Blood culture sample collection device with optimized distal fluid path and pre-placed and sterilized waste sample vacuum tube

Abstract

The blood sample collection system includes a container assembly having a cap and defining a reservoir, the cap disposed at a first end of the container assembly, and a fluid access assembly including a housing defining an interior, a fluid access component, a fluid connector component, and an engagement structure, the fluid access component extending from the first end of the housing into the interior of the housing, the fluid access component defining a lumen. The system also includes a connecting portion having a distal end and a proximal end, the connecting portion including a connector interface disposed at the distal end and a fluid path member fluidly coupled to the connector interface and configured to be coupled to the fluid connector component of the fluid access assembly, the fluid path member configured to reduce hemolysis of a blood sample passing therethrough.

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Provisional Application No. 63 / 329,645, filed April 11, 2022, entitled "Blood Culture Sample Collection Device With Optimized Distal Fluid Pathway and Pre-Placed and Sterilized Waste Sample Evacuum Tube," the entire disclosure of which is incorporated by reference herein in its entirety. FIELD OF THEINVENTION The present disclosure relates generally to systems and methods for drawing blood samples for blood culture testing from a vascular access system, such as a peripheral intravenous catheter (PIVC), for example. More specifically, the system described herein includes a blood collection set having an optimized fluid path distal to a Luer Lock Access Device (LLAD) for drawing multiple blood samples. [Background technology]

[0002] 2. Description of Related Art When blood samples are taken from indwelling vascular access devices, such as percutaneous intravenous catheters (PIVCs), central venous catheters (CVCs), and peripherally inserted central catheters (PICCs), the first 1-10 ml of blood is often wasted (i.e., discarded) to avoid contamination from liquids in the dead space of the vascular access flow paths of these devices. While this extra step reduces contamination of the blood sample, it can be forgotten or performed improperly, compromising the blood sample.

[0003] 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 prescribe the patient's treatment. However, accidental contamination of blood samples is a common problem, resulting in false positives, often resulting in the patient being prescribed unnecessary treatments, such as broad-spectrum antibiotics. To address this concern, some healthcare professionals disinfect the patient's skin prior to the blood collection procedure. This reduces the false positive rate, but the false positive rate remains high (e.g., 3-5%), for example, due to bacteria and / or fungi living in hair follicles. Therefore, some systems also divert a small amount of the initial blood drawn, and the initial (potentially contaminated) amount is discarded. These systems, however, can be expensive and laborious. Furthermore, these systems often rely on puncturing the patient's skin to obtain the sample, which is uncomfortable for the patient.

[0004] Furthermore, needleless blood collection systems such as Velanovascular's PIVO™ are intended to be used with an intravenous catheter placed inside a patient's body. These needleless blood collection systems may be configured to receive a vacuum tube, which when in fluid communication with the patient's vascular system through the needleless blood collection system may draw blood into the vacuum tube's reservoir due to a pressure difference between the reservoir and the patient's vascular system. Because vacuum tubes are often not provided in a sterile state, there may be a risk of contamination each time the vacuum tube is connected to the needleless blood collection system. Even if a medical professional disinfects the surface of the vacuum tube's resealable membrane (e.g., using an alcohol pad), the risk of contamination to the needleless blood collection system may be too high to use the vacuum tube as a waste tube collector before using the needleless blood collection system to collect a blood sample for blood culture.

[0005] To address the possibility of sample contamination due to contact with a non-sterile evacuated tube, blood collection systems have been developed in which an evacuated tube configured to receive a waste blood sample is held in a pre-advanced position within the LLAD via an adapter, which allows both the evacuated tube and the LLAD to be sterilized together, thereby reducing the number of non-sterile steps and connections during the blood culture collection procedure. Examples of such systems are shown and described in U.S. Patent No. 5,399,623, which is incorporated herein by reference in its entirety. However, while the systems shown and described in U.S. Patent No. 5,399,623 address at least a portion of the risk of false positive blood culture samples, they do not consider the risk of hemolysis in subsequent blood samples, which are typically taken after the initial blood culture sample is drawn. [Prior art documents] [Patent documents]

[0006] [Patent Document 1] US Patent Application Publication No. 2021 / 0196167 [Patent Document 2] U.S. Pat. No. 10,076,272 [Patent Document 3] US Patent Publication No. 2017 / 0216564 Summary of the Invention [Problem to be solved by the invention]

[0007] A common problem with drawing blood from a patient using a vascular access device such as a PIVC is that as the blood is drawn into, for example, a blood collection tube, the red blood cells are subject to high shear stress and are therefore susceptible to hemolysis due to the high pressure differential between the vein and the blood collection tube. Such hemolysis can result in the rejection and discarding of the blood sample. [Means for solving the problem]

