Devices and methods for body fluid collection and distribution

Abstract

To provide a device for acquiring a body fluid sample with reduced contamination.SOLUTION: A device 1300 includes a housing 1310 that defines a fluid reservoir 1315 and includes a port 1311 that is in fluid communication with the fluid reservoir. An inlet adapter is removably coupleable to the housing. A user can engage an actuator to move a plunger from a first position in which the fluid reservoir has a first volume, to a second position in which the fluid reservoir has a second volume greater than the first volume, which draws body fluid into the fluid reservoir via the inlet adapter. The actuator modulates a plunger rate of motion below a threshold as the plunger is moved. When a prescribed volume of body fluid is transferred into the fluid reservoir, a volume indicator transitions from a first state to a second state and the inlet adapter can then be removed to transfer the prescribed volume into a sample bottle external to the housing via the port.SELECTED DRAWING: Figure 30

Description

[Technical field]

[0001] (CROSS REFERENCE TO RELATED APPLICATIONS) This application claims priority to and the benefit of U.S. Provisional Patent Application No. 62 / 802,999, entitled "Devices and Methods for Collection and Dispensing of Body Fluids," filed February 8, 2019, the disclosure of which is incorporated herein by reference in its entirety.

[0002] FIELD OF THE DISCLOSURE

[0002] Embodiment(s) described herein relate generally to obtaining bodily fluid samples, and more specifically to devices and methods for obtaining and dispensing bodily fluid samples with reduced contamination. [Background technology]

[0003] Healthcare professionals routinely perform a wide variety of bacterial and other diagnostic tests on patients using parenterally obtained bodily fluids. As advanced diagnostic technologies evolve and improve, the speed, accuracy (both sensitivity and specificity), and value of the information they can provide to clinicians continue to improve. Collecting an appropriate (e.g., recommended) and / or desired volume, and maintaining the integrity of the bodily fluid sample during and / or after collection, ensures that analytical diagnostic results are representative of the patient's in vivo condition. Examples of diagnostic technologies that rely on high quality, uncontaminated, and / or pure bodily fluid samples include, but are not limited to, microbial detection, molecular diagnostics, gene sequencing (e.g., deoxyribonucleic acid (DNA), ribonucleic acid (RNA), next generation sequencing (NGS), etc.), biomarker identification, etc.

[0004] One cause of inaccurate results from such tests is the presence of biological material, which may include cells outside the intended source for sample procurement and / or other external contaminants inadvertently included in the bodily fluid sample being analyzed. In short, when the purity of a sample intended to be derived or collected from a particular bodily fluid source is compromised during the specimen procurement process, the resulting analytical test results may be inaccurate, distorted, adulterated, false positive, false negative, and / or otherwise not representative of the patient's actual condition, which in turn may lead to poor patient status, inaccurate, confusing, uncertain, low confidence, and / or otherwise undesirable clinical decision making.

[0005] Another cause of false positive and / or false negative results may be inaccurate and / or inappropriate volumes of patient samples for a given type of test. For example, overfilling of volume-sensitive blood culture bottles may lead to false positive results, as described in the instructions and / or warning labels of the manufacturers of such culture bottles, as well as in the associated automated continuous monitoring microbial detection systems. On the other hand, insufficient patient sample volume in the medium may result in false negative results.

[0006] Thus, there is a need for devices and methods for procuring bodily fluid samples with reduced contamination. Additionally, a need exists for devices and methods for accurately metering, measuring, and / or dispensing one or more sample volumes of a procured bodily fluid into one or more sample reservoirs for use, for example, in bodily fluid sample testing. Summary of the Invention [Means for solving the problem]

[0007] Described herein are devices and methods for obtaining and / or dispensing a suitable, preferred, and / or recommended volume of a bodily fluid sample with reduced contamination. In some embodiments, the device includes a housing, an injection adapter, an actuator, and a volume indicator. The housing defines a fluid reservoir and includes a port in fluid communication with the fluid reservoir. The injection adapter is removably connectable to the housing and, when connected to the housing, positions the port to be in fluid communication with a source of bodily fluid. The actuator includes a plunger disposed within the fluid reservoir and defining at least a portion of the fluid reservoir. The portion of the actuator is configured to be engaged by a user to move the plunger within the housing from a first position, where the fluid reservoir has a first volume, to a second position, where the fluid reservoir has a second volume, the second volume being greater than the first volume. The increase in volume is operable to draw bodily fluid through the injection adapter into the fluid reservoir. The actuator adjusts a speed of movement of the plunger below a threshold as the plunger moves from the first position to the second position. The volume indicator is configured to transition from a first state to a second state in response to a predetermined volume of bodily fluid disposed within the fluid reservoir. The injection adapter is configured to be removed from the housing after the predetermined volume of bodily fluid has been transferred to the fluid reservoir to allow the predetermined volume to be transferred via the port to a sample bottle external to the housing. [Brief description of the drawings]

