RU2800887C2 - Systems, device and methods for preventing blood collection system contamination - Google Patents

Abstract

FIELD: medical equipment.

SUBSTANCE: system for collecting blood samples contains a container assembly that includes a cap and a defining reservoir. The container node has a first end and a second end, and the cap is located at the first end of the container node. The fluid access assembly includes a housing that defines an internal space, a fluid access component, a fluid connection component, and an engagement piece. The body has a first end and a second end, the fluid access component extends from the first end of the body into the interior of the body and defines a clearance. The fluid connection component is located at the first end of the housing and is configured to be connected to the patient access device so that the lumen of the fluid access component is able to communicate in fluid with the patient's vascular system through the fluid connection component and the patient access device. The adapter includes a first engaging part and a second engaging part. The first adapter engaging part is detachably engaged with the cap of the container assembly, and the second adapter engaging part is configured to engage with the fluid access component engaging part so that in the first configuration in which the first adapter engaging part is in engagement with the cap, and the second engaging part of the adapter is engaged with the engaging part of the fluid access assembly, the cap of the container assembly is located in the interior of the housing at a distance from the fluid access component. A method of using a system for collecting blood samples and an alternative version of the system for collecting blood samples are disclosed.

EFFECT: technical result consists in providing easy and efficient blood collection without contamination of the interface of the blood collection system.

16 cl, 10 dwg

Description

Cross-reference to related applications

[0001] This application claims advantage over and benefit from U.S. Provisional Application No. 62/732,345, filed September 17, 2018, entitled "Systems, Apparatus, and Methods for Preventing Contamination of a Blood Draw System", the entire content of which is thus , is explicitly contained by reference for all purposes.

State of the art

[0002] The embodiments described herein relate to systems, apparatus, and methods for collecting an initial volume of blood during a blood draw.

[0003] When sampling blood from indwelling vascular access devices such as a peripheral intravenous catheter (PIVC), central venous catheter (CVC), or peripherally inserted central venous catheter (PICC), the first 1-10 mL of blood is often wasted (i.e. ., disposed of) to avoid contamination from fluids in the dead space of the vascular access pathway for such devices. This extra step, while reducing the contamination of the blood sample, may be forgotten or incorrectly performed, thus compromising the blood sample.

[0004] 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 guide the patient's treatment. Accidental contamination of a blood sample, however, is a common problem, causing false positive results, which often result in unnecessary courses of treatment (eg, broad-spectrum antibiotics) being prescribed to the patient. To remedy this, some healthcare professionals clean the patient's skin before taking blood. While this reduces the false positive rate, the rate is still significant (eg 3-5%) due to bacteria and/or fungi living in, for example, hair follicles. Consequently, some systems also divert a small volume of the initial blood draw and reject the initial volume. These systems, however, can be expensive to operate and often rely on puncturing the patient's skin with painful needles to collect the sample.

[0005] Additionally, needleless blood collection systems, such as PIVO™, are intended for use in conjunction with intravenous catheters placed in a patient. These needleless blood collection systems can be configured to receive evacuated tubing such that the evacuated tubing, when in fluid communication with a patient's vascular system via the needleless blood collection system, can draw blood into the reservoir of the vacuum tubing due to the pressure differential between the reservoir and the vasculature. the patient's system. Because evacuated tubing is often not provided under sterile conditions, there can be a risk of contamination every time an evacuated tubing is connected to a needleless blood collection system. Even when healthcare workers wipe the surface of the resealable septum of the evacuated tubing (for example, with an alcohol pad), the risk of contamination to the needleless blood collection system may be too high to use the evacuated tubing as an extra tubing before using the needleless blood collection system to collect blood sample for bacteriological analysis of blood.

[0006] Thus, there is a need for a system and method for collecting blood samples, so that the initial blood draw volume for rejection can be collected easily and efficiently without contamination of the interface of the blood draw system.

The essence of the invention

[0007] In some embodiments, the system includes a container assembly, a fluid access assembly, and an adapter. The container assembly includes a cap and defines a reservoir. The container node has a first end and a second end, and a cap is placed on the first end of the container node. The fluid access assembly includes a housing defining an interior space, a fluid access component, a fluid connection component, and an engagement piece. The housing has a first end and a second end, a fluid access component extending from the first end of the housing into the interior of the housing. The fluid access component defines the lumen. The fluid connection component is placed at the first end of the housing and is configured to attach to the patient access device such that the lumen of the fluid access component can be in fluid communication with the patient's vasculature through the fluid connection component and the patient access device . The engaging part of the fluid access assembly is located at the second end of the housing. The adapter includes a first engaging part and a second engaging part. The first adapter engagement is configured to releasably engage with the cap of the container assembly, and the second adapter engagement is configured to releasably engage with the fluid access assembly engagement, so that, in the first configuration, in which the first adapter engagement is engaged with cap, and the second engaging part of the adapter engages with the engaging part of the fluid access assembly, the cap of the container assembly is at least partially located in the interior of the housing and is spaced from the fluid access component.

Brief description of the drawings

[0008] FIG. 1 is a schematic illustration of a system according to an embodiment.

[0009] FIG. 2A and 2B are respective views of the system in assembled configuration and exploded configuration, respectively, according to the embodiment.

[0010] FIG. 2C is a plan view of the system in FIG. 2A.

[0011] FIG. 2D is a perspective view of a section of the system in FIG. 2A.

[0012] FIG. 2E is a side view of the system in FIG. 2A in original configuration.

[0013] FIG. 2F-2I are perspective views of the system in FIG. 2A at various stages of operation.

[0014] FIG. 3A and 3B are respective views of the system in assembled configuration and exploded configuration, respectively, according to the embodiment.

[0015] FIG. 3C is a bottom view of the system in FIG. 3A.

[0016] FIG. 4A and 4B are respective views of the system in assembled configuration and exploded configuration, respectively, according to the embodiment.

[0017] FIG. 5A and 5B are respective views of the system in assembled configuration and exploded configuration, respectively, according to the embodiment.

[0018] FIG. 6A and 6B are perspective views of the system in a first configuration from a first corner and a second corner, respectively, according to an embodiment.

[0019] FIG. 6C is a perspective view of the system in FIG. 6A in the second configuration.

[0020] FIG. 6D is a perspective view of the system in FIG. 6A in the third configuration.

[0021] FIG. 7 is a perspective view of the system in the first configuration according to the embodiment.

[0022] FIG. 8A is a perspective view of an adapter according to an embodiment.

[0023] FIG. 8B is a cross-sectional view of the system including the adapter of FIG. 8A in the first configuration according to the embodiment.

[0024] FIG. 8C is a close-up view of the first section of the system in FIG. 8B.

[0025] FIG. 8D is a close-up view of the second portion of the system in FIG. 8B.

[0026] FIG. 8E is a cross-sectional view of the system in FIG. 8B in the second configuration.

[0027] FIG. 9 is a flowchart of a method according to an embodiment.

[0028] FIG. 10A is an exploded perspective view of a system according to an embodiment.

[0029] FIG. 10B is a distal end view of the system adapter of FIG. 10A.

[0030] FIG. 10C-10E are side views of the system in FIG. 10A at various stages of assembly.

[0031] FIG. 10F is a side sectional view of the system in FIG. 10A in assembled configuration.

[0032] FIG. 10G is a perspective view of the system in FIG. 10A in assembled configuration.

[0033] FIG. 10H is a side view of the system in FIG. 10A in the second configuration.

[0034] FIG. 10I is a side view of the system in FIG. 10A during the transition from the second configuration in FIG. 10H to the third configuration.

Detailed description of the invention

[0035] In some embodiments, the system includes a container assembly, a fluid access assembly, and an adapter. The container assembly includes a cap and defines a reservoir. The container node has a first end and a second end, and a cap is placed on the first end of the container node. The fluid access assembly includes a housing defining an interior space, a fluid access component, a fluid connection component, and an engagement piece. The housing has a first end and a second end, a fluid access component extending from the first end of the housing into the interior of the housing. The fluid access component defines the lumen. The fluid connection component is placed at the first end of the housing and is configured to attach to the patient access device such that the lumen of the fluid access component can be in fluid communication with the patient's vasculature through the fluid connection component and the patient access device . The engaging part of the fluid access assembly is located at the second end of the housing. The adapter includes a first engaging part and a second engaging part. The first adapter engagement is configured to releasably engage with the cap of the container assembly, and the second adapter engagement is configured to releasably engage with the fluid access assembly engagement, so that, in the first configuration, in which the first adapter engagement is engaged with cap, and the second engaging part of the adapter engages with the engaging part of the fluid access assembly, the cap of the container assembly is at least partially located in the interior of the housing and is spaced from the fluid access component.

[0036] In some embodiments, the method includes providing the system in an initial configuration. The system includes a container assembly including a cap and a defining reservoir. The container node has a first end and a second end, the cap is placed on the first end of the container node. The system also includes a fluid access assembly including a housing defining an interior space, a fluid access component, a fluid connection component, and an engagement piece. The housing has a first end and a second end, and the fluid access component extends from the first end of the housing into the interior of the housing. The fluid access component defines the lumen. The fluid connection component is placed at the first end of the housing and is configured to attach to the patient access device such that the lumen of the fluid access component can be in fluid communication with the patient's vasculature through the fluid connection component and the patient access device . The engaging part of the fluid access assembly is located at the second end of the body. The system also includes an adapter including a first engaging part and a second engaging part. The first adapter engagement may be releasably engaged with the cap of the container assembly, and the second adapter engagement may be releasably engaged with the fluid access assembly engagement in the initial configuration such that the cap of the container assembly is at least partially located in the interior housing space and is spaced apart from the fluid access component. The container assembly is movable toward the first end of the fluid access assembly and relative to the adapter such that the cap disengages from the first engagement portion of the adapter and the fluid access component pierces the resealable membrane of the cap such that the reservoir of the container assembly is in communication. fluid with a fluid connection component through the lumen of the fluid access component. The second engagement of the adapter can be detached from the engagement of the fluid access assembly. The container assembly can translate from the first end of the fluid access node and out of the interior of the fluid access node such that the container assembly and adapter are separated from the fluid access node.

[0037] In some embodiments, the system includes a fluid access node and a container node. The fluid access assembly includes a housing defining an interior space, a fluid access component, a fluid connection component, and an engagement piece. The housing has a first end and a second end. The fluid access component extends from the first end of the housing into the interior of the housing. The fluid access component defines the lumen. The fluid connection component is placed at the first end of the housing and is configured to attach to the patient access device such that the lumen of the fluid access component can be in fluid communication with the patient's vasculature through the fluid connection component and the patient access device . The engaging part of the fluid access assembly is located at the second end of the body. The container assembly includes a cap and an engaging piece. The container assembly defines a reservoir and has a first end and a second end. The cap is located at the first end of the container assembly. The container assembly engagement is configured to releasably engage with the fluid access assembly engagement so that, in a first configuration in which the adapter engagement engages with the fluid access assembly engagement, the cap is at least partially received in the interior of the housing and is spaced apart from the fluid access component.