[0008] Summary of the Invention According to one aspect of the present disclosure, a system is disclosed, the system including a container assembly including a cap and defining a reservoir, the container assembly having a first end and a second end, the cap disposed at the first end of the container assembly, and a fluid access assembly having a housing defining an interior, a fluid access component, a fluid connector component, and an engagement structure, the housing having a first end and a second end, the fluid access component extending from the first end of the housing into the interior of the housing, the fluid access component defining a lumen, and the fluid connector component disposed at the first end of the housing. The system also includes a connecting portion having a distal end and a proximal end, the connecting portion having a connector interface disposed at the distal end and a fluid path member fluidly coupled to the connector interface and configured to be coupled to the fluid connector component of the fluid access assembly, the fluid path member configured to reduce hemolysis of a blood sample passing therethrough. The system further includes an adapter including a first engagement structure and a second engagement structure, the first engagement structure of the adapter configured to releasably engage with the cap of the container assembly and the second engagement structure of the adapter configured to releasably engage with the engagement structure of the fluid access assembly, such that the first engagement structure of the adapter engages with the cap and the second engagement structure of the adapter engages with the engagement structure of the fluid access assembly, and in the first configuration, the cap of the container assembly is disposed at least partially within the housing and spaced apart from the fluid access component.

[0009] In some embodiments, the fluid pathway member comprises a flexible tube.

[0010] In some embodiments, the connecting portion includes a compact connector having a proximal connector portion configured to couple the compact connector to a 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 shaped and configured to reduce hemolysis of a blood sample passing therethrough.

[0011] In some embodiments, the connector interface includes one of a threaded luer, a slip luer, a threaded luer lock with collar, a blunt plastic cannula, a male luer, a cannula for PRN access, a needleless connector, or a needle access cannula.

[0012] In some embodiments, the fluid connector component is integrated with the fluid access assembly.

[0013] In some embodiments, the fluid connector component is removably coupled to the fluid access assembly.

[0014] In some embodiments, the container assembly is configured to be transitioned from the first configuration to the second configuration by moving the container assembly toward the first end of the fluid access assembly, the cap is disengaged from the first engagement structure of the adapter, the fluid access component punctures the resealable membrane of the cap, and the reservoir of the container assembly is in fluid communication with the fluid connector component and connecting portion via the lumen of the fluid access component.

[0015] In some embodiments, the reservoir of the container assembly is evacuated.

[0016] In some embodiments, the engagement structure of the fluid access assembly includes a flange extending outwardly relative to a central axis of the housing of the fluid access assembly.

[0017] In some embodiments, the container assembly is a first container assembly, and the system further includes a second container assembly configured to engage with the fluid access component by moving the second container assembly toward the first end of the fluid access assembly after removal of the first container assembly, such that the resealable membrane of the second container assembly is punctured by the fluid access component and the reservoir of the second container assembly is in fluid communication with the fluid connector component via the lumen of the fluid access component.

[0018] According to another aspect of the present disclosure, a method of using a blood sample collection system is disclosed, the method including providing a blood sample collection system, the system including a container assembly having a cap and defining a reservoir, the container assembly having a first end and a second end, the cap disposed at the first end of the container assembly, a fluid access assembly including a housing defining an interior, a fluid access component, a fluid connector component, and an engagement structure, the housing having a first end and a second end, the fluid access component extending from the first end of the housing to an interior of the housing, the fluid access component defining a lumen, the fluid connector component disposed at the first end of the housing, and a connecting portion having a distal end and a proximal end, the connecting portion being an engagement structure. the adapter includes a connecting portion configured to reduce hemolysis of a blood sample passing therethrough, the connecting portion including a connector interface disposed at a distal end of the housing, and a fluid path member configured to be fluidly coupled to the connector interface and coupled to a fluid connector component of a fluid access assembly, the fluid path member configured to reduce hemolysis of a blood sample passing therethrough; and an adapter including a first engaging structure and a second engaging structure, the first engaging structure of the adapter releasably engaged with a cap of the container assembly and the second engaging structure of the adapter releasably engaged with the engaging structure of the fluid access assembly, wherein in a first configuration in which the first engaging structure of the adapter engages with the cap and the second engaging structure of the adapter engages with the engaging structure of the fluid access assembly, the cap of the container assembly is disposed at least partially within the housing and spaced from the fluid access component. The method further includes coupling the connector interface of the connecting portion to the vascular access device and moving the container assembly toward a first end of the fluid access assembly and relative to the adapter, such that the cap disengages from a first engagement structure of the adapter, the fluid access component punctures a resealable membrane of the cap, and a reservoir of the container assembly is in fluid communication with the fluid connector component via an inner lumen of the fluid access component.The method also includes disengaging the second engagement structure of the adapter from the engagement structure of the fluid access assembly and moving the container assembly away from the first end of the fluid access assembly and out from within the fluid access assembly, whereby the container assembly and the adapter are separated from the fluid access assembly.

