installed in the cavity 78, the cavity 78 defined by the sidewall structure 74 compresses the insert 64 so as to retain the insert 64 therein. The insert 64 can also be adhered to the bottom (i.e., base 72) of the retainer portion 68 using a suitable hot melt adhesive or other suitable adhesive, although it is recognized that other suitable methods can also be used to secure the insert 64 (including, for example, mechanically secure) to the retainer portion 68. An annular lip 80 can be formed on the retainer portion 68 (i.e., located on the sidewall structure 74) around the opening 76 to define a land for accommodating the seal 66, wherein the seal 66 cooperates with the annular lip 80 to seal the opening 76 of the cavity 78 and retain the insert 64 in the cavity. The seal 66 seals the cavity 78 of the retainer portion 68 and the insert 64 in the cavity to prevent contamination from the external environment and provide a leak-proof barrier, thereby protecting the contents of the insert 64 and maintaining a sealed, sterile environment. Seal 66 provides an adequate seal over a range of temperatures, pressures, and humidity levels, and may be formed as a peelable top of aluminum or a multi-layer polymer film according to various embodiments. In some embodiments, seal 66 is heat sealed or induction sealed to the open end of scrub cap 60. Seal 66 may include tabs 82 to facilitate handling of seal 66 and removal of seal 66 from scrub cap 60.

[0063] Insert 64 is made of foam material such as injection molding structure, or insert 64 can be die-cut from foam sheet. Insert includes a cleaning substance impregnated therein (while being located in retainer portion 68), such as a solution of a suitable microbicide or bactericide. Based 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 of about 70 percent (70%) of isopropyl alcohol ("IPA") in an aqueous solution. In yet another embodiment, the cleaning substance includes a solution containing about 70 percent (70%) IPA and about 2 percent (2%) CHG in an amount of about 0.2 ml of aqueous solution. In the latter solution, it should be appreciated that in one embodiment, the concentration of IPA can vary from about 60 percent (60%) to about 90 percent (90%), and the concentration of CHG can vary from about 1 percent (1%) to about 5 percent (5%). Other suitable solution compositions and concentrations are also possible. For example, in one embodiment, the cleaning substance can include a povidone iodine or hydrogen peroxide solution.

[0064] According to aspects of the present disclosure, the insert 64 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 64 can further have any of a variety of configurations 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, which enables the insert 64 to better deform / conform around the inner and outer surfaces of the port / connector.

[0065] The connector portion 70 of the scrub cap 60 extends proximally away from the retainer portion 68 and is configured to cooperate with the fluid connector component 226 to secure the scrub cap 60 to the fluid connector component. According to various embodiments, the connector portion 70 can be configured as a Luer connector (e.g., a male Luer connector or a female Luer connector) that can be mated with a corresponding Luer connector provided by the fluid connector component 226 so that the connector portion 70 is fixed in place relative to the fluid connector component 226.

[0066] Next, if Figure 5 As shown, according to one aspect of the present disclosure, the use of the scrub cap 60 as a scrubbing device to clean and disinfect the access port or connector 84 of the VAD is described. The use of the scrub cap 60 begins by removing the seal 66 from the scrub cap 60. After removing the seal 66, the user inserts the connector 84 (according to a non-limiting embodiment, the connector can be configured as a female Luer connector having a threaded outer connector 86 defining a tapered inner cavity or cavity 88) into the foam insert 64. At this time, the various portions of the insert 64 conform to and / or are inserted into the connector 84 (i.e., around the threaded outer connector 86 and into the inner cavity or cavity 88). Once a portion of the connector 84 has been inserted into the foam insert 64 of the scrub cap 60, the scrub cap 60 is rotated relative to the connector 84. For example, the user can keep the connector 84 stationary while rotating the blood sample collection system 50. When the scrub cap 60 is secured in place relative to the blood sample collection system 50—via the connection to the scrub cap 60 by the fluid connector component 226—rotation of the blood sample collection system 50 causes a corresponding rotation of the scrub cap 60. The rotation of the scrub cap 60 relative to the connector 84 can be done entirely in one direction, or can be a back-and-forth twisting motion. The scrub cap 60 is rotated relative to the connector 84 a sufficient number of times to adequately kill any bacteria that the solution-impregnated foam insert 64 contacts, and / or remove any biofilm from the outer peripheral surface of the connector 84 and the threaded outer connector 86 and the inner surface of the lumen or cavity 88 of the connector 84. In this manner, both the outer surface and the inner cavity surface of the connector 84 are scrubbed by the insert 64, causing the cleaning substance therein to disinfect the surface and remove any biofilm disposed thereon.

[0067] After the cleaning and disinfection of the connector 84 is completed via the scrub cap 60, the connector 84 is removed from the scrub cap 60. The scrub cap 60 can then be removed from the fluid connector component 226 of the system 50. After allowing the connector 84 to dry, the blood sample collection system 50 can then be connected to the connector by coupling the fluid connector component 226 to the connector 84.