[0038] In some embodiments, the method includes providing the system in an initial configuration. The system includes a fluid access node and a container node. The fluid access assembly includes a housing defining an interior space, a fluid access component, a fluid connection component, and an engagement piece. The housing has a first end and a second end, a fluid access component extending from the first end of the housing into the interior of the housing. The fluid access component defines the lumen. The fluid connection component is placed at the first end of the housing and is configured to attach to the patient access device such that the lumen of the fluid access component can be in fluid communication with the patient's vasculature through the fluid connection component and the patient access device . The engaging part of the fluid access assembly is located at the second end of the body. The container assembly includes a cap and an engaging piece. The container assembly defines a reservoir and has a first end and a second end. The cap is located at the first end of the container assembly. The container assembly engagement is configured to releasably engage with the fluid access assembly engagement so that, in the initial configuration in which the adapter engagement engages with the fluid access assembly engagement, the cap is at least partially received in the interior of the housing and is spaced apart from the fluid access component. The container assembly can be translated toward the first end of the fluid access assembly such that the container assembly engagement is disengaged from the fluid access assembly engagement and the fluid access component pierces the cap reusable membrane so that the reservoir of the container assembly is located in fluid communication with the fluid connection component through the lumen of the fluid access component. The container assembly can be translated from the first end of the fluid access node and out of the interior of the fluid access node so that the container assembly is separated from the fluid access node.

[0039] FIG. 1 is a schematic illustration of system 100. As shown in FIG. 1, system 100 includes a container assembly 110, a fluid access assembly 120, and an adapter 130. The container assembly 110 may include a cap 112 and may define a reservoir 111. The fluid access assembly 120 may include a housing 128 defining the interior, the engagement piece 122, the fluid access component 124, and the fluid connection component 126. The adapter 130 may include a first hook 131 and a second hook 132. The first hook 131 of the adapter 130 may be configured to releasably engage with the cap 112 of the container assembly 110. The second hook 132 of the adapter 130 may be configured to releasably engage with the engagement piece 122. The first engagement piece 131 of the adapter 130 may be or include any suitable engagement mechanism configured to temporarily or releasably hold the cap 112 in place relative to the adapter 130 and release the cap 112 when the cap 112 is moved relative to the first engaging part 131. The movement may include, for example, translational movement, rotational movement and/or helical movement. The second engagement piece 132 of the adapter 130 and the engagement piece 122 of the fluid access assembly 120 may be or include any suitable engagement mechanism configured to temporarily or releasably engage with each other to temporarily hold the adapter 130 in place relative to the assembly. 120 fluid access assembly or a component of fluid access assembly 120 (eg, housing 128) and release adapter 130 from fluid access assembly 120 (eg, through deformation of adapter 130 resulting from removal of cap 112 from adapter 130, and/ or through deformation and/or movement (for example, rotational, helical and/or translational) of the second engaging piece 132 and/or engaging piece 122 relative to the other of the second engaging piece 132 or engaging piece 122, so that the second engaging piece 132 can be separated from hooking part 122).

[0040] The container assembly 110 may have a first end and a second end. Cap 112 may be placed at the first end of the container assembly. The container assembly 110 may include a tube having an open end and a closed end opposite the open end. Cap 112 may be attached to the open end such that cap 112 and tubing define reservoir 111. Cap 112 may include a resealable membrane. The resealable membrane may be configured such that a fluid access component, such as fluid access component 124, may pierce the resealable membrane to achieve fluid communication with reservoir 111. The cap 112 resealable membrane may be configured to be resealed after fluid access component 124 is detached from cap 112 such that reservoir 111 is fluid-sealed from an area external to container assembly 110. Cap 112 may include ribs and/or one or more flanges placed on outer surface of cap 112. Reservoir 111 may be an evacuated reservoir such that after reservoir 111 is placed in fluid communication with a source of fluid (e.g., by piercing the resealable membrane of cap 112 with a fluid access component connected via fluid with the patient's vasculature), fluid (eg, blood) may be withdrawn into reservoir 111 due to the pressure differential between reservoir 111 and the fluid source. In some embodiments, container assembly 110 may be an evacuated tube. In some embodiments, container assembly 110 may be any suitable standard vacuum tube such as, for example, BD Vacutainer® and/or Greiner Bio-one® VACUETTE®. Cap 112 may be formed from rubber, for example. The tube may be formed, for example, from plastic.

[0041] The fluid access assembly 120 may have a first end and a second end. The fluid access component 124 may be placed within the interior of the housing 128 and may extend from the first end of the housing 128 into the interior of the housing 128. For example, in some embodiments, the fluid access component 124 may have a first end and a second end opposite the first end. The first end of the fluid access component 124 may be attached to the first end of the housing 128, and the second end may be placed within the interior of the housing 128. In some embodiments, the fluid access component 124 may include a lumen defining needle. In some embodiments, the fluid access assembly 120 may include a flexible sheath configured to translate relative to the needle such that the second end of the needle may be exposed.

[0042] The fluid connection component 126 may be placed on and/or attached to the first end of the housing 128. For example, the housing 128 may define an outlet fluidly connected to the lumen of the fluid access component 124 to which the fluid connection component 126. In some embodiments, fluid connection component 126 may include any suitable component configured to attach housing 128 to a patient access tube (e.g., patient access device) such that the lumen of fluid access component 124 is in fluid communication with, for example, the patient's vascular system. For example, in some embodiments, the fluid connection component 126 may be a Luer connector. In some embodiments, the fluid connection component 126 may be the outlet of the housing 128 that defines the clearance. In some embodiments, fluid connection component 126 may be integrally formed with housing 128. In some embodiments, fluid connection component 126 and fluid access component 124 may be integrally formed. For example, the fluid connection component 126 and the fluid access component 124 may be formed as a double ended needle. In some embodiments, the fluid connection component 126 may include a needle such that the fluid connection component 126 can be directly attached to the patient's vascular system. In some embodiments, the second end of housing 128 may define a fluid path and/or intermediate reservoir between fluid connection component 126 and fluid access component 124 such that fluid connection component 126 and fluid access component 124 are in fluid communication.

[0043] The engagement piece 122 of the fluid access assembly 120 may include a flange extending perpendicularly from the central axis of the housing 128. In some embodiments, the flange may be extended such that the flange extends further from the central axis of the housing 128 in a first direction compared to with the second direction. For example, the flange may form an elongated surface of the fluid access assembly 120 placed in a plane containing the second end of the housing 128.

[0044] In some embodiments, the fluid access node 120 may be any suitable standard holder, such as, for example, Greiner Bio-one® VACUETTE® Blood Culture Holder, JELCO® Saf-T Holder® sold by Smiths Medical, and/or BD Vacutainer® Holder. In some embodiments, fluid access node 120 may be configured to attach to and/or otherwise engage an indwelling peripheral intravenous (PIV) catheter. For example, in some embodiments, the fluid access assembly 120 may include and/or be connected to any fluid transfer device or portion of the fluid transfer device shown and/or described in U.S. Patent No. 10,076,272 entitled "Systems and Methods for Phlebotomy Through A Peripheral IV Catheter" filed August 26, 2014, and/or US Patent Publication No. 2017/0216564 (referred to herein as '564 Publication) entitled "Devices and Methods for Fluid Transfer Through a Placed Intravenous Catheter" registered on February 2, 2016, the descriptions of each of which are referenced in this document in their entirety. For example, in some embodiments, body 128 and fluid access component 124 of fluid access assembly 120 may be the same or similar in structure and/or function to the container housing and needle of the '564 publication.

[0045] The first engagement piece 131 of the adapter 130 may be any suitable piece configured to releasably engage with the cap 112 of the container assembly 110. In some embodiments, the first engagement piece 131 of the adapter 130 may be the inner surface of the adapter 130 that defines the through hole. The inner surface of adapter 130 may have a diameter small enough relative to the outer diameter of cap 112 such that the inner surface and cap 112 can be engaged in a friction fit. In some embodiments, the first engagement piece 131 may include a piece corresponding to the piece on cap 112 such that adapter 130 and cap 112 can be releasably engaged.

[0046] The second engagement piece 132 of the adapter 130 may be any engagement piece configured to releasably engage with the engagement piece 122 of the fluid access assembly 120. For example, the second engaging piece 132 may include two oppositely placed protrusions. A latch may be placed at the end of each lug. Each latch may be shaped and sized to receive a flange portion of the engagement piece 122 of the fluid access assembly 120 . In some embodiments, the adapter 130 may be pivotable with respect to the fluid access assembly 120 such that the second engagement member 132 (e.g., latches) can be turned out of engagement with the engagement member 122 of the fluid access assembly 120 (e.g., flange). In some embodiments, the second hook 132 may include a plurality of tabs (eg, two), each tab having a first end connected to the base of the adapter 130 via a flexible connection and a latch located at the opposite end of the tab. In some embodiments, each of the tabs may be bent and may form an outer diameter portion of the adapter 130. Such an adapter may be detached from the engagement portion 122 of the fluid access assembly 120, such as through rotation and/or deformation (such as bending). In some embodiments, the second engagement piece 132 may include a plurality of protrusions including latches configured to snap over the flange of the engagement member 122. For example, the second engagement members 132 may include two or three snap tabs. To separate such an adapter 130 from the housing 128, the user may disengage each latch tab by pulling the latch away from the flange of the engagement piece 122 so that the lug disengages from the flange of the engagement piece 122.

[0047] In some embodiments, fluid access assembly 120 may include a container size adapter such that container assemblies 110 of various sizes and shapes can be used (e.g., housed and stabilized) with fluid access assembly 120. In some embodiments, adapter 130 may be configured (eg, shaped and sized) to engage with container size adapter engagement in similar ways as described above with respect to engagement 122 of fluid access assembly 120. In some embodiments, the adapter 130 may be configured (e.g., shaped and sized) to receive a container size adapter portion into the second engagement piece 132 of the adapter 130 when the second engagement piece 132 of the adapter 130 engages with the engagement piece 122 of the fluid access assembly 120 .