[0008] [Figure 1A] FIG. 1A is a schematic diagram of a bodily fluid collection and distribution device according to one embodiment, shown in a first state. [Figure 1B] FIG. 1B is a schematic diagram of a bodily fluid collection and distribution device according to one embodiment, shown in a second condition. [Figure 1C] FIG. 1C is a schematic diagram of a bodily fluid collection and distribution device according to one embodiment, shown in a third condition. [Diagram 2] FIG. 2 is a perspective view of a bodily fluid collection and distribution device according to one embodiment. [Diagram 3]3 is a top view of the bodily fluid collection and distribution device of FIG. [Figure 4] 4 is a left side view of the bodily fluid collection and distribution device of FIG. [Diagram 5] 5 is a rear view of the bodily fluid collection and distribution device of FIG. [Figure 6] 6 is a cross-sectional view of the bodily fluid collection and distribution device of FIG. 2 taken along line 6-6 of FIG. [Figure 7] 7 is a cross-sectional view of the bodily fluid collection and distribution device of FIG. 2 taken along line 7-7 of FIG. [Figure 8] 8 is a partially exploded perspective view of the bodily fluid collection and distribution device of FIG. 2. FIG. [Figure 9] FIG. 9 is a perspective view of a bodily fluid collection and distribution device, according to one embodiment. [Figure 10] FIG. 10 is a top view of a bodily fluid collection and distribution device, according to one embodiment. [Figure 11] FIG. 11 is a side view of a bodily fluid collection and distribution device, according to one embodiment. [Figure 12] FIG. 12 is a perspective view of a bodily fluid collection and distribution device according to an embodiment. [Figure 13] FIG. 13 is a perspective view of a bodily fluid collection and distribution device according to an embodiment. [Figure 14] FIG. 14 is a perspective view of a bodily fluid collection and distribution device according to an embodiment. [Figure 15] FIG. 15 is a perspective view of a bodily fluid collection and distribution device according to an embodiment. [Figure 16] FIG. 16 is a top view of a bodily fluid collection and distribution device according to an embodiment, showing a first condition. [Figure 17] FIG. 17 is a top view of a bodily fluid collection and distribution device according to an embodiment, showing a second condition. [Figure 18] FIG. 18 is a top view of a bodily fluid collection and distribution device according to an embodiment, showing a third condition. [Figure 19] FIG. 19 is a top view of an embodiment of a bodily fluid collection and distribution device, showing a fourth condition. [Figure 20]FIG. 20 is a perspective view of a bodily fluid collection and distribution device according to an embodiment, shown in a first condition. [Figure 21] FIG. 21 is a perspective view of a bodily fluid collection and distribution device according to an embodiment, shown in a second condition. [Figure 22] FIG. 22 is a perspective view of a bodily fluid collection and distribution device according to an embodiment, shown in a third condition. [Diagram 23] FIG. 23 is a perspective view of a bodily fluid collection and distribution device according to an embodiment, shown in a first condition. [Figure 24] FIG. 24 is a perspective view of a bodily fluid collection and distribution device according to an embodiment, shown in a second condition. [Diagram 25] FIG. 25 is a perspective view of a bodily fluid collection and distribution device according to an embodiment, shown in a third condition. [Figure 26] FIG. 26 is a perspective view of a bodily fluid collection and distribution device according to one embodiment. [Figure 27] FIG. 27 is a perspective view of a bodily fluid collection and distribution device according to an embodiment, shown in a first condition. [Figure 28] FIG. 28 is a perspective view of a bodily fluid collection and distribution device according to an embodiment, shown in a second condition. [Figure 29] FIG. 29, for example, is a perspective view of a bodily fluid collection and distribution device according to one embodiment shown in various positions. [Diagram 30] 30A-30C are front and rear views of a bodily fluid collection and distribution device, according to one embodiment. [Diagram 31] FIG. 31 is a rear view of a bodily fluid collection and distribution device, according to one embodiment. [Diagram 32] 32 is a cross-sectional view of the bodily fluid collection and distribution device of FIG. 30, showing a first condition. [Diagram 33] FIG. 33 is a cross-sectional view of the bodily fluid collection and distribution device of FIG. 30, showing a second condition. [Diagram 34] FIG. 34 is a cross-sectional view of the bodily fluid collection and distribution device of FIG. 30, showing a third condition. [Diagram 35]FIG. 35 is a graph showing the relationship between vacuum and / or displaced volume and draw rate for drawing bodily fluid into a reservoir using various methods. [Diagram 36] FIG. 36 is a graph showing the rate at which a reservoir having a fixed fill volume can be filled using various methods. [Figure 37] FIG. 37 is a flow chart illustrating a method of using a bodily fluid transfer and distribution device, according to one embodiment. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0009] In some instances, patient samples are tested for the presence of one or more potentially undesirable microorganisms, such as bacteria, fungi, or yeast (e.g., Candida). During diagnostic testing, various techniques can be employed to assist in detecting the presence of microorganisms, as well as other types of biological material, specific types of cells, biomarkers, proteins, antigens, enzymes, blood components, and / or the like. Examples include, but are not limited to, molecular polymerase chain reaction (PCR), magnetic resonance and other magnetic analysis platforms, automated microscopy, spatial clonal isolation, flow cytometry, whole blood ("culture-free") specimen analysis (e.g., NGS) and related techniques, morphokinetic cell analysis, and / or other common or advanced techniques utilized in clinical testing to characterize patient samples and / or to detect, identify, type, classify, and / or characterize specific organisms, antibiotic susceptibility, and / or the like.

[0010] In some cases, microbiology testing involves culturing a patient sample for a period of time (e.g., from less than an hour to several hours to several days, or longer or shorter depending on the diagnostic technique being employed) in one or more containers that may contain culture media, common additives, and / or other types of solutions that are conducive to microbial growth. Microorganisms and / or organisms present in the patient sample will grow and / or develop in the culture media over time, which can be detected by automated, continuous monitoring, and / or other methods specific to the analytical platform and technology used for detection, identification, and / or the like. The presence of microorganisms and / or organisms in the culture media (by observation of carbon dioxide, and / or other detection methods) can be detected by the presence of the microorganisms and / or organisms in the culture media (by observation of carbon dioxide, and / or other detection methods). A positive result (denoted as "positive result") indicates the presence of a similar microorganism and / or organism in the patient sample, which in turn indicates the presence of a similar microorganism and / or organism in the patient's bodily fluid from which the sample was obtained. In other examples, the bodily fluid sample may be analyzed directly for the presence of the microorganism and / or organism (i.e., not cultured). Thus, upon determining that a microorganism is present in the sample used for testing, the patient may be diagnosed and prescribed one or more antibiotics or other treatments specifically designed to treat or otherwise remove the undesirable microorganism and / or organism from the patient.

[0011] However, patient samples can become contaminated during procurement and / or suffer from false positive or false negative results. For example, microorganisms from the body surface (e.g., microorganisms present on the skin) that are removed during the specimen procurement process (e.g., directly or indirectly via tissue fragments, hair follicles, sweat glands, and other skin appendage structures) may then be transferred with the patient sample to a culture medium, test vial, or other suitable specimen collection or transfer container, and / or may otherwise be included in the specimen to be analyzed. Another possible source of contamination is from the person (e.g., physician, phlebotomist, nurse, technician, etc.) drawing the patient sample. In particular, the instruments, consumables, and / or devices used during the patient sample procurement process often include multiple fluid interfaces (by way of example and not limitation, patient-to-needle, needle-to-transfer adapter, transfer adapter-to-sample container, catheter hub-to-syringe, syringe-to-transfer adapter, needle / tube-to-sample container, and / or any combination thereof), each of which can introduce a potential contamination point. In some instances, such contaminants may thrive in culture media and / or be identified by other non-culture-based diagnostic techniques, resulting in an ultimate false-positive microbiological test result that may inaccurately reflect the presence or absence of such microorganisms in the patient (i.e., in vivo).

[0012] In some cases, false positive and / or false negative results may result from inaccurate and / or inappropriate volumes of patient samples for a given type of test. For example, overfilling of volume-sensitive blood culture bottles may lead to false positive results, as described in the manufacturer's instructions and / or warning labels of such culture bottles, as well as in the associated automated continuous monitoring microbial detection systems. On the other hand, insufficient patient sample volume in the culture medium may result in false negative results (e.g., failure to identify microorganisms actually present in the patient).

