A blood sample collection system with an integrated scrubbing cap and its method of use.

Abstract

A system is provided herein that includes a container assembly having a cap and defining a reservoir, and a fluid access assembly comprising a housing defining an interior, a fluid access component and a fluid connector component, wherein the housing has a distal end and a proximal end, the fluid access component extends from the distal end of the housing into the interior of the housing, the fluid access component defines a lumen, and the fluid connector component is located at the distal end of the housing. A scrubbing cap is provided at or adjacent to the distal end of the fluid access assembly, and the scrubbing cap comprises a scrubbing insert and a housing defining a cavity configured to hold the scrubbing insert therein.

Description

Technical Field

[0001] The present invention relates to a blood sample collection system integrated with a scrubbing cap and a method of using the same.

Background Art

[0002] This application claims priority to U.S. Provisional Patent Application No. 63 / 461,712, filed on April 25, 2023, entitled "Blood Sample Collection System Integrated with a Scrubbing Cap and Method of Using the Same", the entire disclosure of which is incorporated herein by reference.

[0003] Catheters are generally used to administer fluids into a patient's body and withdraw fluids (e.g., blood, etc.) outside the body in various environments including hospitals and home care, etc., and fluids are administered or blood is withdrawn through a vascular access device (VAD) including a catheter inserted into the patient's vascular system. Common VADs include plastic catheters inserted into a patient's vein, and the length of the catheter varies, for example, several centimeters when the VAD is a peripheral intravenous catheter (PIVC) and several tens of centimeters when the VAD is a central venous catheter (CVC). The VAD may be indwelling for a short term (several days), medium term (several weeks), or long term (several months to several years).

[0004] In some applications, VADs are used to collect blood samples in connection with the performance of blood cultures. Blood cultures are often used as a tool to detect the presence of bacteria or fungi in a patient's blood sample, identify the type of bacteria or fungi present, and determine the patient's treatment strategy. Collection of venous blood samples for blood culture testing is currently performed by venipuncture using a blood collection set fitted with a Luer Lock Access Device (LLAD). During the insertion process, the venipuncture device can pick up microorganisms from the skin or the insertion process itself, and such microorganisms can then be transferred to the blood culture sample, potentially leading to a false-positive test result for sepsis. To minimize the risk of false positives, a discard sample is usually taken, and the initial amount of blood that is likely to contain microorganisms from the skin is removed, for example, by discarding the first 1-10 ml of blood. However, this process also carries some risk, as the collection of a discard sample adds a non-sterile step, technique, and connection, increasing the risk of microbial contamination of subsequent blood culture samples.

[0005] Conventional devices, such as those described in Patent Document 1 by Velano Vascular, Inc., address the above complications by adding an adapter to the LLAD, which sterilizes the entire assembly (including the waste sample) by holding the waste sample in a pre-advance position, and reduces the number of non-sterile steps and connections in the blood culture sample collection procedure. This reduces the overall risk of microbial contamination of blood culture samples and also reduces the risk of false positives.

[0006] While the aforementioned LLAD addresses some of the risks of false positives in blood culture samples, it does not address the risks associated with clinicians failing to disinfect the VAD access port or connector before connecting the LLAD, or with insufficient disinfection. Specifically, while clinicians often disinfect the access port by scrubbing it with an alcohol wipe before connecting the LLAD, the use of alcohol wipes to clean and disinfect the access port is often ineffective in completely disinfecting all internal / external surfaces of the access port, including (potentially) the complex threaded area around the luer portion that connects to the LLAD. Furthermore, in some cases, clinicians may forget to wipe the access port before connecting the LLAD. If the access port is not properly disinfected, false positives in blood cultures may occur.

[0007] Therefore, in this field, there is a need for means to ensure that clinicians can effectively disinfect the access port of a VAD before installing a blood collection device. [Prior art documents] [Patent Documents]

[0008] [Patent Document 1] U.S. Patent Application Publication No. 2021 / 0196167 [Patent Document 2] U.S. Patent Application No. 17 / 146,388 [Patent Document 3] U.S. Patent Application No. 17 / 401,506 [Patent Document 4] U.S. Patent Application No. 17 / 496,858 [Overview of the Initiative]

[0009] A system is provided herein that includes a container assembly having a cap and defining a reservoir, wherein the container assembly has a distal end and a proximal end, and the cap is located at the distal end of the container assembly. The system also includes a fluid access assembly comprising a housing defining an interior, a fluid access component and a fluid connector component, wherein the housing has a distal end and a proximal end, the fluid access component extends from the distal end of the housing into the interior of the housing, the fluid access component defines a lumen, and the fluid connector component is located at the distal end of the housing. The system further includes a scrubbing cap provided at or adjacent to the distal end of the fluid access assembly, wherein the scrubbing cap includes a scrubbing insert and a housing defining a cavity configured to hold the scrubbing insert therein.

[0010] In some embodiments, the fluid connector component comprises a Luer connector configured to connect to an access port of a vascular access device, and the connector portion of the scrubbing cap engages with the Luer connector to secure the scrubbing cap to the fluid access assembly.

[0011] In some embodiments, the luer connector comprises one of a slip luer, a threaded luer, or a collared luer lock.

[0012] In some embodiments, the system includes an adapter comprising a first engagement mechanism and a second engagement mechanism, wherein the first engagement mechanism of the adapter is configured to releasably engage with the cap of the container assembly, and the second engagement mechanism of the adapter is configured to releasably engage with an engagement mechanism of the housing of the fluid access assembly, thereby, in a first configuration in which the first engagement mechanism of the adapter engages with the cap and the second engagement mechanism of the adapter engages with the engagement mechanism of the fluid access assembly, the cap of the container assembly is at least partially located within the housing and spaced apart from the fluid access components.