[0048] The system 100 has a first configuration (eg, the original configuration) in which the first engagement piece 131 of the adapter 130 engages with the cap 112 and the second engagement member 132 engages with the engagement member 122 of the fluid access assembly 120. When the first engaging piece 131 of the adapter 130 engages with the cap 112 and the second engaging piece 132 engages with the engaging piece 122 of the fluid access assembly 120, the cap 112 may be spaced apart from the fluid access component 124 so that the reservoir 111 is insulated along fluid from the outside to container assembly 110. In a first configuration, cap 112 may be at least partially housed in adapter 130 and/or body 128. For example, the first end of cap 112 may be housed within body 128 from adapter 130 or inside adapter 130). In some embodiments, the first end of the cap 112 may be placed and held in the adapter 130, but close to the body 128 in the first configuration. In some embodiments, the system 100 may be sterilized in a first configuration and packaged for sterile transport to a user (eg, a healthcare professional).

[0049] The system 100 has a second configuration in which the lumen of the fluid access component 124 is in fluid communication with the reservoir 111. To transition the system 100 from the first configuration to the second configuration, the container assembly 110 can translate towards the first end of the assembly 120 so that the cap 112 engages with the fluid access component 124 (e.g., the fluid access component 124 pierces the cap 112) and the portion of the fluid access component 124 is placed within the reservoir 111. For example, in embodiments , in which the container assembly 110 is engaged with the first engagement piece 131 by a friction fit, a force may be applied to the container assembly 110 to overcome the force applied by the first engagement member 131 on the container assembly 110 (e.g., the lid 112) and translate the container assembly 110 into engagement with the fluid access component 124. In a second configuration, when fluid connection component 126 is fluidly connected to the patient's vascular system, fluid (eg, blood) can be drawn through fluid connection component 126, through fluid access component 124, and into reservoir 111 container node 110.

[0050] When enough blood has been drawn into reservoir 111, system 100 may transition from a second configuration to a third configuration in which container assembly 110 and adapter 130 are separated from fluid access assembly 120. For example, container assembly 110 may be translated relative to fluid access assembly 120 such that cap 112 is positioned proximate the second end of housing 128. In response to disengaging cap 112 from fluid access component 124, reservoir 111 may be fluidly isolated from environment external to the container assembly 110 (for example, due to the fact that the cap 112 has a resealable membrane). The adapter 130 may then be disconnected from the fluid access assembly 120 by detaching the second engagement piece 132 from the engagement piece 122, such as by rotating, snapping, or deforming (e.g., bending) one or more portions of the second engagement piece 132 from the engagement piece 122 of the assembly. 120 fluid access. Adapter 130 and container assembly 110 may then optionally be discarded.

[0051] After the adapter 130 and container assembly 110 are removed from the fluid access assembly 120, the second container assembly may be inserted into the interior of the housing and engaged with the fluid access component 124 such that the second container assembly may withdraw fluid (e.g., blood) into the reservoir of the second container assembly through the fluid connection component 126 and the fluid access component 124 . In some embodiments, the second container assembly may include a medium (eg, casein-soy culture medium) in a reservoir of the second container configured for use to perform a blood culture when combined with a patient's blood sample in the reservoir. Any suitable number of container assemblies may be engaged with the fluid access component 124 to withdraw fluid from the patient for various tests.

[0052] FIG. 2A and 2B are perspective views of system 200 in an assembled and exploded configuration, respectively. System 200 may be the same or similar in structure and/or function to any of the systems herein, such as, for example, system 100 described above with respect to FIG. 1. As shown in FIG. 2A, system 200 includes container assembly 210, fluid access assembly 220, and adapter 230. As shown in FIG. 2B, container assembly 210 may include a cap 212 and tube 214. Tube 214 may have a first end connected to cap 212 and a second closed end 216. Cap 212 and tube 214 may define reservoir 211. Fluid access assembly 220 may include a housing 228 defining an interior 221, an engagement piece 222, a fluid access component 224, and a fluid connection component 226. The adapter 230 may include a first hook 231 and a second hook 232. The first hook 231 of the adapter 230 may be configured to releasably engage with the cap 212 of the container assembly 210. The second hook 232 of the adapter 230 may be configured to releasably engage with the engaging piece 222.

[0053] Cap 212 may include a resealable membrane such that a fluid access component, such as fluid access component 224, may pierce the resealable membrane to achieve fluid communication with reservoir 211. Resealable cap membrane 212 may be configured to reseal upon detachment of fluid access component 224 from cap 212 such that reservoir 211 is fluid-sealed from an area external to container assembly 210. Additionally, reservoir 211 may be an evacuated reservoir, so that when reservoir 211 is in fluid communication with a source of fluid (e.g., through piercing the resealable membrane of cap 212 with a fluid access component (e.g., fluid access component 224) fluidly connected to the vascular system patient), fluid may be drawn into reservoir 211 due to the pressure differential between reservoir 211 and the fluid source. As shown in FIG. 2B, cap 212 may include a plurality of ribs 218 and an annular flange 219 located on the outer surface of cap 212.

[0054] The fluid access assembly 220 may have a first end 223 and a second end 225. The fluid access component 224 may be placed within the interior space 221 of the housing 228 and extendable from the first end 223 of the housing 228 into the interior space 221 of 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, a first end of the fluid access component 224 connected to the first end of the housing 228, and a second end of the fluid access component 224, placed in the interior space 221 of the housing 228. The fluid access component 224 may include a needle that defines the lumen.

[0055] The fluid connection component 226 may be placed on and/or attached to the first end 223 of the housing 228. For example, the housing 228 may define an outlet fluidly connected to the lumen of the fluid access component 224, which may be a fluid connection component 226 is attached. The fluid connection component 226 may include any suitable component configured to attach the housing 228 to the patient access tube such that the lumen of the fluid access component 224 is in fluid communication with, for example, the patient's vasculature. For example, in some embodiments, the fluid connection component 226 may be a Luer connector.

[0056] The engagement piece 222 of the fluid access assembly 220 may include a flange extending perpendicularly from the central axis of the body 228. The engagement piece 222 may form a proximal surface of the fluid access assembly 220 and may be placed in a plane containing the second end of the body 228. As shown in FIG. 2C, which is a plan view of the system 200, the engagement piece 222 may extend further from the central axis of the body 228 in a first direction as compared to a second direction. For example, as shown in FIG. 2C, in one direction, the engagement piece 222 may have a length D1. In a second direction perpendicular to the first direction, the engagement piece 222 may have a length D2. The length D1 may be greater than the length D2.

[0057] The first engagement piece 231 of the adapter 230 may be configured to releasably engage with the cap 212 of the container assembly 210. The first engagement piece 231 of the adapter 230 may include an inner surface of the adapter 230, the inner surface defining a through hole. The central axis of the through hole may be configured to be coaxial with the central axis of the housing 228 of the fluid access assembly 220 . As shown in FIG. 2D, which is a perspective view of adapter 230 and a portion of container assembly 210, the inner surface of adapter 230 may have a diameter sufficiently small relative to the outer diameter of annular flange 219 of cap 212 such that the inner surface and cap 212 can be engaged by a friction fit. In some embodiments, the inner surface of the adapter 230 may have a diameter small enough relative to the outer diameter of the ribs 218 of the cap 212 such that the inner surface and the ribs 218 of the cap 212 can be engaged in a friction fit.

[0058] The second engagement piece 232 of the adapter 230 may be configured to releasably engage with the engagement piece 222 of the fluid access assembly 220 . For example, the second engagement piece 232 may include two oppositely placed protrusions 233. A latch 234 may be placed at the end of each protrusion 233. As shown, for example, in FIG. 2E, which is a side view of the system 200 in the first configuration, each latch 234 may be shaped and sized to receive a flange portion of the engagement piece 222 of the fluid access assembly 220.

[0059] To disengage adapter 230 from fluid access assembly 220, adapter 230 may be rotatable relative to fluid access assembly 220 such that a second engaging member 232 (e.g., latches) can be disengaged from engagement member 222 ( for example, flanges) node 220 access to the fluid. For example, as shown in FIG. 2C, the engagement members 232 of the adapter 230 may be sized to engage with a portion of the engagement member 222 having a length D1 in the first configuration. The adapter 230 can be rotated so that the hooks 232 can disengage from the length D1 portion of the hook 222 and instead align with the length D2 portion of the hook 222. Since the length D2 is shorter than the distance between the latches 232, the latches 232 will not engage with the engagement piece 222 after rotation, and the adapter 230 can then be separated from the container assembly 210.

[0060] FIG. 2F-2I are perspective views of the system 200 at various stages of use. As shown in FIG. 2F, the system 200 has a first configuration (eg, the original configuration) in which the first engagement piece 231 of the adapter 230 engages with the cap 212 and the second engagement member 232 engages with the engagement member 222 of the fluid access assembly 220. When the first engagement piece 231 of the adapter 230 engages with the cap 212 and the second engagement piece 232 engages with the engagement piece 222 of the fluid access assembly 220, the cap 212 may be spaced apart from the fluid access component 224 so that the reservoir 211 is insulated along fluid from the outside to container assembly 210. In a first configuration, cap 212 may be at least partially housed within adapter 230 and body 228. be placed within interior space 221 of housing 228. In some embodiments, system 200 may be sterilized in a first configuration and packaged for sterile transport to a user (eg, healthcare professional).

[0061] As shown in FIG. 2G, the system 200 may be transferred to a second configuration in which the lumen of the fluid access component 224 is in fluid communication with the reservoir 211. To transfer the system 200 from the first configuration to the second configuration, the container assembly 210 may be translated in the direction of arrow A toward the first end 223 of the fluid access assembly 220 such that the cap 212 engages with the fluid access component 224 (e.g., the fluid access component 224 pierces the cap 212) and the portion of the fluid access component 224 is placed inside the reservoir 211. In a second configuration, when fluid connection component 226 is fluidly attached to the patient's vascular system, fluid (eg, blood) can be drawn through fluid connection component 226, through fluid access component 224, and into a reservoir. 211 of container assembly 210 (for example, due to a pressure differential between reservoir 211 of container assembly 210 and the patient's vasculature).

[0062] As shown in FIG. 2H, when sufficient blood has been drawn into the reservoir 211, the system 200 can be transferred from the second configuration to a third configuration in which the second engagement piece 232 of the adapter 230 is disengaged from the engagement piece 222 of the fluid access assembly 220. In some embodiment, the volume of blood drawn into reservoir 211 is sufficient to capture any bacteria or fungus from the fluid path that may be drawn through fluid access assembly 220 during initial blood draw (e.g., due to a biofilm formed in the patient). For example, the volume of blood drawn may be between 0.1 and 10 ml. In some embodiments, the volume of blood drawn may be between 0.1 and 1 ml. In some embodiments, the volume of blood drawn may be between 1 and 10 ml. The adapter 230 can be rotated in the direction of arrow B relative to the fluid access assembly 220 so that the second engagement piece 232 of the adapter 230 disengages from the engagement piece 222.