[0013] Such inaccurate results due to contamination, adulteration, and / or inaccurate sample volumes are of concern when attempting to diagnose or treat a wide range of suspected illnesses, diseases, infections, patient conditions, and / or other diseases of concern. For example, a false negative result from a microbiology test can result in a misdiagnosis of a patient's illness and / or delayed treatment, and in some cases, can result in the patient's death. Conversely, a false positive result from a microbiology test can not only result in the patient being unnecessarily subjected to one or more antimicrobial therapies, causing serious side effects to the patient, including, for example, death, but can also create unnecessary burdens and costs to the healthcare system due to extended patient stays and / or other complications associated with incorrect treatment. Using imaging devices that result in such erroneous results is of concern both from a cost standpoint and from a patient safety standpoint, as unnecessary exposure to focused radiation associated with various imaging modalities (e.g., CT scans) has many known adverse effects on long-term patient health. Additionally, challenges exist in training medical professionals to derive accurate, desired, and / or recommended sample volumes and / or to ensure that accurate, desired, and / or recommended sample volumes are used according to the particular test being performed.

[0014] In some embodiments, the device includes a housing, an injection adapter, an actuator, and a volume indicator. The housing defines a fluid reservoir and is in fluid communication with the fluid reservoir. The injection adapter includes a port for fluidly connecting the fluid reservoir to the fluid reservoir. The injection adapter is removably connectable to the housing and, when connected to the housing, positions the port for fluid communication with a source of bodily fluid. The actuator includes a plunger disposed within the fluid reservoir and defining at least a portion of the fluid reservoir. The portion of the actuator is configured to be engaged by a user to move the plunger within the housing from a first position, where the fluid reservoir has a first volume, to a second position, where the fluid reservoir has a second volume, the second volume being greater than the first volume. The increase in volume is operable to draw bodily fluid into the fluid reservoir through the injection adapter. The actuator adjusts a speed of movement of the plunger below a threshold as the plunger moves from the first position to the second position. The volume indicator is configured to transition from a first state to a second state in response to a predetermined volume of bodily fluid disposed within the fluid reservoir. The injection adapter is configured to be removed from the housing after the predetermined volume of bodily fluid has been transferred to the fluid reservoir so that the predetermined volume can be transferred via the port to a sample bottle external to the housing.

[0015] In some embodiments, the device includes a housing, an infusion adapter, an actuator, and a volume indicator. The housing defines a fluid reservoir and includes a port in fluid communication with the fluid reservoir. The infusion adapter is removably connectable to the housing and, when connected to the housing, places the port in fluid communication with a source of bodily fluid. The actuator includes a plunger disposed within the fluid reservoir and defining at least a portion of the fluid reservoir. The actuator is configured to move the plunger within the housing between a first position and a second position. The fluid reservoir has a first volume when the plunger is in the first position and a second volume greater than the first volume when the plunger is in the second position. An increase in the volume of the fluid reservoir is operable to draw bodily fluid into the fluid reservoir through the infusion adapter. The volume indicator transitions from a first state associated with a predetermined volume of bodily fluid being transferred to the fluid reservoir to a second state. The predetermined volume is less than the second volume of the fluid reservoir. The volume indicator is configured to at least temporarily stop movement of the plunger toward the second position when in the second condition.

[0016] In some embodiments, the method places an injection adapter of the fluid transfer device in fluid communication with a source of bodily fluid. The injection adapter is removably connectable to a housing of the fluid transfer device such that a port fluidly connects the injection adapter to a fluid reservoir defined by the housing. An actuator of the fluid transfer device engages to move a plunger disposed within the fluid reservoir and defining at least a portion of the fluid reservoir from a first position toward a second position. Movement of the plunger creates a negative pressure operable to draw bodily fluid through the injection adapter and into the fluid reservoir. Once a predetermined volume of bodily fluid has been transferred into the fluid reservoir, a volume indicator transitions from a first state to a second state. In response to the volume indicator transitioning from the first state to the second state, the plunger is stopped before the plunger moves to the second position. The injection adapter is removed from the housing and the housing, and a predetermined volume of bodily fluid is transferred from the fluid reservoir through the port to a sample bottle external to the fluid transfer device.

[0017] In some embodiments, the device includes a housing, an infusion adapter, an actuator, and a volume indicator. The housing defines a fluid reservoir and includes a port in fluid communication with the fluid reservoir. The infusion adapter at least temporarily couples to the housing and is in fluid communication with the port. The infusion adapter is configured to fluidly connect the port with a source of bodily fluid. The actuator includes a plunger disposed therein and defining at least a portion of the fluid reservoir and an engagement member configured to be engaged by a user to move the plunger within the housing. The actuator is configured to adjust a rate at which the plunger moves from a first position, in which the fluid reservoir has a first volume, to a second position, in which the fluid reservoir has a second volume greater than the first volume. Increasing the volume of the fluid reservoir is operable to draw a volume of bodily fluid into the fluid reservoir. The volume indicator is configured to transition from a first state to a second state in response to a predetermined volume of bodily fluid being disposed in the fluid reservoir.

[0018] In some embodiments, the bodily fluid collection and dispensing device can be configured to procure an appropriate, suitable, and / or recommended volume of bodily fluid sample with reduced contamination. In some embodiments, the bodily fluid collection and dispensing device and / or a diversion device coupled thereto can divert an initial volume of bodily fluid to a pre-sample reservoir. The initial volume of bodily fluid is sequestered in or by the bodily fluid collection and dispensing device and / or the diversion device before allowing a subsequent volume of bodily fluid to flow into a fluid reservoir at least partially defined by the bodily fluid collection and dispensing device. In some cases, the initial volume of bodily fluid may include microorganisms and / or other contaminants, and sequestering the initial volume may reduce or substantially prevent microorganisms and / or other contaminants in the subsequent volume of bodily fluid (e.g., a sample volume of the bodily fluid). In this manner, the subsequent volume of bodily fluid can be used for diagnostic or other testing, while the initial volume of bodily fluid can be discarded, reinjected into the patient, and / or used for diagnostics and / or other tests that are less sensitive to potential microorganisms and / or other contaminants.

[0019] In some embodiments, the bodily fluid collection and dispensing device can include an actuator that can be engaged and / or operated by a user to draw in a volume of bodily fluid (e.g., after an initial volume of bodily fluid has been diverted). For example, one or more portions of the actuator can be moved within and / or relative to a fluid reservoir of the bodily fluid collection and dispensing device to draw in the volume of bodily fluid into the fluid reservoir. In some cases, the actuator can be configured to control, regulate, and / or limit the speed at which one or more portions of the actuator can move, thereby allowing a user to control the volume of bodily fluid transferred to the bodily fluid reservoir and / or the amount of negative pressure or suction force applied on or against the source of the bodily fluid (e.g., within a patient's vein).