[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 the first end of the fluid access assembly, thereby releasing the cap from the first engagement mechanism of the adapter, and the fluid access component perforating the resealable membrane of the cap, so that the reservoir of the container assembly is in fluid communication with the fluid connector component and connection portion through the lumen of the fluid access component.

[0014] In some embodiments, the system includes an extension member having a distal end and a proximal end, the proximal end of the extension member being connected to the fluid connector component, the extension member being configured to reduce hemolysis of a blood sample passing therethrough, and the connector portion of the scrubbing cap engaging with the distal end of the extension member to secure the scrubbing cap to the extension member.

[0015] In some embodiments, the extension member includes a connector interface located at the distal end and configured to connect the extension member to an access port of a vascular access device, and a flexible tube fluidly connected to the connector interface and configured to connect to the fluid connector component of the fluid access assembly, the flexible tube being configured to reduce hemolysis of a blood sample passing through it.

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

[0017] In some embodiments, the connector interface or the distal connector comprises one of the following: a threaded luer, a slip luer, a collared threaded luer lock, a blunt-ended plastic cannula, a male luer, a cannula for PRN access, a needle-free connector, or a needle access cannula.

[0018] In some embodiments, the connector portion of the scrubbing cap secures the scrubbing cap by a twisting engagement, and the scrubbing cap is removable so that the system can be connected to the access port of the vascular access device.

[0019] In some embodiments, the scrubbing insert comprises an elastic material containing an absorbed antimicrobial solution or antimicrobial agent, configured to disinfect the surface of the access port of the vascular access device.

[0020] In some embodiments, the scrubbing cap includes a seal mounted on the cavity to seal the scrubbing insert within the cavity.

[0021] A method for using a blood sample collection system is provided herein. The method includes providing a blood sample collection system comprising: a container assembly comprising a cap defining a reservoir, the container assembly having a distal end and a proximal end, the cap being positioned at the distal end of the container assembly; a fluid access assembly comprising a housing defining an interior, a fluid access component and a fluid connector component, the housing having a distal end and a proximal end, the fluid access component extending from the distal end of the housing into the interior of the housing, the fluid access component defining a lumen, and the fluid connector component being positioned at the distal end of the housing; and a scrubbing cap provided at or adjacent to the distal end of the housing, the scrubbing cap comprising a scrubbing insert and a housing defining a cavity configured to hold the scrubbing insert therein. The method also includes positioning the scrubbing cap on the access port of a vascular access device, thereby bringing the access port into contact with the scrubbing insert, and cleaning the access port with the scrubbing insert.

[0022] In some embodiments, the fluid connector component includes a Luer connector configured to connect to the access port, and the connector portion of the scrubbing cap engages with the Luer connector to secure the scrubbing cap to the fluid access assembly.

[0023] In some embodiments, the method also includes removing the scrubbing cap from the luer connector following cleaning of the access port and coupling the luer connector to the access port to dispose the fluid access assembly in fluid connection with the vascular access device.

[0024] In some embodiments, the 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 therethrough, and a connector portion of the scrubbing cap engaging the distal end of the extension member to secure the scrubbing cap to the extension member.

[0025] In some embodiments, the method also includes removing the scrubbing cap from the distal end of the extension member following cleaning of the access port and coupling the distal end of the extension member to the access port to dispose the fluid access assembly in fluid connection with the vascular access device.

[0026] In some embodiments, the system includes an adapter including a first engagement mechanism and a second engagement mechanism, the first engagement mechanism of the adapter being configured to releasably engage a cap of the container assembly, and the second engagement mechanism of the adapter being configured to releasably engage an engagement mechanism of a housing of the fluid access assembly, such that in a first configuration in which the first engagement mechanism of the adapter engages the cap and the second engagement mechanism of the adapter engages the engagement mechanism of the fluid access assembly, the cap of the container assembly is disposed at least partially within the interior of the housing and spaced from the fluid access components.

[0027] In some embodiments, the method also includes translating the container assembly toward the first end of the fluid access assembly and toward the adapter so that the cap is released from the first engagement mechanism of the adapter, the fluid access component perforates the resealable membrane of the cap so that the reservoir of the container assembly is in fluid communication with the fluid connector component through the lumen of the fluid access component; detaching the second engagement mechanism of the adapter from the engagement mechanism of the fluid access assembly; and pulling the container assembly away from the first end of the fluid access assembly and translating it outward from the interior of the fluid access assembly so that the container assembly and the adapter are separated from the fluid access assembly.

[0028] In some embodiments, the scrubbing cap comprises a seal mounted on the cavity to seal the scrubbing insert within the cavity, and the method further includes removing the seal from the scrubbing cap to position the scrubbing cap over the access port of the vascular access device, thereby allowing the scrubbing insert to come into contact with the access port.

[0029] In some embodiments, cleaning the access port involves applying a twisting motion to the blood sample collection system. [Brief explanation of the drawing]

[0030] [Figure 1] Figure 1 is a schematic diagram of a blood sample collection system according to one embodiment. [Figure 2] Figure 2 is a side view of a blood sample collection system according to one embodiment. [Figure 3A] Figure 3A is a rear perspective view of the blood sample collection system shown in Figure 2 in the first configuration. [Figure 3B]Figure 3B is a rear perspective view of the blood sample collection system of Figure 2 in the second configuration. [Figure 4] Figure 4 is an exploded view of a scrubbing cap included in the blood sample collection system shown in Figure 2, according to one embodiment. [Figure 5] Figure 5 is a cross-sectional view showing the scrubbing cap from Figure 4 engaged with the access port of a vascular access device. [Figure 6] Figure 6 is a side view of a blood sample collection system according to another embodiment. [Figure 7] Figure 7 is a side view of a blood sample collection system according to another embodiment. [Figure 8] Figure 8 is a side view of a blood sample collection system according to another embodiment. [Modes for carrying out the invention]

[0031] The following description is provided to enable those skilled in the art to create and use the described embodiments intended for carrying out the invention. However, various modifications, equivalents, variations, and substitutions will be readily apparent to those skilled in the art. Any and all such modifications, variations, equivalents, and substitutions are intended to be included in the spirit and scope of this disclosure.