[0019] In some embodiments, the method further includes sterilizing the blood sample collection system prior to coupling the connector interface of the connecting portion to the vascular access device.

[0020] In some embodiments, the method includes disengaging the second engagement structure of the adapter from the engagement structure of the fluid access assembly, the step including at least one of rotating, unlatching, or deforming the adapter relative to the housing of the fluid access assembly.

[0021] In some embodiments, the container assembly is a first container assembly, and the method further includes, after moving the first container assembly away from the first end of the fluid access assembly and out from within the fluid access assembly, moving a second container assembly toward the first end of the fluid access assembly, wherein a resealable membrane of the second container assembly is punctured by the fluid access component and a reservoir of the second container assembly is in fluid communication with the fluid connector component via an inner lumen of the fluid access component.

[0022] In some embodiments, moving the container assembly toward the first end of the fluid access assembly and relative to the adapter such that the fluid access component punctures the resealable membrane of the cap causes the reservoir of the container assembly to be evacuated, thereby drawing a blood sample from the indwelling vascular access device fluidly coupled to the connecting portion, through the fluid pathway member, through the fluid access component, and into the reservoir of the container assembly.

[0023] According to another aspect of the present disclosure, a system is disclosed, the system including a fluid access assembly having a housing defining an interior, a fluid access component, a fluid connector component, and an engagement structure, the housing having a first end and a second end, the fluid access component extending from the first end of the housing into the interior of the housing, the fluid access component defining a lumen, the fluid connector component disposed at the first end of the housing, and the engagement structure of the fluid access assembly disposed at the second end of the housing. The system also includes a container assembly including a cap and an engagement structure, the container assembly defining a reservoir, the container assembly having a first end and a second end, the cap disposed at the first end of the container assembly, the engagement structure of the container assembly configured to releasably engage with the engagement structure of the fluid access assembly, and in a first configuration in which the engagement structure of the adapter engages with the engagement structure of the fluid access assembly, the cap is at least partially disposed within the interior of the housing and spaced apart from the fluid access component. The system further includes a connecting portion having a distal end and a proximal end, the connecting portion including a connector interface disposed at the distal end and a fluid pathway member fluidly coupled to the connector interface and configured to be coupled to a fluid connector component of the fluid access assembly, the fluid pathway member configured to reduce hemolysis of a blood sample passing therethrough.

[0024] In some embodiments, the fluid pathway member comprises a flexible tube.

[0025] In some embodiments, the connection portion includes a compact connector having a proximal connector portion configured to couple the compact connector to a 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 shaped and configured to reduce hemolysis of a blood sample passing therethrough.

[0026] In some embodiments, the container assembly is configured to be transitioned from the first configuration to the second configuration by moving the container assembly toward the first end of the fluid access assembly, such that the engaging structure of the container assembly disengages from the engaging structure of the fluid access assembly, the fluid access component punctures the resealable membrane of the cap, and the reservoir of the container assembly is in fluid communication with the fluid connector component and connecting portion via the lumen of the fluid access component.

[0027] In some embodiments, the connector interface includes one of a threaded luer, a slip luer, a threaded luer lock with collar, a blunt plastic cannula, a male luer, a cannula for PRN access, a needleless connector, or a needle access cannula.

[0028] Further details and advantages of the present invention will become apparent from the following detailed description taken in conjunction with the accompanying drawings, in which like parts are designated with like reference numerals throughout. [Brief description of the drawings]

[0029] [Figure 1] FIG. 1 is a schematic diagram of a blood sample collection system according to one aspect of the present disclosure. [Diagram 2] FIG. 2 is a side view of the blood sample collection system of FIG. 1. [Diagram 3] FIG. 13 is a perspective view of a compact connector for use in a blood sample collection system according to another aspect of the present disclosure. [Figure 4A] FIG. 2 is a rear perspective view of the blood sample collection system of FIG. 1 in a first configuration. [Figure 4B] 2 is a rear perspective view of the blood sample collection system of FIG. 1 in a second configuration. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0030] Description of the Preferred Embodiments The following description is provided to enable a person skilled in the art to make and use the described embodiments contemplated for practicing the invention. However, various modifications, equivalents, variations, and alternatives will remain readily apparent to those skilled in the art. All such modifications, variations, equivalents, and alternatives are intended to be within the spirit and scope of the present disclosure.

[0031] Hereinafter, for purposes of explanation, the terms "upper", "lower", "right", "left", "vertical", "horizontal", "top", "bottom", "lateral", "longitudinal" and their derivatives will refer to the present invention as they are oriented in the drawings. However, it should be understood that the present invention may assume various alternative modifications, unless expressly specified otherwise. It should also be understood that the specific devices illustrated in the accompanying drawings and described in the following specification are merely exemplary embodiments of the present invention. Hence, specific dimensions and other physical characteristics relating to the embodiments disclosed herein are not to be considered as limiting.