[0020] In some embodiments, the bodily fluid collection and dispensing device can include a volume indicator configured to ensure an appropriate and / or desired volume of bodily fluid is collected and / or transferred to a fluid reservoir defined by the bodily fluid collection and dispensing device. The bodily fluid collection and dispensing device can be configured to automatically divert and / or control the flow of fluid into and / or out of the fluid reservoir. For example, the volume indicator can be configured to transition from a first state to a second state after a first measured or predetermined volume of bodily fluid is collected. In some embodiments, the volume indicator can provide an indication to a user when placed in the second state indicative of the measured, collected and / or predetermined volume of bodily fluid that has been disposed in the fluid reservoir. Additionally or alternatively, the volume indicator can be configured to gate, control, restrict, and / or substantially prevent additional amounts of bodily fluid from being delivered to the fluid reservoir until and / or unless a user engages and / or manipulates the volume indicator to transition the volume indicator out of the second state (e.g., toward the first state or a third state different from the first state and the second state). For example, in some cases, a user may transition the volume indicator from the second state to deliver an additional amount of bodily fluid to the fluid reservoir.

[0021] In some embodiments, the bodily fluid collection and dispensing device can be configured to transfer a volume of bodily fluid contained in the bodily fluid reservoir to one or more sample containers, culture bottles, sample reservoirs and / or vials, test assays, and / or the like. For example, a user can manipulate the bodily fluid collection and dispensing device (e.g., an actuator and / or other suitable part of the device) to transfer a predetermined and / or desired volume of bodily fluid from the fluid reservoir, for example, to a culture bottle. In some embodiments, a volume indicator can control, regulate, and / or distribute the bodily fluid flowing from the fluid reservoir to the culture bottle. For example, In some embodiments, the volume indicator can automatically transition to a state that substantially gates and / or prevents flow of bodily fluid from being delivered from the fluid reservoir in response to a predetermined and / or desired volume of bodily fluid being delivered to the culture bottle. Thus, the bodily fluid collection and dispensing device can ensure that a known, predetermined, and / or desired volume of bodily fluid is delivered to the culture bottle.

[0022] These concepts, features and / or aspects, along with other concepts, features and / or aspects, are described in further detail herein and / or illustrated in the drawings with respect to specific embodiments.

[0023] As used in this specification and the appended claims, the singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise. Thus, for example, the term "member" is intended to mean a single member or combination of members, and "material" is intended to mean one or more materials or combinations thereof.

[0024] As used herein, the terms "about," "approximately," and / or "substantially," when used in connection with stated values ​​and / or other geometric relationships, are intended to mean that the structure so defined is the nominal value and / or the described geometric relationship. In some instances, the terms "about," "approximately," and / or "substantially" can generally mean and / or generally assume plus or minus 10% of the described value or relationship. For example, about 0.01 includes 0.009 and 0.011, about 0.5 includes 0.45 and 0.55, about 10 includes 9-11, and about 1000 includes 900-1100. It is understood that while the values ​​described may be desirable, some variation may occur as a result of, for example, manufacturing tolerances, physiological and / or physical characteristics, or other practical considerations (e.g., pressure or force applied through a portion of a device, conduit, lumen, etc.). As such, the terms "about," "approximately," and / or "substantially" may be used herein to account for such tolerances and / or considerations.

[0025] As described in more detail herein, any of the devices and methods can be used to obtain a bodily fluid sample with reduced contamination, for example, by diverting a "pre-sample" volume of bodily fluid prior to collecting a "sample" volume of bodily fluid. As used herein, "bodily fluid" can include any fluid obtained directly or indirectly from a patient's body. For example, "bodily fluid" can include, but is not limited to, blood, cerebrospinal fluid, urine, bile, lymphatic fluid, saliva, synovial fluid, serous fluid, pleural fluid, amniotic fluid, mucus, sputum, vitreous humor, air, and the like, or any combination thereof.

[0026] The terms "pre-sample", "first", and / or "initial" can be used interchangeably to describe and / or refer to a deposit, portion, or volume of bodily fluid that is transferred, diverted, and / or isolated prior to obtaining a "sample" volume. In some embodiments, the terms "pre-sample", "first", and / or "initial" can refer to a predetermined, defined, desired, or given volume, portion, or amount of bodily fluid. For example, in some embodiments, the predetermined and / or desired pre-sample volume of bodily fluid can be about 0.1 milliliters (mL), about 0.2 mL, about 0.3 mL, about 0.4 mL, about 0.5 mL, about 1.0 mL, about 2.0 mL, about 3.0 mL, about 4.0 mL, about 5.0 mL, about 10.0 mL, about 20 mL, about 50 mL, and / or any volume or fraction of a volume therebetween. In other embodiments, the pre-sample volume can be greater than 50 mL or less than 0.1 mL. In some particular embodiments, the predetermined and / or desired pre-sample volume can be between about 0.1 mL and about 5.0 mL. In other embodiments, the pre-sample volume can be, for example, a single drop of bodily fluid, a few drops of bodily fluid, e.g., an initial collection volume from a bodily fluid source, or a volume of about 0.1 mL to about 5.0 mL. It can be the combined volume of any number of lumens that form (or a portion of) a flow path to a chamber, portion, reservoir, etc. (eg, an isolation chamber).

[0027] On the other hand, the terms "sample," "second," and / or "subsequent" when used in the context of a volume of bodily fluid can refer to a volume, percentage, or amount of bodily fluid, either a random volume of bodily fluid collected after transferring, diverting, isolating, and / or separating a pre-sample volume of bodily fluid, or a predetermined or desired volume. For example, in some embodiments, the desired sample volume of bodily fluid can be about 10 mL to about 60 mL. In other embodiments, the desired sample volume of bodily fluid can be less than 10 mL or more than 60 mL. In some embodiments, for example, the sample volume can be based, at least in part, on one or more tests, evaluations, analyses, and / or processes performed on the sample volume. In some embodiments, multiple sample volumes having known, predetermined, and / or desired volumes can be dispensed from a fluid reservoir containing a volume of bodily fluid (e.g., a volume of bodily fluid greater than a known, predetermined, and / or desired single sample volume).