[0032] For the purposes of the following description, the terms “upper,” “lower,” “right,” “left,” “vertical,” “horizontal,” “top,” “bottom,” “lateral,” “longitudinal,” and their derivatives are used in relation to the present invention as oriented in the drawings. However, it should be understood that the present invention may envision various alternative variations unless expressly specified otherwise. It should also be understood that the particular devices shown in the accompanying drawings and described in the following specification are merely illustrative embodiments of the present invention. Therefore, the specific dimensions and other physical characteristics relating to the embodiments disclosed herein should not be considered limiting.

[0033] In this disclosure, the distal end of a component or the distal end of a device means the end furthest from the user's hand when the component or device is in use, i.e., when the user is preparing or using the blood collection device, and the proximal end means the end closest to the user's hand. Similarly, in this application, the terms “in the distal direction” and “distally” mean the direction toward the access connector portion of the fluid transfer device, and the terms “in the proximal direction” and “proximally” mean the direction opposite to the direction of the connector.

[0034] Although not illustrated or described herein, it should be understood that the blood sample collection systems described below can be used for blood collection from any suitable vascular access device (VAD), such as the BD NEXIVA® Closed IV Catheter system, BD CATHENA® Catheter system, BD VENFLON® Pro Safely Shielded IV Catheter system, BDNEOFLON® IV Cannula system, or BD INSYTE® AUTOGUARD® BC Shielded IV Catheter system, or from another suitable vascular access device.

[0035] Embodiments of this disclosure primarily describe blood sample collection systems used in PIVC. However, embodiments of this disclosure are equally applicable to the use of other catheter devices.

[0036] Referring to Figures 1-3, a blood sample collection system 50 according to one embodiment of the present disclosure is shown. Figure 1 is a schematic diagram of a blood sample collection system 50 according to one embodiment. The system 50 includes a container assembly 210, an adapter 230, a fluid access assembly 220, and a scrubbing cap 60.

[0037] As described in detail below, the container assembly 210 may be any suitable standard vacuum tube, and the fluid access assembly 220 may be any suitable standard holder. For example, the container assembly 210 may be supplied as the BD VACUTAINER® manufactured by Becton, Dickinson and Co., and the fluid access assembly 220 may be supplied as the BD VACUTAINER® holder device. More generally, the container assembly 210 may include a cap 212 and define a reservoir 211, while the fluid access assembly 220 may include a housing 228 defining the interior, an engagement mechanism 222, fluid access components 224, and fluid connector components 226.

[0038] The adapter 230 may include a first engagement mechanism 231 and a second engagement mechanism 232. The first engagement mechanism 231 of the adapter 230 may be configured to releasably engage with the cap 212 of the container assembly 210, and the second engagement mechanism 232 of the adapter 230 may be configured to releasably engage with the engagement mechanism 222 of the fluid access assembly 220. The first engagement mechanism 231 of the adapter 230 may be any suitable engagement mechanism, or may include such a suitable engagement mechanism, configured to temporarily or releasably hold the cap 212 in a position relative to the adapter 230 and to release the cap 212 when the cap 212 moves relative to the first engagement mechanism 231. Such movement may include, for example, translational motion, rotational motion, and / or helical motion. The second engagement mechanism 232 of the adapter 230 and the engagement mechanism 222 of the fluid access assembly 220 are any suitable engagement mechanisms, or may include such engagement mechanisms, configured to temporarily or releasably engage with each other to temporarily hold the adapter 230 in position relative to the fluid access assembly 220 or a component of the fluid access assembly 220 (e.g., the housing 228), and to release the adapter 230 from the fluid access assembly 220 (e.g., via deformation of the adapter 230 due to the release of the cap 212 from the adapter 230, and / or via deformation and / or movement (e.g., rotation, helical, and / or translation) of the second engagement mechanism 232 and / or the other engagement mechanism 222, so that the second engagement mechanism 232 can be separated from the engagement mechanism 222).

[0039] The container assembly 210 may include a distal end and a proximal end. The cap 212 may be located at the distal end of the container assembly 210. In some embodiments, the container assembly 210 may include a tube having an open end and a closed end opposite the open end. The cap 212 is connected to the open end, so that the cap 212 and the tube can define the reservoir 211. In some embodiments, the cap 212 may include a resealable membrane. The resealable membrane may be configured so that a fluid access component, such as a fluid access component 224, can perforate the resealable membrane to achieve fluid communication with the reservoir 211. The resealable membrane of the cap 212 is configured to reseal the fluid access component 224 upon detachment from the cap 212, thereby fluidly isolating the reservoir 211 from the external area of ​​the container assembly 210. In some embodiments, the cap 212 may include a ridge and / or one or more flanges located on its outer surface. The reservoir 211 can be a vacuum reservoir, so that when the reservoir 211 is in fluid communication with a fluid source (for example, by puncturing the resealable membrane of the cap 212 using a fluid access component fluidly connected to the patient's vascular system), the pressure difference between the reservoir 211 and the fluid source draws a fluid (e.g., blood) into the reservoir 211. In some embodiments, the container assembly 210 can be a vacuum tube, and the cap 212 can be formed from any suitable material, such as rubber. The tube can be formed from plastic, for example.