[0032] In this disclosure, the distal end of a component or device means the end furthest from the user's hand and the proximal end means the end closest to the user's hand when the component or device is in the use position, i.e., when a user is holding the blood collection device in preparation for or during use. Similarly, in this application, the terms "distally" and "distally" mean the direction toward the access connector portion of the fluid transfer device and the terms "proximally" and "proximally" mean the direction opposite to the direction of the connector.

[0033] 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, such as, for example, the BD NEXIVA™ Closed IV Catheter System, the BD CATHENA™ Catheter System, the BD VENFLON™ Pro Safely Shielded IV Catheter System, the BD NEOFLON™ IV Cannula System, the BD INSYTE™ AUTOGUARD™ BC Shielded IV Catheter System, or other suitable vascular access device.

[0034] Embodiments of the present disclosure will be described primarily in the context of a blood sample collection system for use in a PIVC, however, embodiments of the present disclosure extend to use in other catheter devices as well.

[0035] 1, 2, 4A, and 4B, a blood sample collection system 50 according to one aspect of the present disclosure is shown. FIG. 1 is a schematic diagram of a blood sample collection system 50 according to one embodiment. System 50 includes a container assembly 210, an adapter 230, a fluid access assembly 220, and a connecting portion 100. Container assembly 210 may include a cap 212 and may define a reservoir 211. Fluid access assembly 220 may include a housing 228 defining an interior, an engagement structure 222, a fluid access component 224, and a fluid connector component 226.

[0036] The adapter 230 may include a first engagement structure 231 and a second engagement structure 232. The first engagement structure 231 of the adapter 230 may be configured to releasably engage with the cap 212 of the container assembly 210, and the second engagement structure 232 of the adapter 230 may be configured to releasably engage with the engagement structure 222 of the fluid access assembly 220. The first engagement structure 231 of the adapter 230 may be or include any suitable engagement mechanism configured to temporarily or releasably hold the cap 212 in position relative to the adapter 230 and to release the cap 212 upon movement of the cap 212 relative to the first engagement structure 231. The movement may include, for example, a translational movement, a rotational movement, and / or a helical movement. The second engagement structure 232 of the adapter 230 and the engagement structure 222 of the fluid access assembly 220 may be or include any suitable engagement structure configured to temporarily or releasably engage with one another to temporarily hold the adapter 230 in a 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 caused by release of the cap 212 from the adapter 230, and / or via deformation and / or movement (e.g., rotational, helical, and / or translational) of the second engagement structure 232 and / or the engagement structure 222 relative to the other of the second engagement structure 232 or the engagement structure 222 such that the second engagement structure 232 may be separated from the engagement structure 222).

[0037] The container assembly 210 may include a first end and a second end. The cap 212 may be disposed at the first 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 may be coupled to the open end, with the cap 212 and the tube defining the reservoir 211. In some embodiments, the cap 212 may include a resealable membrane. The resealable membrane may be configured such that a fluid access component, such as the fluid access component 224, may puncture the resealable membrane to achieve fluid communication with the reservoir 211. The resealable membrane of the cap 212 may be configured to reseal upon detachment of the fluid access component 224 from the cap 212, with the reservoir 211 being fluidly isolated from an area exterior to the container assembly 210. In some embodiments, the cap 212 may include a ridge and / or one or more flanges disposed on an exterior surface thereof. The reservoir 211 may be a vacuum reservoir, such that when the reservoir 211 is placed in fluid communication with a fluid source (e.g., by piercing the resealable membrane of the cap 212 with a fluid access component fluidly coupled to the patient's vasculature), fluid (e.g., blood) may be drawn into the reservoir 211 due to a pressure differential between the reservoir 211 and the fluid source. In some embodiments, the container assembly 210 may be a vacuum tube. In some embodiments, the container assembly 210 may be any suitable standard vacuum tube, such as, for example, BD VACUTAINER® from Becton Dickinson & Company, VACUETTE® from Greiner Bio-one®, etc. The cap 212 may be formed of any suitable material, such as, for example, rubber. The tube may be formed, for example, from plastic.

[0038] The fluid access assembly 220 may also have a first end and a second end. The fluid access component 224 may be disposed within the housing 228 and may extend from the first end of the housing 228 into the housing 228. For example, in some embodiments, the fluid access component 224 may have a first end and a second end opposite the first end. The first end of the fluid access component 224 may be coupled to the first end of the housing 228 and the second end may be disposed within the housing 228. In some embodiments, the fluid access component 224 may include a needle defining 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 be moved relative to the needle such that the second end of the needle may be selectively exposed.

