Universal carrier adapter and method of use

Abstract

Reducing contamination (e.g., touch-point contamination) of body fluid samples and / or equipment used to obtain body fluid samples. The device includes a housing defining an interior volume, a distal coupler configured to be at least temporarily coupled to a distal end portion of the housing and disposed in fluid communication with a source of bodily fluid, a fluid communicator disposed in the interior volume, and a lock coupled to the housing. The lock is transitionable between a first configuration in which the lock couples the distal coupler to the housing such that a portion of the fluid communicator extends through a seal in the distal coupler and places the distal coupler in fluid communication with the proximal end portion of the housing, and a second configuration in which the lock allows removal of the distal coupler. The lock is configured to be transitioned back to the first configuration after removal of the distal coupler to restrict access to the fluid communicator through the distal end portion of the housing.

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority to and benefit of U.S. Provisional Patent Application No. 62 / 986,244, filed March 6, 2020, entitled "Universal Transfer Adapters and Methods of Using the Same," the entire disclosure of which is incorporated herein by reference.

[0002] background FIELD OF THE INVENTION

[0002] Embodiments described herein relate generally to the procurement of bodily fluid samples, and more particularly to fluid transfer adapters configured to reduce sources of touch-point contamination. [Background technology]

[0003]

[0003] Healthcare professionals routinely perform various types of microbiological tests and a wide range of other diagnostic tests on patients using parenterally obtained bodily fluids. As bacterial culture tests and / or other advanced diagnostic techniques evolve and improve, the speed, accuracy (both sensitivity and specificity), and value of the information that can be provided to clinicians continue to improve. Examples of diagnostic techniques that may rely on high-quality (uncontaminated and / or pure) bodily fluid samples may include, but are not limited to, microbial detection (e.g., culture), molecular diagnostics (e.g., molecular polymerase chain reaction (PCR)), gene sequencing (e.g., deoxyribonucleic acid (DNA), ribonucleic acid (RNA), whole blood ("culture-free") specimen analysis and related techniques or next-generation sequencing (NGS)), biomarker identification, magnetic resonance and other magnetic analytical platforms, automated microscopy, spatial clonal isolation, flow cytometry, morphokinetic cell analysis, and / or other common or advanced / evolving techniques used to characterize patient specimens and / or to detect, identify, type, classify, and / or characterize specific organisms, antibiotic susceptibility, etc.

[0004] However, some known tests and / or diagnostic techniques can be susceptible to contamination, which can lead to inaccurate, distorted, faulty, false-positive, false-negative, and / or otherwise unrepresentative results of the patient's actual condition (or in vivo condition). One cause of inaccurate results from such tests is the presence of biological material, which may include cells other than the intended source for obtaining the sample and / or other extraneous contaminants that are inadvertently included in the bodily fluid sample being analyzed. For example, despite disinfecting the skin at the insertion site, tissue debris, hair follicles, sweat glands, and / or other skin appendages and / or microorganisms residing therein ("skin-resident microorganisms") may be dislodged during venipuncture and transferred to and / or otherwise included in the specimen to be analyzed, thereby contaminating the sample and / or distorting the results of one or more tests performed on the sample.

[0005] While some known devices and / or systems may reduce the likelihood of contamination, for example, by diverting and sequestering an initial amount of bodily fluid likely containing contaminants, other potential sources of contamination may remain. For example, some sample acquisition instrumentation, supplies, and / or systems may include multiple user and / or fluid interfaces (e.g., patient-to-needle, needle-to-transfer adapter, transfer adapter-to-sample container, catheter hub-to-syringe, syringe-to-transfer adapter, needle / tubing-to-sample container, and / or any other fluid interface or any combination of one or more thereof), which may introduce additional potential points of contamination (e.g., "touch-point contamination"). Furthermore, some sample acquisition instrumentation, such as transfer adapters, may be designed for use with specific supplies, sample containers, culture bottles, etc., which may reduce standardization and increase the likelihood of improper, inefficient, contaminating, and / or unsafe use. Summary of the Invention [Problem to be solved by the invention]

[0006]

[0006] Accordingly, a need exists for improved devices, systems, and / or methods for reducing contamination (eg, touch point contamination) of bodily fluid samples and / or instrumentation used to obtain bodily fluid samples. [Means for solving the problem]

[0007] overview Described herein are devices and methods for a universal transfer adapter configured to reduce sources of contamination, such as touchpoint contamination. In some embodiments, the device includes a housing, a distal coupler, a fluid communicator, and a lock. The housing has a proximal end portion and a distal end portion and defines an interior volume. The distal coupler is configured to be at least temporarily coupled to the distal end portion of the housing and disposed in fluid communication with a source of bodily fluid. The fluid communicator is disposed in the interior volume of the housing. The lock is coupled to the housing and is transitionable between a first configuration in which the lock couples the distal coupler to the housing such that a portion of the fluid communicator extends through a seal in the distal coupler, disposing the distal coupler in fluid communication with the proximal end portion of the housing, and a second configuration in which the lock allows removal of the distal coupler. The lock is configured to transition from the second configuration back to the first configuration after removal of the distal coupler, restricting access to the fluid communicator through the distal end portion of the housing. [Brief explanation of the drawings]

[0008] BRIEF DESCRIPTION OF THE DRAWINGS [Figure 1A] 1 is a schematic diagram of a transfer adapter in a first configuration, according to an embodiment. [Figure 1B] 8 is a schematic diagram of a transfer adapter in a second configuration, according to an embodiment. [Figure 2]

[0009] FIG. 1 is a perspective view of a transfer adapter coupled to a fluid collection device, according to an embodiment. [Figure 3]

[0010] FIG. 3 is a front view of the transfer adapter and fluid collection device of FIG. 2. [Figure 4]

[0011] FIG. 3 is an exploded view of the front of the transfer adapter and fluid collection device of FIG. 2. [Figure 5]

[0012] 5 is a cross-sectional view of the transfer adapter and fluid collection device of FIG. 1 shown in a first configuration taken along line 5-5. [Figure 6]

[0013] 6 is a cross-sectional view of the transfer adapter and fluid collection device of FIG. 2 shown in a first configuration taken along line 6-6. [Figure 7]

[0014] 1 is a cross-sectional view of a transfer adapter showing various internal features. [Figure 8] 1 is a cross-sectional view of a transfer adapter showing various internal features. [Figure 9]

[0015] 1 is a front view of a transfer adapter coupled to a fluid collection device and transitioned from a first configuration to a second configuration. [Figure 10]

[0016] 10 is a cross-sectional view of the transfer adapter and fluid collection device of FIG. 9, showing the transfer adapter coupler removed from the transfer adapter housing. [Figure 11]

[0017] FIG. 1 is a perspective view of a transfer adapter according to an embodiment. [Figure 12]

[0018] 12 is a cross-sectional view of the carrying adapter of FIG. 11 shown in a first state. [Figure 13] 12 is a cross-sectional view of the carrier adapter of FIG. 11 shown in a second condition. [Figure 14]

[0019] 10A-10C are diagrams of portions of a transfer adapter having various configurations according to different embodiments. [Figure 15] 1A-1C are diagrams of portions of a transfer adapter having various configurations according to different embodiments. [Figure 16] 1A-1C are diagrams of portions of a transfer adapter having various configurations according to different embodiments. [Figure 17]

[0020] 1A-1C are diagrams of a portion of a delivery adapter having one or more features configured to protect a user against accidental and / or unwanted contact with a fluid communication device of the delivery adapter, according to different embodiments. [Figure 18] 1A-1C are diagrams of a portion of a delivery adapter having one or more features configured to protect a user against accidental and / or unwanted contact with a fluid communication device of the delivery adapter, according to different embodiments. [Figure 19] 1A-1C are diagrams of a portion of a delivery adapter having one or more features configured to protect a user against accidental and / or unwanted contact with a fluid communication device of the delivery adapter, according to different embodiments. [Figure 20] 1A-1C are diagrams of a portion of a delivery adapter having one or more features configured to protect a user against accidental and / or unwanted contact with a fluid communication device of the delivery adapter, according to different embodiments. [Figure 21] 1A-1C are diagrams of a portion of a delivery adapter having one or more features configured to protect a user against accidental and / or unwanted contact with a fluid communication device of the delivery adapter, according to different embodiments. [Figure 22] 1A-1C are diagrams of a portion of a delivery adapter having one or more features configured to protect a user against accidental and / or unwanted contact with a fluid communication device of the delivery adapter, according to different embodiments. [Figure 23] 1A-1C are diagrams of a portion of a delivery adapter having one or more features configured to protect a user against accidental and / or unwanted contact with a fluid communication device of the delivery adapter, according to different embodiments. [Figure 24] 1A-1C are diagrams of a portion of a delivery adapter having one or more features configured to protect a user against accidental and / or unwanted contact with a fluid communication device of the delivery adapter, according to different embodiments. [Figure 25]1A-1C are diagrams of a portion of a delivery adapter having one or more features configured to protect a user against accidental and / or unwanted contact with a fluid communication device of the delivery adapter, according to different embodiments. [Figure 26] 1A-1C are diagrams of a portion of a delivery adapter having one or more features configured to protect a user against accidental and / or unwanted contact with a fluid communication device of the delivery adapter, according to different embodiments. [Figure 27] 1A-1C are diagrams of a portion of a delivery adapter having one or more features configured to protect a user against accidental and / or unwanted contact with a fluid communication device of the delivery adapter, according to different embodiments. [Figure 28]

[0021] 1A-1C are diagrams of a portion of a transport adapter having one or more features configured to provide and / or enhance a user interface of the transport adapter, according to different embodiments. [Figure 29] 2A-2C are diagrams of portions of a transport adapter having one or more features configured to provide and / or enhance a user interface of the transport adapter, according to different embodiments. [Figure 30] 2A-2C are diagrams of portions of a transport adapter having one or more features configured to provide and / or enhance a user interface of the transport adapter, according to different embodiments. [Figure 31] 2A-2C are diagrams of portions of a transport adapter having one or more features configured to provide and / or enhance a user interface of the transport adapter, according to different embodiments. [Figure 32] 2A-2C are diagrams of portions of a transport adapter having one or more features configured to provide and / or enhance a user interface of the transport adapter, according to different embodiments. [Figure 33]2A-2C are diagrams of portions of a transport adapter having one or more features configured to provide and / or enhance a user interface of the transport adapter, according to different embodiments. [Figure 34] 2A-2C are diagrams of portions of a transport adapter having one or more features configured to provide and / or enhance a user interface of the transport adapter, according to different embodiments. [Figure 35]

[0022] 10 is a flowchart illustrating a method of using a transport adapter, according to an embodiment. [Figure 36]

[0023] 1 is a cross-sectional view of a portion of a syringe including, for example, an integrated adapter, according to an embodiment. DETAILED DESCRIPTION OF THE INVENTION

[0009] Detailed Description

[0024] For example, described herein are devices and methods for a universal transfer adapter configured to reduce sources of contamination, such as one or more touchpoint contamination. Any of the embodiments and / or methods described herein may be configured to transfer bodily fluids while reducing the number of user and / or fluid interfaces that could be potential sources of contamination. The embodiments and / or methods described herein may also simplify and / or standardize at least a portion of the sample or specimen acquisition process, thereby increasing the efficiency and predictability associated with sample or specimen collection. Furthermore, the embodiments and / or methods described herein may increase user safety by limiting and / or reducing the likelihood of inadvertent "needlesticks" (e.g., unwanted puncture of the skin by a needle) and / or other unwanted contact with bodily fluids or non-sterile (e.g., used) portions of the device.

[0010]

[0025] In some embodiments, the device includes a housing, a distal coupler, a fluid communicator, and a lock. The housing has a proximal end portion and a distal end portion and defines an interior volume. The distal coupler is configured to be at least temporarily coupled to the distal end portion of the housing and disposed in fluid communication with a source of bodily fluid. The fluid communicator is disposed in the interior volume of the housing. The lock is coupled to the housing and is transitionable between a first configuration in which the lock couples the distal coupler to the housing and a portion of the fluid communicator extends through a seal in the distal coupler to place the distal coupler in fluid communication with the proximal end portion of the housing, and a second configuration in which the lock allows removal of the distal coupler. The lock is configured to transition from the second configuration back to the first configuration after removal of the distal coupler to restrict access to the fluid communicator through the distal end portion of the housing.

[0011]

[0026] In some embodiments, the device includes a housing, a fluid communicator, a stage, and a biasing member. The housing has a proximal end portion and a distal end portion and defines an interior volume. The proximal end portion has a proximal coupler. The fluid communicator is disposed in the interior volume of the housing and is fluidly coupled to the proximal coupler. The stage is disposed within the housing and is movable between a first position and a second position. The biasing member is disposed within the housing and contacts a proximal side of the stage. The biasing member is configured to bias the stage to the first position such that the stage substantially blocks access to the fluid communicator through the distal end portion of the housing. The biasing member enables the stage to move to the second position in response to a force applied to the distal side of the stage, such that a portion of the fluid communicator extends through the stage, thereby allowing access to the fluid communicator through the distal end portion of the housing.

[0012]

[0027] In some embodiments, the delivery adapter includes a housing having a proximal end portion and a distal end portion. The proximal coupler is disposed along the proximal end portion of the housing. The delivery adapter further includes a fluid communicator disposed in an interior volume of the housing and fluidly coupled to the proximal coupler. In some implementations, a method of using the delivery adapter includes coupling a fluid collection device to the proximal coupler of the delivery adapter. A lock coupled to the distal end portion of the housing is transitioned from a locked configuration to an unlocked configuration. A stage disposed in the interior volume of the housing is moved from a first position, in which the stage restricts access to the fluid communicator through the distal end portion of the housing, to a second position, in which at least a portion of the fluid communicator extends through the stage. When the stage is in the second position, bodily fluid flow is permitted through the fluid communicator into or out of the fluid collection device coupled to the proximal coupler.