[0040] The fluid access assembly 220 may have a distal end and a proximal end. The fluid access component 224 is located inside the housing 228 and may extend from the distal end of the housing 228 into the interior of the housing 228. For example, in some embodiments, the fluid access component 224 may have a distal end and a proximal end opposite the distal end. The distal end of the fluid access component 224 may be connected to the distal end of the housing 228, and the proximal end may be located inside the housing 228. In some embodiments, the fluid access component 224 may include a needle that defines a lumen. In some embodiments, the fluid access assembly 220 may include a flexible needle sheath that substantially surrounds the needle and is configured to translate relative to the needle so that the proximal end of the needle can be selectively exposed.

[0041] The fluid connector component 226 may be integrated with the distal end of the housing 228 or may be detachably connected. For example, the housing 228 may define a fluid-connected outlet to the lumen of a fluid access component 224 that can be connected to the fluid connector component 226. In some embodiments, the fluid connector component 226 may include any suitable component configured to connect the housing 228 to a connector or access port of a patient's access tube. For example, in some embodiments, the fluid connector component 226 may be a Luer connector. The Luer connector may take the form of, for example, a slip Luer, a threaded Luer, or a collared Luer lock. In some embodiments, the fluid connector component 226 may be an outlet of the housing 228 that defines a lumen.

[0042] As shown in Figures 1-3, the engagement mechanism 222 of the fluid access assembly 220 may include a flange extending perpendicularly from the central axis of the housing 228. In some embodiments, the flange can be elongated so as to extend further in a first direction than in a second direction from the central axis of the housing 228. For example, the flange can form an elongated surface of the fluid access assembly 220 positioned in a plane including the proximal end of the housing 228.

[0043] The first engagement mechanism 231 of the adapter 230 may be any suitable mechanism configured to releasably engage with the cap 212 of the container assembly 210. In some embodiments, the first engagement mechanism 231 of the adapter 230 may be an inner surface of the adapter 230 defining a through hole. The inner surface of the adapter 230 has a diameter sufficiently smaller than the outermost diameter of the cap 212, so that the inner surface and the cap 212 can engage by friction fitting. In some embodiments, the first engagement mechanism 231 includes a mechanism corresponding to a mechanism on the cap 212, so that the adapter 230 and the cap 212 can be releasably engaged.

[0044] The second engagement mechanism 232 of the adapter 230 may be any suitable mechanism configured to engage releasably with the engagement mechanism 222 of the fluid access assembly 220. For example, the second engagement mechanism 232 may include two opposing tabs. A latch may be positioned at the end of each tab. Each latch may be shaped and sized to accept a portion of the flange of the engagement mechanism 222 of the fluid access assembly 220. In some embodiments, the adapter 230 is rotatable relative to the fluid access assembly 220, thereby allowing the second engagement mechanism 232 (e.g., the latch) to rotate to disengage from the engagement mechanism 222 (e.g., the flange) of the fluid access assembly 220. In some embodiments, the second engagement mechanism 232 may include a plurality (e.g., two) of arms, each of which has a distal end connected to the base of the adapter 230 via a flexible joint, and a latch positioned at the opposite end of the arm. In some embodiments, each of the arms may be curved and form a portion of the outer circumference of the adapter 230. Such an adapter can be detached from the engagement mechanism 222 of the fluid access assembly 220, for example, by rotation and / or deformation (e.g., bending). In some embodiments, the second engagement mechanism 232 may comprise a plurality of tabs, each containing a latch configured to snap into the flange of the engagement mechanism 222. For example, the second engagement mechanism 232 may comprise two or three latch tabs. To detach such an adapter 230 from the housing 228, the user can detach each latch tab by pulling the latch away from the flange of the engagement mechanism 222, thereby releasing the tab from engagement with the flange of the engagement mechanism 222.

[0045] According to the embodiment, the adapter 230 enables the use of container assemblies 210 of various sizes and shapes together with the fluid access assembly 220 (for example, placed within the fluid access assembly 220 and stabilized by the fluid access assembly 220). As described above, the adapter 230 is configured to engage with the engagement mechanism 222 of the fluid access assembly 220 (for example, shape and size), and when the second engagement mechanism 232 of the adapter 230 engages with the engagement mechanism 222 of the fluid access assembly 220, the second engagement mechanism 232 of the adapter 230 accepts a portion of the engagement mechanism 222.

[0046] Referring to Figure 3A, the system 50 has a first configuration (e.g., initial configuration) in which a first engagement mechanism 231 of the adapter 230 engages with the cap 212 and a second engagement mechanism 232 engages with the engagement mechanism 222 of the fluid access assembly 220. When the first engagement mechanism 231 of the adapter 230 engages with the cap 212 and the second engagement mechanism 232 engages with the engagement mechanism 222 of the fluid access assembly 220, the cap 212 is separated from the fluid access component 224 and the reservoir 211 is fluidly isolated from the external environment of the container assembly 210. In the first configuration, the cap 212 may be located at least partially within the adapter 230 and / or the housing 228. For example, the distal end of the cap 212 may be located inside the housing 228 (either protruding from the adapter 230 or inside the adapter 230). In some embodiments, the distal end of the cap 212 is located and held within the adapter 230 in the first configuration, but may be located proximal to the housing 228. In some embodiments, the entire system 50 can be sterilized in the first configuration and packaged for sterile transport to the user (e.g., healthcare professional).