[0039] The fluid connector component 226 may be integral with or removably coupled to a first end of the housing 228. For example, the housing 228 may define an outlet fluidly coupled to a lumen of the fluid access component 224 to which the fluid connector component 226 may be coupled. In some embodiments, the fluid connector component 226 may include any suitable component configured to couple the housing 228 to a patient access tube. For example, in some embodiments, the fluid connector component 226 may be a luer connector. The luer connector may be in the form of, for example, a slip luer, a threaded luer, a collared luer lock, or the like. In some embodiments, the fluid connector component 226 may be an outlet of the housing 228 that defines a lumen.

[0040] Still referring to FIG. 1 , the system 50 further includes a connection portion 100 configured to reduce hemolysis of a blood sample drawn into the container assembly 210. The connection portion 100 may include a connector interface 102 and a fluidic resistance optimized fluid path member 104. The connector interface 102 may be configured as any suitable interface capable of coupling the connection portion 100 to an access port of a vascular access device, such as, for example, a PIVC. For example, in some embodiments, the connector interface 102 may be configured as a threaded luer, a slip luer, a threaded luer lock with collar, a blunt plastic cannula (with or without an alligator-style connection clip), a male luer (with or without an alligator-style connection clip), a cannula for PRN access, a needleless connector, or a needle access cannula.

[0041] The fluid path member 104 may 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 FIGS. 2, 4A, 4B, 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, which in turn may limit the maximum shear stress experienced by blood cells during blood collection. As discussed above, it is the shear stress in blood cells (especially the walls of blood cells) that is believed to be the primary cause of hemolysis and mechanical damage to blood cells. Thus, optimizing the fluid path member 104 for fluid resistance may reduce hemolysis of the collected blood sample.

[0042] However, although FIGS. 2, 4A, and 4B show the fluid pathway member 104 formed as a flexible tube, the present disclosure is not limited thereto. For example, in some embodiments, the fluid pathway member 104 may be formed as a compact connector, a metal or plastic cannula, or a molded axial fluid pathway. With reference to FIG. 3, a compact connector 300 according to an aspect of the present disclosure is shown. It should be understood that the compact connector 300 may be used in place of, for example, a length of flexible tubing. The compact connector 300 may include a proximal connector portion 302 configured to couple the compact connector 300 to, for example, the fluid connector component 226 of the fluid access assembly 220. A distal connector portion 304 may be provided to couple the compact connector 300 to, for example, an access port of a vascular access device. Additionally, a central portion 306 may be provided, which is shaped and configured to increase flow resistance and therefore reduce hemolysis. Other configurations for the fluid pathway member 104 are also possible. For example, the fluid path member 104 may be configured similarly to one or more of the fluid resistance optimized fluid paths described in any one of U.S. patent application Ser. No. 17 / 146,388, U.S. patent application Ser. No. 17 / 401,506, and U.S. patent application Ser. No. 17 / 496,858, the disclosures of which are incorporated by reference in their entireties herein.

[0043] 1, 2, 4A, and 4B, the engagement structure 222 of the fluid access assembly 220 may include a flange that extends perpendicularly from a central axis of the housing 228. In some embodiments, the flange may be elongated such that it extends farther from the central axis of the housing 228 in a first direction than in a second direction. For example, the flange may form an elongated surface of the fluid access assembly 220 disposed in a plane that includes the second end of the housing 228.

[0044] In some embodiments, the fluid access assembly 220 may be any suitable standard holder, such as, for example, the VACUETTE® blood culture holder from Greiner Bio-one®, the Saf-T Holder® device from JELCO® sold by Smiths Medical, and / or the VACUTAINER® holder device from BD. In some embodiments, the fluid access assembly connector interface 102 may be configured to be coupled to and / or engaged with an indwelling peripheral venous catheter (PIVC). For example, in some embodiments, the connector interface 102 (and thus the system 50) may be coupled to any fluid transfer device or portion of a fluid transfer device shown and / or described in U.S. Patent No. 6,399,432, filed Aug. 26, 2014, entitled “System and Method for Venous Dissection via a Peripheral Venous Catheter,” and / or U.S. Patent No. 6,399,432, filed Feb. 2, 2016, entitled “Device and Method for Fluid Transfer via a Placed Venous Catheter,” the disclosures of each of which are incorporated herein by reference in their entirety.

[0045] The first engagement structure 231 of the adapter 230 may be any suitable structure configured to releasably engage with the cap 212 of the container assembly 210. In some embodiments, the first engagement structure 231 of the adapter 230 may be an inner surface of the adapter 230 that defines a throughbore. The inner surface of the adapter 230 may include a diameter sufficiently smaller than an outermost diameter of the cap 212 such that the inner surface and the cap 212 may be engaged by a friction fit. In some embodiments, the first engagement structure 231 includes a structure corresponding to a structure on the cap 212 such that the adapter 230 and the cap 212 may be releasably engaged.