[0013]

[0028] As used in this specification and / or any claims contained herein, the singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise. Thus, for example, the term "element" shall mean a single element or a combination of elements, "material" shall mean one or more materials, etc.

[0014]

[0029] As used herein, "body fluid" may include any fluid obtained directly or indirectly from a patient's body. For example, "body fluid" includes, but is not limited to, blood, cerebrospinal fluid, urine, bile, lymph, saliva, synovial fluid, serous fluid, pleural fluid, amniotic fluid, mucus, sputum, vitreous humor, air, and the like, or any combination thereof.

[0015]

[0030] As used herein, the terms "proximal" and "distal" refer to directions closer to and away from a user who places the device in contact with a patient, respectively. Thus, for example, the end of the device that first touches the patient's body is the distal end of the device, while the opposite end of the device (e.g., the end of the device that is manipulated by the user) is the proximal end of the device.

[0016]

[0031] As used herein, the terms "about," "approximately," and / or "substantially," when used in connection with one or more stated values ​​and / or one or more geometric structures or relationships, are intended to mean that the value or characteristic so defined encompasses the nominally stated value or described characteristic. In some cases, the terms "about," "approximately," and / or "substantially" may generally mean and / or generally consider the stated value or characteristic within a desired tolerance (e.g., ±10% of the stated value or characteristic). For example, a value of about 0.01 may include 0.009 and 0.011, a value of about 0.5 may include 0.45 and 0.55, a value of about 10 may include 9-11, and a value of about 1000 may include 900-1100. Similarly, a first surface may be described as substantially parallel to a second surface when the surfaces are nominally parallel. While the stated values, structures, and / or relationships may be desirable, it is to be understood that some variations may occur, for example, as a result of manufacturing tolerances or other practical considerations (e.g., pressures or forces exerted by device portions, conduits, lumens, etc.). Accordingly, the terms "about," "approximately," and / or "substantially" may be used herein to account for such tolerances and / or considerations.

[0017]

[0032] The embodiments described herein can be configured to transfer bodily fluids substantially free of contaminants to one or more fluid collection devices. As used herein, a "fluid collection device" can include, but is not limited to, any suitable vessel, container, reservoir, bottle, adapter, dish, vial, syringe, instrument, needle, lumen-defining device (e.g., sterile flexible tubing), diagnostic and / or testing machine, etc. In some embodiments, the fluid collection device can be substantially similar to or the same as known sample containers, such as, for example, Vacutainer® (manufactured by Becton Dickinson and Company (BD)), BacT / ALERT® SN, or BacT / ALERT® FA (manufactured by Biomerieux, Inc.), and / or any suitable reservoir, vial, microvial, microliter vial, nanoliter vial, container, microcontainer, nanocontainer, etc.

[0018]

[0033] In some embodiments, a fluid collection device, such as, for example, a sample vessel, container, bottle, etc., may be empty prior to receiving a sample volume of bodily fluid. For example, in some embodiments, the fluid collection device or reservoir may provide and / or be configured to provide or generate a vacuum or suction, such as, for example, a vacuum-based collection tube (e.g., a Vacutainer®), a syringe, etc. In other embodiments, the fluid collection device may contain any suitable additive, medium, substance, enzyme, oil, fluid, etc. For example, the fluid collection device may be, for example, a sample or culture bottle containing aerobic or anaerobic medium. The sample or culture bottle may receive a bodily fluid sample, which may then be tested (e.g., after incubation and by in vitro diagnostic (IVD) testing, and / or any other suitable test) for the presence of, for example, gram-positive bacteria, gram-negative bacteria, yeast, fungi, and / or any other organisms. If such testing of the medium yields a positive result, the medium is subsequently tested using a PCR-based system to identify the specific organism. In some embodiments, the sample container may contain, for example, any suitable additives in addition to or in place of the medium. Such additives may include, for example, heparin, citrate, ethylenediaminetetraacetic acid (EDTA), oxalate, sodium polyanethol sulfonate (SPS), etc. In some embodiments, the fluid collection device may contain any suitable additives or medium and may be evacuated and / or otherwise devoid.

[0019]

[0034] Generally, the term "media" may be used to describe a substance configured to react with organisms in a bodily fluid (e.g., microorganisms such as bacteria), while the term "additive" may be used to describe a substance configured to react with portions of a bodily fluid (e.g., constituent cells of blood, serum, synovial fluid, etc.). However, it should be understood that a sample container may contain any suitable substance, liquid, solid, powder, lyophilized compound, gas, etc. Furthermore, when referring to an "additive" in a sample container, it should be understood that the additive may be or include a culture medium, e.g., aerobic and / or anaerobic medium contained in a culture bottle, an additive, and / or any other suitable substance or combination of substances contained in a culture bottle and / or any other suitable reservoir such as those described above. That is, the embodiments described herein may be used with any suitable fluid reservoir containing any suitable substance or combination of substances, etc.

[0020]

[0035] The embodiments and / or portions thereof described herein may be formed or constructed of one or more biocompatible materials. In some embodiments, biocompatible materials may be selected based on one or more properties of the constituent materials, such as, for example, stiffness, toughness, durometer, bioreactivity, etc. Examples of suitable biocompatible materials include metals, glasses, ceramics, elastomers, thermoplastics, polymers, etc. Examples of suitable metals include pharmaceutical-grade stainless steel, gold, titanium, nickel, iron, platinum, tin, chromium, copper, and / or alloys thereof. Polymeric materials may be biodegradable or non-biodegradable. Examples of suitable biodegradable polymers include polylactides, polyglycolides, polylactide-co-glycolides (PLGA), polyanhydrides, polyorthoesters, polyetheresters, polycaprolactones, polyesteramides, poly(butyric acid), poly(valeric acid), polyurethanes, and / or blends and copolymers thereof. Examples of non-biodegradable polymers include nylon, polyester, polycarbonate, polyacrylate, polysiloxane (silicone), polymers of ethylene-vinyl acetate and other acyl-substituted cellulose acetates, non-degradable polyurethanes, polystyrene, polyvinyl chloride, polyvinyl fluoride, poly(vinylimidazole), chlorosulfonated polyolefins, polyethylene, polyethylene oxide, polytetrafluoroethylene (PTFE), polyether ether ketone (PEEK), and / or blends and copolymers thereof.

[0021]

[0036] The embodiments and / or portions thereof described herein may include components formed from one or more parts, features, structures, etc. When referring to such components, it should be understood that the component may be formed by a single piece having any number of sections, regions, portions, and / or properties, or may be formed by multiple parts or features. For example, when referring to a structure such as a wall or chamber, the structure may be considered to be a single structure comprising multiple parts, or multiple separate substructures joined to form the structure, etc. Thus, a monolithically constructed structure may include, for example, a set of substructures. Such a set of substructures may include multiple parts that are either contiguous or discontinuous with one another. A set of substructures may also be fabricated from multiple items or components that are produced separately and later joined (e.g., by welding, adhesive, or any suitable method).

[0022]

[0037] The embodiments herein, and / or various features or advantageous details thereof, will be more fully described with reference to the non-limiting embodiments shown in the accompanying drawings and detailed in the following description. Descriptions of well-known components and processing techniques are omitted so as not to unnecessarily obscure the embodiments herein. The examples used herein are intended to facilitate an understanding of how the embodiments herein may be practiced and to enable those skilled in the art to further practice the embodiments herein. While some of the embodiments are described herein as being used to obtain bodily fluids for one or more culture sample tests, it should be understood that the embodiments are not limited to such use. Any of the embodiments and / or methods described herein may be used to transfer a flow of bodily fluid to any suitable device disposed in fluid communication therewith. Thus, although specific examples are described herein, the devices, methods, and / or concepts are not limited to such specific examples.

[0023]

[0038] 1A and 1B illustrate a transfer device 100 according to one embodiment. The transfer device 100 (also referred to herein as a "transfer adapter," "adapter," and / or "device") may be of any suitable shape, size, and / or configuration. In some implementations, the transfer adapter 100 is configured to transfer bodily fluids while reducing the number of user and / or fluid interfaces that could potentially be sources of contamination. More specifically, in some implementations, the transfer adapter 100 may be coupled to a fluid collection device (or any other suitable device) and used to transfer bodily fluids from a source (e.g., a bodily fluid source such as a patient's vein) to the fluid collection device. Additionally, the transfer adapter 100 may be used to transfer at least a portion of the bodily fluid from the fluid collection device to a second collection device or container (e.g., a sample bottle, culture bottle, etc.).

[0024]

[0039] As shown, the delivery adapter 100 includes a housing 110, a fluid communicator 130, a lock 150, and a stage 140. The housing 110 may be of any suitable shape, size, and / or configuration. In some embodiments, as described in further detail herein, the size and / or shape of the housing 110 may be based, at least in part, on the size and / or shape of one or more devices configured to be used in conjunction with the delivery adapter 100. The housing 110 includes a proximal end portion 111 and a distal end portion 112 and defines an interior volume. The proximal end portion 111 of the housing 110 is substantially open and is sized and configured to receive and / or be configured to be physically and / or fluidly coupled, directly or indirectly, to one or more devices, such as, for example, a fixed or removable coupler, a fluid collection device, a fluid transfer device, a needle, etc. For example, the proximal end portion 111 of the housing 110 may be coupled to and / or include a proximal coupler, which in turn may be at least temporarily coupled to a fluid collection device. For example, the proximal coupler may be physically and fluidly coupled to the syringe connector or coupler by a threaded coupling, a luer coupling, and / or any other suitable connection. In other embodiments, the proximal coupler may be fixedly coupled or connected to the syringe connector (e.g., integrally or monolithically formed, pre-assembled, etc.) and / or to any other suitable device.

[0025]

[0040] Proximal end portion 111 of housing 110 (or its proximal coupler) may be in fluid communication with fluid communicator 130 disposed within the interior volume of housing 110. As such, when proximal end portion 111 of housing 110 (or its proximal coupler) is coupled to a syringe, operation of the syringe may create a negative pressure differential and / or suction force operable to draw fluid (e.g., bodily fluid) through delivery adapter 100 (e.g., via fluid communicator 130) and into the syringe, or a positive pressure differential and / or force operable to expel fluid (e.g., bodily fluid) from the syringe and out through delivery adapter 100 (e.g., via fluid communicator 130).

[0026]

[0041] In some implementations, the proximal end portion 111 of the housing 110 (or its proximal coupler) can be coupled, directly or indirectly, to a bodily fluid source. For example, in some implementations, the proximal end portion 111 of the housing 110 can include a proximal coupler, such as a luer lock, that can be coupled to a corresponding coupler on a needle, a lumen-containing device, or the like, or a combination thereof. In such implementations, the proximal coupler can receive a flow of bodily fluid from the bodily fluid source, which can in turn be transferred through the delivery adapter 100 and via the fluid communicator 130. In some implementations, the proximal coupler (or proximal end portion 111 of the housing 110) may be configured with a fluid diversion mechanism, such as those described in U.S. Pat. No. 8,197,420, filed December 13, 2007 ("Systems and Methods for Parenterally Procuring Bodily-Fluid Samples with Reduced Contamination") ("the '420 Patent"); U.S. Pat. No. 8,535,241, filed October 22, 2012 ("Fluid Diversion Mechanism for Bodily-Fluid Sampling") ("the '241 Patent"); U.S. Pat. No. 9,022,950, filed September 23, 2014 ("Fluid Diversion Mechanism for Bodily-Fluid Sampling") ("the '950 Patent"); U.S. Pat. No. 9,788,774, filed September 18, 2014 ("Methods and Apparatus for Selectively Procuring Bodily-Fluid Samples") ("the '950 Patent"); No. 9,149,576, filed October 9, 2013 ("Systems and Methods for Delivering a Fluid to a Patent with Reduced Contamination"), ("The '576 Patent"); U.S. Patent No. 9,204,864, filed July 29, 2013 ("Fluid Diversion Mechanism for Bodily-Fluid Sampling"), ("The '864 Patent");U.S. Patent Application Publication No. 2018 / 0140240, filed November 20, 2017 ("Systems and Methods for Sample Collection with Reduced Hemolysis") ("'240 Publication"); U.S. Patent Application Publication No. 2018 / 0353117, filed June 11, 2018 ("Fluid Control Devices and Methods of Using the Same") ("'117 Publication"); U.S. Patent Application Publication No. 2019 / 0076074, filed September 12, 2018 ("Fluid Control Devices and Methods of Using the Same") ("'074 Publication"); U.S. Patent Application Publication No. 2019 / 0175087, filed December 7, 2018 ("Fluid Control Devices and Methods of Using the Same") No. 2019 / 0365303, filed May 30, 2019, titled "Fluid Control Devices and Methods of Using the Same," (the "'303 Publication"); U.S. Patent Application Publication No. 2020 / 0289039, filed March 11, 2020, titled "Fluid Control Devices and Methods of Using the Same," (the "'039 Publication"); and / or U.S. Patent Application No. 17 / 119,732, filed December 11, 2020, titled "Fluid Transfer Devices with Integrated Flow-Based Assay and Methods of Using the Same," (the "'732 Application"), the disclosures of which are incorporated herein by reference in their entireties.

[0027]

[0042] Distal end portion 112 of housing 110 is substantially open and is sized and configured to receive and / or directly or indirectly removably couple to one or more devices, such as, for example, a fixed or removable coupler, a fluid collection device, a fluid transfer device, a sample container, a needle, etc. In some embodiments, for example, transfer adapter 100 may optionally include a distal coupler 125 that may be removably coupled to distal end portion 112 of housing 110. Optional distal coupler 125 may, in turn, at least temporarily couple (directly or indirectly) to a source of bodily fluid. For example, optional distal coupler 125 may be a luer connector, a non-luer connector, and / or any other suitable coupling device that may be removably coupled to a device that includes a lumen in fluid communication with a patient's vein (e.g., a butterfly needle or other suitable type of needle, an intravenous (IV) catheter, a midline catheter, a peripherally inserted central catheter (PICC), a device that includes an intermediate lumen, sterile flexible tubing, etc.). In other cases, the bodily fluid source need not be a patient, but instead may be any suitable volume, reservoir, container, vial, dish, etc., containing bodily fluid. In some embodiments, optional distal coupler 125 may be indirectly coupled to the bodily fluid source via one or more intermediate devices, such as, for example, sterile tubing, a transfer device, a diversion device, a separation device, and / or one or more other intermediate devices. For example, optional distal coupler 125 may be coupled to a transfer, diversion, and / or separation device, such as any of those described in the '420 patent, the '241 patent, the '950 patent, the '774 patent, the '576 patent, the '864 patent, the '240 publication, the '117 publication, the '074 publication, the '087 publication, the '303 publication, the '039 publication, and / or the '732 application.