[0047] Next, referring to Figure 3B, the system 50 also has a second configuration in which the lumen of the fluid access component 224 is in fluid communication with the reservoir 211. To transition the system 50 from the first configuration to the second configuration, the container assembly 210 is translated distally toward the distal end of the fluid access assembly 220, thereby allowing the cap 212 to engage with the fluid access component 224 (for example, the fluid access component 224 perforates the cap 212), and a portion of the fluid access component 224 to be positioned within the reservoir 211. For example, in an embodiment in which the container assembly 210 engages with the first engagement mechanism 231 by friction fitting, a force may be applied to the container assembly 210 that overcomes the force applied to the container assembly 210 (e.g., the cap 212) by the first engagement mechanism 231 and translates the container assembly 210 to engage with the fluid access component 224. In the second configuration, if the fluid connector component 226 is fluidically connected to the patient's vascular system (for example, by connecting the blood sample collection system 50 to the VAD, and by connecting the fluid connector component 226 to the VAD access port), the fluid (e.g., blood) is drawn into the reservoir 211 of the container assembly 210 via the fluid connector component 226 and the fluid access component 224.

[0048] Once sufficient blood has been drawn into the reservoir 211, the system 50 may transition from a second configuration to a third configuration (not shown) in which the container assembly 210 and adapter 230 are separated from the fluid access assembly 220. For example, the container assembly 210 may be translated relative to the fluid access assembly 220 such that the cap 212 is positioned near the proximal end of the housing 228. Once the cap 212 is released from the fluid access component 224, the reservoir 211 is fluidically isolated from the external environment of the container assembly 210 because the cap 212 has a resealable membrane. The adapter 230 can then be separated from the fluid access assembly 220, for example, by rotating, snapping, or deforming one or more portions of the second engagement mechanism 232 from the engagement mechanism 222 of the fluid access assembly 220, thereby separating the second engagement mechanism 232 from the engagement mechanism 222. The adapter 230 and container assembly 210 can be discarded as needed, especially since this initial blood sample may be considered a "discard sample".

[0049] After the adapter 230 and container assembly 210 are removed from the fluid access assembly 220, a second container assembly is inserted into the housing and engaged with the fluid access component 224, allowing the second container assembly to draw blood into its reservoir via the fluid connector component 226 and the fluid access component 224. In some embodiments, the second container assembly may contain a culture medium (e.g., soybean casein digest broth) in the reservoir of the second container, configured to be used for blood culture when mixed with the patient's blood sample in the reservoir. Any suitable number of container assemblies can be engaged with (and then disengaged from) the fluid access component 224 to collect fluid from the patient for various tests. Furthermore, since many of the main components of the system 50 do not need to be removed between blood collections, the workflow for healthcare workers is improved. In addition, the overall reduction in connection points compared to conventional blood collection methods reduces the risk of sample contamination during blood collection. Furthermore, the fact that the entire System 50 can be supplied in sterile packaging further reduces the overall risk of contamination of blood culture samples.

[0050] According to aspects of this disclosure, when the blood sample collection system 50 is initially connected to the VAD access port, such as by connecting the fluid connector component 226 to the access port, it is recognized that it is desirable to disinfect the access port before connecting the blood sample collection system 50. That is, in order to prevent microbial invasion and the possibility of catheter-associated bloodstream infections (CRBSI), it is desirable to clean and sterilize the access port before engaging the fluid connector component 226 with the access port (for example, by mating the female and male Luer connectors).

[0051] According to an aspect of the present disclosure, a scrubbing cap 60 is integrated with the distal end 52 of the blood sample collection system 50 to clean and sterilize the access port before engaging the system 50 with the access port. The scrubbing cap 60 is fixed to a fluid connector component 226 and is configured to engage with the access port to allow cleaning and sterilization of the inner and / or outer surfaces of the access port by twisting and rubbing motions between the scrubbing cap 60 and the access port. Once the cleaning and sterilization of the access port is complete, the scrubbing cap 60 can be removed from the fluid connector component 226, thereby allowing the fluid connector component 226 to be connected to the access port and blood collection to be performed by operating the system 50 as described above.

[0052] As shown in Figures 1 and 2, and also in Figures 4 and 5, the scrubbing cap 60 includes a cap housing 62, a scrubbing insert 64, and a peelable seal 66. The housing 62 is a integrally molded structure by injection molding and may be made of an alcohol-compatible material such as polypropylene or polyethylene. The housing 62 is typically described as including a holder portion 68 that holds the insert 64 therein, and a connector portion 70 configured to mate with a fluid connector component 226 of the blood sample collection system 50.

[0053] The holder portion 68 may have a cup shape formed by a base 72 and a side wall structure 74 defining an opening 76 at one end thereof. The side wall structure 74 is integrally formed with the base 72 and defines a cavity 78 configured to accommodate the insert 64. In some embodiments, the cavity 78 may have a cylindrical cross-sectional shape and a depth suitable for concavely accommodating the insert 64. However, it is understood that the holder portion 68 and the cavity 78 defined therein can take other shapes, such as square or hexagonal, and that the shape and size of the holder portion 68, its cavity 78, and the insert 64 placed therein may be configured so that the scrubbing cap 60 can clean medical devices of a particular size and configuration in which the scrubbing cap 60 is used (i.e., the catheter connector 20 of the catheter assembly 12).

[0054] The holder portion 68 may be sized such that, when the insert 64 is fitted into the cavity 78, the cavity 78 defined by the side wall structure 74 compresses the insert 64 and holds it within. A suitable hot melt glue or other suitable adhesive may be used to bond the insert 64 to the bottom (i.e., base 72) of the holder portion 68, but it is recognized that other suitable methods, including, for example, mechanical fastening, may also be used to secure the insert 64 to the holder portion 68. An annular lip 80 is formed around the opening 76 of the holder portion 68 (i.e., the side wall structure 74) to define a land for receiving a seal 66, which, in cooperation with the annular lip 80, seals the opening 76 of the cavity 78 and holds the insert 64 therein. The seal 66 protects the contents of the insert 64 and maintains a sealed sterile environment by sealing the cavity 78 of the holder portion 68 and the insert 64 therein from contamination from the external environment and acting as a leak-proof barrier. The seal 66 provides sufficient sealing at various temperature, pressure, and humidity levels and, depending on the embodiment, may be formed as a peel-back top of aluminum or a multilayer polymer film. In some embodiments, the seal 66 is bonded to the open end of the scrubbing cap 60 by a heat seal or induction seal. The seal 66 may include a tab 82 to facilitate the operation of the seal 66 and its removal from the scrubbing cap 60.