[0046] The second engagement structure 232 of the adapter 230 may be any suitable structure configured to releasably engage with the engagement structure 222 of the fluid access assembly 220. For example, the second engagement structure 232 may include two oppositely disposed tabs. A latch may be disposed at the end of each tab. Each latch may be shaped and sized to receive a portion of a flange of the engagement structure 222 of the fluid access assembly 220. In some embodiments, the adapter 230 may be rotatable relative to the fluid access assembly 220, and the second engagement structure 232 (e.g., the latch) may be rotated out of engagement with the engagement structure 222 (e.g., the flange) of the fluid access assembly 220. In some embodiments, the second engagement structure 232 may include multiple arms (e.g., two), each arm having a first end coupled to a base of the adapter 230 via a flexible joint and a latch disposed at an opposing end of the arm. In some embodiments, each arm may be curved and form a portion of the circumference of the adapter 230. Such an adapter may be decoupled from the engagement structure 222 of the fluid access assembly 220, for example, by rotating and / or deforming (e.g., bending). In some embodiments, the second engagement structure 232 may include multiple tabs including latches configured to snap onto a flange of the engagement structure 222. For example, the second engagement structure 232 may include two or three latch tabs. To separate such an adapter 230 from the housing 228, a user may decouple each latch tab by pulling the latch away from the flange of the engagement structure 222, causing the tab to be released from engagement with the flange of the engagement structure 222.

[0047] In some embodiments, the fluid access assembly 220 may include a container size adaptor such that container assemblies 210 of various sizes and shapes may be used with (e.g., disposed within and stabilized by) the fluid access assembly 220. In some embodiments, the adapter 230 may be configured (e.g., shaped and sized) to engage with an engagement structure of the container size adaptor in a manner similar to that described above with respect to the engagement structure 222 of the fluid access assembly 220. In some embodiments, the adapter 230 may be configured (e.g., shaped and sized) to receive a portion of the container size adaptor into the second engagement structure 232 of the adapter 230 when the second engagement structure 232 of the adapter 230 is engaged with the engagement structure 222 of the fluid access assembly 220.

[0048] 4A, the system 50 has a first configuration (e.g., an initial configuration) in which the first engagement structure 231 of the adapter 230 is engaged with the cap 212 and the second engagement structure 232 is engaged with the engagement structure 222 of the fluid access assembly 220. When the first engagement structure 231 of the adapter 230 engages with the cap 212 and the second engagement structure 232 engages with the engagement structure 222 of the fluid access assembly 220, the cap 212 is spaced apart from the fluid access component 224 and the reservoir 211 is fluidly isolated from an environment external to the container assembly 210. In the first configuration, the cap 212 may be at least partially disposed within the adapter 230 and / or the housing 228. For example, a first end of the cap 212 may be disposed within the housing 228 (protruding from the adapter 230 or disposed within the adapter 230). In some embodiments, the first end of cap 212 may be disposed and retained in the first configuration within adapter 230 but proximal to housing 228. In some embodiments, the entire system 50 may be sterilized in the first configuration and packaged for sterile transportation to a user (e.g., a healthcare provider).

[0049] 4B, 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 moved distally in a direction "A" toward the first end of the fluid access assembly 220 such that the cap 212 engages the fluid access component 224 (e.g., the fluid access component 224 pierces the cap 212) and a portion of the fluid access component 224 is disposed within the reservoir 211. For example, in an embodiment in which the container assembly 210 engages the first engagement structure 231 by a friction fit, a force may be applied to the container assembly 210 to overcome the force applied to the container assembly 210 (e.g., the cap 212) by the first engagement structure 231, moving the container assembly 210 into engagement with the fluid access component 224. In the second configuration, when the connector interface 102 is fluidly coupled to the patient's vascular system, fluid (e.g., blood) can be drawn through the fluid pathway member 104, through the fluid connector component 226, through the fluid access component 224, and into the reservoir 211 of the container assembly 210.

[0050] Once sufficient blood has been drawn into the reservoir 211, the system 50 may be transitioned 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 access assembly 220. For example, the container assembly 210 may be transitioned relative to the fluid access assembly 220 with the cap 212 disposed near the second end of the housing 228. In response to the cap 212 being disengaged from the fluid access component 224, the cap 212 having a resealable membrane may fluidly isolate the reservoir 211 from an environment external to the container assembly 210. The adapter 230 may then be separated from the fluid access assembly 220 by decoupling the second engagement structure 232 from the engagement structure 222, for example, by rotating, unsnapping, or deforming one or more portions of the second engagement structure 232 from the engagement structure 222 of the fluid access assembly 220. Thereafter, adapter 230 and container assembly 210 may optionally be discarded, particularly as this initial blood sample may be considered a "discard sample."