[0068] Although in Figures 1 to 3B A blood sample collection system 50 according to a particular embodiment is shown and described in FIG. 1 , but it should be appreciated that the system 50 may have other suitable configurations. According to other aspects of the present disclosure, various alternative configurations of the system 50 are described below.

[0069] Refer again Figure 1 (referring to the elements shown in dashed lines therein), and now also referring to Figure 6 and Figure 7, the system 50 is shown to optionally include an extension member 100, wherein the extension member 100 is configured to reduce hemolysis of a blood sample drawn into the container assembly 210. Figure 6 In some embodiments, the extension member 100 may include a connector interface (or VAD access / connector interface) 102 and a fluid path member with optimized fluid resistance (or fluid path for protecting blood fluid (hemoshield fluid)) 104. The connector interface 102 can be configured as any suitable interface capable of coupling the extension member 100 to the access port of the VAD. For example, in some embodiments, the connector interface 102 can be configured as a threaded Luer, a sliding Luer, a threaded Luer lock with a collar, a blunt plastic cannula (with or without an alligator-type connection clip), a male Luer (with or without an alligator-type connection clip), a cannula for a pro re nata (PRN, an abbreviation for "pro re nata") access, a needleless connector, or a needle access cannula.

[0070] Fluid path member 104 may be formed of any suitable element that is capable of providing optimized fluid resistance to reduce hemolysis of one or more blood samples as blood flows between connector interface 102 and fluid connector component 226. Figure 6 In the illustrated embodiment, the fluid path member 104 is formed by a flexible tube. The inner diameter and length of the flexible tube can be selected to limit the maximum blood sampling rate, which in turn can limit the maximum shear stress experienced by blood cells during blood sampling. As described above, shear stress on blood cells (particularly shear stress on blood cell walls) is considered to be the main source of blood cell hemolysis and mechanical damage. Therefore, by optimizing the fluid resistance of the fluid path member 104, hemolysis of the collected blood sample can be reduced.

[0071] However, although Figure 6 The extension member 100 is shown to include a connector interface 102 and a fluid path member 104 formed as a flexible tube, but the present disclosure is not limited thereto. For example, in some embodiments, the extension member 100 can be formed as a compact connector. Figure 7 , Figure 7A compact connector 300 according to one aspect of the present disclosure is shown. It should be understood that the compact connector 300 can be used to replace the connector interface 102 and the fluid path component 104. The compact connector 300 can include a proximal connector portion 302, which is configured to couple the compact connector 300 to, for example, a fluid connector component 226 of a fluid path assembly 220. A distal connector portion 304 can be provided for coupling the compact connector 300 to, for example, an access port of a vascular access device. In addition, a central portion 306 can be provided, wherein the central portion 306 is shaped and configured to increase flow resistance, thereby reducing hemolysis. Other configurations of the fluid path component 104 are also possible. For example, the fluid path member 104 can be configured as one or more fluid resistance optimized flow paths similar to those described in any of U.S. application Ser. No. 17 / 146,388, U.S. application Ser. No. 17 / 401,506, and U.S. application Ser. No. 17 / 496,858, the disclosures of which are incorporated herein by reference in their entirety.

[0072] exist Figure 6 and Figure 7 In the embodiment of the present invention, the scrubbing cap 60 (such as Figure 4 3 (as shown in detail in FIG. 3 ) is disposed on the distal end of the extension member 100, for example, on the connector interface 102 (or on the distal connector portion 304 if the extension member is configured as a compact connector 300). The scrub cap 60 is configured as described in detail above, but the connector portion 70 of the scrub cap 60 cooperates with the connector interface 102 to secure the scrub cap 60 to the connector interface. As described above, the connector interface 102 can be configured as a threaded Luer, a sliding Luer, a threaded Luer lock with a collar, a blunt plastic sleeve (with or without an alligator-type connection clip), a male Luer (with or without an alligator-type connection clip), a sleeve for PRN access, a needleless connector, or a needle access sleeve, and the connector portion 70 can be configured to have a corresponding structure that provides for the scrub cap 60 to cooperate with the connector interface 102, for example, one embodiment has a structure of the connector interface 102 as a female Luer connector.

[0073] Now refer to Figure 8 , Figure 8 A blood sample collection system 50 according to yet another embodiment is shown, wherein the system 50 does not include the extension member 100 or the adapter 230 - that is, the system 50 includes only the container assembly 210, the fluid pathway assembly 220, and the scrub cap 60. In the illustrated embodiment, the scrub cap 60 is Figures 1 to 5The connector portion 70 of the scrub cap 60 is configured to engage / mate with the fluid pathway assembly 220 in the same manner as in the system of FIG. 2 - the connector portion 70 of the scrub cap 60 is configured to mate with the fluid connector component 226 to secure the scrub cap 60 to the fluid connector component. As previously described, in some embodiments, the connector portion 70 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 226, so that the connector portion 70 is fixed in place relative to the fluid connector component 226.