[0055] The insert 64 may be made of a foamed material, for example, by injection molding, or by die-cutting from a foamed sheet. The insert is impregnated with a cleaning substance (while contained within the holder portion 68), such as a solution of a suitable disinfectant or microbial killer. The cleaning substance may contain any suitable type and amount of antimicrobial disinfectant, depending on the size of the foamed insert. For example, in one embodiment, an aqueous solution containing about 2% (by volume) chlorhexidine gluconate (chlorhexidine solution, "CHG") is used in an amount of about 0.20 cc to about 0.75 cc. If necessary, a solution containing about 0.50 cc can be used. In another embodiment, the cleaning substance includes a solution containing about 70% isopropyl alcohol ("IPA") in an aqueous solution. In yet another embodiment, the cleaning substance includes a solution containing about 70% IPA and about 2% CHG in an aqueous solution in an amount of about 0.2 ml. In the latter solution, it has been recognized that in one embodiment, the concentration of IPA can vary from about 60% to about 90%, and the concentration of CHG can vary from about 1% to about 5%. Other suitable solution compositions and concentrations are also possible. For example, in one embodiment, a povidone-iodine or hydrogen peroxide solution can be included in the cleaning substance.

[0056] According to aspects of the present disclosure, the insert 64 may be configured (e.g., molded) to have a predetermined shape that conforms to the specific shape of the VAD access port or connector to be cleaned. The insert 64 may further have various structures that enable effective cleaning of the port / connector, for example, a patterned or roughened top surface and / or gaps or slits formed in the foam material that allow the insert 64 to deform / conform better along the inner and outer surfaces of the port / connector.

[0057] The connector portion 70 of the scrubbing cap 60 extends proximal to the holder portion 68 and is configured to mate with the fluid connector component 226 to secure the scrubbing cap 60. According to one embodiment, the connector portion 70 may be configured as a luer connector (e.g., a male luer connector or a female luer connector) that can mate with a corresponding luer connector provided by the fluid connector component 226, thereby securing the connector portion 70 in a predetermined position relative to the fluid connector component 226.

[0058] The following describes a method, as shown in Figure 5, of using the scrubbing cap 60 as a scrubbing device for cleaning and sterilizing the access port or connector 84 of a VAD, according to one aspect of the present disclosure. The use of the scrubbing cap 60 begins with removing the seal 66 from the scrubbing cap 60. After removing the seal 66, the connector 84 (which in a non-limiting embodiment may be configured as a female Luer connector having a threaded external connector 86 defining a tapered lumen or cavity 88) is inserted by the user into the foam insert 64. At this time, a portion of the insert 64 aligns with the periphery of the connector 84 and / or is inserted into the connector 84 (i.e., around the threaded external connector 86 and into the lumen 88). Once a portion of the connector 84 is inserted into the foam insert 64 of the scrubbing cap 60, the scrubbing cap 60 rotates relative to the connector 84. For example, the user may rotate the blood sample collection system 50 while keeping the connector 84 fixed. The scrubbing cap 60 is fixed in place relative to the blood sample collection system 50 via the fluid connector component 226 being connected to the scrubbing cap 60, and therefore the scrubbing cap 60 rotates in accordance with the rotation of the blood sample collection system 50. The rotation of the scrubbing cap 60 relative to the connector 84 may be in one direction only, or it may be rotated back and forth. The scrubbing cap 60 rotates relative to the connector 84 a sufficient number of times to thoroughly kill bacteria that the solution-impregnated foam insert 64 comes into contact with, and / or remove biofilm from the outer surface and threaded external connection portion 86 of the connector 84, as well as the inner surface of the lumen 88 of the connector 84. In this way, both the outer and inner surfaces of the connector 84 are cleaned by the insert 64, and the cleaning substance within it disinfects the surface and removes any biofilm adhering thereto.

[0059] Once the cleaning and sterilization of the connector 84 by the scrubbing cap 60 is complete, the connector 84 is removed from the scrubbing cap 60. The scrubbing cap 60 can then be removed from the fluid connector component 226 of the system 50. After drying the connector 84, the blood sample collection system 50 can be connected to the connector 84 by connecting the fluid connector component 226 to the connector 84.

[0060] Figures 1-3 illustrate and describe a blood sample collection system 50 according to a particular embodiment, but it is recognized that the system 50 may have other suitable configurations. Several alternative configurations of the system 50 according to further aspects of this disclosure are described below.

[0061] Referring again to Figure 1 (the elements shown by dashed lines in the figure), and also to Figures 6 and 7, the system 50 is shown to optionally include an extension member 100, which is configured to reduce hemolysis of the blood sample drawn into the container assembly 210. In the embodiment of Figure 6, the extension member 100 may include a connector interface 102 and a fluid path member 104 with optimized fluid resistance. The connector interface 102 may be configured as any suitable interface that can connect the extension member 100 to the access port of the VAD. For example, in some embodiments, the connector interface 102 may be configured as a threaded luer, slip luer, collared threaded luer lock, blunt-end plastic cannula (with or without alligator clip), male luer (with or without alligator clip), PRN access cannula, needle-free connector, or needle access cannula.