[0028]

[0043] As described in further detail herein, bodily fluid may be transferred from a patient and / or other bodily fluid source to delivery adapter 100 through optional distal coupler 125. In some implementations, distal coupler 125 may be detached from distal end portion 112 of housing 110 after a desired amount of bodily fluid has been transferred to delivery adapter 100 or to a fluid collection device (e.g., a syringe) to which the fluid is movably coupled to delivery adapter 100. In some implementations, as described in further detail herein, after the distal coupler 125 is removed, a second fluid collection device, such as a sample bottle, culture bottle, empty container, etc., may be at least partially inserted into the distal end portion 112 of the housing 110 to allow at least a portion of the collected bodily fluid (e.g., at least a portion of the bodily fluid contained in the fluid collection device coupled to the proximal end portion 111 of the housing 110 (or its proximal coupler)) to be transferred through the transfer adapter 100 (e.g., through the fluid communicator 130) into the second fluid collection device (e.g., a sample bottle).

[0029]

[0044] The fluid communication device 130 is disposed within the interior volume of the housing 110. The fluid communication device 130 may be any suitable device configured to establish fluid communication between two or more components. For example, the fluid communication device 130 may be a conduit, a tube, and / or a lumen-defining device. In some embodiments, the fluid communication device 130 is a needle having a pointed or beveled distal end or tip. In other embodiments, the fluid communication device 130 is a needle or tube with a blunt distal end or tip. The proximal end portion of the fluid communication device is in fluid communication with the proximal end portion 111 of the housing (or its proximal coupler). As described above, the proximal end portion 111 or the proximal coupler may in turn be directly or indirectly coupled to a fluid collection device such as a syringe, sample container, needle, etc. Thus, the lumen defined by the fluid communication device 130 may be disposed in fluid communication with the interior volume or lumen of the fluid collection device, allowing bodily fluids to be transferred therebetween. As an example, as described in further detail herein with reference to specific embodiments, the proximal coupler of the housing 110 may be coupled to a syringe that can be operated to draw bodily fluid into the syringe through the fluid communicator 130 and expel the bodily fluid from the syringe through the fluid communicator 130.

[0030]

[0045] In implementations that include an optional distal coupler 125, the arrangement of the distal coupler 125 and the fluid communicator 130 may be such that when the distal coupler 125 is coupled to the distal end portion 112 of the housing 110 (see, e.g., FIG. 1A ), at least a distal end portion of the fluid communicator 130 extends into and / or otherwise engages with a portion of the distal coupler 125. For example, a portion of the distal coupler 125 may be disposed within the interior volume of the housing 110 when coupled to the distal end portion 112, such that the distal end portion of the fluid communicator 130 extends through and / or pierces a septum, seal, port, etc. of the distal coupler 125. Thus, as described in further detail herein, when the distal coupler 125 is coupled to the housing 110, the lumen of the fluid communication device 130 is placed in fluid communication with the distal coupler 125 and, for example, the proximal coupler or other portions of the housing 110, allowing the flow of fluid (e.g., bodily fluids such as blood) to be transferred therebetween.

[0031]

[0046] 1A and 1B, the delivery adapter 100 may include a sheath disposed within the interior volume and around or over at least a portion of the fluid communicator 130. In some embodiments, the sheath may be a relatively flexible covering or the like configured to surround at least a portion of the fluid communicator 130, for example, to at least temporarily maintain the sterility of the fluid communicator 130 and / or reduce the likelihood of unwanted user or patient contact with portions of the fluid communicator 130. As described in further detail herein, the sheath may be configured to transition between a first state in which a distal end portion of the fluid communicator 130 extends through and / or is otherwise uncovered by the sheath, and a second state in which the distal end portion of the fluid communicator 130 is disposed within and / or is otherwise covered by the sheath.

[0032]

[0047] Lock 150 of delivery adapter 100 may be of any suitable shape, size, and / or configuration. In some embodiments, lock 150 may be configured to selectively couple optional distal coupler 125 to distal end portion 112 of housing 110. In some embodiments, lock 150 may be transitionable between a first configuration ( FIG. 1A ) in which a portion of lock 150 engages a portion of optional distal coupler 125, thereby coupling distal coupler 125 to housing 110, and a second configuration ( FIG. 1B ) in which lock 150 does not engage distal coupler 125, thereby allowing distal coupler 125 to be removed from distal end portion 112 of housing 110. For example, lock 150 may include one or more shoulders configured to engage and / or contact one or more shoulders (or tabs) of optional distal coupler 125, thereby coupling distal coupler 125 to housing 110 by maintaining a portion of distal coupler 125 within the interior volume.

[0033]

[0048] In some embodiments, lock 150 may be transitioned between a first configuration and a second configuration by rotating lock 150 (and / or a portion thereof) relative to housing 110. The arrangement of lock 150 may be such that rotating lock 150 relative to housing 110 rotates one or more shoulders (or one or more other portions) of lock 150 to an offset position relative to one or more shoulders (or tabs or one or more other portions) of optional distal coupler 125. In other words, rotating lock 150 may cause lock 150 to disengage and / or be removed from contact with distal coupler 125, which in turn allows distal coupler 125 to be removed from housing 110. While lock 150 is described as being rotated between a first configuration and a second configuration relative to housing 110, it should be understood that the lock may be configured to transition in any suitable manner between any suitable number of configurations, states, etc. For example, in some embodiments, the lock may be transitioned by a rotational movement (e.g., as just described), a translational movement (e.g., via a slider, trigger, button, etc.), and / or any other suitable change in state, configuration, arrangement, etc.

[0034]

[0049] The transport adapter 100 and / or lock 150 or lock assembly also include a stage 140. The stage 140 may be a platform, disk, shelf, ring, plate, seal, etc., disposed within the interior volume of the housing 110 and movable between a first distal, or biased, position and a second proximal, or unbiased, position. Although not shown in FIGS. 1A and 1B , the stage 140 may include and / or otherwise contact a biasing member or energy storage member on a proximal side or face of the stage 140. In some embodiments, the biasing member is a spring and / or any other energy storage member, biasing member, etc. The biasing member may be configured to position the stage 140 in a desired or biased position (e.g., a distal or first position). For example, the biasing member may be configured to position the stage 140 in a desired, biased, or first position where the stage 140 is at, near, and / or adjacent to the distal end portion 112 of the housing 110, as shown in FIG. 1B . In other words, the biasing member may bias the stage 140 to a distal position. Additionally, when the stage 140 is in the biased or first configuration, state, and / or position, the stage 140 may be in a distal position relative to the fluid communicator 130, thereby limiting, blocking, and / or substantially preventing access to the fluid communicator 130 (FIG. 1B).

[0035]

[0050] 1B , before the distal coupler 125 is coupled to the distal end portion 112 of the housing 110, the stage 140 is disposed between the optional distal coupler 125 and, for example, a portion of the interior volume of the housing 110 and / or a fluid communicator 130 disposed within the portion of the interior volume of the housing 110. As such, when the distal coupler 125 is coupled to the housing 110 and the stage 140 is pushed or moved toward the proximal end portion 111 of the housing 110 (e.g., moved from a first position to a second position as shown in FIG. 1A ), at least a portion of the distal coupler 125 (e.g., a portion or face of a diaphragm) can be disposed in contact with the stage 140. In other implementations, the stage 140 can be disposed between a fluid collection device, such as a sample vessel, culture bottle, empty container, etc., and a portion of the interior volume of the housing 110 and / or a fluid communicator 130 disposed within the portion of the interior volume of the housing 110. As such, when coupled to and / or inserted into the distal end portion 112 of the housing 110 to push or move the stage 140 from a distal or first position to a proximal or second position, at least a portion of the fluid collection device can be positioned in contact with the stage 140.

[0036]

[0051] In some implementations, when coupled to the housing 110, the optional distal coupler 125, the fluid collection device, and / or any other suitable device may contact the stage 140, push and / or move it proximally, which in turn may transition the biasing member to a second, unbiased, and / or compressed state or configuration. Furthermore, when the stage 140 and biasing member are in the second, unbiased, compressed, and / or proximal position or state, at least a portion of the fluid communicator 130 may extend through and be distal to the stage 140, as shown in FIG. 1A . In some embodiments, this arrangement may allow the fluid communicator 130 to engage, pierce, and / or extend through a portion of the distal coupler 125 or the fluid collection device (e.g., a septum, frangible seal, port, inlet surface, etc.), thereby establishing fluid communication between the fluid communicator 130 and the fluid collection device and / or the optional distal coupler 125. Thus, the stage 140 may be, for example, a spring-loaded stage, platform, seal, etc. that may be biased to a position that restricts and / or blocks access to the fluid communication device 130 in a first state or configuration and allows access to the fluid communication device 130 in a second state or configuration.

[0037]

[0052] In some implementations, the delivery adapter 100 may be pre-assembled, packaged, and / or shipped in a first state or configuration in which a fluid collection device is physically and / or fluidly coupled to the proximal end portion 111 of the housing 110. For example, the delivery adapter 100 may be pre-assembled, packaged, and / or shipped with the proximal coupler of the housing 110 coupled to a syringe or the like. In some implementations, the optional distal coupler 125 may also be coupled to the distal end portion 112 of the housing 110 with the lock 150 in the locked configuration.

[0038]

[0053] An example of using the delivery adapter 100 with the optional distal coupler 125 and syringe pre-assembled is described below. However, it should be understood that the process or method of use described below is presented by way of example only and not limitation. Other uses of the delivery adapter 100 are possible and may be described in further detail herein with reference to specific embodiments. For example, the delivery adapter 100 need not be pre-assembled, but rather may be assembled and / or otherwise coupled to any desired device or devices by a user or medical professional.

[0039]

[0054] When pre-assembled, the adapter 100 may be in a first configuration or state, as shown in FIG. 1A . For example, the lock 150 may be in a first configuration (e.g., a locked configuration) with the optional distal coupler 125 secured or coupled to the housing 110. As described above, the stage 140 is in a proximal, compressed, or second position when the distal coupler 125 is coupled to the housing 110, allowing at least a portion of the fluid communicator 130 to extend through and / or distally of the stage 140. In some implementations, a septum or other portion of the distal coupler 125 may engage a portion of a sheath that at least partially surrounds the fluid communicator 130, moving the sheath to a compressed configuration, thereby exposing a portion of the fluid communicator 130. As such, the fluid communicator 130 punctures and / or extends through the septum, extending distally relative to the stage 140 and out of the sheath. Therefore, because the fluid communicator 130 is fluidly coupled to the proximal coupler, the fluid communicator 130 fluidly couples the distal coupler 125 and the proximal coupler.

[0040]

[0055] In some implementations, a medical professional can remove the pre-assembled adapter 100, distal coupler 125, and syringe from a sterile package and fluidly couple the optional distal coupler 125 directly or indirectly to a bodily fluid source. For example, the medical professional can couple the distal coupler 125 to a proximal port, coupler, and / or connector of an apparatus, which in turn is in fluid communication with a bodily fluid source, such as a butterfly needle, an intravenous catheter, and / or an access device. In some cases, the distal coupler 125 can be coupled to an intermediate transfer, diversion, and / or separation apparatus that can be configured to (i) accept a flow of bodily fluid from the bodily fluid source, (ii) divert an initial or first portion of the bodily fluid (which is likely to contain contaminants), (iii) separate the initial or first portion of the bodily fluid, and (iv) allow a subsequent or second portion of the bodily fluid to flow through the apparatus to the optional distal coupler 125. Although described as being coupled to an access device and / or intermediate transport device, etc., in other implementations, the adapter 100 may be pre-assembled and / or packaged with any such device or devices connected to the distal coupler 125.

[0041]

[0056] In the first configuration and / or state, a user or medical professional can manipulate the syringe, for example, by moving the plunger of the syringe proximally. The movement of the plunger in turn creates a negative pressure differential within the syringe, which is operable to draw a quantity of bodily fluid into the distal coupler 125, through the fluid communicator 130, through the adapter 100, and into the interior volume of the syringe.

[0042]

[0057] After obtaining the desired amount of bodily fluid in the syringe, the user or medical professional can operate the device 100 by transitioning the lock 150 from a first or locked configuration or state to a second or unlocked configuration or state. In some cases, the user may decouple and / or disconnect the distal coupler 125 from the bodily fluid source or a device in fluid communication with the bodily fluid source before transitioning the lock 150. In other cases, the user need not decouple and / or disconnect the distal coupler 125. After the lock 150 has been transitioned to the second or unlocked configuration or state, the user may decouple or remove the distal coupler 125 from the housing 110, thereby placing the delivery adapter 100 in the second configuration, as shown in FIG. 1B.

[0043]

[0058] The distal coupler 125 may be configured such that removal of the distal coupler 125 from the housing 110 withdraws the fluid communicator 130 from the distal coupler 125 and / or the septum included therein. In some embodiments, the septum may be a self-healing septum, port, material, etc. that may transition or self-heal to a sealed state and / or configuration when the fluid communicator 130 is withdrawn, for example, thereby preventing leakage of bodily fluids associated with a portion of the fluid flow path distal to the septum.