[0028] When describing a relationship between a given volume of bodily fluid and a collected volume of bodily fluid, it should be understood that the values ​​include a suitable tolerance as described above. For example, when stating that a collected volume of bodily fluid is substantially equal to a given volume of bodily fluid, the collected volume and the given volume are nominally equal within a suitable tolerance. In some cases, the tolerance can be determined by the intended use of the collected volume of bodily fluid. For example, in some cases, an assay of blood cultures can be about 99% accurate if the collected blood volume is within 1.0%-5.0% of the manufacturer's (or evidence-based practice) recommended volume. As an example, a manufacturer's recommended volume for an assay of bodily fluid is 10 milliliters (mL) per sample collection bottle, and a total of four or six collection bottles are used (i.e., a total volume of 40 ml-60 ml), plus or minus 5%, would provide about a 99% confidence level. Thus, a collection volume of 10.5 mL would provide results with greater than about 99% confidence, while a collection volume of 11 mL would provide results with less than about 99% confidence. In other examples, the suitable tolerance may be 0.1%, 0.5%, 1.0%, 2.0%, 3.0%, 4.0%, 5.0%, 6.0%, 7.0%, 8.0%, 9.0%, 10.0%, or any percentage therebetween. In yet other examples, the tolerance may be greater than 10.0%. Any of the embodiments described herein may be included in and / or used in combination with any suitable flow metering mechanism and / or device configured to meter flow and / or otherwise measure a volume of bodily fluid within a suitable tolerance. In some implementations, the flow metering mechanism and / or device may be positioned to minimize or eliminate cumulative tolerances that may result from a combination of inaccurate measurements, human error, and / or the like.

[0029] The embodiments described herein can be configured to selectively transfer bodily fluids to one or more fluid collection device(s). In some embodiments, the fluid collection device can include, but is not limited to, any suitable container, reservoir, bottle, adapter, dish, vial, nanoliter vial, container, microliter container, nanoliter container, syringe, device, diagnostic and / or testing machine, and / or the like. As a specific example, in some instances, any of the embodiments and / or methods described herein can be used to transfer a sample volume to a sample reservoir, some of which are described in, for example, U.S. Pat. No. 8,197,420, entitled "Systems and Methods for Parenterally Procuring Bodily-Fluid Samples with Reduced Contamination," filed December 13, 2007 (the "'420 Patent") and / or U.S. Pat. No. 6,219,420, entitled "Systems and Methods for Sample Collection with Reduced Hemolympus Samples with Reduced Contamination," filed November 20, 2017 (the "'420 Patent"). No. 2018 / 0140240 (the "'240 publication"), entitled "Fluid Collection Device," the disclosures of each of which are incorporated herein by reference in their entireties. In other embodiments, the fluid collection device may be substantially similar or equivalent to known sample containers, such as, for example, the Vacutainer® (manufactured by Becton, Dickinson and Company ("BD")), BacT / ALERT® SN or BacT / ALERT® FA (manufactured by Biomerieux, Inc.), and / or the like.

[0030] In some embodiments, the sample reservoir can be a sample or culture bottle, such as, for example, an aerobic culture bottle or an anaerobic culture bottle. In this manner, the culture bottle can receive a bodily fluid sample, which can then be tested (e.g., via an in vitro diagnostic (IVD) test, and / or any other suitable test) for the presence of, for example, gram-positive bacteria, gram-negative bacteria, yeast, fungi, and / or other organisms. In some instances, the culture bottle can receive a bodily fluid sample, and the culture medium (disposed therein) can be tested for the presence of any suitable organism. If such testing of the culture medium yields a positive result, the culture medium can be subsequently tested using a PCR-based system to identify the specific organism. Additionally, as described in more detail herein, in some instances, diverting a pre-sample or initial volume of bodily fluid can reduce and / or substantially eliminate contaminants in the bodily fluid sample that may otherwise lead to inaccurate test results.

[0031] The sample containers, reservoirs, bottles, dishes, vials, etc. described herein may be empty prior to receiving a sample volume of bodily fluid, or may contain, for example, any suitable additives, culture media, substances, enzymes, oils, fluids, and / or the like. For example, in some embodiments, the sample reservoir may contain an aerobic or anaerobic culture medium (e.g., a nutrient-rich and / or environmentally controlled medium for promoting growth, and / or other suitable culture medium(s)) that occupies at least a portion of the interior volume defined by the sample reservoir. In some embodiments, the sample reservoir may contain any suitable additives or the like, for example, heparin, citrate, ethylenediaminetetraacetic acid (EDTA), oxalate, SPS, and / or the like, that also occupy at least a portion of the interior volume defined by the sample reservoir. In other embodiments, the sample reservoir may be any suitable container used to collect a specimen.

[0032] The term "culture medium" can be used to describe a substance configured to react with organisms in the bodily fluid (e.g., microorganisms such as bacteria), and the term "additive" can be used to describe a substance configured to react with a portion of the bodily fluid (e.g., constituent cells of blood, serum, synovial fluid, etc.), and it should be understood that the sample reservoir can include any suitable substance, liquid, solid, powder, lyophilized compound, gas, etc. Furthermore, when referring to an "additive" in the sample reservoir, it should be understood that the additive can be a culture medium, such as an aerobic culture medium and / or an anaerobic culture medium, contained in a culture bottle, an additive, and / or any other suitable substance, or a combination of substances contained in the culture bottle and / or other suitable reservoirs described above. That is, the embodiments described herein can be used with any suitable fluid reservoir or the like containing any suitable substance. Furthermore, any of the embodiments and / or methods described herein can be used to transfer a volume of bodily fluid to a reservoir (or the like) that does not contain culture medium, additives, and / or other substances prior to receiving a flow of bodily fluid.

[0033] Some embodiments include a method for obtaining a bodily fluid for one or more culture sample tests. Although described herein as being used in a method for detecting a body fluid, it should be understood that the embodiments are not limited to such use. Any of the embodiments and / or methods described herein can 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 intended to be limited to such specific examples. Additionally, samples collected through the use of any of the devices described herein can be used in any suitable test, such as those described above.

[0034] Any of the embodiments and / or portions thereof described herein can be formed or constructed of one or more biocompatible materials. In some embodiments, the biocompatible material can 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, or polymers. Examples of suitable metals include pharmaceutical grade stainless steel, gold, titanium, nickel, iron, platinum, tin, chromium, copper, and / or alloys thereof. Polymeric materials can 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, polyesters, polycarbonates, polyacrylates, ethylene vinyl acetate and other acyl-substituted cellulose acetate polymers, non-degradable polyurethanes, polystyrene, polyvinyl chloride, polyvinyl fluoride, poly(vinylimidazole), chlorosulfonated polyolefins, polyethylene oxide, and / or blends and copolymers thereof.