[0062] The fluid path member 104 can be formed from any suitable element that can provide optimized fluid resistance to reduce hemolysis of the blood sample as blood flows between the connector interface 102 and the fluid connector component 226. In the embodiment shown in Figure 6, the fluid path member 104 is formed from a flexible tube. The inner diameter and length of the flexible tube may be selected to limit the maximum blood collection rate, thereby limiting the maximum shear stress experienced by the blood cells during collection. As mentioned above, shear stress on blood cells (particularly the blood cell walls) is considered to be the main cause of hemolysis and mechanical damage to the blood cells. Therefore, optimizing the fluid resistance of the fluid path member 104 can reduce hemolysis of the collected blood sample.

[0063] In 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 disclosure is not limited thereto. For example, in some embodiments, the extension member 100 may be formed as a compact connector. Referring to Figure 7, a compact connector 300 according to one aspect of the disclosure is shown. It should be understood that the compact connector 300 may be used instead of the connector interface 102 and the fluid path member 104. The compact connector 300 may include, for example, a proximal connector portion 302 configured to connect the compact connector 300 to a fluid connector component 226 of a fluid access assembly 220. A distal connector portion 304 may be provided to connect the compact connector 300 to, for example, an access port of a vascular access device. Furthermore, a central portion 306 may be provided, which is formed and configured to increase fluid resistance and thereby suppress hemolysis. Other configurations of the fluid path member 104 are also possible. For example, the flow path 104 may be configured similarly to one or more fluid-resistance-optimized flow paths described in any of Patent Documents 2, 3, and 4, the disclosures thereof being incorporated herein by reference as a whole.

[0064] In the embodiments shown in Figures 6 and 7, the scrubbing cap 60 (shown in detail in Figure 4) is provided on the distal end of the extension member 100, for example, on the connector interface 102 (or the distal connector portion 304 if the extension member is provided as a compact connector 300). The scrubbing cap 60 is configured as described in detail above, with the connector portion 70 of the scrubbing cap 60 mating with the connector interface 102 to secure the scrubbing cap 60 to it. As described above, the connector interface 102 may be configured as a threaded luer, slip luer, collared threaded luer lock, blunt-ended plastic cannula (with or without alligator clip), male luer (with or without alligator clip), PRN access cannula, needle-free connector, or needle access cannula, and the connector portion 70 may be configured to have a corresponding structure that enables mating of the scrubbing cap 60 with the connector interface 102, and in one embodiment the structure of the connector interface 102 is, for example, a female luer connection.

[0065] Referring to Figure 8, yet another embodiment of the blood sample collection system 50 is shown, where 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 access assembly 220, and the scrubbing cap 60. In the illustrated embodiment, the scrubbing cap 60 engages / mates with the fluid access assembly 220, similar to the system in Figures 1-5, and the connector portion 70 of the scrubbing cap 60 is configured to mate with the fluid connector component 226, thereby securing the scrubbing cap 60 to the fluid connector component 226. As previously stated, in some embodiments, the connector portion 70 is configured as a Luer connector (e.g., a male Luer connector or a female Luer connector) that enables mating with a corresponding Luer connector provided by the fluid connector component 226, thereby securing the connector portion 70 in place relative to the fluid connector component 226.

[0066] In the embodiments of the system 50 described above with respect to Figures 1-8, the fluid access assembly 220, adapter 230, container assembly 210, and extension member 100 are used in combination with the scrubbing cap 60, but it should be understood that this disclosure is not limited thereto. That is, the scrubbing cap 60 may be used in combination with other blood collection assemblies, including those shown and described in various embodiments of Patent Document 1, which is incorporated herein by reference in whole.

[0067] The above detailed description has described several embodiments of a blood sample collection system configured to collect blood while a catheter is in place; however, those skilled in the art can modify and change these embodiments without departing from the scope and spirit of the invention. Therefore, the above description is illustrative and not limiting. The invention as described above is defined by the appended claims, and any modifications to the invention that fall within the meaning and equivalents of the claims are encompassed within that scope.

Claims

1. A container assembly comprising a cap and defining a reservoir, wherein the container assembly has a distal end and a proximal end, and the cap is positioned at the distal end of the container assembly, A fluid access assembly comprising a housing defining an interior, a fluid access component, and a fluid connector component, wherein the housing has a distal end and a proximal end, the fluid access component extends from the distal end of the housing into the interior of the housing, the fluid access component defines an interior lumen, and the fluid connector component is located at the distal end of the housing. A scrubbing cap provided at the distal end of the fluid access assembly, or adjacent to the distal end of the fluid access assembly, wherein the scrubbing cap is Scrubbing insert and A housing defining a cavity configured to hold the scrubbing insert therein, A scrubbing cap equipped with, A system that includes this.

2. The fluid connector component comprises a Luer connector configured to connect to an access port of a vascular access device, and the scrubbing cap comprises a connector portion configured to engage with the Luer connector to secure the scrubbing cap to the fluid access assembly. The system according to claim 1.

3. The lure connector comprises one of the following: a slip lure, a threaded lure, or a collared lure lock. The system according to claim 2.

4. The adapter comprises a first engagement mechanism and a second engagement mechanism, wherein the first engagement mechanism of the adapter is configured to releasably engage with the cap of the container assembly, and the second engagement mechanism of the adapter is configured to releasably engage with the engagement mechanism of the housing of the fluid access assembly, thereby in a first configuration in which the first engagement mechanism of the adapter engages with the cap and the second engagement mechanism of the adapter engages with the engagement mechanism of the fluid access assembly, the cap of the container assembly is at least partially located within the housing and spaced apart from the fluid access components. The system according to any one of claims 1 to 3.