[0063] As shown in FIG. 2I, after the second engagement piece 232 of the adapter 230 is disengaged from the engagement piece 222 of the fluid access assembly 220, the container assembly 210 and the adapter 230 may be separated from the fluid access assembly 220. The container assembly 210 can be translated in the direction of arrow C relative to the fluid access assembly 220 so that the cap 212 is disengaged from the fluid access component 224 so that the reservoir 211 is once again fluidly insulated from the environment external to the container assembly. 210, and adapter 230 and container assembly 210 can be detached from fluid access assembly 220. Adapter 230 and container assembly 210 can then be discarded. In some embodiments, the container assembly 210 can translate a distance in the direction of arrow C before the adapter 230 rotates in the direction of arrow B and disengages from the engagement piece 222.

[0064] In some embodiments, the adapter may define a gap between each protrusion and the latch. For example, FIG. 5A and 5B are an assembled perspective view and an exploded view of the assembly for system 500, respectively. System 500 may be the same or similar in structure and/or function to any of the systems described herein, such as, for example, system 200. For example, container assembly 510 may be the same or similar in structure and/or functions in relation to the container node 210 and will not be further described in this document. The fluid access node 520 may be the same or similar in structure and/or function to the fluid access node 210 and will not be further described here. Adapter 530 may be similar in structure and/or function to adapter 230 described above. For example, the adapter 530 may include a second engagement piece 532 including two oppositely spaced and oppositely extendable protrusions 535. Each protrusion 535 may be attached to the latch 534 via a flexible hinge 539A. The adapter 530 may define a gap 539 between each latch 534 and the lug 535. Thus, instead of pivoting the entire adapter 530 relative to the engagement portion 522 of the fluid access assembly 520, the latch 534 may be rotated relative to the latch 535 via a flexible hinge 539A such that the adapter 530 may be separated from the node 520 access to the fluid. For example, each latch 534 can rotate about an axis through a flexible hinge 539A that is placed parallel to the central axis of the adapter 530 and/or can rotate about a plane in which the proximal surface of the protrusions 535 is located so that the adapter 530 can translate away from the assembly 520 fluid access (eg, by a user pulling the adapter 530 relative to the fluid access node 520).

[0065] FIG. 3A and 3B are an exploded perspective view and an exploded exploded view of the system 300, respectively. System 300 may be the same or similar in structure and/or function to any of the systems herein, such as, for example, system 100 described above with respect to FIG. 1 and/or system 200. As shown in FIG. 3A, system 300 includes container assembly 310, fluid access assembly 320, and adapter 330. As shown in FIG. 3B, container assembly 310 may include a cap 312 and tube 314. Tube 314 may have a first end connected to cap 312 and a second closed end 316. Cap 312 and tube 314 may define reservoir 311. Fluid access assembly 320 may include a housing 328 defining interior space 321, an engagement piece 322, a fluid access component 324, and a fluid connection component 326. The adapter 330 may include a first hook 331 and a second hook 332. The first hook 331 of the adapter 330 may be configured to releasably engage with the cap 312 of the container assembly 310. The second hook 332 of the adapter 330 may be configured to releasably engage with the engaging piece 322.

[0066] Cap 312 may include a resealable membrane such that a fluid access component, such as fluid access component 324, can pierce the resealable membrane to achieve fluid communication with reservoir 311. Resealable cap membrane 312 may be configured to reseal upon detachment of fluid access component 324 from cap 312 such that reservoir 311 is fluid sealed from an area external to container assembly 310. Additionally, reservoir 311 may be an evacuated reservoir, so that when the reservoir 311 is in fluid communication with a source of fluid (for example, through piercing the resealable membrane of the cap 312 with a fluid access component fluidly connected to the patient's vasculature), fluid can be withdrawn into the reservoir 311 due to the pressure difference between the reservoir 311 and the fluid source. As shown in FIG. 3B, cap 312 may include ribs 318 and an outwardly projecting annular flange 319 placed on the outer surface of cap 312. Cap 312 may be formed from rubber, for example. Tube 314 may be formed from plastic, for example.

[0067] The fluid access assembly 320 may have a first end 323 and a second end 325. The fluid access component 324 may be placed in the interior 321 of the housing 328 and may extend from the first end 323 of the housing 328 into the interior 321 of the housing 328. For example, in some embodiments, the fluid access component 324 may have a first end and a second end opposite the first end, a first end of the fluid access component 324 connected to the first end of the housing 328, and a second end of the fluid access component 324, located in the interior 321 of the housing 328. The fluid access component 324 may include a needle that defines the lumen.

[0068] The fluid connection component 326 may be attached to the first end 323 of the housing 328. For example, the fluid connection component 326 may be attached to the housing 328 and may define an outlet fluidly connected to the lumen of the fluid access component 324. environment. The fluid connection component 326 may include any suitable component configured to connect the housing 328 to the patient access tube such that the lumen of the fluid access component 324 is in fluid communication with, for example, the patient's vasculature. In some embodiments, fluid connection component 326 may be integrally formed with housing 328.

[0069] The engagement piece 322 of the fluid access assembly 320 may include a flange extending perpendicularly from the central axis of the housing 328. The engagement member 322 may form an elongated surface of the fluid access assembly 320 placed in a plane containing the second end of the housing 328. As shown in FIG. 3B, engagement piece 322 may include portions (i.e., flange extensions 327A) that extend further from the central axis of housing 328 compared to other portions (i.e., flange portions 327B) of engagement member 322 extending from the central axis of the housing 328. The flange extensions 327A may be opposed and may each have a curved outer edge. The flange portions 327B may be opposed and may each have a straight outer edge. Flange extensions 327A may be separated from each other by flange sections 327B. In some embodiments, the fluid access node 320 may be any suitable standard holder, such as, for example, a Greiner Bio-one® VACUETTE® Blood Culture Holder.

[0070] The first engagement piece 331 of the adapter 330 may be configured to releasably engage with the cap 312 of the container assembly 310. The first engagement piece 331 of the adapter 330 may include an inner surface of the adapter 330, the inner surface defining a through hole. The central axis of the through hole may be configured to be coaxial with the central axis of the housing 328 of the fluid access assembly 320 . As shown in FIG. 3C, which is a bottom view of the system 300, the inner surface of the adapter 330 may have a diameter sufficiently small relative to the outer diameter of the outwardly projecting annular flange 319 of the cap 312 such that the inner surface and the cap 312 can be engaged by a friction fit. In some embodiments, the inner surface of the adapter 330 may have a diameter small enough relative to the outer diameter of the ribs 318 of the cap 312 such that the inner surface and the ribs 318 of the cap 312 can be engaged in a friction fit.

[0071] The second engagement piece 332 of the adapter 330 may be configured to releasably engage with the engagement piece 322 of the fluid access assembly 320 . For example, the second engaging piece 332 may include two curved tabs 335. Each curved tab 335 has a first end attached to the base 338 of the adapter 330 via a flexible connection 337. The second end of each curved tab 335 includes a latch 334, as can be seen in fig. 3A and 3B. As can be seen in FIG. 3C, adapter 330 may have a common outer circular profile, and each of the curved tabs 335 and base 338 may define slot 339. In some embodiments, latches 334 may be configured to receive flange extensions 327A and may be separated from flange extensions 327A by means of rotation of the adapter 330 relative to the engagement piece 322 until the latches 334 disengage from the flange extensions 327A, and then the adapter 330 can be pulled proximately away from the first end 323 of the body 328. In some embodiments, the latch 334 can be configured to receive flange portions 327B, and adapter 330 can be separated from engagement piece 322 by rotating container assembly 310 relative to body 328 sufficiently such that curved tabs 335 disengage from flange portions 327B by bending out of engagement by bending flexible joint 337. For example, each latch 334 can rotate about an axis through flexible connection 337 that is placed parallel to the center axis of adapter 330 and/or can rotate about a plane in which the proximal surface of base 338 is placed so that adapter 330 can translate away from fluid access assembly 320 (eg, by a user pulling adapter 330 relative to fluid access node 320). Adapter 330 may then be separated from container assembly 310.

[0072] While adapter 330 is shown and described as including two curved tabs 335, in some embodiments, adapter 330 may include any suitable number of tabs having any suitable shape. For example, adapter 330 may include three or four tabs, each tab having a first end connected to a base similar to base 338 via a flexible connection similar to connection 337, and a second end including a latch similar to latch 334. In some embodiments, tabs 335 and base 338 may be configured such that tabs 335 are straight and extend from base 338 in a substantially straight line.

[0073] FIG. 4A and 4B are an exploded perspective view and an exploded exploded view of system 400, respectively. System 400 may be the same or similar in structure and/or function to any of the systems herein, such as, for example, system 100 described above with respect to FIG. 1 and/or system 200. As shown in FIG. 4A, system 400 includes a container assembly 410, a fluid access assembly 420, and an adapter 430. System 400 may also include a container size adapter 440. As shown in FIG. 4B, container assembly 410 may include a cap 412 and tube 414. Tube 414 may have a first end connected to cap 412 and a second closed end 416. Cap and tube 414 may define reservoir 411. Fluid access assembly 420 may include including a housing 428 defining an internal space 421, an engagement piece 422, a fluid access component 424, and a fluid connection component 426. Housing 428 may have a stepped outer profile such that housing 428 includes a first inner diameter portion 428A and a second inner diameter portion 428B. The first inner diameter portion 428A may define a first portion 421A of the inner space 421, and the second inner diameter portion 428B may define a second portion 421B of the inner space 421. The adapter 430 may include a first engaging piece 431 and a second engaging piece 432. The first engaging piece 431 of the adapter 430 may be configured to releasably engage with the cap 412 of the container assembly 410. The second engagement piece 432 of the adapter 430 may be configured to releasably engage with the engagement member 422 of the fluid access assembly 420.

[0074] The container size adapter 440 may include a first outer diameter portion 442A, a second outer diameter portion 442B, and a base 444. The first outer diameter portion 442A may have a smaller outer diameter than the second outer diameter portion 442A. The first outer diameter portion 442A may be shaped and sized to be received into the second portion 421A of the interior space 421. The second outer diameter portion 442B may be shaped and sized to be received into the second portion 421B of the interior space 421. The first outer diameter portion 442A , the second outside diameter portion 442B, and the base 444 may collectively define a through hole through which the container assembly can translate into engagement with the fluid access component 424. The base 444 can extend radially with respect to the central axis of the body 428 beyond the outer diameter of the second outer diameter section 442B. Base 444 may have a circular outer edge. Container size adapter 440 may be attached to fluid access assembly 420 as shown in FIG. 4A so that the through hole of the container size adapter 440 can support a smaller container assembly 410 having a cylindrical shape.