[0051] After removing the adapter 230 and the container assembly 210 from the fluid access assembly 220, a second container assembly may be inserted into the interior of the housing and engaged with the fluid access component 224, and the second container assembly may draw blood into a reservoir of the second container assembly via the fluid connector component 226 and the fluid access component 224. In some embodiments, the second container assembly may contain a medium (e.g., soybean casein digest medium) in a reservoir in the second container assembly that is configured to be used to perform blood cultures when mixed with a patient's blood sample in the reservoir. Any suitable number of container assemblies may be engaged (and then disengaged) with the fluid access component 224 to draw fluid from the patient for various tests. Because the system 50 includes a fluid path member 104 connected to the fluid connector component 226, hemolysis of these subsequent blood draw samples may be reduced. Additionally, many of the major components of the system 50 do not need to be removed between blood draws, improving the workflow of the healthcare provider. Additionally, there may be a reduced risk of sample contamination during blood collection due to an overall reduction in connections made compared to traditional blood collection methods, which, combined with the ability to provide the entire system 50 in a sterile package, reduces the overall risk of contamination of blood culture samples.

[0052] 1, 2, 4A, and 4B utilizes fluid access assembly 220, adapter 230, and container assembly 210 in combination with connecting portion 100 for reduced hemolysis of a blood sample, it should be understood that the present disclosure is not so limited. That is, connecting portion 100 may be utilized with other blood collection assemblies, including those shown and described in various embodiments in U.S. Patent Application Publication No. 2006 / 0139994, the entirety of which is incorporated herein by reference.

[0053] Although the foregoing detailed description has described several embodiments of a blood sample collection system configured to collect blood during catheter placement, those skilled in the art may make modifications and variations to these embodiments without departing from the scope and spirit of the invention. Accordingly, the foregoing description is intended to be illustrative rather than limiting. The above-described invention is defined by the appended claims, and all modifications thereto that come within the meaning and range of equivalency of the claims are intended to be embraced therein.

Claims

1. 1. A system comprising: a container assembly including a cap and defining a reservoir, the container assembly having a first end and a second end, the cap disposed on the first end of the container assembly; a fluid access assembly comprising a housing defining an interior, a fluid access component, a fluid connector component, and an engagement structure, the housing having a first end and a second end, the fluid access component extending from the first end of the housing into an interior of the housing, the fluid access component defining a lumen, and the fluid connector component disposed at the first end of the housing; a connecting portion having a distal end and a proximal end, the connecting portion comprising a connector interface disposed at the distal end, and a fluid path member fluidly coupled to the connector interface and configured to be coupled to the fluid connector component of the fluid access assembly, the fluid path member configured to reduce hemolysis of a blood sample passing therethrough; and an adapter including a first engagement structure and a second engagement structure, the first engagement structure of the adapter configured to releasably engage with the cap of the container assembly and the second engagement structure of the adapter configured to releasably engage with the engagement structure of the fluid access assembly, wherein the first engagement structure of the adapter engages with the cap and the second engagement structure of the adapter engages with the engagement structure of the fluid access assembly, and in a first configuration, the cap of the container assembly is at least partially disposed within the interior of the housing and spaced from the fluid access component.

2. The system of claim 1 , wherein the fluid pathway member comprises a flexible tube.

3. 2. The system of claim 1, wherein the connection portion 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 shaped and configured to reduce hemolysis of a blood sample passing therethrough.

4. 10. The system of claim 1, wherein the connector interface comprises one of a threaded luer, a slip luer, a threaded luer lock with collar, a blunt plastic cannula, a male luer, a cannula for PRN access, a needleless connector, or a needle access cannula.

5. The system of claim 1 , wherein the fluid connector component is integral with the fluid access assembly.

6. The system of claim 1 , wherein the fluid connector component is removably coupled to the fluid access assembly.

7. 2. The system of claim 1, wherein the container assembly is configured to be transitioned from a first configuration to a second configuration by moving the container assembly toward the first end of the fluid access assembly, the cap is disengaged from the first engagement structure of the adapter, the fluid access component punctures a resealable membrane of the cap, and the reservoir of the container assembly is in fluid communication with the fluid connector component and the connecting portion via an internal cavity of the fluid access component.

8. 10. The system of claim 1, wherein the reservoir of the container assembly is evacuated.

9. 2. The system of claim 1, wherein the engagement structure of the fluid access assembly includes a flange extending outwardly relative to a central axis of the housing of the fluid access assembly.

10. 2. The system of claim 1, wherein the container assembly is a first container assembly, the system further comprising a second container assembly configured to engage the fluid access component by moving the second container assembly toward the first end of the fluid access assembly after removal of the first container assembly, wherein a resealable membrane of the second container assembly is pierced by the fluid access component and a reservoir of the second container assembly is in fluid communication with the fluid connector component via the internal cavity of the fluid access component.