[0044]

[0059] Removal of the distal coupler 125 allows the stage 140 to move to its distal, biased, or first position. For example, a biasing member (e.g., a spring) or the like may apply a force to the stage 140, returning it to the biased first position. More specifically, the biasing member may be made expandable, which in turn moves the stage 140 distally until the stage 140 and biasing member are in the biased or distal position. In some implementations, the stage 140 may be configured to selectively engage a portion of a sheath such that distal movement of the stage 140 results in distal movement of at least a portion of the sheath. As such, the sheath may cover at least a distal end portion of the fluid communicator 130 when the stage 140 is in the distal or first position. In some cases, after distal coupler 125 is removed from housing 110, a user may transition lock 150 back to the first or locked configuration or state, with a portion of lock 150 securing stage 140 in the distal or biased position. As such, stage 140 and sheath collectively limit and / or substantially prevent access to and / or contact with fluid communicator 130.

[0045]

[0060] In some implementations, it may be desirable to transfer at least a portion of the bodily fluid disposed in the syringe into a separate fluid collection device, such as a sample bottle, a culture bottle, a testing device, or the like. For example, in some cases, if not already in the second or unlocked configuration, a user may transition lock 150 back to the second or unlocked configuration and insert a portion of a culture bottle into distal end portion 112 of housing 110. In some embodiments, the size, shape, and / or configuration of at least distal end portion 112 of housing 110 is such that any suitable and / or commercially available culture bottle can be placed within housing 110. Furthermore, a surface of the culture bottle may contact stage 140 and may move and / or transition stage 140 from a distal position toward a proximal position as the culture bottle is inserted into housing 110. As such, an unsheathed portion of fluid communicator 130 may extend distally relative to stage 140 and may be punctured and / or otherwise inserted into a portion of the culture bottle, thereby establishing fluid communication between the syringe and the culture bottle. Thus, a user may transfer a desired amount of bodily fluid from a syringe to a culture bottle through transfer adapter 100 by manipulating a syringe plunger or relying on vacuum filling (e.g., negative pressure differential) of the culture bottle, without the need for additional equipment and / or components that may introduce potential contamination points.

[0046]

[0061] While the use of transfer adapter 100 with optional distal coupler 125 has been described above, in other implementations, transfer adapter 100 may be used without distal coupler 125. In such implementations, for example, proximal end portion 111 of housing 110 (or its proximal coupler) may be coupled directly or indirectly to a bodily fluid source. For example, as described above, the proximal coupler may be coupled to an access device, a transfer device, and / or a combination thereof, which is in turn in fluid communication with the bodily fluid source. In this implementation, lock 150 may be in (or may be placed in) an unlocked configuration, and a fluid collection device, such as a sample bottle, culture bottle, testing device, or the like, may be inserted into distal end portion 112 of housing 110. As such, bodily fluid may flow from the bodily fluid source, through transfer adapter 100, and into a culture bottle (or the like), in a manner substantially similar to that described with respect to the flow of bodily fluid from a syringe to a culture bottle when using optional distal coupler 125.

[0047]

[0062] 2-10 illustrate a transfer device 200 according to another embodiment. The transfer device 200 (also referred to herein as a "transfer adapter," "adapter," and / or "device") may be of any suitable shape, size, and / or configuration. In some implementations, the transfer device 200 transfers bodily fluids while being configured to reduce the number of user and / or fluid interfaces that could be potential sources of contamination. More specifically, in some implementations, the transfer device 200 may be coupled to a fluid collection device (or any other suitable device) and used to transfer bodily fluids from a source (e.g., a bodily fluid source such as a patient's vein) to the fluid collection device. Additionally, the transfer device 200 may be used to transfer at least a portion of the bodily fluid from the fluid collection device to a second collection device or container (e.g., a sample bottle, culture bottle, etc.).

[0048]

[0063] 2 and 3 show perspective and front views, respectively, of delivery device 200 shown coupled to a syringe 290, as described in further detail herein. Figure 4 is an exploded view of delivery device 200. As shown, delivery device 200 includes a housing 210, a proximal coupler 220, a distal coupler 225, a fluid communicator 230, and a lock 250.

[0049]

[0064] Housing 210 may be of any suitable shape, size, and / or configuration. In some embodiments, the size and / or shape of housing 210 may be based, at least in part, on the size and / or shape of one or more devices configured for use with delivery device 200, as described in further detail herein.

[0050]

[0065] Housing 210 includes proximal end portion 211 and distal end portion 212 and defines an interior volume. Proximal end portion 211 of housing 210 is substantially open and is sized and configured to receive and / or be coupled to proximal coupler 220. Proximal coupler 220 is, in turn, configured to at least temporarily couple to a fluid collection device. For example, in the embodiment shown in FIGS. 2-10 , proximal coupler 220 is configured to physically and fluidly couple to connector 292 of syringe 290 via a threaded coupling, a luer coupling, and / or any other suitable connection. In other embodiments, proximal coupler 220 may be fixedly coupled or connected (e.g., integrally or monolithically formed, pre-assembled, etc.) to connector 292 of syringe 290.

[0051]

[0066] The distal end portion 212 of the housing 210 is substantially open and is sized and configured to receive and / or removably couple to a distal coupler 225. The distal coupler 225 is then at least temporarily coupled (directly or indirectly) to a bodily fluid source. For example, the distal coupler 225 may be a luer connector, a non-luer connector, and / or any other suitable coupling device that may be removably coupled to a device including a lumen that is in fluid communication with a patient's vein (e.g., a butterfly needle, an intravenous (IV) catheter, a peripherally inserted central catheter (PICC), a device including an intermediate lumen, etc.). In other cases, the bodily fluid source need not be a patient, but instead may be any suitable volume, reservoir, container, vial, etc., containing bodily fluid. In some embodiments, the distal coupler 225 may be indirectly coupled to the bodily fluid source through one or more intermediate devices, such as, for example, sterile tubing, transfer, bypass, and / or separation devices, and / or one or more other intermediate devices.

[0052]

[0067] As described in further detail herein, bodily fluid can be transferred from a patient and / or other bodily fluid source to the transfer device 200 through the distal coupler 225. In some implementations, the distal coupler 225 is detached from the distal end portion 212 of the housing 210 after a desired amount of bodily fluid has been transferred to the transfer device 200. In some implementations, as described in further detail herein, after the distal coupler 225 is detached, a second fluid collection device, such as a sample bottle, culture bottle, empty container, etc., can be at least partially inserted into the distal end portion 212 of the housing 210, allowing at least a portion of the bodily fluid contained in the fluid collection device (e.g., syringe 290) coupled to the proximal coupler 220 to be transferred through the transfer device 200 and into the second fluid collection device (e.g., a sample bottle).

[0053]

[0068] As shown in Figures 4-6, fluid communication device 230 is disposed within interior volume 213 of housing 210. Fluid communication device 230 may be any suitable device configured to establish fluid communication between two or more components. For example, fluid communication device 230 may be a conduit, a tube, and / or a lumen-defining device. More specifically, in the example shown in Figures 2-10, fluid communication device 230 is a needle having, for example, a pointed or beveled distal end or tip. In other embodiments, fluid communication device 230 may have a blunt distal end or tip.

[0054]

[0069] Fluid communicator 230 has a proximal end portion coupled to and in fluid communication with proximal coupler 220 (see, e.g., FIGS. 5 and 6 ). Proximal coupler 220, in turn, is in fluid communication with the interior volume of syringe 290 when proximal coupler 220 is coupled to connector 292 of syringe 290. Thus, as described in further detail herein, the lumen defined by fluid communicator 230 is fluidly coupled to the interior volume of syringe 290, and delivery device 200 and / or syringe 290 may be manipulated to transfer fluid therebetween.

[0055]

[0070] The fluid communicator 230 has a distal end portion configured to engage the distal coupler 225 when the distal coupler 225 is coupled to the distal end portion 212 of the housing 210. For example, as shown in Figures 5 and 6, a portion of the distal coupler 225 is disposed within the interior volume 213 when coupled to the distal end portion 212 of the housing 210 such that the distal end portion of the fluid communicator 230 extends through and / or pierces the septum 226 of the distal coupler 225. Thus, as described in further detail herein, when the distal coupler 225 is coupled to the housing 210, the lumen of the fluid communicator 230 places the distal coupler 225 in fluid communication with the proximal coupler 220, enabling the transfer of a fluid flow (e.g., a bodily fluid such as blood) therebetween.

[0056]

[0071] Delivery device 200 also includes a sheath 232 disposed within interior volume 213 and around or over at least a portion of fluid communicator 230. In some embodiments, sheath 232 may be a relatively flexible covering or the like configured to surround at least a portion of fluid communicator 230, for example, to at least temporarily maintain sterility of fluid communicator 230 and / or reduce the likelihood of unwanted user or patient contact with portions of fluid communicator 230. As described in further detail herein, sheath 232 may be configured to transition between a first state in which a distal end portion of fluid communicator 230 extends through and / or is otherwise not covered by the sheath 232 (see, e.g., FIGS. 5 and 6 ) and a second state in which the distal end portion of fluid communicator 230 is disposed within and / or otherwise covered by the sheath 232 (see, e.g., FIG. 10 ).

[0057]

[0072] Lock 250 of delivery device 200 may be of any suitable shape, size, and / or configuration. In some embodiments, lock 250 may be configured to selectively couple distal coupler 225 to distal end portion 212 of housing 210. In some embodiments, lock 250 may be transitionable between a first configuration in which a portion of lock 250 engages a portion of distal coupler 225, thereby coupling distal coupler 225 to housing 210, and a second configuration in which lock 250 does not engage distal coupler 225, thereby allowing distal coupler 225 to be removed from distal end portion 212 of housing 210. For example, as shown in FIGS. 7 and 8 , lock 250 may include one or more shoulders 251 configured to engage and / or contact one or more shoulders 227 (or tabs) of distal coupler 225, thereby coupling distal coupler 225 to housing 210 by maintaining a portion of distal coupler 225 within interior volume 213.

[0058]

[0073] In some embodiments, lock 250 may be transitioned between the first and second configurations by rotating lock 250 (and / or a portion thereof) relative to housing 210. The arrangement of lock 250 may be such that rotating lock 250 relative to housing 210 rotates one or more shoulders 251 of lock 250 into an offset position relative to one or more shoulders 227 (or tabs) of distal coupler 225. In other words, rotating lock 250 may cause lock 250 to disengage and / or be removed from contact with distal coupler 225, which in turn allows distal coupler 225 to be removed from housing 210. Although lock 250 is described as being rotated between the first and second configurations relative to housing 210, it should be understood that the lock may be configured to be transitioned in any suitable manner. For example, in some embodiments, the lock may be transitioned by a rotational movement (e.g., as just described), a translational movement (e.g., a slider, trigger, button, etc.), and / or any other suitable change in state, configuration, arrangement, etc. Although lock 250 is shown and described as rotating, it should be understood that lock 250 is not limited to such a configuration.

[0059]

[0074] 7 and 8 , the transport device 200 and / or lock 250 or lock assembly also includes a biasing member 235 and a stage 240. In this embodiment, the stage 240 is a platform, disk, shelf, ring, plate, etc. that is disposed between the distal coupler 225 and the biasing member 235 when the distal coupler 225 is coupled to the housing 210. More specifically, when the distal coupler 225 is coupled to the housing 210 to push or move the stage 240 toward the proximal end portion 211 of the housing 210, at least a portion of the distal coupler 225 (e.g., a portion or face of the diaphragm 226) is disposed in contact with the stage 240.

[0060]

[0075] As shown, the opposite side of the stage 240 is in contact with the biasing member 235. In some embodiments, the biasing member 235 is a spring and / or any other energy storage member, biasing member, or the like. The biasing member 235 is configured to position the stage 240 in a desired or biased position. For example, in this embodiment, the biasing member 235 may be configured to position the stage 240 in a desired, biased, or first position, where the stage 240 is at, near, and / or adjacent to the distal end portion 212 of the housing 210 (see, e.g., FIG. 10 ). In other words, the biasing member 235 may bias the stage 240 to a distal position. As shown in FIG. 10 , when the stage 240 is in the biased or first configuration, state, and / or position, the stage 240 may be in a distal position relative to the fluid communication device 230, thereby limiting, blocking, and / or substantially preventing access to the fluid communication device 230. Similarly, stage 240 may include and / or form a seal or the like that may isolate or substantially isolate fluid communicator 230 within the interior volume of housing 210. In other words, stage 240 may include and / or form a seal between the open distal end of housing 210 and fluid communicator 230, thereby limiting, blocking, and / or substantially preventing access to fluid communicator 230 through the distal end of housing 210 prior to inserting or coupling distal coupler 225 to housing 210.

[0061]

[0076] As described in further detail herein, when coupled to housing 210, distal coupler 225 may contact stage 240 and push and / or move it proximally, which in turn may transition biasing member 235 to a second, unbiased, and / or compressed state or configuration, as shown in Figures 7 and 8. Furthermore, when stage 240 and biasing member 235 are in the second, unbiased, and / or compressed, and / or proximal position or state, at least a portion of fluid communicator 230 extends through and is distal to stage 240, as shown in Figures 5 and 6. In some embodiments, this arrangement allows fluid communicator 230 to engage, pierce, and / or extend through a portion of septum 226 of distal coupler 225, thereby establishing fluid communication between distal coupler 225 and fluid communicator 230. Thus, the stage 240 may be, for example, a spring-loaded stage or platform that may be biased to a position that restricts and / or blocks access to the fluid communication device 230 in a first state or configuration, and allows access to the fluid communication device 230 in a second state or configuration.