[0035] 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 components may be formed by a single part having any number of sections, regions, parts, and / or features, 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 as a single structure having multiple parts, or multiple separate substructures or the like that are connected to form the structure. 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 continuous or discontinuous with each other. A set of substructures may also be manufactured from multiple items or components that are manufactured separately and later connected (e.g., via welding, adhesives, snaps, and / or any suitable method).

[0036] 1A-1C are schematic diagrams of a bodily fluid collection and dispensing device 1 according to one embodiment. The bodily fluid collection and dispensing device 1 (also referred to herein as the "device") can be of any suitable shape size and / or configuration. In some embodiments, the device 1 can have a size and / or shape that enhances and / or promotes ergonomics and / or ease of use. In some embodiments, the device 1 and / or at least a portion thereof can be similar in form and / or function to a syringe and / or similar device configured to receive and at least temporarily contain a fluid therein. In some implementations, the device 1 can be operated to draw a large volume of bodily fluid from a bodily fluid source (e.g., a patient) into a portion of the device 1 at a flux below a threshold flow rate. Although not shown in FIGS. 1A-1C, in some embodiments, the device 1 can include, be coupled to, and / or be integrated with a device that can divert and at least temporarily isolate an initial volume of bodily fluid drawn from the bodily fluid source. In some cases, by diverting and isolating the initial volume of bodily fluid, the presence of contaminants in subsequent volumes of bodily fluid drawn into portions of device 1 can be reduced and / or substantially eliminated, as described in detail in the '420 patent.

[0037] As shown in FIGS. 1A-1C, the device 1 includes a housing 10, a fluid reservoir 15, an injection adapter 20, an actuator 40, and a volume indicator 50. The housing 10 can be of any suitable shape, size, and / or configuration. For example, in some embodiments, the housing 10 can have an elongated and / or substantially cylindrical shape similar to some known syringes. In other embodiments, the housing 10 can have any other suitable shape. In some embodiments, the size of the housing 10 can be based at least in part on a desired volume or amount of fluid to be at least temporarily contained therein. For example, in some embodiments, the housing 10 can include and / or at least partially form a fluid reservoir 15, and the size and / or volume of the housing 10 can be based at least in part on a desired volume of fluid to be transferred to and / or from the fluid reservoir 15.

[0038] Housing 10 is configured to contain, accommodate, and / or form at least a portion of fluid reservoir 15, actuator 40, and volume indicator 50. Housing 10 is in fluid communication with fluid reservoir 15 and includes port 11 that is physically and fluidly connectable, at least temporarily, to injection adapter 20 (see, e.g., FIGS. 1A and 1B). In some cases, injection adapter 20 can be removed or disconnected from port 11, which can be fluidly connected to one or more external collection reservoirs, sample bottles, culture bottles, etc. (see, e.g., FIG. 1C).

[0039] The fluid reservoir 15 is disposed within and / or formed by the housing 10. For example, in some embodiments, the fluid reservoir 15 may be formed independently of the housing 10 and inserted or disposed within a portion of the housing 10 during manufacture. In other embodiments, at least a portion of the housing 10 and at least a portion of the fluid reservoir 15 may be monolithically and / or integrally formed. The fluid reservoir 15 may have and / or define any suitable volume. For example, in some embodiments, the fluid reservoir 15 may have a volume of about 5.0 mL to about 60.0 mL, about 10.0 mL to about 50.0 mL, about 20.0 mL to about 40.0 mL, or about 30.0 mL. In some embodiments, the fluid reservoir 15 may have a volume of about 20.0 mL, about 25.0 mL, or about 30 mL. In other embodiments, the fluid reservoir 15 may have a volume of less than about 5.0 mL or more than about 60.0 mL. Fluid reservoir 15 is in fluid communication with port 11 of housing 10, and thus can receive or convey a flow of fluid via port 11, as described in further detail herein. Although not shown in FIGS. 1A-1C, in some embodiments, device 1 can include a pre-sample reservoir that is fluidly isolated from fluid reservoir 15 and configured to receive an initial volume of bodily fluid that is transferred to housing 10.

[0040] The actuator 40 may be of any suitable shape, size, and / or configuration. For example, in some embodiments, the actuator 40 may include a syringe-like plunger and one or more portions configured to be engaged by a user to move the syringe-like plunger within the housing 10. In some embodiments, the syringe-like plunger (referred to herein simply as "plunger") may include a seal that forms a fluid-tight seal with an inner surface of the fluid reservoir 15 (or an inner surface of the housing 10 that defines a portion of the fluid reservoir 15). Thus, the plunger of the actuator 40 may form and / or define at least a portion of the fluid reservoir 15. For example, the fluid reservoir 15 may be and / or have a volume collectively defined by and / or between the inner surface of the housing 10, the port 11, and the plunger of the actuator 40.

[0041] Actuator 40 may be operated to move a plunger within housing 10 to increase or decrease the volume of fluid reservoir 15. In some cases, increasing the volume of fluid reservoir 15 may decrease the pressure (e.g., negative pressure, vacuum, suction, etc.) within fluid reservoir 15 operable to draw fluid (e.g., bodily fluid) into fluid reservoir 15 through port 11. Conversely, decreasing the volume of fluid reservoir 15 may increase the pressure within fluid reservoir 15 operable to expel fluid from fluid reservoir 15 through port 11, as described in further detail herein.

[0042] In some embodiments, the arrangement of the actuator 40 can be such that the actuator 40 and / or a portion thereof is configured to control and / or regulate the rate of change of the volume of the fluid reservoir 15. For example, in some embodiments, a first portion of the actuator 40 can be engaged and / or manipulated by a user to transition and / or move a second portion of the actuator 40 including, for example, a plunger. In some implementations, the first portion of the actuator 40 (e.g., an engagement portion, etc.) can be directly or indirectly coupled to the second portion of the actuator 40 (e.g., at least the plunger of the actuator 40) and configured to use and / or transfer at least a portion of the force exerted by the user on the first portion of the actuator 40 to a known, predetermined and / or regulated force to transition and / or move the second portion of the actuator 40. Alternatively, in some implementations, the actuator 40 and / or one or more portions thereof can be configured to control and / or regulate the rate of change of the volume of the fluid reservoir 15, which in turn can control and / or regulate the flow rate of fluid into and out of the fluid reservoir 15. As described in further detail herein, in some implementations, such control and / or adjustment may allow a user to increase the amount of control over the flow rate of fluid into and out of the fluid reservoir 15, thereby allowing a user to more precisely control the volume of fluid transferred into and / or out of the fluid reservoir 15.