[0075] Cap 412 may include a resealable membrane such that a fluid access component, such as fluid access component 424, can pierce the resealable membrane to achieve fluid communication with reservoir 411. Resealable cap membrane 412 may be configured to reseal upon detachment of fluid access component 424 from cap 412 such that reservoir 411 is fluid-sealed from an area external to container assembly 410. Additionally, reservoir 411 may be an evacuated reservoir, so that when the reservoir 411 is in fluid communication with a source of fluid (for example, through piercing the resealable membrane of the cap 412 with a fluid access component fluidly connected to the patient's vasculature), fluid can be withdrawn into the reservoir 411 due to the pressure difference between the reservoir 411 and the fluid source. As shown in FIG. 4B, cap 412 may include ribs 418 and an outwardly extending annular flange 419 placed on the outer surface of cap 412. Cap 412 may be formed from rubber, for example. Tube 414 may be formed from plastic, for example.

[0076] The fluid access assembly 420 may have a first end 423 and a second end 425. The fluid access component 424 may be placed in the interior 421 of the housing 428 and may extend from the first end 423 of the housing 428 into the interior 421 of the housing 428. For example, in some embodiments, the fluid access component 424 may have a first end and a second end opposite the first end, a first end of the fluid access component 424 connected to the first end of the housing 428, and a second end of the fluid access component 424, placed in the interior space 421 of the housing 428. The fluid access component 424 may include a needle that defines the lumen.

[0077] The fluid connection component 426 may be attached to the first end 423 of the housing 428. For example, the fluid connection component 426 may be attached to the housing 428 and may define an outlet fluidly connected to the lumen of the fluid access component 424 environment. The fluid connection component 426 may include any suitable component configured to attach the housing 428 to the patient access tube such that the lumen of the fluid access component 424 is in fluid communication with, for example, the patient's vasculature. In some embodiments, the fluid connection component 426 may be a Luer lock.

[0078] The engaging piece 422 of the fluid access assembly 420 may include a flange extending perpendicularly from the central axis of the housing 428. The engaging member 422 may form the surface of the fluid access assembly 420 and may be placed in a plane containing the second end of the housing 428 As shown in FIG. 4B, engagement piece 422 may include portions (i.e., flange extensions 427A) that extend further from the central axis of body 428 compared to other portions (i.e., flange portions 427B) of engagement member 422 extending from the central axis of the housing 428. The flange extensions 427A may be opposed and may each have a curved outer edge. The flange extensions 427B may be oppositely placed and may each have a straight outer edge. Flange extensions 427A may be separated from each other by flange sections 427B. In some embodiments, fluid access assembly 420 may be any suitable standard holder, and container size adapter 440 may be any suitable container size adapter, such as, for example, the JELCO® Saf-T Holder® device sold by Smiths Medical.

[0079] The first engagement piece 431 of the adapter 430 may be configured to releasably engage with the cap 412 of the container assembly 410. The first engagement piece 431 of the adapter 430 may include an inner surface of the adapter 430, the inner surface defining a through hole. The central axis of the through hole may be configured to be coaxial with the central axis of the housing 428 of the fluid access assembly 420 . The inner surface of adapter 430 may have a diameter small enough relative to the outer diameter of the outwardly protruding annular flange 419 of cap 412 such that the inner surface and cap 412 can be engaged by a friction fit. In some embodiments, the inner surface of the adapter 430 may have a diameter small enough relative to the outer diameter of the ribs 418 of the cap 412 such that the inner surface and the ribs 418 of the cap 412 can be engaged in a friction fit.

[0080] The second engagement piece 432 of the adapter 430 may be configured to releasably engage with the engagement piece 422 of the fluid access assembly 420 . For example, the second engagement piece 432 may include three tabs or protrusions 435 extending transversely from the central axis of the housing 428. Each tab 435 has a first end attached to the base 438 of the adapter 430. The second end of each curved tab 435 includes a latch 434, as can be seen in FIG. 4A and 4B. The latches 434 may be configured to receive the outer edge of the base 444 of the container size adapter 440 and the flange extensions 427A and/or flange portions 427B, and may be separated from the flange extensions 427A and/or flange portion 427B by extending the lug 434A transversely outward relative to the central axis. housing so that latch 434 disengages the outer edge of base 444 and flange extension 427A and/or flange portions 427B. Adapter 430 may then be separated from fluid access assembly 420 and container assembly 410.

[0081] Although not shown, in some embodiments, instead of separating the adapter from the fluid access assembly through rotation, snapping, or deformation (e.g., bending), the adapter can be broken so that the adapter and container assembly can be removed. For example, the adapter may include perforations such that the adapter may be configured to break in some places to separate.

[0082] In some embodiments, the adapter may include a plurality of protrusions that are configured to deform (e.g., bend) and/or break so that the adapter can translate (e.g., with the container assembly) relative to the fluid access assembly. For example, FIG. 6A and 6B are a near side perspective view and a far side perspective view of the system 600, respectively. System 600 may be similar in structure and/or function to any of the systems described herein, such as, for example, system 100 and/or system 200. For example, system 600 includes container node 610, access node 620 to the fluid and an adapter 630. Container assembly 610 may be the same or similar in structure and/or function to container assembly 110 and/or container assembly 210. For example, container assembly 610 may include tube 614 and cap 612. Tube 614 and cap 612 may collectively define reservoir 611. Fluid access assembly 620 may be the same or similar in structure and/or function to fluid access assembly 110 and/or fluid access assembly 210. For example, the fluid access assembly 620 may include a housing 628 defining an internal space and having a first end 623 and a second end 625. The fluid access assembly 620 may also include a fluid access component 624, a connection component 626 fluid and engaging piece 622.

[0083] Adapter 630 may be similar to any of the adapters described herein, such as adapter 130 and/or adapter 230 described above. For example, adapter 630 may include a first engagement piece or portion including an inner surface of adapter 630 and defining an opening configured to receive cap 612 of container assembly 610. The inner surface of adapter 630 may have a diameter sufficiently small relative to the outer diameter of cap 612 (eg, the annular flange of the cap 612 and/or the ribs of the cap 612) so that the inner surface of the adapter 630 and the outer surface of the cap 612 can be engaged by a friction fit. The adapter 630 may have a first end 631 and a second end 633 opposite the first end 631. The adapter 630 may include an inwardly protruding flange 637 placed adjacent or adjacent to the first end 631 of the adapter 630. The inwardly protruding flange 637 may be configured to protect the container assembly 610 from being translated in the direction of arrow D (e.g., towards the first end 623 of body 628) relative to adapter 630 due to engagement between cap 612 and inwardly protruding flange 637.

[0084] As shown in FIG. 6A and 6B, the adapter 630 may include a second engagement member including a plurality of protrusions 632 configured to extend transversely from the central axis of the adapter 630 (eg, outward) in the first configuration. Although four lugs 632 are shown, adapter 630 may include any suitable number of lugs (eg, one, two, three, five, or more). In some embodiments, in a first configuration, the protrusions 632 may be configured to engage with the engagement piece 622 (e.g., proximal flange) of the fluid access assembly 620 and to hold the adapter 630 in place relative to the fluid access component 624 such that the first the end 631 of the adapter 630 is spaced from the fluid access component 624 of the fluid access assembly 620 . In some embodiments, in a first configuration, the projections 632 are configured to engage with the engagement piece 622 of the fluid access assembly 620 (e.g., a proximal flange) and support the adapter 630 such that the reservoir 611 of the container assembly 610 is fluidly isolated from the component 624 access to fluid. The protrusions 632 can be configured to deform (e.g., bend or bend) and/or break so that when a force above a threshold force is applied to the adapter 630 in the direction of arrow D (e.g., by pushing the adapter 630 towards the first end 623 of the housing 628), the protrusions 632 can bend or break so that the adapter 630 and cap 612 can translate towards the fluid access component 624. In some embodiments, the projections 632 may include any suitable feature (eg, a perforation or prefracture) such that the projections 632 bend or break in a predictable manner.

[0085] System 600 may have a first configuration (eg, initial configuration) in which the first engagement of adapter 630 engages with cap 612 and projections 632 engage with engagement of 622 of fluid access assembly 620. When the first engagement portion of adapter 630 engages cap 612 and the second engagement portion 632 engages engagement portion 622 of fluid access assembly 620, cap 612 may be spaced apart from fluid access component 624 such that reservoir 611 is fluidly insulated. environment for container assembly 610. In a first configuration, cap 612 may be at least partially housed in adapter 630 and/or housing 628.

[0086] As shown in FIG. 6C, which is a perspective view of the system 600 in the second configuration, the system 600 may have a second configuration in which the lumen of the fluid access component 624 is in fluid communication with the reservoir 611. To transition the system 600 from the first configuration to the second configuration, the container the assembly 610 can translate towards the first end 623 of the body 628 of the fluid access assembly 620 such that the cap 612 exerts force on the adapter 630 such that the projections 632 bend or break. Cap 612 may then further translate into engagement with fluid access component 624 (eg, fluid access component 624 pierces cap 612 and a portion of fluid access component 624 is placed in reservoir 611). Although FIG. 6C shows the protrusions 632 as protruding outward from the adapter 630 in the second configuration, the protrusions 632 may be bent proximately or detached from the remainder of the adapter 630 in the second configuration. In a second configuration, when fluid connection component 626 is in fluid communication with the patient's vascular system, fluid (eg, blood) can be drawn through fluid connection component 626, through fluid access component 624, and into reservoir 611 container node 610.

[0087] When enough blood has been drawn into reservoir 611, system 600 may transition from a second configuration to a third configuration in which container assembly 610 and adapter 630 are separated from fluid access assembly 620. For example, the container assembly 610 may be translated relative to the fluid access assembly 620 so that the cap 612 is positioned proximate the second end 625 of the body 628. from the environment external to the container assembly 610 (for example, due to the fact that the cap 612 has a resealable membrane). The adapter 630 may then be detached from the fluid access assembly 620 by further translation of the container assembly 610 away from the first end 623 of the housing 628 as shown in FIG. 6d. Adapter 630 and container assembly 610 may then optionally be discarded.

[0088] After the adapter 630 and container assembly 610 are removed from the fluid access assembly 620, the second container assembly may be inserted into the interior of the housing 628 and engaged with the fluid access component 624 such that the second container assembly can withdraw fluid (e.g., , blood) into the reservoir of the second container assembly through the fluid connection component 626 and the fluid access component 624 . In some embodiments, the second container assembly may include a medium (eg, casein-soy culture medium) in a reservoir of the second container configured for use to perform a blood culture when combined with a patient's blood sample in the reservoir. Any suitable number of container assemblies may be engaged with the fluid access component 624 to withdraw fluid from the patient for various tests.