[0062]

[0077] In some implementations, delivery device 200 may be pre-assembled, packaged, and / or shipped in a first state or configuration in which syringe 290 is coupled to proximal coupler 220 and distal coupler 225 is coupled to a distal end portion of housing 210. During use, a medical professional may remove pre-assembled device 200 and syringe 290 from the sterile packaging and fluidly couple distal coupler 225 directly or indirectly to a source of bodily fluid. For example, in some cases, a medical professional may couple distal coupler 225 to a proximal port, coupler, and / or connector of the device, which is then in fluid communication with the source of bodily fluid. In other cases, device 200 may be pre-assembled and / or packaged with any suitable device connected to distal coupler 225. As described above, the device may be, for example, a butterfly needle, an intravenous catheter, and / or an access device. In other cases, the device may be an intermediate transfer, diversion, and / or separation device that may be configured to receive a flow of bodily fluid, divert an initial portion of the bodily fluid (which is likely to contain contaminants), separate the initial portion of the bodily fluid, and allow a subsequent portion of the bodily fluid to flow through the device to the distal coupler 225.

[0063]

[0078] In some embodiments, the transfer, diversion, and / or separation devices may be any suitable devices. For example, such devices may be similar and / or substantially the same as any of the transfer, diversion, and / or separation devices described in the '420 patent, the '241 patent, the '950 patent, the '774 patent, the '576 patent, the '864 patent, the '240 publication, the '117 publication, the '074 publication, the '087 publication, the '303 publication, the '039 publication, and / or the '732 application (all of which are incorporated by reference above).

[0064]

[0079] Lock 250 may be in a first configuration (e.g., a locked configuration) such that distal coupler 225 is secured or coupled to housing 210. As shown in FIGS. 5 and 6 , stage 240 is in a proximal or compressed position when distal coupler 225 is coupled to housing 210. Additionally, septum 226 of distal coupler 225 may engage a portion of sheath 232 to move sheath 232 to the compressed configuration. As such, fluid communicator 230 punctures and / or extends through septum 226, which extends out of sheath 232 distally of stage 240. Because fluid communicator 230 is fluidly coupled to proximal coupler 220, fluid communicator 230 establishes fluid communication between distal coupler 225 and proximal coupler 220, as shown in FIGS. 5 and 6 . In this configuration and / or state, a user or medical professional can manipulate syringe 290, for example, by moving plunger 293 of syringe 290 in a proximal direction (see, e.g., FIGS. 9 and 10 ). Movement of plunger 293 then creates a negative pressure differential within syringe 290 that is operable to draw a quantity of bodily fluid into distal coupler 225, through fluid communicator 230, through proximal coupler 220 and connector 292, and into the interior volume of syringe 290.

[0065]

[0080] After obtaining the desired amount of bodily fluid in syringe 290, the user or medical professional can operate device 200 by transitioning lock 250 from a first or locked configuration or state to a second or unlocked configuration or state, as shown in Figure 9. In some cases, the user may detach and / or disconnect distal coupler 225 from the bodily fluid source or a device in fluid communication with the bodily fluid source before transitioning lock 250. In other cases, the user does not need to detach and / or disconnect distal coupler 225.

[0066]

[0081] Once lock 250 is transitioned to a second or unlocked configuration or state, a user may disengage or remove distal coupler 225 from housing 210, as shown by the arrow in FIG. 10. Distal coupler 225 may be configured such that removing distal coupler 225 from housing 210 withdraws fluid communicator 230 from septum 226. In some embodiments, septum 226 may be a self-healing septum, port, material, etc. that can transition or self-repair to a sealed state and / or configuration when fluid communicator 230 is withdrawn, for example, to prevent leakage of bodily fluids associated with a portion of the fluid flow path distal to septum 226.

[0067]

[0082] Removal of distal coupler 225 then allows biasing member 235 (e.g., a spring) to return to a biased or initial configuration. More specifically, in this embodiment, biasing member 235 is allowed to extend, which then moves stage 240 distally until stage 240 and biasing member 235 are in the biased or distal position. Additionally, stage 240 may be configured to selectively engage a portion of sheath 232, such that distal movement of stage 240 causes distal movement of at least a portion of sheath 232. As shown, when stage 240 is in the distal position, sheath 232 may completely cover at least a distal end portion of fluid communicator 230. In some cases, after distal coupler 225 is removed from housing 210, a user may transition lock 250 back to the first or locked configuration or state, such that a portion of lock 250 secures stage 240 in the distal or biased position shown in FIG. 10. As such, stage 240 and sheath 232 may collectively limit and / or substantially prevent access to and / or contact with fluid communicator 230.

[0068]

[0083] In some implementations, it may be desirable to transfer at least a portion of the bodily fluid disposed within syringe 290 to a separate fluid collection device, such as a sample bottle, culture bottle, testing equipment, etc. For example, in some cases, if not already in the second or unlocked configuration, a user can transition lock 250 back to the second or unlocked configuration and insert a portion of a culture bottle into distal end portion 212 of housing 210. In some embodiments, the size, shape, and / or configuration of at least distal end portion 212 of housing 210 may allow any suitable and / or commercially available culture bottle to be disposed within housing 210. Furthermore, a surface of the culture bottle may contact stage 240 and may move and / or transition stage 240 from a distal position toward a proximal position as the culture bottle is inserted into housing 210. As such, the unsheathed portion of fluid communicator 230 may extend distally relative to stage 240 and may be punctured and / or otherwise inserted into a portion of the culture bottle, thereby placing syringe 290 in fluid communication with the culture bottle. Thus, a user may manipulate plunger 293 of syringe 290 or rely on vacuum filling (e.g., negative pressure differential) of the culture bottle to transfer a desired amount of bodily fluid from syringe 290 to the culture bottle via transfer device 200, without the need for additional equipment and / or components that may introduce potential contamination points.

[0069]

[0084] 11-13 are diagrams of a transfer device 300 according to another embodiment. The transfer device 300 (also referred to herein as a "transfer adapter," "adapter," and / or "device") may be of any suitable shape, size, and / or configuration. In some implementations, the transfer device 300 is configured to transfer bodily fluids while reducing the number of user and / or fluid interfaces that could potentially be sources of contamination. More specifically, in some implementations, the transfer device 300 may be coupled to a fluid collection device (or any other suitable device) and used to transfer bodily fluids from a source (e.g., a bodily fluid source, such as a patient's vein) to the fluid collection device. Furthermore, the transfer device 300 may be used to transfer at least a portion of the bodily fluid from the fluid collection device to a second collection device or container (e.g., a sample bottle, culture bottle, etc.). Portions and / or aspects of the transfer device 300 may be similar or substantially the same as portions and / or aspects of the transfer devices 100 and / or 200 described above. Therefore, such parts and / or aspects may not be described in further detail herein.

[0070]

[0085] Figure 11 is a perspective view of delivery device 300. Figures 12 and 13 are cross-sectional views of delivery device 300 in a first configuration and a second configuration, respectively. As shown, delivery device 300 includes a housing 310, a proximal coupler 320, a fluid communicator 330, a sheath 332, a biasing member 335, a stage 340, and a lock 350.

[0071]

[0086] Housing 310 may be of any suitable shape, size, and / or configuration. In some embodiments, the size and / or shape of housing 310 may be based, at least in part, on the size and / or shape of one or more devices configured for use with delivery device 300. In some embodiments, housing 310 is similar to or substantially the same as housing 210 described above with reference to Figures 2-10. Accordingly, although multiple portions of housing 310 may be identified, such similar portions of housing 310 will not be described in further detail herein.

[0072]

[0087] The housing 310 includes a proximal end portion 311 and a distal end portion 312 and defines an interior volume. The proximal end portion 311 of the housing 310 is substantially open and is sized and configured to receive and / or be coupled to a proximal coupler 320. The proximal coupler 320 is then at least temporarily coupled (directly or indirectly) to a source of bodily fluid. For example, the proximal coupler 320 may be coupled and / or connected to a device including a lumen in fluid communication with a patient's vein (e.g., a butterfly needle, an IV catheter, a PICC line, a device including an intermediate lumen, etc.). In some embodiments, the proximal coupler 320 may be indirectly coupled to the source of bodily fluid via one or more intermediate devices, such as sterile tubing, transfer, bypass, and / or isolation devices, and / or one or more other intermediate devices. For example, proximal coupler 320 may be coupled to a fluid transfer device such as any of those described in the '420 patent, the '241 patent, the '950 patent, the '774 patent, the '576 patent, the '864 patent, the '240 publication, the '117 publication, the '074 publication, the '087 publication, the '303 publication, the '039 publication, and / or the '732 application. In other embodiments, proximal coupler 320 may be coupled to any suitable device. Thus, while distal coupler 225 was described above as providing fluid communication between the bodily fluid source and transfer device 200, in this embodiment, proximal coupler 320 provides fluid communication between the bodily fluid source and transfer device 300.

[0073]

[0088] Distal end portion 312 of housing 310 is substantially open and is sized and configured to receive a fluid collection device such as, for example, a sample bottle, a culture bottle, an empty container, etc. While device 200 is described above as including a distal coupler 225 removably coupled to housing 210, in the embodiment shown in Figures 11-13, transfer device 300 does not include and / or need not include a distal coupler. In this embodiment, for example, as described in further detail herein, transfer device 300 may be configured to transfer a flow of bodily fluid to be received by proximal coupler 320, flow through fluid communicator 330, and into a fluid collection device at least partially inserted into distal end portion 312 of housing 310.

[0074]

[0089] 12 and 13 , the fluid communicator 330 is disposed within the interior volume 313 of the housing 310. The fluid communicator 330 may be any suitable device configured to establish fluid communication between two or more components. For example, the fluid communicator 330 may be a conduit, a tube, a needle, a lumen-defining device, or the like. The fluid communicator 330 has a proximal end portion coupled to and in fluid communication with the proximal coupler 320, which in turn is fluidly coupleable to a fluid transfer device, such as those described above. The fluid communicator 330 has a distal end portion configured to engage a portion of a fluid collection device when the fluid collection device is at least partially inserted into the distal end portion 312 of the housing 310. Thus, the lumen defined by the fluid communicator 330 is configured to fluidly couple the proximal coupler 320 to a fluid collection device at least partially disposed within the housing 310. Delivery device 300 also includes a sheath 332 disposed within interior volume 313 and around or over at least a portion of fluid communicator 330 (see, e.g., FIGS. 12 and 13). In some embodiments, fluid communicator 330 and sheath 332 may be similar in form and / or function to fluid communicator 230 and sheath 232, respectively, described above, and therefore will not be described in further detail herein.

[0075]

[0090] Lock 350 of delivery instrument 300 may be of any suitable shape, size, and / or configuration. In some embodiments, lock 350 may be similar in form and / or function to lock 250, and therefore, portions and / or aspects of lock 350 will not be described in further detail herein. Lock 350 is configured to transition between a first configuration and a second configuration. While lock 250 was described above as coupling distal coupler 225 to housing 210 when in the first or locked configuration, in the embodiment shown in FIGS. 11-13 , delivery instrument 300 does not include and / or need not be coupled to a distal coupler. However, similar to lock 250, as described in further detail herein, lock 350 is configured to lock stage 340 in a desired position when in the first or locked configuration, and to allow stage 340 to be released and / or moved when in the second or unlocked configuration.

[0076]

[0091] Stage 340 may be any suitable shape, size, and / or configuration. For example, in some embodiments, stage 340 may be a platform, disk, shelf, ring, plate, etc. configured to selectively restrict access to fluid communicator 330, as described above with reference to stage 240. As shown in FIGS. 12 and 13 , a proximal side or face of stage 340 is in contact with biasing member 335. In some embodiments, biasing member 335 is a spring and / or any other energy storage member, biasing member, etc. Biasing member 335 is configured to position stage 340 in a desired or biased position. For example, biasing member 335 may be configured to position stage 340 in a desired, biased, or first position, where stage 340 is at, near, and / or adjacent to distal end portion 312 of housing 310 (see, e.g., FIG. 12 ). As described above with reference to stage 240, when in the biased or first configuration, state, and / or position, stage 340 is distal to fluid communicator 330, thereby restricting, blocking, and / or substantially preventing access to fluid communicator 330. Similarly, stage 340 may include and / or form a seal or the like that may isolate or substantially isolate fluid communicator 330 within the interior volume of housing 310. In other words, stage 340 may include and / or form a seal between the open distal end of housing 310 and fluid communicator 330, thereby restricting, blocking, and / or substantially preventing access to fluid communicator 330 through the distal end of housing 310.

[0077]

[0092] As described in further detail herein, when the fluid collection device is at least partially inserted into the housing 310, a surface of the fluid collection device may contact the stage 340 and push and / or move it proximally, which in turn may transition the biasing member 335 to a second, unbiased, and / or compressed state or configuration, as shown in Figure 13. As described in more detail above with reference to the device 200, when the stage 340 and biasing member 335 are in the second, unbiased, and / or compressed and / or proximal position or state, at least a portion of the fluid communicator 330 extends through and is distal to the stage 340, thereby allowing the fluid communicator 330 to engage, pierce, and / or extend through a surface of the fluid collection device, thereby providing fluid communication between the proximal coupler 320 and the fluid collection device (not shown).

[0078]

[0093] In some implementations, the transfer device 300 may be packaged and / or shipped in a first state or configuration in which the stage 340 is in a distal position, thereby restricting access to the fluid communicator 330. In some implementations, the transfer adapter 300 or device may be coupled to or pre-assembled with a fluid transfer device, bypass device, isolation device, etc., connected to the proximal coupler 320. In other embodiments, the transfer adapter 300 or device is packaged independently of other devices, such as fluid transfer devices.

[0079]

[0094] During use, a medical professional may remove device 300 from the sterile packaging and fluidly couple proximal coupler 320 directly or indirectly to a source of bodily fluid. For example, in some cases, a medical professional may couple proximal coupler 320 to a proximal port, coupler, and / or connector of a diversion and / or separation device, such as any of those described in the '420 patent, the '241 patent, the '950 patent, the '774 patent, the '576 patent, the '864 patent, the '240 publication, the '117 publication, the '074 publication, the '087 publication, the '303 publication, the '039 publication, and / or the '732 application. The diversion and / or separation device (referred to as a "diversion device") is then in fluid communication with a source of bodily fluid (e.g., a butterfly needle, an IV catheter, a PICC line, a midline line, an access device, etc.).