[0043] By way of example, in some embodiments, the first portion of the actuator 40 may be one or more wheels, dials, pinions, levers, pneumatic or hydraulic actuators, rods, etc., which are directly or indirectly coupled to the second portion of the actuator 40 (e.g., the plunger 40). In some embodiments, the first portion of the actuator 40 may be coupled to the second portion of the actuator 40 via one or more racks, tracks, channels, flow paths, energy storage members and / or biasing members (e.g., one or more springs), chain links and / or the like. In some implementations, the direct or indirect coupling between the first portion of the actuator 40 (e.g., an engagement portion or member) and the second portion of the actuator 40 (e.g., the plunger) may be selected and / or designed to regulate the transfer of energy and / or force therebetween. For example, in some implementations, the first portion of the actuator 40 may be a wheel that is indirectly coupled to the second portion of the actuator 40 via one or more racks and pinions. In such implementations, the force applied to the second portion of the actuator 40 can be adjusted, regulated, and / or controlled, for example, by increasing or decreasing the gear ratio between the wheel, pinion, and / or rack.

[0044] In other embodiments, the transfer of energy and / or force can be adjusted and / or controlled via any suitable mechanism, such as increasing or decreasing the size and / or shape of a track, channel, flow path, etc., increasing or decreasing the spring constant and / or strength of one or more components, increasing or decreasing the size and / or number of components in a link of a chain, increasing or decreasing the flow rate of a gas or fluid, and / or any other suitable mechanism or method such as any of those described herein. In other embodiments, the transfer and / or dispensing device can adjust the rate of change of the volume of the fluid reservoir 15 and / or the flow rate of fluid into and out of the fluid reservoir 15. Specific examples and / or methods of controlling and / or regulating can control and / or regulate the rate of change of the volume of a fluid reservoir and include any suitable method and are not intended to be limited to the specific examples and / or methods described herein.

[0045] The volume indicator 50 may be of any suitable shape, size, and / or configuration. For example, in some embodiments, the volume indicator 50 is a button, a knob, a dial, a lever, a pointer, and / or any other suitable indicator. The volume indicator 50 may be configured to transition or be transitioned from a first state to a second state to provide an indication related to the volume of fluid disposed within the fluid reservoir 15. For example, the volume indicator 50 may transition (e.g., automatically) from a first state to a second state in response to a known, desired, and / or predetermined volume of bodily fluid being disposed within the fluid reservoir 15. In some embodiments, the known, desired, and / or predetermined volume of bodily fluid may be based at least in part on a volume of bodily fluid (e.g., blood) suitable for one or more tests, etc., or configured to be performed on or using the bodily fluid, e.g., blood culture tests and / or the like. In some embodiments, the known, desired, and / or predetermined volume is, for example, 1.0 mL, 2.0 mL, 3.0 mL, 4.0 mL, 5.0 mL, 6.0 mL, 7.0 mL, 8.0 mL, 9.0 mL, 10.0 mL, 15.0 mL, 20.0 mL, or any suitable volume or fraction of a volume therebetween. In other embodiments, the known, desired, and / or predetermined volume can be less than 1.0 mL or more than 20.0 mL.

[0046] As an example, the known, desired, and / or predetermined volume may be 10.0 mL. Thus, the volume indicator 50 may transition and / or be transitioned from a first state to a second state in response to 10.0 mL of bodily fluid being transferred and / or disposed in the fluid reservoir 15. In some embodiments, the volume indicator 50 may transition from a first state in which the volume indicator 50 (e.g., a button, etc.) is pressed or disposed substantially within the housing 10 to a second state in which the volume indicator 50 is raised relative to the housing 10 (e.g., at least a portion of the button extends outside or from the housing 10). When in the second state, the volume indicator 50 may indicate to a user that 10.0 mL has been disposed in the fluid reservoir 10. In response, the user may decide to continue drawing additional amounts of bodily fluid into the fluid reservoir 15 (e.g., by continuing to engage the actuator 40) or to stop or terminate the procurement process.

[0047] In some embodiments, the volume indicator 50 may also be configured to at least temporarily place the device 1 and / or the actuator 40 in a state or configuration that limits and / or substantially prevents movement of at least a portion of the actuator 40 (e.g., movement of the plunger within the housing 10). For example, as described above, the volume indicator 50 may be a button (or the like) that can be moved or transitioned to a second state, such that the button extends out of or from the surface of the housing 10. In some embodiments, the volume indicator 50 may, for example, be selectively engaged with any suitable portion of the actuator 40 to limit and / or substantially prevent movement of the plunger while the volume indicator 50 is in the second state. Thus, a user may manipulate the volume indicator 50 and / or apply a force to the volume indicator 50 that is operable to transition the volume indicator 50 from the second state. In some embodiments, for example, the volume indicator 50 may transition toward the first state and / or back to the first state. In other embodiments, the volume indicator 50 may transition toward and / or to a third state that is different from the first state and the second state.

[0048] The infusion adapter 20 is configured to at least temporarily couple to the port 11 of the housing 10. The infusion adapter 20 may be of any suitable shape, size, and / or configuration. The infusion adapter 20 may include a lumen-containing device configured to fluidly couple with a bodily fluid source. For example, in some embodiments, the infusion adapter 20 may include a needle or catheter configured to be inserted into a patient's vein or artery. In other embodiments, the infusion adapter 20 is configured to establish a fluid connection between the infusion adapter 20 and a bodily fluid source and / or an intermediate device (e.g., a flow shunt device, a placed intravenous catheter, and / or other suitable device).

[0049] 1A and 1B, when the injection adapter 20 is coupled to the housing 10, the injection adapter 20 is fluidly coupled to the port 11. In some embodiments, the port 11 of the housing 10 can include a needle or other piercing member configured to advance through a penetrable, sealable, and / or frangible portion of the injection adapter 20. For example, the injection adapter 20 can include a self-sealing port that is pierced by the needle or piercing member of the port 11 when the injection adapter 20 is coupled thereto and returns to a sealed state or the like when the injection adapter 20 is removed from the housing 10. In such embodiments, the needle and / or piercing member can be positioned to fluidly couple an interior portion of the injection adapter 20 with the fluid reservoir 15, thereby allowing fluid (e.g., bodily fluid) to be transferred from the injection adapter 20 to the fluid reservoir 15. In other embodiments, the injection adapter 20 and the port 11 can include and / or collectively form a Luer-type connection and / or any other suitable physical and / or fluidic interaction.