[0089] In some embodiments, the system does not include an adapter, but instead, the container assembly may include one or more engaging parts configured to engage directly with the engaging part of the fluid access assembly. For example, FIG. 7 is a perspective view of system 700. System 700 may be similar in structure and/or function to any of the systems described herein, such as, for example, system 100 and/or system 200. For example, system 700 includes container node 710 and node 720 access to the fluid. Container assembly 710 may be the same or similar in structure and/or function to container assembly 710 and/or container assembly 710. For example, container assembly 710 may include tube 714 and cap 712. Tube 714 and cap 712 may collectively define reservoir 711. Fluid access assembly 720 may be the same or similar in structure and/or function to fluid access assembly 110 and/or fluid access assembly 210. For example, the fluid access assembly 720 may include a housing 728 defining an internal space and having a first end 723 and a second end 725. The fluid access assembly 720 may also include a fluid access component 724, a connection component 726 fluid and engaging piece 722 (for example, the proximal flange).

[0090] The fluid access assembly 720 may include a plurality of projections 732. The projections 732 may be the same or similar in structure and/or function to the projections 632 described above with reference to system 600. For example, projections 732 may extend transversely from the central axis of the cap 712 (for example, outward) in the first configuration. Although four projections 732 are shown, cap 712 may include any suitable number of projections (eg, one, two, three, five, or more). In some embodiments, in a first configuration, the protrusions 732 may be configured to engage with the engagement piece 722 (e.g., proximal flange) of the fluid access assembly 720 and to hold the cap 712 in place relative to the fluid access component 724 such that the cap 712 is spaced from the fluid access component 724 of the fluid access assembly 720 (ie, such that the fluid access component 724 does not touch the cap 712). In some embodiments, in a first configuration, the projections 732 are configured to engage with the engagement portion 722 of the fluid access assembly 720 (e.g., a proximal flange) and support the cap 712 such that the reservoir 711 of the container assembly 710 is fluidly isolated from the component 724 access to the fluid. The protrusion 732 may be configured to deform (e.g., bend or bend) and/or break such that when a force above a threshold force is applied to the cap 712 in a direction extending from the second end 725 to the first end 723 of the body 728 (e.g., by pushing the cap 712 toward the first end 723 of the body 728), the projections 732 may bend or break due to a force on the container assembly 710 towards the first end 723 of the body 728 greater than the force of the engaging member 722 on the projections 732 (which may be a force holding the housing 728 stationary) so that the cap 712 can translate towards the fluid access component 724. In some embodiments, the projections 732 may include any suitable feature (eg, a perforation or prefracture) such that the projections 732 bend or break predictably.

[0091] The system 700 may have a first configuration (eg, initial configuration) in which the protrusions 732 engage with the engagement piece 722 of the fluid access assembly 720. When the protrusions 732 engage with the engagement piece 722 of the fluid access assembly 720, the cap 712 may be spaced from the fluid access component 724 such that the cap 712 is not in contact with the fluid access component 724 and the reservoir 711 is insulated. in fluid from the outside of container assembly 710. In a first configuration, cap 712 may be at least partially housed within housing 728.

[0092] The system 700 may have a second configuration in which the lumen of the fluid access component 724 is in fluid communication with the reservoir 711. To transition the system 700 from the first configuration to the second configuration, the container assembly 710 may be translated towards the first end 723 of the housing 728 of the fluid access assembly 720 such that the projections 732 bend or break relative to the cap 712. For example, the projections 732 may be bent such that the projections 732 extend from the cap 712 a shorter distance than the projections 732 are pulled when system 700 is in the first configuration. The projections 732 may be configured to translate with the cap 712 in the housing 728 when bent or curved. Cap 712 may then further translate into engagement with fluid access component 724 (eg, fluid access component 724 pierces cap 712 and a portion of fluid access component 724 is placed in reservoir 711). In a second configuration, when fluid connection component 726 is in fluid communication with the patient's vascular system, fluid (eg, blood) can be drawn through fluid connection component 726, through fluid access component 724, and into reservoir 711 container node 710.

[0093] When enough blood has been drawn into reservoir 711, system 700 may transition from a second configuration to a third configuration in which container assembly 710 and adapter 730 are separated from fluid access assembly 720. For example, the container assembly 710 may be translated relative to the fluid access assembly 720 so that the cap 712 is positioned proximate the second end 725 of the housing 728. from the environment external to the container assembly 710 (for example, due to the fact that the cap 712 has a resealable membrane). Cap 712 may then be detached from fluid access assembly 720 by further translation of container assembly 710 away from first end 723 of housing 728. Adapter 730 and container assembly 710 may then optionally be discarded.

[0094] Upon removal of the container assembly 710 from the fluid access assembly 720, the second container assembly may be inserted into the interior of the housing 728 and engaged with the fluid access component 724 so that the second container assembly may withdraw fluid (e.g., blood) into the reservoir of the second container assembly through the fluid connection component 726 and the fluid access component 724 . In some embodiments, the second container assembly may include a medium (eg, casein-soy culture medium) in a second container reservoir configured for use to perform blood cultures when combined with a patient's blood sample in the reservoir. Any suitable number of container assemblies may be engaged with the fluid access component 724 to withdraw fluid from the patient for various tests.

[0095] In some embodiments, the system may include an adapter including flexible wings configured to engage with the cap of the container assembly. For example, FIG. 8A-8E are various views of the components of system 800. In particular, FIGS. 8A is a perspective view of adapter 830 of system 800. Adapter 830 may include a proximal flange 852 (i.e., the first engagement piece) and a plurality of flexible winglets 854. Each flexible winglet 854 may include a distal end wall 856 and an inner wall 858. The inner walls 858 of each flexible flap 854 may be configured to form at least a portion of the opening 853. Each flexible flap 854 may be separated from an adjacent flexible flap 854 by a slot 851. The adapter 830 may include any suitable number of flexible flaps. 854.

[0096] As shown in FIG. 8B, the system may also include a container assembly 810, a fluid access assembly 820, and an adapter 830. The system 800 may be similar in structure and/or function to any of the systems described herein, such as, for example, system 100 and/or system 200. For example, container assembly 810 may be the same or similar in structure and/or function to container assembly 110 and/or container assembly 210. Container assembly 810 may include tube 814 and cap 812 Tube 814 and cap 812 may collectively define reservoir 811. Fluid access assembly 820 may be the same or similar in structure and/or function to fluid access assembly 110 and/or fluid access assembly 210. For example, the fluid access assembly 820 may include a housing 828 defining an interior space and having a first end 823 and a second end 825. The fluid access assembly 820 may also include a fluid access component 824, a connection component 826 fluid and engaging piece 822 (for example, the proximal flange).

[0097] Adapter 830 may be similar to any of the adapters described herein, such as adapter 130 and/or adapter 230 described above. For example, the proximal flange 852 may engage with the engagement piece 822 of the fluid access assembly 820 so that the adapter 830 is prevented from being translated toward the first end 823 of the fluid access assembly 820. The inner wall 858 of each flexible winglet 854 of the adapter 830 is configured to engage and retain the cap 812 of the container assembly 810. For example, the inner wall 858 of each flexible winglet 854 may define a groove 855 such that the grooves 855 of each flexible winglet 854 substantially form a circular groove. . A cap flange 812, such as an annular flange 819, may be configured to be received by the grooves 855 of the flexible wings 854. the winglet 854 is pushed into engagement with the inner surface of the housing 828. Thus, the container assembly 810 and adapter 830 can be secured relative to the fluid access assembly 820. Engagement between flange 830 and first engagement portion 822 and between flexible wings 854 and cap 812 may prevent container assembly 810 from being translated toward first end 823 of body 828. Although system 800 is shown and described as having cap 812 including an annular flange 819 and flexible wings 854 having grooves 855, in some embodiments, cap 812 and inner surfaces 858 of flexible wings 854 may be appropriately tapered so that cap 812 can be held by flexible wings 854.

[0098] The system 800 may have a first configuration (eg, an initial configuration) in which the proximal flange 852 of the adapter 830 engages with the first engaging portion 822 (as shown in FIG. 8C, which is a close-up of the first portion in FIG. 8B), and the cap 812 engages with the flexible flaps 854 (as shown in Fig. 8D, which is a close-up of the second portion in Fig. 8B). In a first configuration, cap 812 may be spaced apart from fluid access component 824 such that reservoir 811 is fluidly isolated from the outside of container assembly 810. In a first configuration, cap 812 may be at least partially housed in adapter 830. and/or housing 828.

[0099] The system 800 may have a second configuration in which the lumen of the fluid access component 824 is in fluid communication with the reservoir 811. To transition the system 800 from the first configuration to the second configuration, the container assembly 810 may be translated towards the first end 823 of the housing 828 of the fluid access assembly 820 so that the cap 812 applies force to the adapter 830 so that the flexible tabs 832 bend and the cap 812 is translated behind the adapter 830 towards the first end 823 of the housing 828. The cap 812 can then further translate move into engagement with the fluid access component 824 (eg, the fluid access component 824 pierces the cap 812 and the portion of the fluid access component 824 is placed in the reservoir 811). In a second configuration, when fluid connection component 826 is fluidly connected to the patient's vascular system, fluid (eg, blood) can be drawn through fluid connection component 826, through fluid access component 824, and into reservoir 811 container node 810. As shown in FIG. 8E, when the cap 812 is engaged with the fluid access component 824, the tube 814 can be freely placed in the hole 853 (ie, because the outer diameter of the tube 814 is smaller than the diameter of the hole 853 defined by the flexible wings 854).

[00100] When enough blood has been drawn into reservoir 811, system 800 may transition from a second configuration to a third configuration in which container assembly 810 and adapter 830 are separated from fluid access assembly 820. For example, container assembly 810 may be translated relative to fluid access assembly 820 such that cap 812 is positioned proximate second end 825 of housing 828. In response to disengagement of cap 812 from fluid access component 824, reservoir 811 may be fluid-sealed from the environment external to the container assembly 810 (for example, due to the fact that the cap 812 has a resealable membrane). The adapter 830 may then be detached from the fluid access assembly 820 by further translation of the container assembly 810 away from the first end 823 of the housing 828 as shown in FIG. 8D. Adapter 830 and container assembly 810 may then optionally be discarded.