[0080]

[0095] In some implementations, a user or medical professional can operate the diversion device to initiate the flow of bodily fluid into the diversion device. The diversion device can be configured to automatically or manually (e.g., in response to user intervention) divert and separate an initial portion of the bodily fluid transferred into the diversion device. Once the initial portion of the bodily fluid has been separated, the diversion device can automatically or manually allow subsequent bodily fluid to flow through the diversion device and into the proximal coupler 320. In some implementations, the proximal coupler 320 can be coupled to the diversion device before the diversion device receives the bodily fluid flow, and the bodily fluid flow can be drawn into and / or through the diversion device in response to a fluid collection device being at least partially inserted into the distal end portion 312 of the housing 310. In other implementations, the proximal coupler 320 of the delivery device 300 can be coupled to the diversion device after the diversion device separates the initial portion of the bodily fluid.

[0081]

[0096] As described above, delivery device 300 may be in a first configuration and / or state prior to use. As such, lock 350 is in a first configuration (e.g., locked configuration) such that stage 340 is distal to fluid communicator 330, thereby blocking and / or restricting access thereto, as shown in FIG. 12 . After connecting proximal coupler 320 to the bypass device, a user or medical professional may transition delivery device 300 to a second configuration and / or state. For example, in some embodiments, a user may rotate and / or otherwise transition lock 350 from the first or locked configuration to a second or unlocked configuration. As described above, when lock 350 is in the second or unlocked configuration, stage 340 is permitted to move (e.g., proximally) relative to fluid communicator 330, thereby providing access thereto.

[0082]

[0097] With instrument 300 in a second configuration and / or state (e.g., when lock 350 is in the unlocked configuration), a user can insert a portion of a fluid collection device into and / or through distal end portion 312 of housing 310. The fluid collection device may be, for example, any suitable and / or commercially available culture bottle, sample bottle, empty container, etc. As described above with reference to instrument 200, inserting the fluid collection device into housing 310 is such that as the fluid collection device is advanced into housing 310, a surface of the fluid collection device contacts a distal side or face of stage 340, moving and / or transitioning stage 340 from a distal position ( FIG. 12 ) toward a proximal position ( FIG. 13 ). As such, the unsheathed portion of the fluid communication device 330 may extend distally relative to the stage 340 and may puncture and / or otherwise be inserted through a surface of the fluid collection device, thereby placing the proximal coupler 320 in fluid communication with the fluid collection device (e.g., through the fluid communication device 330).

[0083]

[0098] With the fluid communicator 330 in fluid communication with the fluid collection device, the transport device 300 can be configured to transfer bodily fluid from a diversion device coupled to the proximal coupler 320 into the fluid collection device. As described above, in some implementations, the transport device 300 can be coupled to the diversion device before or after the diversion device receives a flow of bodily fluid. In some implementations, the fluid collection device can establish a negative pressure and / or otherwise be at least partially emptied, thereby causing a suction force to be applied through the fluid communicator 330 when the fluid communicator 330 punctures and / or is otherwise inserted into the fluid collection device. The suction force can then be operable to draw bodily fluid into the diversion device, which can automatically divert and separate an initial amount of bodily fluid, and once separated, can allow subsequent flows of bodily fluid to flow through the diversion device, avoiding the separated initial amount. Thus, delivery device 300 can receive the subsequent flow of bodily fluid and transfer the flow into the fluid collection device (e.g., via proximal coupler 320 and fluid communicator 330). In some cases, separating the initial amount of bodily fluid can also separate contaminants that may be contained in the initial amount, ensuring that the subsequent flow of bodily fluid is substantially free of contamination. Furthermore, restricting access to fluid communicator 330 prior to inserting the fluid collection device into housing 310 can also reduce and / or eliminate potential sources of contamination. Therefore, bodily fluid transferred into the fluid collection device is less likely to be contaminated and / or substantially free of contamination.

[0084]

[0099] While delivery devices 100, 200, and / or 300 have been specifically illustrated and described above, it should be understood that delivery devices 100, 200, and / or 300 are presented by way of example only and not limitation. Various changes and / or modifications may be made to facilitate the use and / or compatibility of the devices and / or portions or aspects thereof. For example, FIGS. 14-34 illustrate portions and / or features of various delivery devices, one or more of which may be incorporated into delivery devices 100, 200, and / or 300. Although not shown or described herein, it should be understood that the delivery devices illustrated in FIGS. 14-34 may include any of the features, components, portions, etc. of delivery devices 100, 200, and / or 300 and may be used in conjunction with any of the fluid collection devices, diversion devices, separation devices, etc. described herein.

[0085]

[0100] 14 illustrates a portion of a delivery device 400 according to an embodiment. The delivery device 400 includes a housing 410 having a proximal coupler 420 and a fluid communicator 430 disposed within the housing 410 and in fluid communication with the proximal coupler 420. In this example, the delivery device 410 includes a set of flexible fingers, flanges, arms, extensions, etc. (referred to herein as "fingers 414"). As shown, the flexible fingers 414 may be configured to flex, bend, and / or elastically deform in response to the insertion of a fluid collection device 480 into the housing 410. In some implementations, the flexible fingers 414 may allow fluid collection devices of various sizes and / or shapes to be inserted into the housing 410. Additionally, in some implementations, the flexible fingers 414 may apply a frictional force to a surface of the fluid collection device, thereby helping to secure the fluid collection device to the housing 410.

[0086]

[0101] 15 shows a portion of a delivery device 500 according to another embodiment. The delivery device 500 includes a housing 510 including a set of flexible fingers 514 similar to the flexible fingers 414 described above. In this example, the flexible fingers 514 may include a smooth, rounded, and / or curved inner surface, which may facilitate insertion of a fluid collection device 580 into the delivery device 500. In some implementations, the inner surface of the fingers 514 may include a surface finish or texture configured to increase the amount of friction between the inner surface and the outer surface of the fluid collection device 580. In some implementations, the fingers 514 may be relatively rigid, and the inner surface of the fingers may be formed of a relatively soft or pliable material that may at least partially conform to the outer surface of the fluid collection device 580 when inserted into the fluid collection device.

[0087]

[0102] FIG. 16 shows a portion of a delivery device 600 according to another embodiment. The delivery device 600 includes a housing 610 having a proximal coupler 620 and a fluid communicator (not shown) disposed within the housing and in fluid communication with the proximal coupler 620. In this example, the housing 610 includes a set of slits or the like between which a flexible and / or deformable portion 615 of the housing 610 is disposed. In some implementations, this arrangement allows the housing 610 (or at least a portion thereof) to deform or compress when a fluid collection device is inserted into the housing 610. In this manner, the height of the housing 610 is compressed or reduced, which in turn may shorten the distance between the distal end portion of the housing 610 and a fluid communicator disposed within the housing 610. As such, a fluid communicator may be inserted into a fluid collection device that might not otherwise be inserted a sufficient distance into the housing 610.

[0088]

[0103] Any of the delivery devices described herein may include one or more features, portions, and / or arrangements configured to limit and / or prevent unwanted access of the fluid communicator. As noted above, in some embodiments, the fluid communicator may be a needle with a sharp distal end, which may present a risk of unwanted needle stick or puncture for the patient and / or user. Therefore, any of the delivery devices may include one or more features, portions, and / or arrangements that may enhance and / or increase patient and / or user safety by selectively limiting access to the fluid communicator.

[0089]

[0104] 17 shows a portion of a delivery device 700 according to one embodiment. Delivery device 700 includes a housing 710 and a fluid communicator 730 disposed within housing 710. In this example, housing 710 includes and / or defines a spiral inner track 716 that allows an inner sheath 732 that would otherwise cover fluid communicator 730 to twist and compress in response to insertion of a fluid collection device into housing 710. The twisting and compression of inner sheath 732, in turn, exposes a portion of fluid communicator 730, allowing it to be inserted into the fluid collection device.

[0090]

[0105] FIG. 18 shows a portion of a delivery device 800 according to another embodiment. The delivery device 800 includes a housing 810 and a fluid communicator 830 disposed within the housing 810. In this example, the delivery device 800 includes a stage 840 (e.g., a plate, disk, platform, etc.) that selectively limits access to the fluid communicator 830. For example, the stage 840 can selectively engage a set of latches 817 formed by an inner surface of the housing 810 that are configured to at least temporarily maintain the stage 840 in a distal position (shown in FIG. 18 ). When a fluid collection device is inserted into the housing 810, a surface of the fluid collection device applies a force to the stage 840 that is operable to release the stage 840 from the latches 817 and move the stage 840 proximally, allowing the fluid communicator 830 to be inserted into the fluid collection device. In other implementations, the fluid collection device can engage the latches 817 when inserted into the housing 810. In such implementations, the surface of the fluid collection device can deflect latches 817 outward to release stage 840, allowing stage 840 to move proximally. In some cases, such an arrangement can be beneficial because it makes it less likely that a user's fingers will deflect all of the latches 817 (e.g., on two or more sides of housing 810) simultaneously, and therefore less likely to release stage 840.

[0091]

[0106] FIG. 19 illustrates a portion of a delivery instrument 900 according to another embodiment. The delivery instrument 900 includes a housing 910 and a fluid communicator 930 disposed within the housing 910. In this example, the delivery instrument 900 includes a stage 940 that selectively restricts access to the fluid communicator 930. The delivery instrument 900 also includes a biasing member 935 (e.g., a spring) that biases and / or at least temporarily maintains the stage in a distal position that restricts and / or prevents access to the fluid communicator 930. As shown, the housing 910 may be two-part, including, for example, a lock 950 that can transition from a first or locked configuration to a second or unlocked configuration. Additionally, the interior surface of the housing 910 may include and / or form one or more engagement or gripping features 917A (e.g., protrusions or ribs formed from a material with a relatively high coefficient of friction, such as rubber or silicone). In some implementations, a user may, for example, insert a portion of the fluid collection device into the housing 910 so that the engagement or gripping feature 917A contacts a surface of the fluid collection device. In some cases, after inserting the fluid collection device into the housing 910, the user may rotate the fluid collection device, and the frictional force between the engagement or gripping feature 917A and the surface of the fluid collection device may be sufficient to rotate a first portion of the housing 910 relative to a second portion of the housing 910, thereby transitioning the lock 950 from a first or locked configuration to a second or unlocked configuration. Once the lock 950 is in the second or unlocked configuration, the first portion of the housing 910 may be allowed to move relative to the second portion of the housing 910, thereby allowing the fluid collection device to be advanced relative to the fluid communicator 930 so that the fluid communicator 930 punctures the fluid collection device.

[0092]

[0107] 20 and 21 illustrate a portion of a delivery device 1000 according to another embodiment, shown in a first configuration and a second configuration, respectively. The delivery device 1000 includes a housing 1010 and a fluid communication device (not shown) disposed within the housing 1010. In this example, the delivery device 1000 includes a door 1018 that selectively closes and opens to allow access to the fluid communication device. In some embodiments, for example, the door 1018 may include a tab or catch that may be engaged or grasped by a user to transition the door 1018 between a closed and an open configuration. As shown in FIG. 20 , the delivery device 1000 is in the first configuration when the door 1018 is in the closed configuration, thereby blocking access to the fluid communication device. As shown in FIG. 21 , the delivery device 1000 is in the second configuration when the door 1018 is disposed in the open configuration, thereby allowing access to the fluid communication device. In this embodiment, the door 1018 is shown as including a hinge that allows the door 1018 to pivot or rotate between a closed state and an open state. Additionally, the door 1018 may include a finger guard (e.g., a protrusion, an extension, a ridge, and / or any other suitable feature) configured to prevent accidental contact with the fluid communicator when opening the door 1018. In other embodiments, the door may be configured to transition between the closed state and the open state in any suitable manner.

[0093]

[0108] 22 shows a portion of a delivery device 1100 according to another embodiment. The delivery device 1100 includes a housing 1110 and a fluid communicator 1130 disposed within the housing 1110. In this example, the delivery device 1100 includes a door 1118 that selectively closes and opens to allow access to the fluid communicator 1130. Additionally, in this embodiment, the door 1118 may include a catch, tab, protrusion, and / or feature that may be engaged by a portion of the fluid collection device to move the door 1118 between a closed and an open state, thereby reducing the risk of contamination associated with a user coming into contact with the door 1118.

[0094]

[0109] 23 shows a portion of a delivery device 1200 according to another embodiment. The delivery device 1200 includes a housing 1210 and a fluid communicator 1230 disposed within the housing 1210. In this example, the delivery device 1200 includes two doors 1218 that collectively transition between a closed state and an open state to allow access to the fluid communicator 1230. Additionally, in this embodiment, each door 1218 may include an engagement feature disposed on the exterior of the housing 1210 that is manipulated by a user to open or close the door 1218. For example, in some implementations, a user may apply an inward force to the engagement feature, which in turn moves the door 1218 in an outward direction to the open state.

[0095]

[0110] 24 illustrates a portion of a delivery device 1300 according to another embodiment. The delivery device 1300 includes a housing 1310 and a fluid communicator 1330 disposed within the housing 1310. In this example, the delivery adapter 1300 includes an inner sheath 1319 that at least partially covers and / or blocks access to the fluid communicator 1330. The housing 1310 may include and / or form an oval opening or the like that may selectively receive a portion of the inner sheath 1319. More specifically, at least a portion of the inner sheath 1319 may have a substantially circular shape with a diameter larger than a narrow portion of the oval opening formed by the housing 1310. In this embodiment, the housing 1310 is configured to be compressed by a user to change and / or deform a portion of the housing 1310, causing the oval opening to be squeezed or deformed into a circular opening with a diameter larger than the diameter of the inner sheath 1319. In this manner, a user can insert a fluid collection device into the housing 1310 and compress or move the inner sheath proximally and at least partially through the circular opening, exposing a portion of the fluid communication device 1330.