[0074] Although the above reference Figures 1 to 8 The described embodiment of the system 50 uses the fluid pathway assembly 220, adapter 230, container assembly 210 and extension member 100 in combination with the scrub cap 60, but it should be understood that the present disclosure is not limited thereto. That is, the scrub cap 60 can be used with other blood collection assemblies, including those blood collection assemblies shown and described in various embodiments of U.S. Application Publication No. 2021 / 0196167, which is incorporated herein by reference in its entirety.

[0075] 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 scope of the claims are included within the scope of the appended claims.

Claims

1. A blood sample collection system, characterized in that: The blood sample collection system comprises: a container assembly including a cap and defining a reservoir, the container assembly having a distal end and a proximal end, the cap being disposed at the distal end of the container assembly; a fluid pathway assembly comprising a housing defining an interior, a fluid pathway component, and a fluid connector component, the housing having a distal end and a proximal end, the fluid pathway component extending from the distal end of the housing into the interior of the housing, the fluid pathway component defining an internal cavity, the fluid connector component disposed on the distal end of the housing; and A scrub cap is disposed at or adjacent to the distal end of the fluid pathway assembly, the scrub cap comprising: Scrub the insert; and A housing defines a cavity configured to retain the scrubbing insert therein.

2. The blood sample 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, wherein the scrub cap includes a connector portion configured to engage with the Luer connector to secure the scrub cap to the fluid access assembly.

3. The blood sample collection system according to claim 2, wherein: The Luer connector includes one of a sliding Luer, a threaded Luer, or a Luer lock with a collar.

4. The blood sample collection system according to claim 2, wherein: The blood sample collection system includes an adapter, the adapter including a first engagement feature and a second engagement feature, the first engagement feature of the adapter being configured to releasably engage with the cap of the container assembly, and the second engagement feature of the adapter being configured to releasably engage with an engagement feature of the fluid pathway assembly, such that in a first configuration in which the first engagement feature of the adapter is engaged with the cap and the second engagement feature of the adapter is engaged with the engagement feature of the fluid pathway assembly, the cap of the container assembly is at least partially disposed within an interior of the housing of the fluid pathway assembly and is spaced apart from the fluid pathway component.

5. The blood sample collection system according to claim 4, wherein: The container assembly is configured to be converted from the first configuration to the second configuration by translating the container assembly toward the first end of the fluid pathway assembly, so that the cap is disengaged from the first engagement feature of the adapter and the fluid pathway component pierces the resealable membrane of the cap, so that the reservoir of the container assembly is in fluid communication with the fluid connector component and the connector portion via the inner cavity of the fluid pathway component.

6. The blood sample collection system according to claim 1, wherein: The blood sample collection system includes an extension member having a distal end and a proximal end, the proximal end of the extension member being coupled to the fluid connector component, wherein the extension member is configured to reduce hemolysis of a blood sample passing through the extension member, and wherein the scrub cap includes a connector portion configured to engage with the distal end of the extension member to secure the scrub cap to the extension member.

7. The blood sample collection system according to claim 6, wherein: The extension member comprises: a connector interface disposed at the distal end of the extension member and configured to couple the extension member to an access port of a vascular access device; and A flexible tube is fluidly coupled to the connector interface and is configured to be coupled to the fluid connector component of the fluid pathway assembly, wherein the flexible tube is configured to reduce hemolysis of a blood sample passing through the flexible tube.

8. The blood sample collection system according to claim 6, wherein: The extension member comprises a compact connector comprising: a proximal connector portion configured to couple the compact connector to the fluid connector component; a distal connector portion configured to couple the compact connector to an access port of a vascular access device; and A central portion is shaped and configured to reduce hemolysis of a blood sample passing through the central portion.

9. The blood sample collection system according to claim 7, wherein: The connector interface includes one of: a threaded Luer, a sliding Luer, a threaded Luer lock with a collar, a blunt plastic cannula, a male Luer, a cannula for PRN access, a needleless connector, or a needle access cannula.

10. The blood sample collection system according to claim 8, wherein: The distal connector portion includes one of: a threaded Luer, a sliding Luer, a threaded Luer lock with a collar, a blunt plastic cannula, a male Luer, a cannula for PRN access, a needleless connector, or a needle access cannula.

11. The blood sample collection system according to claim 2, wherein: The connector portion of the scrub cap secures the scrub cap via a twist-on engagement, wherein the scrub cap is removable to enable the blood sample collection system to be connected to an access port of a vascular access device.

12. The blood sample 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.

13. The blood sample collection system according to claim 1, wherein: The scrub cap includes a seal attached over the cavity to seal the scrub insert within the cavity.

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