[00101] After the adapter 830 and container assembly 810 are removed from the fluid access assembly 820, the second container assembly may be inserted into the interior of the housing 828 and engaged with the fluid access component 824 such that the second container assembly can withdraw fluid (e.g. , blood) into the reservoir of the second container assembly through the fluid connection component 826 and the fluid access component 824. In some embodiments, the second container assembly may include a medium (eg, casein-soy culture medium) in a second container reservoir configured for use to perform blood cultures when combined with a patient's blood sample in the reservoir. Any suitable number of container assemblies may be engaged with the fluid access component 824 to withdraw fluid from the patient for various tests.

[00102] FIG. 9 is a flow diagram illustrating method 900. Method 900 may be performed using any suitable system or device, such as any of the systems or devices described herein. For example, method 900 may be a method of using a system including, in an initial configuration, a container assembly having a cap and defining a reservoir, the container assembly having a first end and a second end, the cap being placed at the first end of the container assembly. The system may also include a fluid access assembly including a housing defining an interior space, a fluid access component, a fluid connection component, and an engagement piece. The housing may have a first end and a second end, and the fluid access component may extend from the first end of the housing into the interior of the housing. The fluid access component may define a lumen. The fluid connection component may be located at the first end of the housing and may be configured to attach to the patient access device such that the lumen of the fluid access component can be in fluid communication with the patient's vasculature through the fluid connection component and the device. access to the patient. The patient access device may include, for example, a needle and a tube. In some embodiments, the fluid access assembly engagement piece may be placed on and/or attached to the second end of the housing. The system may also include an adapter having a first engaging part and a second engaging part. The first adapter engagement may be releasably engaged with the cap of the container assembly, and the second adapter engagement may be releasably engaged with the fluid access assembly engagement in the initial configuration such that the cap of the container assembly is at least partially located in the interior housing space and is spaced apart from the fluid access component.

[00103] The method 900 also includes translational movement of 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 portion of the adapter and the fluid access component pierces the cap's resealable membrane, so that the container assembly reservoir is in fluid communication with the fluid connection component through the lumen of the fluid access component, at 904. At 906, the second adapter engagement may be detached from the fluid access assembly engagement. In some embodiments, detaching the second engagement of the adapter from the engagement of the fluid access assembly includes at least one of rotating, snapping, and/or bending the adapter relative to the body of the fluid access assembly. The container assembly can translate from the first end of the fluid access node and out of the interior of the fluid access node such that the container assembly and adapter are separated from the fluid access node, at 906.

[00104] In some embodiments, before the system is provided, the system may be sterilized. For example, in some embodiments, the system may be sterilized in its original configuration. In some embodiments, the system may be sterilized prior to assembly to its original configuration, and the system may then be assembled such that sterility is maintained.

[00105] In some embodiments, the container assembly may be discarded after being separated from the fluid access assembly.

[00106] In some embodiments, the container assembly is the first container assembly, and, after the first container assembly is translated from the first end of the fluid access node and out of the interior of the fluid access node, the second container assembly can be translated towards the first end of the fluid access assembly such that the resealable membrane of the second container assembly is pierced by the fluid access component and the reservoir of the second container assembly is in fluid communication with the fluid connection component through the lumen of the fluid access component. In some embodiments, the reservoir of the second container assembly may include media configured to be combined with a blood sample to perform a blood culture.

[00107] In some embodiments, translational movement of the container assembly toward the first end of the fluid access assembly and relative to the adapter such that the fluid access component pierces the cap's resealable membrane causes the reservoir to draw fluid from a fluid source connected at fluid with the fluid connection component, through the fluid access component and into the reservoir of the container assembly due to the fact that the reservoir of the container assembly is evacuated. In some embodiments, the fluid source is the patient's vascular system.

[00108] In some embodiments, the system may include an adapter configured to be rotationally and radially secured relative to the fluid access assembly. For example, FIG. 10A-10I are various views of the components of system 1000. In particular, FIGS. 10A is an exploded perspective view of system 1000. System 1000 includes container assembly 1010, fluid access assembly 1020, and adapter 1030. System 1000 may be similar in structure and/or function to any of the systems described herein. , such as, for example, system 100 and/or system 200. For example, container assembly 1010 may be the same or similar in structure and/or function to container assembly 110 and/or container assembly 210. Container assembly 1010 may include tube 1014 and cap 1012 themselves. Tube 1014 and cap 1012 may collectively define a reservoir.

[00109] The fluid access assembly 1020 may include a first body section 1020A and a second body section 1020B. The first body portion 1020A may define an interior space 1021A configured to receive a second body portion 1020B. The second housing portion 1020B may define an interior space 1021B. The fluid access node 1020 includes a fluid access component 1024 and a fluid connection component 1026 . The second body portion 1020B includes a plurality of engaging parts 1022 protruding from the tubular portion of the second body portion 1020B. Each engagement piece 1022 defines a recess extending from the central axis of the second body portion 1020B. As shown in FIG. 10A, the engaging parts 1022 may each have a stepped outer profile corresponding to a stepped outer surface of the inner surface of the first body portion 1020A so that the second body portion 1020B can be received into the interior 1021A of the first body portion 1020A with the flange 1027 placed at the proximal end. 1025B of a second housing section 1020B located adjacent the proximal end 1025A of the first housing section 1020A (eg, the end opposite the distal end 1023B of the first housing section 1020A including the fluid connection component 1026).

[00110] The adapter 1030 includes a proximal flange 1036 and a plurality of flexible protrusion portions 1031 (ie, collectively forming the first engagement piece). Adapter 1030 also includes a plurality of protruding portions 1032, i.e., second engaging parts). Each protrusion portion 1032 connects to and protrudes from (e.g., extends radially relative to) the protrusion portion 1031 relative to the central axis of the adapter 1030. The flexible protrusion portions 1031 collectively form an opening configured to receive a portion of the container assembly 1010 (e.g., the cap 1012 of the container assembly 1010) . The flexible projection portions 1031 may each include a curved inner surface configured to engage the outer surface of the cap 1012 of the container assembly 1010. As shown in FIG. 10B, which is a distal end view of adapter 1030, each protrusion portion 1031 may be separated from an adjacent flexible protrusion portion 1031 by a slot 1051. Each slot 1051 may be any suitable shape (eg, rectangular or triangular) and may extend from the free end of each portion 1031. protrusion to the interface (for example, hinge area) between section 1031 projection and flange 1036 and/or through the section of the flange 1036 to increase the flexibility section 1031 protrusion relative to other sections 1031 projection. When the adapter 1030 is in a neutral configuration (eg, when the container assembly 1020 is not placed in the hole through the adapter 1030 defined by the protrusion portions 1031), the protrusion portions 1031 may define a smaller diameter opening compared to when the adapter engages with the cap 1012 of the container assembly 1020 Although the second body portion 1020B is shown as having three engagement members 1022 and the adapter 1030 is shown as having three raised portions 1032, in some embodiments, the second body portion 1020B may have any suitable number of engagement members 1022 and the adapter 1030 may have any suitable number protrusions 1032. The adapter 1030 may be formed from any suitable material such as, for example, polypropylene.

[00111] Each protruding portion 1032 may be configured to be received by the engagement portion 1022 of the second body portion 1020B (e.g., when the adapter 1030 is inserted into the interior 1021B of the second body portion 1020B so that the flange 1036 is adjacent to the flange 1027 of the second body portion 1020B) . In some embodiments, when the projections 1032 are received into the recesses of the engagements 1022 and the adapter 1030 is in a neutral configuration, a gap may be defined between the outer edge of the projections 1032 and the inner surface of the engagements 1022 such that the adapter 1030 is slidable relative to the second section 1020B of the housing. When the cap 1012 is received into the opening defined by the protrusion portions 1031, the protrusion portions 1032 may be placed in contact with the inner surface of the engaging parts 1022 so that the adapter 1030 is held in place relative to the second body portion 1020B. In some embodiments, when the adapter 1030 is placed within the interior space 1021B of the second body portion 1020B, the raised portions 1032 may touch the inner surface of the engagement portions 1022 in both a neutral configuration, in which the cap 1012 is not placed in an opening in the adapter 1030, and a configuration in which the cap 1012 is received in the hole in the adapter 1030, but the protruding portions 1032 exert more force on the inner surface of the engagement portions 1022 when the cap 1012 is received in the hole in the adapter 1030 so that the adapter 1030 is held in place relative to the second body portion 1020B.

[00112] In some embodiments, the adapter 1030 may be in a neutral configuration where the cap 212 is not placed in the hole defined by the lip portions 1032 and when the cap 1012 is placed in the hole defined by the lip portions 1032 such that the inner diameter of the hole is the same in both configurations of the container assembly 1010. The engagement members 1022 may define depressions that are shallow enough relative to the central axis of the second body portion 1020B (e.g., the distance between the inner surface of each engagement member 1022 facing the central axis and the central axis is sufficiently small) such that , when the adapter 1030 is engaged with the second body portion 1020B so that the protrusions 1030 are placed in the recesses of the engaging parts 1022, the inner surface of each engaging part 1022 exerts a force on the protruding portion 1032 in the direction of the central axis, so that the protrusion portions 1031 are pushed into a tighter engagement with a cap 1012 so that the cap 1012 is immobilized relative to the adapter 1030 and the node 1020 access to the fluid.

[00113] FIG. 10C-10E are side views of system 1000 at various stages of assembly to assemble system 1000 into a first configuration (eg, the original configuration shown in FIG. 10G, which is a perspective view). The second housing portion 1020B may be inserted into the interior space 1021A of the first housing portion 1020A (as shown in FIG. 10C). As shown in FIG. 10D, the adapter 1030 may then be attached to the container assembly 1010 such that the cap 1012 fits into the opening of the adapter 1030 defined by the protrusion portions 1031. As shown in FIG. 10E and 10F, which are a side view and a side sectional view of the system 1000, respectively, the adapter 1030 and the container assembly 1010 can then be inserted into the interior 1021B of the second body section 1020C so that the flange 1036 of the adapter 1030 is adjacent to the flange 1027 of the second section. 1020B of the body and the protrusions 1032 are placed in the recesses defined by the engaging parts 1022. As shown in FIG. 10F, in such a configuration (e.g., the first or original configuration), the protrusion portions 1032 are in contact with the inner surface of the engaging portions 1022 such that the protrusion portions 1031 exert a holding force on the cap 1012 due to engagement between the inner surface of the engaging portions 1022 and the protruding portions 1032 As shown in FIG. 10E and 10F, in the initial configuration, the cap 1012 is spaced apart from the fluid access component 1024 (e.g., a stem defining a clearance in fluid communication with the fluid connection component 1026) such that the reservoir of the container assembly 1010 is fluidly insulated. environment from the environment of the container node 1010. As shown in FIG. 10E and 10F, cap 1012 may be at least partially (eg, completely) housed in adapter 1030 and/or fluid access assembly 1020.