5. The container assembly is configured to transition from the first configuration to the second configuration by translating the container assembly toward the first end of the fluid access assembly, thereby releasing the cap from the first engagement mechanism of the adapter, the fluid access component puncturing the resealable membrane of the cap, and the reservoir of the container assembly fluidly communicating with the fluid connector component and connection portion through the lumen of the fluid access component. The system according to claim 4.

6. The device comprises an extension member having a distal end and a proximal end, the proximal end of the extension member being connected to the fluid connector component, the extension member being configured to reduce hemolysis of a blood sample passing through it, and the scrubbing cap having a connector portion configured to engage with the distal end of the extension member to secure the scrubbing cap to the extension member. The system according to claim 1.

7. The extension member is A connector interface positioned at the distal end and configured to connect the extension member to the access port of a vascular access device, A flexible tube configured to be fluidly connected to the connector interface and to be connected to the fluid connector component of the fluid access assembly, wherein the flexible tube is configured to reduce hemolysis of a blood sample passing through it, The system according to claim 6, comprising:

8. The extension member is equipped with a compact connector, and the compact connector is The compact connector is configured to connect to the fluid connector component, and the proximal connector portion is configured to connect to the fluid connector component. The aforementioned compact connector comprises a distal connector portion configured to connect to the access port of a vascular access device, A central portion formed and configured to reduce hemolysis of blood samples passing through it, The system according to claim 6, comprising:

9. The connector interface or distal connector comprises one of the following: a threaded luer, a slip luer, a collared threaded luer lock, a blunt-ended plastic cannula, a male luer, a cannula for PRN access, a needle-free connector, or a needle access cannula. The system according to claim 7 or 8.

10. The connector portion of the scrubbing cap secures the scrubbing cap by a twist-type engagement, and the scrubbing cap is removable so that the system can be connected to the access port of a vascular access device. The system according to any one of claims 2 to 9.

11. The scrubbing insert comprises an elastic material containing an absorbed antimicrobial solution or antimicrobial agent, configured to disinfect the surface of the access port of the vascular access device. The system according to any one of claims 1 to 10.

12. The scrubbing cap comprises a seal mounted on the cavity to seal the scrubbing insert within the cavity. The system according to any one of claims 1 to 11.

13. A method using a blood sample collection system, To provide a blood sample collection system, the system is A container assembly comprising a cap and defining a reservoir, wherein the container assembly has a distal end and a proximal end, and the cap is positioned at the distal end of the container assembly, A fluid access assembly comprising a housing defining an interior, a fluid access component, and a fluid connector component, wherein the housing has a distal end and a proximal end, the fluid access component extends from the distal end of the housing into the interior of the housing, the fluid access component defines an interior lumen, and the fluid connector component is located at the distal end of the housing. A scrubbing cap provided at the distal end of the housing, or adjacent to the distal end of the housing, wherein the scrubbing cap is Scrubbing insert and A housing defining a cavity configured to hold the scrubbing insert therein, This includes, Position the scrubbing cap on the access port of the vascular access device, thereby bringing the access port into contact with the scrubbing insert, The access port is cleaned with the scrubbing insert, A method that includes this.

14. The fluid connector component comprises a luer connector configured to connect to the access port, and the scrubbing cap comprises a connector portion that engages with the luer connector to secure the scrubbing cap to the fluid access assembly. The method according to claim 13.

15. Following the cleaning of the access port, the scrubbing cap is removed from the lure connector, The Luer connector is connected to the access port, and the fluid access assembly is positioned to be fluidly connected to the vascular access device. The method according to claim 14, including the method described in claim 14.

16. The system comprises an extension member having a distal end and a proximal end, the extension member being configured to reduce hemolysis of blood samples passing through it, and the scrubbing cap comprising a connector portion that engages with the distal end of the extension member to secure the scrubbing cap to the extension member. The method according to claim 13.

17. Following the cleaning of the access port, the scrubbing cap is removed from the distal end of the extension member, The distal end of the extension member is connected to the access port, and the fluid access assembly is positioned to be fluidly connected to the vascular access device. The method according to claim 16, including the method described in claim 16.

18. The system includes an adapter comprising a first engagement mechanism and a second engagement mechanism, wherein the first engagement mechanism of the adapter is configured to releasably engage with the cap of the container assembly, and the second engagement mechanism of the adapter is configured to releasably engage with the engagement mechanism of the housing of the fluid access assembly, thereby, in a first configuration, the first engagement mechanism of the adapter engages with the cap and the second engagement mechanism of the adapter engages with the engagement mechanism of the fluid access assembly, wherein the cap of the container assembly is at least partially located within the housing and spaced apart from the fluid access components. The method according to any one of claims 13 to 17.

19. The container assembly is translated toward the first end of the fluid access assembly and toward the adapter, thereby disengaging the cap from the first engagement mechanism of the adapter, the fluid access component perforating the resealable membrane of the cap, and the reservoir of the container assembly fluidly communicating with the fluid connector component through the lumen of the fluid access component. Disconnecting the second engagement mechanism of the adapter from the engagement mechanism of the fluid access assembly, The container assembly is pulled away from the first end of the fluid access assembly and translated outwards from the inside of the fluid access assembly, thereby separating the container assembly and the adapter from the fluid access assembly. The method according to claim 18, including the method described in claim 18.

20. The scrubbing cap comprises a seal mounted on the cavity to seal the scrubbing insert within the cavity, and the method further includes removing the seal from the scrubbing cap to position the scrubbing cap over the access port of the vascular access device, thereby allowing the scrubbing insert to come into contact with the access port. The method according to any one of claims 13 to 19.

21. Cleaning the access port includes applying a twisting motion to the blood sample collection system. The method according to any one of claims 13 to 20.

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