11. 1. A method of using a blood sample collection system, the method comprising: Providing the blood sample collection system, the system comprising: a container assembly including a cap and defining a reservoir, the container assembly having a first end and a second end, the cap disposed on the first end of the container assembly; a fluid access assembly comprising a housing defining an interior, a fluid access component, a fluid connector component, and an engagement structure, the housing having a first end and a second end, the fluid access component extending from the first end of the housing into an interior of the housing, the fluid access component defining a lumen, and the fluid connector component disposed at the first end of the housing; a connecting portion having a distal end and a proximal end, the connecting portion comprising a connector interface disposed at the distal end, and a fluid path member fluidly coupled to the connector interface and configured to couple to the fluid connector component of the fluid access assembly, the fluid path member configured to reduce hemolysis of a blood sample passing therethrough; providing an adapter including a first engagement structure and a second engagement structure, the first engagement structure of the adapter being releasably engaged with the cap of the container assembly and the second engagement structure of the adapter being releasably engaged with the engagement structure of the fluid access assembly, wherein in a first configuration in which the first engagement structure of the adapter engages with the cap and the second engagement structure of the adapter engages with the engagement structure of the fluid access assembly, the cap of the container assembly is disposed at least partially within the housing and spaced apart from the fluid access component; coupling the connector interface of the connecting portion to a vascular access device; moving the container assembly toward the first end of the fluid access assembly and relative to the adapter, such that the cap disengages from the first engagement structure of the adapter, the fluid access component pierces a resealable membrane of the cap, and the reservoir of the container assembly is in fluid communication with the fluid connector component via the lumen of the fluid access component; disengaging the second engagement structure of the adapter from the engagement structure of the fluid access assembly; and moving the container assembly away from the first end of the fluid access assembly and out of an interior of the fluid access assembly, wherein the container assembly and the adapter are separated from the fluid access assembly.

12. 12. The method of claim 11, further comprising the step of sterilizing the blood sample collection system prior to coupling the connector interface of the connecting portion to the vascular access device.

13. 12. The method of claim 11, wherein disengaging the second engagement structure of the adapter from the engagement structure of the fluid access assembly includes at least one of rotating, unlatching, or deforming the adapter relative to the housing of the fluid access assembly.

14. 12. The method of claim 11, wherein the container assembly is a first container assembly, the method further comprising: the step of moving a second container assembly toward the first end of the fluid access assembly after moving the first container assembly away from the first end of the fluid access assembly and out from the interior of the fluid access assembly, wherein a resealable membrane of the second container assembly is punctured by the fluid access component and a reservoir of the second container assembly is in fluid communication with the fluid connector component via the internal cavity of the fluid access component.

15. 12. The method of claim 11, wherein moving the container assembly toward the first end of the fluid access assembly and relative to the adapter with the fluid access component piercing the resealable membrane of the cap causes the reservoir of the container assembly to be evacuated, thereby drawing a blood sample from an indwelling vascular access device fluidly coupled to the connecting portion, through the fluid pathway member, through the fluid access component, and into the reservoir of the container assembly.

16. 1. A system comprising: a fluid access assembly having a housing defining an interior, a fluid access component, a fluid connector component, and an engagement structure, the housing having a first end and a second end, the fluid access component extending from the first end of the housing into the interior of the housing, the fluid access component defining a lumen, the fluid connector component disposed at the first end of the housing, and the engagement structure of the fluid access assembly disposed at the second end of the housing; a container assembly including a cap and an engagement structure, the container assembly defining a reservoir, the container assembly having a first end and a second end, the cap disposed on the first end of the container assembly, the engagement structure of the container assembly configured to releasably engage with the engagement structure of the fluid access assembly, and in a first configuration in which an adapter engagement structure engages with the engagement structure of the fluid access assembly, the cap is disposed at least partially within the interior of the housing and spaced from the fluid access component; 1. A system comprising: a connection portion having a distal end and a proximal end, the connection portion comprising a connector interface disposed at the distal end, and a fluid path member fluidly coupled to the connector interface and configured to be coupled to the fluid connector component of the fluid access assembly, the fluid path member configured to reduce hemolysis of a blood sample passing therethrough.

17. 20. The system of claim 16, wherein the fluid pathway member comprises a flexible tube.

18. 17. The system of claim 16, wherein the connection portion includes 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 shaped and configured to reduce hemolysis of a blood sample passing therethrough.

19. 17. The system of claim 16, wherein the container assembly is configured to be transitioned from a first configuration to a second configuration by moving the container assembly toward the first end of the fluid access assembly, the engagement structure of the container assembly disengaging from the engagement structure of the fluid access assembly, the fluid access component puncturing a resealable membrane of the cap, and the reservoir of the container assembly fluidly communicating with the fluid connector component and the connecting portion via an internal cavity of the fluid access component.

20. 17. The system of claim 16, wherein the connector interface comprises one of a threaded luer, a slip luer, a threaded luer lock with collar, a blunt plastic cannula, a male luer, a cannula for PRN access, a needleless connector, or a needle access cannula.

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