[00114] As shown in FIG. 10H, the system 1000 may have a second configuration in which the lumen of the fluid access component 1024 is in fluid communication with the reservoir of the container assembly 1010. To transition the system 1000 from the first configuration to the second configuration, the container assembly 1010 may be translated towards to the distal end 1023A of the first body portion 1020A of the fluid access assembly 1020 by applying a translational force to the container assembly 1010 (e.g., to the closed end 1014 of the container assembly) that overcomes the holding force applied by the protrusion portions 1031 on the cap 1012 so that the cap 1012 translationally moves beyond the adapter 1030 towards the first end 1023A of the first housing section 1020A. The cap 1012 may then further translate into engagement with the fluid access component 1024 (eg, the fluid access component 1024 pierces the cap 1012 and a portion of the fluid access component 1024 is placed in the reservoir of the container assembly 1010). In a second configuration, when the fluid connection component 1026 is fluidly connected to the patient's vasculature (eg, after the cap shown in FIG. 10H is removed), fluid (eg, blood) can be drawn through the connection component 1026 fluid, through the fluid access component 1024, and into the reservoir of the container assembly 1010.

[00115] When enough blood has been drawn into the reservoir of the container assembly 1010, the system 1000 may be transferred from the second configuration to a third configuration in which the container assembly 1010 and adapter 1030 are separated from the fluid access assembly 1020. For example, as shown in FIG. 10I, when the cap 1012 engages with the fluid access component 1024, the adapter 1030 can be removed from the interior space 1021B of the second body portion 1020B (for example, due to the fact that the cap 1012 no longer fits in the opening defined by the protrusion portions 1031 and due to the application holding force against the protrusion portions 1031 and protrusion portions 1032 relative to the inner surface of the engaging parts 1022). The component assembly 1010 can translate relative to the fluid access assembly 1020 such that the cap 1012 is positioned adjacent to the flange 1027 of the second body portion 1020B. In response to disengagement of the cap 1012 from the fluid access component 1024, the reservoir of the container assembly 1010 may be fluidly sealed from the environment external to the container assembly 1010 (eg, due to the fact that the cap 1012 has a resealable membrane). The container assembly 1010 can then be further translated away from the first end 1023A of the first body section 1020A and away from the first end 1023B of the second body section 1020B. Adapter 1030 and container assembly 1010 may then optionally be discarded.

[00116] After the adapter 1030 and container assembly 1010 are removed from the fluid access assembly 1020, the second container assembly can be inserted into the interior 1021A of the first body portion 1020A and engaged with the fluid access component 1024 so that the second container assembly can withdraw fluid medium (eg, blood) into the reservoir of the second container assembly through the fluid connection component 1026 and the fluid access component 1024 . In some embodiments, the second container assembly may be or include a blood culture vial. In some embodiments, the second container assembly may include a medium (e.g., casein-soy culture medium) in a reservoir of the second container assembly configured for use to perform a blood culture when combined with a patient's blood sample in the reservoir. Any suitable number of container assemblies may be engaged with the fluid access component 1024 to withdraw fluid from the patient for various tests. Due to the placement of the first container assembly 1020 and adapter 1030 relative to the fluid access assembly 1020 prior to engagement of the second container assembly with the fluid access component 1024 (e.g., in both the original configuration and the second configuration), the fluid access assembly 1020, including the fluid access component 1024 can be accessed in a sterile manner by the second container assembly due to the fact that the interior of the fluid access assembly 1020 including the fluid access component 1024 is kept free of contamination prior to engagement of the second container assembly. node with a component 1024 access to the fluid.

[00117] While various embodiments have been described above, it should be understood that they have been presented by way of example only and not limitation. When the methods described above indicate some events occurring in some order, the ordering of some of the cases may be modified. Additionally, some of the cases may be performed concurrently in a parallel process, when possible, as well as performed sequentially as described above.

[00118] When the diagrams and/or embodiments described above indicate certain components placed in certain orientations or positions, the placement of the components may be changed. While the embodiments have been separately shown and described, it will be appreciated that various changes in form and detail may be made. Any portion of the apparatus and/or methods described herein may be combined in any combination except for mutually exclusive combinations. The embodiments described herein may include various combinations and/or subcombinations of functions, components, and/or features of the various embodiments described.

Claims (28)

1. A system for collecting blood samples, comprising: a container assembly including a cap and defining a reservoir, wherein the container assembly has a first end and a second end, the cap being positioned at a first end of the container assembly; a fluid access assembly including a housing defining an internal space, a fluid access component, a fluid connection component, and an engagement piece, 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, wherein the fluid access component defines the lumen, wherein the fluid connection component is located at the first end of the housing and is configured to be connected to the patient access device so that the lumen of the fluid access component is able to communicate in fluid communication with the patient's vascular system via a fluid connection component and a patient access device; And an adapter including a first engagement part and a second engagement part, wherein the first adapter engagement part is releasably engaged with the cap of the container assembly, and the second adapter engagement part is configured to engage with the fluid access assembly engagement part so that in of the first configuration, in which the first adapter engagement is in engagement with the cap and the second adapter engagement is in engagement with the fluid access assembly engagement, the cap of the container assembly was at least partially located within the interior of the body and spaced from a fluid access component. 2. The system of claim. 1, in which the container assembly is configured to transition from the first configuration to the second configuration by translational movement of the container assembly towards the first end of the fluid access node so that the cap disengages from the first engaging part of the adapter and the fluid access component pierced the resealable membrane of the cap such that the reservoir of the container assembly was in fluid communication with the fluid connection component through the lumen of the fluid access component. 3. The system according to claim 1, in which the tank of the container unit is under vacuum. 4. The system of claim 1, wherein the fluid access assembly engagement includes a flange extending outwardly relative to a central axis of the fluid access assembly housing. 5. The system of claim 1, wherein the container assembly is the first container assembly and further comprises a second container assembly configured to engage with the fluid access component upon removal of the first container assembly by translational movement of the second container assembly towards the first end of the assembly access to the fluid such that the resealable membrane of the second container assembly is pierced by the fluid access component and the reservoir of the second container assembly is in fluid communication with the fluid connection component through the lumen of the fluid access component. 6. The system of claim 1, wherein the reservoir of the second container assembly includes a medium configured to be combined with a blood sample to perform a blood culture. 7. The system of claim. 1, in which the housing of the fluid access node includes a first housing section and a second housing section, and the first housing section defines the interior space, and the second housing section includes an engaging part, while the second housing section made with the possibility of partial placement in the inner space of the first section of the housing. 8. A method of using a system for collecting blood samples, and the system in its original configuration includes: a container assembly including a cap and defining a reservoir, wherein the container assembly has a first end and a second end, with the cap placed at the first end of the container assembly, a fluid access assembly including a housing defining an internal space, a fluid access component, a fluid connection component, and an engaging part, wherein the housing has a first end and a second end, wherein at least a portion of the fluid access component fluid extends from the first end of the housing into the interior of the housing, wherein the fluid access component defines the lumen, wherein the fluid connection component is located at the first end of the housing and is configured to be connected to the patient access device in such a way that the lumen of the access component to the fluid medium is capable of fluid communication with the patient's vascular system through a fluid connection component and a patient access device, wherein the engaging part of the fluid access assembly is located at the second end of the body, and an adapter including a first engagement and a second engagement, wherein the first engagement of the adapter is releasably engaged with the cap of the container assembly, and the second engagement of the adapter is releasably engaged with the engagement of the fluid access assembly in the initial configuration such that the cap of the container assembly is at least partially located within the interior of the body and spaced from the fluid access component, the method comprising: translationally moving the container assembly toward the first end of the fluid access assembly and relative to the adapter so that the cap disengages from the first engaging part of the adapter, and the fluid access component pierces the resealable membrane of the cap so that the reservoir of the container assembly is in communication fluidly with a fluid connection component through the lumen of the fluid access component; disconnecting the second engagement part of the adapter from the engagement part of the fluid access assembly; And translationally moving the container assembly from the first end of the fluid access node and from the interior of the fluid access node so that the container assembly and adapter are separated from the fluid access node. 9. The method of claim 8, further comprising sterilizing the system. 10. The method of claim 8, wherein releasing the second engagement of the adapter from the engagement of the fluid access assembly includes at least one of rotating, snapping, and/or deforming the adapter relative to the body of the fluid access assembly. 11. The method of claim 8, wherein the container node is the first container node, the method further comprising: after the first container assembly is translated from the first end of the fluid access assembly and from the interior of the fluid access assembly, the second container assembly is translated towards the first end of the fluid access assembly so that the resealable membrane of the second container assembly is pierced by the access component to the fluid, and the reservoir of the second container assembly is in fluid communication with the fluid connection component through the lumen of the fluid access component. 12. The method of claim 11, wherein the reservoir of the second container of the assembly includes a medium configured to be combined with a blood sample to perform a blood culture. 13. The method of claim 8, wherein translation of the container assembly toward the first end of the fluid access assembly and relative to the adapter such that the fluid access component pierces the cap's resealable membrane causes the reservoir to withdraw fluid from the fluid source , fluidly connected to the fluid connection component, through the fluid access component, and into the reservoir of the container assembly due to the reservoir of the container assembly being under vacuum. 14. The method of claim 13 wherein the fluid source is the patient's vascular system. 15. System for collecting blood samples, containing: a fluid access assembly including a housing defining an internal space, a fluid access component, a fluid connection component, and an engagement piece, 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, wherein the fluid access component defines the lumen, wherein the fluid connection component is located at the first end of the housing and is configured to be attached to the patient access device, so that the lumen of the fluid access component is able to communicate with the patient's vascular system through the fluid connection component and the patient access device, wherein the engaging part of the fluid access assembly is located at the second end of the housing; And a container assembly including a cap and an engaging piece, wherein the container assembly defines a reservoir, the container assembly having a first end and a second end, the cap being placed at the first end of the container assembly, the container assembly engaging member being releasably engaged with the engaging part of the fluid access assembly, so that in the first configuration, in which the engaging part of the adapter is in engagement with the engaging part of the fluid access assembly, the cap is at least partially located in the interior of the body and spaced from the fluid access component environment, wherein the engaging part of the container assembly includes protrusions extending laterally from the central axis of the container assembly. 16. The system of claim. 15, wherein the container assembly is configured to transition from the first configuration to the second configuration by translational movement of the container assembly towards the first end of the fluid access node, so that the engaging part of the container assembly disengages from the engaging part the fluid access assembly, and the fluid access component pierces the resealable membrane of the cap such that the reservoir of the container assembly is in fluid communication with the fluid connection component through the lumen of the fluid access component.