[0096]

[0111] 25 shows a portion of a delivery device 1400 according to another embodiment. The delivery device 1400 includes a housing 1410 and a fluid communicator 1430 disposed within the housing 1410. In this example, the housing 1410 has a substantially oval shape and / or an oval-shaped opening at a distal end of the housing 1410. Additionally, the distal end of the housing 1410 may form one or more shoulders 1419 that at least partially block or obstruct an interior volume of the housing 1410. As described above with reference to the delivery device 1300, in this example, the housing 1410 of the delivery device 1400 is configured to be compressed or squeezed by a user, causing the distal end of the housing 1410 to deform to increase the size of the opening formed by the one or more shoulders 1419. For example, the housing 1410 may be compressed or squeezed such that the shape and / or size of the opening formed by the one or more shoulders 1419 is sufficient to accommodate at least a portion of a fluid collection device.

[0097]

[0112] 26 illustrates a portion of a delivery device 1500 according to another embodiment. The delivery device 1500 includes a housing 1510 and a fluid communicator 1530 disposed within the housing 1510. In this example, the delivery device 1500 includes a door 1518 that is movably or releasably coupled to the housing 1510. As shown, the delivery device 1500 further includes a release mechanism 1521 that can be operated by a user to release and / or otherwise enable the door 1518 to transition from a closed state to an open state. For example, the release mechanism 1521 can be a trigger, a latch, an actuator, etc. As described above, the door 1518 can limit and / or block access to the fluid communicator 1530 when the door 1518 is in a closed state and can allow a fluid collection device to access the fluid communicator 1530 when the door 1518 is in an open state.

[0098]

[0113] 27 illustrates a portion of a delivery device 1600 according to another embodiment. The delivery device 1600 includes a housing 1610 and a fluid communicator 1630 disposed within the housing 1610. In this example, the delivery device 1600 includes a door 1618 movably or releasably coupled to the housing 1610. As shown, the delivery device 1600 further includes a release mechanism 1621 that can be operated by a user to release and / or otherwise enable the door 1618 to transition from a closed state to an open state. For example, in this embodiment, the release mechanism 1621 can be a cam or the like, which can pivot or rotate to release the door 1618. As described above, the door 1618 can limit and / or block access to the fluid communicator 1630 when the door 1618 is in a closed state and can allow a fluid collection device to access the fluid communicator 1630 when the door 1618 is in an open state.

[0099]

[0114] Any of the delivery devices described herein may include one or more features, portions, and / or arrangements configured to enhance, improve, and / or facilitate a user interface. In some implementations, enhancing, improving, facilitating, and / or controlling a user interface may limit and / or mitigate safety risks and / or contamination risks, at least in part by controlling how a user interacts with and / or interfaces with at least a portion of the delivery device.

[0100]

[0115] 28 shows a portion of a delivery device 1700 according to another embodiment. The delivery device 1700 includes a housing 1710 and a fluid communicator 1730 disposed within the housing 1710. In this example, the housing 1710 may include an extended and / or flared end portion or flange, which may, for example, increase the distance between the tip of the fluid communicator 1730 and the distal edge of the housing 1710. Additionally, in some embodiments, the distal end portion or flange of the housing 1710 may be flared a sufficient amount to allow any suitable fluid collection device to be inserted into the housing 1710 and placed in fluid communication with the fluid communicator 1730. In this implementation, the housing 1710 and / or its flared distal end portion or flange may improve and / or facilitate the user interface, for example, by providing a horizontal or substantially horizontal surface (or other surface) that allows a user to apply a downward or distally directed force to the housing 1710 to facilitate coupling of a transfer device to a fluid collection device (e.g., a sample bottle).

[0101]

[0116] 29 shows a portion of a delivery device 1800 according to another embodiment. The delivery device 1800 includes a housing 1810 and a fluid communicator 1830 disposed within the housing 1810. In this example, a proximal coupler of the delivery device 1800 is physically and fluidly coupled to a bypass and / or isolation device 1885. A distal end portion of the housing 1810 may include one or more loops 1822 that may be engaged by a user's fingers. In this manner, the loops 1822 may provide a secure way for a user to engage and / or hold the delivery device 1800, for example, when the user is inserting a fluid collection device.

[0102]

[0117] 30 shows a portion of a delivery device 1900 according to another embodiment. The delivery device 1900 includes a housing 1910 and a fluid communicator 1930 disposed within the housing 1910. In this example, a proximal coupler of the delivery device 1900 is physically and fluidly coupled to a bypass and / or separation device 1985. A proximal end portion of the housing 1910 may include one or more handles, tabs, hooks, arms, etc. (referred to herein as "handles 1922") that may be engaged by a user's fingers. In this manner, the handles 1922 may provide a secure way for a user to engage and / or hold the delivery device 1900, for example, when the user is inserting a fluid collection device.

[0103]

[0118] 31 illustrates a portion of a delivery device 2000 according to another embodiment. The delivery device 2000 includes a housing 2010 and a fluid communicator 2030 disposed within the housing 2010. In this example, a proximal coupler 2023 of the delivery device 2000 is physically and fluidly coupled to a diversion and / or isolation device 2085. More specifically, in this embodiment, the proximal coupler 2023 may form a bend or the like to position the diversion and / or isolation device 2085 in a desired orientation when coupled to the proximal coupler 2023. In some embodiments, for example, the proximal coupler 2023 may form a 90° or substantially 90° bend to position the diversion and / or isolation device 2085 in an orthogonal or perpendicular orientation relative to the housing 2010 of the delivery device 2000. In some embodiments, such an arrangement may improve and / or enhance visibility of a user interface associated with the transport device 2000 and / or portions of the diversion and / or separation device 2085 .

[0104]

[0119] 32 shows a portion of a delivery device 2100 according to another embodiment. The delivery device 2100 includes a housing 2110 and a fluid communicator 2130 disposed within the housing 2110. In this example, a proximal coupler 2123 of the delivery device 2100 is physically and fluidly coupled to a diversion and / or isolation device 2185. More specifically, in this embodiment, the proximal coupler 2123 may form a bend or the like to position the diversion and / or isolation device 2185 in a desired orientation when coupled to the proximal coupler 2123. In some embodiments, for example, the proximal coupler 2123 may form a 90° or substantially 90° bend to position the diversion and / or isolation device 2185 in an orthogonal or perpendicular orientation relative to the housing 2110 of the delivery device 2100. Additionally, the orientation and / or arrangement of the diversion and / or separation device 2185 relative to the housing 2110 may be such that the fluid communicator 2130 extends from a substantially central portion of the diversion and / or separation device 2185. In some embodiments, such an arrangement may improve and / or enhance visibility of a user interface associated with the delivery device 2100 and / or portions of the diversion and / or separation device 2185.

[0105]

[0120] 33 illustrates a portion of a delivery device 2200 according to another embodiment. The delivery device 2200 includes a housing 2210 and a fluid communicator 2230 disposed within the housing 2210. In this example, a proximal coupler 2223 of the delivery device 2200 may be physically and fluidly coupled to a bypass and / or isolation device (not shown). A distal end portion of the housing 2210 may include one or more handles, tabs, hooks, arms, etc. (referred to herein as "handles 2221") that may be engaged by a user's fingers. In this manner, the handles 2221 may provide a secure way for a user to engage and / or hold the delivery device 2200, for example, when the user inserts a fluid collection device. Additionally, one or more of the handles 2221 may be reconfigurable between a first state or configuration and a second state or configuration. For example, in some implementations, at least one of the handles 2221 may have a first state and / or configuration in which the handle 2221 extends from one side of the housing 2210, and a second state and / or configuration in which the handle 2221 may be compressed or reconfigured and inserted into a portion of the housing 2210 to block and / or substantially limit access to the fluid communicator 2230. In this manner, the handle 2221 may be configured to enhance the user interface associated with the delivery device 2200 as well as provide an additional safety feature that protects against unwanted contact with the fluid communicator 2230.

[0106]

[0121] 34 shows a portion of a delivery device 2300 according to another embodiment. The delivery device 2300 includes a housing 2310 and a fluid communicator 2330 disposed within the housing 2310. In this example, the housing 2310 may have an interior surface (or a portion thereof) that includes an overmolded section 2326 formed from a relatively soft and / or relatively high-friction material. In this manner, the overmolded section 2326 may contact a surface of the fluid collection device when the fluid collection device is inserted into the housing 2310, and the frictional force therebetween may be sufficient to at least temporarily hold the fluid collection device in a fixed position relative to the delivery device 2310. In some cases, such an arrangement may allow a user to release their grip on the delivery device 2310 without having to, for example, detach or disengage the fluid collection device from the delivery device 2310.

[0107]

[0122] 35 shows a flowchart of a method 10 for using a transfer adapter according to an example implementation. The transfer adapter may be substantially similar to any of the transfer adapters described herein. In some implementations, the transfer adapter may be substantially similar to and / or used in a substantially similar manner as transfer adapter 200 (e.g., may include and / or be used with, for example, an optional distal coupler, etc.). In some implementations, the transfer adapter may be substantially similar to and / or used in a substantially similar manner as transfer adapter 300 (e.g., may not include and / or be used with, for example, an optional distal coupler, etc.). In any implementation, the transfer adapter may include at least a housing, a fluid communicator disposed within the housing, a lock coupled to a distal end portion of the housing, and a stage movable within the housing.

[0108]

[0123] As shown, method 10 includes, at 11, coupling a fluid collection device to a proximal coupler of a delivery adapter. The fluid collection device may be any of those described herein. For example, in some implementations, the fluid collection device may be a syringe, as described above with reference to delivery adapter 200 shown in FIGS. 2-10. In other implementations, the proximal coupler may be directly or indirectly coupled to a source of bodily fluid (e.g., via a needle, catheter, access device, delivery device, bypass device, separation device, and / or any other suitable device). For example, in some implementations, the proximal coupler may be coupled to a fluid transfer device such as any of those described in the '420 patent, the '241 patent, the '950 patent, the '774 patent, the '576 patent, the '864 patent, the '240 publication, the '117 publication, the '074 publication, the '087 publication, the '303 publication, the '039 publication, and / or the '732 application.

[0109]

[0124] A lock coupled to the distal end portion of the housing is transitioned from a locked configuration to an unlocked configuration at 12. As described above with reference to adapters 100, 200, and / or 300, the lock may be rotated relative to the housing to transition between the locked and unlocked configurations. In other implementations, the lock may be moved in a linear motion, may be a push button or toggle, and / or may be transitioned in any other manner. As described above, the lock in the locked configuration may selectively engage a stage to maintain the stage in a distal or biased position in which the stage limits and / or substantially prevents access to a fluid communicator through the distal end portion of the housing (e.g., the stage may include a seal, etc., that may seal the open distal end portion of the housing from a fluid communicator disposed therein). In some implementations, such sealing, blocking, and / or isolation may be the collective result of a stage and a sheath that, for example, may at least temporarily surround the distal end portion of the fluid communicator.

[0110]

[0125] Transitioning the lock from a locked configuration to an unlocked configuration may disengage the lock from the stage, thereby allowing the stage to move in response to an applied force. Method 10 includes moving the stage at 13 from a first or distal position, in which the stage limits access to a fluid communicator disposed in an interior volume of the housing, to a second or proximal position, in which at least a portion of the fluid communicator extends through, beyond, and / or distally of the stage. As such, when the stage is in the second position, flow of bodily fluid through the fluid communicator into or out of the fluid collection device is permitted at 14.

[0111]

[0126] In some implementations, for example, as described above with reference to delivery adapter 200, the stage may be moved in response to a distal coupler coupled to a distal end portion of the housing. In such implementations, the proximal coupler may be coupled to a syringe or the like, and the distal coupler may be coupled (directly or indirectly) to a source of bodily fluid. Thus, a user can manipulate the syringe to draw bodily fluid from the source, into and through the distal coupler, through the fluid communicator and proximal coupler, and into the syringe.

[0112]

[0127] In other implementations, the stage may be moved in response to a second fluid collection device being coupled and / or inserted into the distal end portion of the housing, as described above with reference to transfer adapter 300. In such implementations, the second fluid collection device may be, for example, a culture bottle, and the proximal coupler may be coupled (directly or indirectly) to a bodily fluid source. Thus, a user draws bodily fluid from the bodily fluid source, into and through the proximal coupler, through the fluid communicator, and into the culture bottle.

[0113]

[0128] While method 10 is described above as enabling the flow of bodily fluid from a bodily fluid source into a syringe and / or a second collection device (e.g., a culture bottle), in some implementations, method 10 may also be performed by and / or otherwise include transferring the bodily fluid from the syringe to the second collection device. For example, as described above, a volume of bodily fluid may be drawn from a bodily fluid source into a syringe using a delivery adapter with an optional distal coupler. After receiving the desired volume of bodily fluid, the optional distal coupler may be removed from the delivery adapter, and the stage may be allowed to return to the distal, biased, or first position. In some cases, the user may optionally transition the lock to a locked configuration.

[0114]

[0129] In this implementation, it is desirable to transfer at least a portion of the bodily fluid disposed in the syringe to a separate fluid collection device, such as a sample bottle, culture bottle, testing device, or the like. Therefore, if not already in the second or unlocked configuration, a user may transition the lock back to the second or unlocked configuration and insert a portion of the culture bottle into the distal end portion of the housing, as described above with reference to use of the transfer adapter without the optional distal coupler. Insertion of the culture bottle or the like places its surface in contact with the stage with the lock in the second or unlocked configuration, and further insertion moves and / or transitions the stage from the distal position toward the proximal position. As such, the exposed distal end portion of the fluid communicator may extend distally relative to the stage and puncture and / or otherwise insert into a portion of the culture bottle, thereby establishing fluid communication between the syringe and the culture bottle. Therefore, the user can operate the syringe plunger or rely on vacuum filling (e.g., negative pressure differential) of the culture bottle to transfer the desired amount of body fluid from the syringe to the culture bottle through the transfer adapter without the need for additional equipment and / or components that could introduce potential contamination points.

[0115]

[0130] While various embodiments have been described above, it should be understood that they are presented by way of example only, and not limitation. While the above-described schematic diagrams and / or embodiments show some components arranged in certain orientations or positions, the arrangement of components may be modified. While the embodiments have been illustrated and described in detail, it should be understood that various changes in form and detail may be made. While various embodiments have been described as having particular features, concepts, and / or combinations of components, other embodiments are possible that have any combination or subcombination of any features, concepts, and / or components from any of the embodiments described herein.

[0116]

[0131] The specific configuration of the various components may also vary. For example, the size and specific shape of the various components may differ from the illustrated embodiments while still providing the functionality as described herein. In some embodiments, varying the size and / or shape of such components may reduce the overall dimensions of the device and / or increase the ergonomics of the device without changing the device's functionality. In some embodiments, the size and / or shape of the various components may be specifically selected for a desired or intended use. Thus, it should be understood that the size, shape, and / or arrangement of the embodiments and / or their components may be adapted for a given use unless the context expressly dictates otherwise.

[0117]

[0132] For example, while stages 240 and 340 are described above as being moved or translated by biasing members 235 and 335, respectively, in other embodiments, stages 240 and / or 340 may be manually actuated, moved, and / or translated. For example, in some embodiments, the transfer adapter may include an actuator, tab, slider, button, and / or other suitable feature directly or indirectly coupled to the stage. In such embodiments, a user may apply a force to the feature to move the feature, which may in turn move the stage between a first configuration and / or position (e.g., a distal or locked position) and a second configuration and / or position (e.g., a proximal or unlocked position).

[0118]

[0133] While locks 150, 250, and / or 350 are described above as rings coupled to and configured to rotate relative to housings 110, 210, and / or 310, respectively, in other embodiments, the transport adapter or device may include any suitable lock. For example, in some embodiments, the lock may be configured to move translationally between a locked and an unlocked configuration. In other embodiments, the lock may be configured to transition between any number of states without substantial movement (e.g., without translation or rotation). In still other embodiments, the transport device need not include a lock. In such embodiments, for example, a stage may be manually actuated and / or at least temporarily fixed to a fixed position based on the amount of friction between one or more components and / or by any other suitable means. Similarly, in some embodiments, a distal coupler or any other suitable connection (e.g., distal coupler 225) may be at least temporarily coupled to the housing by friction or any other suitable coupling or engagement. In some embodiments, the transport device need not include a lock or stage. In such embodiments, any of the features, concepts, and / or embodiments (or portions thereof) may be used to limit and / or block access to the fluid communication device to reduce potential sources of contamination.

[0119]

[0134] Although the proximal coupler 220 of the delivery device 200 is described above as being coupled to the connector 292 of the syringe 290, in other embodiments, the delivery adapter may be coupled to any suitable portion of a syringe and / or other device. For example, in some embodiments, a syringe may be configured such that a plunger, actuator, etc. is in fluid communication with the syringe's internal volume or fluid reservoir. In such embodiments, the plunger, actuator, etc. may include a port or connector that may be coupled to a coupler of the delivery device or adapter similar to the proximal couplers 120, 220, and / or 320 described herein. More specifically, while the delivery adapter 300 is described above as connecting to a fluid delivery device via the proximal coupler 320, in some implementations, the proximal coupler 320 may be coupled to a port of the syringe. In this manner, the delivery adapter 320 may be coupled to the actuator or plunger of the syringe and may extend from and / or be otherwise disposed proximally of the syringe. In some embodiments, such an arrangement may be substantially similar to the syringe and delivery adapter combination described, for example, in U.S. Patent Application Publication No. 2016 / 0361006 ("'006 Publication"), filed June 13, 2016 ("Devices and Methods for Syringe-Based Fluid Transfer for Bodily-Fluid Sampling"), the disclosure of which is incorporated herein by reference in its entirety.

[0120]

[0135] In some implementations, a syringe may include a valve or other flow control device that may control, modulate, regulate, enable / disable, etc., flow into and / or through the syringe, thereby facilitating the use of a delivery adapter (described above) coupled proximally to the syringe. In some implementations, a valve or the like may be incorporated into, for example, a coupler or connector of the syringe or other fluid collection device, or may be coupled or included as a separate component. For example, FIG. 36 shows a portion of a syringe 2490 including a coupler 2492 that includes a valve 2448. In this embodiment, the valve 2448 may be movably disposed on the coupler 2492 of the syringe 2490. The valve 2448 may include, for example, a pair of seals 2449 spaced a predetermined distance apart to selectively engage portions of an interior surface of the syringe 2490 (or its coupler 2492). The valve 2448 may define a channel with an outlet disposed between the seals 2449.

[0121]

[0136] In this embodiment, before coupler 2492 of syringe 2490 is coupled to a corresponding coupler of another device, valve 2448 may be in a first configuration and / or position (e.g., a distal position) where the outlet of the channel is disposed within an annular space defined by an inner surface of syringe 2490, an outer surface of valve 2448, and two seals 2449. Furthermore, coupling coupler 2492 to a corresponding coupler of another device may be operable to transition and / or move valve 2448 from the first configuration and / or position (e.g., a distal position) to a second configuration and / or position (e.g., a proximal position).

[0122]

[0137] In some implementations, proximal movement of the valve 2448 moves the proximal seal 2449 away from, and thereby disengages, the interior surface of the syringe 2490. As such, the channel of the valve 2448 is now in fluid communication with the interior volume of the syringe 2490 via the outlet. Thus, a user can operate the syringe 2490 by moving the actuator or plunger of the syringe 2490 proximally, thereby creating a negative pressure differential or suction force within the syringe 2490, which is operable to draw a flow of bodily fluid through the channel and the outlet of the valve 2448 and into the interior volume of the syringe 2490.

[0123]

[0138] As described above, the actuator and / or plunger 2493 of syringe 2490 may define a channel, lumen, etc. configured to allow sampling of a volume of bodily fluid contained in syringe 2490, for example, as described in the '006 publication. For example, after transferring a volume of bodily fluid into syringe 2490 (e.g., by moving plunger 2493 proximally, away from valve 2448), a transfer adapter (e.g., transfer adapters 100, 200, and / or 300) may be coupled to actuator and / or plunger 2493 such that a fluid communication device of the transfer adapter is in fluid communication with a channel extending through plunger 2493. Additionally, a fluid collection device, such as, for example, a culture bottle, may be inserted into the transfer adapter such that the fluid communication device is in fluid communication with the interior volume of the culture bottle. In this manner, plunger 2493 may be moved, for example, in a distal direction, thereby increasing pressure within syringe 2490, which is operable to expel at least a portion of the bodily fluid contained therein into and through the channel of plunger 2493, into and through the fluid communicator, and into the culture bottle. Valve 2448 may facilitate such sampling because the increase in pressure within syringe 2490 causes valve 2448 to move to a distal position (if not already in the distal position), which is operable to fluidly isolate and / or seal the opening of valve 2448 from the interior volume of syringe 2490 proximal to at least one seal of valve 2448. Valve 2448 therefore prevents bodily fluid within syringe 2490 from expelling through syringe coupler 2492, thereby facilitating and / or enabling sampling from syringe 2490 (e.g., through a transfer adapter and fluid collection device coupled thereto).

[0124]

[0139] Any number of portions and / or features of the embodiments described herein may be used with (or modified for use with) any suitable fluid transfer device, fluid collection device, fluid storage device, etc. For example, in some implementations, the proximal adapter 320 of the transfer device 300 may be physically and / or fluidly coupled to a syringe, as described above with reference to the transfer device 200. Alternatively, the proximal adapter 320 may be physically and / or fluidly coupled to any other suitable device. For example, in some implementations, the transfer device or adapter may be coupled to a device configured to collect, divert, separate, isolate, etc., an initial volume of bodily fluid that may likely contain contaminants displaced during venipuncture or the like. In some cases, contaminants, such as microorganisms present on the skin, are contained in the separated initial volume of bodily fluid, and one or more subsequent volumes of bodily fluid transferred to and / or through the transfer device or adapter are substantially free of contaminants associated with accessing a bodily fluid source (e.g., a vein). Examples of such devices may include, for example, any of the devices and / or embodiments described in the '420 patent, the '241 patent, the '950 patent, the '774 patent, the '576 patent, the '864 patent, the '240 publication, the '117 publication, the '074 publication, the '087 publication, the '303 publication, the '039 publication, and / or the '732 application, the disclosures of which are incorporated herein by reference in their entirety.

[0125]

[0140] Although one or more methods or method steps using a device may be described herein as including a certain order of steps, in other embodiments, the order of some events and / or actions in any of the methods or processes described herein may be modified, and such modifications are in accordance with variations of the present invention. Furthermore, some events and / or actions may be performed simultaneously in a parallel process, where possible, as well as sequentially as described above. Some steps may be partially completed or omitted before proceeding to a subsequent step. For example, while a device may be described herein as transitioning from a first state or configuration to a second state or configuration, such as in a separate operation, it should be understood that the devices described herein may be configured to transition from the first state or configuration to the second state or configuration automatically and / or passively, and that such transition may occur over a period of time. In other words, the transition from a first state to a second state may, in some cases, be relatively gradual.

Claims

1. A housing including an open distal end portion and a proximal end portion configured to be coupled to a fluid collection device, A stage is disposed within the housing and is movable between a first position and a second position, A lock coupled to the housing, wherein the lock in a first locked configuration is configured to couple a distal coupler within the open distal end portion of the housing, thereby establishing a fluid passage between an access device coupled to the distal coupler and the proximal end portion of the housing, the fluid passage being configured to receive a flow of bodily fluids therethrough, and the lock being configured to transition from the first locked configuration to an unlocked configuration to detach the distal coupler from the housing, The apparatus is configured such that, with the distal coupler removed, the lock transitions to a second locking configuration to engage with the stage, maintaining the stage in the first position, thereby blocking the stage from accessing a portion of the fluid flow path through the open distal end portion of the housing.

2. The apparatus according to claim 1, wherein the stage is configured to move from a first position to a second position in response to the distal coupler being coupled to the housing.

3. The apparatus according to claim 1, wherein the lock is further configured to transition from the second locked state to the unlocked state to disengage the stage, allowing the stage to move from the first position to the second position in such a way that the sample container is at least partially positioned within the open distal end portion of the housing.

4. The apparatus according to claim 3, wherein the stage in the second position is configured to allow at least a portion of the bodily fluid to be transferred from the fluid collection device through the housing to the sample container.

5. The apparatus according to claim 1, further comprising a fluid communicator disposed within the housing and in fluid communication with the proximal end portion of the housing.

6. The apparatus according to claim 5, wherein the fluid communicator is configured to extend through the seal of the distal coupler when the distal coupler is coupled to the housing, thereby establishing fluid communication between the distal coupler and the proximal end portion of the housing.

7. The apparatus according to claim 5, wherein the fluid communicator is a needle having a pointed distal end, and the stage is configured to block access to the pointed distal end of the needle when in the first position.

8. The apparatus according to claim 7, wherein the fluid communicator is configured to puncture the surface of the sample container to establish fluid communication between the fluid collection device and the sample container when the sample container is at least partially located within the open distal end portion of the housing.

9. The apparatus according to claim 7, further comprising a bias member disposed within the housing and in contact with a portion of the stage to bias the stage to a first position.

10. The apparatus according to claim 9, wherein the bias member is configured to allow the stage to be moved to the second position when the lock is in the unlocked position, so that the pointed distal end portion of the fluid communicator extends through the stage, thereby allowing access to the fluid communicator through the open distal end portion of the housing.

11. A housing including an open distal end portion and a proximal end portion configured to be coupled to a fluid collection device, A stage is disposed within the housing and is movable between a first position and a second position, A lock coupled to the housing, The lock in the first locked configuration is configured to connect a distal coupler to the open distal end portion of the housing, thereby establishing fluid communication between the access device connected to the distal coupler and the fluid collection device connected to the proximal end portion of the housing, allowing the flow of bodily fluids between them; the lock is configured to transition from the first locked configuration to an unlocked configuration, thereby allowing the distal coupler to be removed from the housing; With the distal connector removed, the lock is A second locking configuration in which the lock engages with the stage to maintain the stage in the first position, or In the unlocked configuration, the stage is movable from a first position to a second position so that the body fluid can be transferred from the fluid collection device through the housing to the sample container, corresponding to the open distal end portion of the housing receiving a portion of the sample container. A device including a lock, configured to be in at least one of the following:

12. The apparatus according to claim 11, wherein the stage is configured to be in the second position when the distal coupler is coupled to the housing.

13. The apparatus according to claim 11, further comprising a fluid communicator disposed within the housing and in fluid communication with the proximal end portion of the housing.

14. The apparatus according to claim 13, wherein the fluid communicator is configured to extend through the seal of the distal coupler when the distal coupler is coupled to the housing, thereby establishing fluid communication between the distal coupler and the proximal end portion of the housing.

15. The apparatus according to claim 13, wherein the fluid communicator is a needle having a pointed distal end, and the stage is configured to block access to the pointed distal end of the needle when in the first position.

16. The apparatus according to claim 15, wherein the fluid communicator is configured to puncture the surface of the sample container to establish fluid communication between the fluid collection device and the sample container when the sample container is at least partially located within the open distal end portion of the housing.

17. The apparatus according to claim 15, further comprising a bias member disposed within the housing and in contact with a portion of the stage, wherein the bias member is configured to bias the stage to the first position.

18. The apparatus according to claim 17, wherein the bias member is configured to allow the stage to be moved to the second position when the lock is in the unlocked position, so that a portion of the pointed distal end portion of the fluid communicator extends through the stage, thereby allowing access to the fluid communicator through the open distal end portion of the housing.

19. The apparatus according to claim 11, wherein the lock is coupled to the open distal end portion of the housing.

20. The apparatus according to claim 11, wherein the fluid collection device is a syringe.

Images