[0050] As shown in FIG. 1C, in some cases, the injection adapter 20 can be decoupled and / or otherwise removed from the housing 10 after the desired volume of fluid has been transferred to the fluid reservoir 15. In some embodiments, decoupling of the injection adapter 20 from the port 11 can expose a needle and / or piercing member coupled to the port 11, which can physically and / or fluidly couple the port 11 to any suitable external device and / or reservoir. For example, in some embodiments, the port 11 can be configured to physically and / or fluidly couple to a culture bottle or other sample reservoir. In other embodiments, the port 11 can be coupled to and / or include any suitable transfer adapter, such as those described in U.S. Pat. No. 10,123,783, entitled “Apparatus and Methods for Disinfection of a Specimen Container,” filed March 3, 2015 (referred to herein as the “'783 patent”), the disclosure of which is incorporated herein by reference in its entirety.

[0051] In some embodiments, the infusion adapter 20 can be configured to collect, divert, and / or isolate an initial volume of bodily fluid received from a bodily fluid source (e.g., a patient). For example, in some embodiments, the infusion adapter 20 can have a first state or configuration in which the initial volume of bodily fluid is transferred to a first portion of the infusion adapter 20 (e.g., via a first flow path, etc.) and can transition from the first state or configuration to a second state and / or configuration in which (1) the initial volume of bodily fluid is isolated by or within the first portion of the infusion adapter 20 and (2) a subsequent volume of bodily fluid can be transferred through the infusion adapter 20 to the fluid reservoir 15, via a second flow path, etc. Thus, the subsequent volume of bodily fluid can be substantially free of contaminants, etc., that would otherwise be included in the initial volume of bodily fluid. In other embodiments, the infusion adapter 20 can be configured to couple to a diversion device, etc., configured to divert and isolate the initial volume of bodily fluid. In still other embodiments, the diversion device, etc., can be integrated and / or included in the device 1 (e.g., disposed at least partially in the housing 10).

[0052] The collection, diversion, and / or isolation of the initial volume of bodily fluid can be performed in any suitable manner with any suitable device or combination of devices. For example, in some embodiments, the collection, diversion, and / or isolation of the initial volume of bodily fluid can be performed using any suitable method and / or device combination, including any of the methods described in the '420 patent, the '240 publication, and / or the '783 patent, U.S. Patent Publication No. 2015 / 0342510 (the '510 publication), filed June 2, 2015, entitled "Sterile Bodily-Fluid Collection Device and Methods," U.S. Patent Publication No. 8,535,241 (the '214 patent), filed October 12, 2012, entitled "Fluid Diversion Mechanism for Bodily-Fluid Sampling," U.S. Patent No. 8,535,241 (the '214 patent), filed May 29, 2013 ... No. 9,060,724 (the '724 patent), entitled "Syringe-Based Fluid Diversion Mechanism for Bodily-Fluid Sampling," filed on December 2, 2013; U.S. Patent No. 9,155,495 (the '495 patent), entitled "Devices and Methods for Syringe-Based Fluid Sampling," filed on June 13, 2016; No. 9,950,084 (the '084 patent), filed September 6, 2016, entitled "Apparatus and Methods for Maintaining Sterility of a Specimen Container," U.S. Patent Publication No. 2018 / 0353117 (the '117 publication), filed June 11, 2018, entitled "Fluid Control Devices and Methods of Using the Same," U.S. Patent Publication No. 2019 / 0076074 (the '074 publication), filed September 12, 2018, entitled "Fluid Control Devices and Methods of Using the Same," and / or U.S. Patent Publication No. 2019 / 0076074 (the '074 publication), filed December 7, 2018, entitled "Fluid Control Devices and Methods of Using the Same," This can be done using the apparatus (or portions thereof), concepts, and / or methods described in U.S. Patent Publication No. 2019 / 0175087 (the '087 publication), entitled "Same,"

[0053] In some cases, a user can use the device 1 to obtain a quantity of bodily fluid that is substantially free of contaminants, and then use the device 1 to deliver at least one desired and precise (e.g., appropriate, suitable, and / or recommended) volume of the procured bodily fluid to a corresponding sample reservoir, such as, for example, an aerobic or anaerobic culture bottle. For example, as described above, a user can establish a fluid connection between the fluid reservoir 15 and a bodily fluid source via the injection adapter 20 and the port 11 of the housing 10. In some cases, a user can engage the device 1, the injection adapter 20, and / or a device connected to the injection adapter 20 to divert and isolate an initial volume of bodily fluid. In other examples, a user can divert and isolate an initial volume of bodily fluid via a connected or separate diversion device. In still other examples, a user need not divert an initial volume of bodily fluid.

[0054] After establishing a fluid connection with a source of bodily fluid, a user may engage and / or manipulate the actuator 40 to transition the actuator 40 from a first state to or toward a second state. For example, the actuator 40 may be engaged and / or manipulated to move a plunger of the actuator 40 from a first position, in which the fluid reservoir 15 has a first volume (FIG. 1A), to (or toward) a second position, in which the fluid reservoir 15 has a second volume (FIG. 1B), which is greater than the first volume. Movement of the plunger from the first position to the second position may result in an increase in the volume of the fluid reservoir 15, which in turn creates a negative pressure differential and a pressure drop that are operable in drawing a volume of bodily fluid into the fluid reservoir 15. In some cases, diverting the initial volume of bodily fluid can ensure that the volume of bodily fluid transferred to fluid reservoir 15 is substantially free of contamination that could result in erroneous results during testing.

[0055] After drawing a predetermined volume of bodily fluid into the fluid reservoir 15, the volume indicator 50 can transition (e.g., automatically) from its first state (FIG. 1A) to a second state (FIG. 1B) to provide a user with an indication that the predetermined volume is contained in the fluid reservoir 15. In some cases, the predetermined volume can be based on a desired volume (e.g., 10.0 mL of bodily fluid) configured to be transferred to an aerobic culture bottle. In other embodiments, the predetermined volume can be any suitable volume. In some cases, the user can stop drawing bodily fluid after the predetermined volume is placed in the fluid reservoir 15. In other embodiments, the user can continue to engage and / or operate the actuator 40 to draw additional amounts of bodily fluid into the fluid reservoir 15. For example, in some embodiments, the user can engage and / or transition the volume indicator 50 to move the volume indicator 50 from its second state, thereby transferring additional amounts of bodily fluid to the fluid reservoir 15.

[0056] In some implementations, the actuator 40 arrangement can be configured to control, meter, and / or regulate the rate at which bodily fluid is transferred to the fluid reservoir 15 (e.g., to control, limit, and / or regulate the rate at which a plunger can move into or relative to the fluid reservoir 15). Thus, the negative pressure differential and / or suction force within the fluid reservoir 15 can be regulated and / or limited. Furthermore, limiting the rate of fluid transfer into the fluid reservoir 15 can enhance and / or facilitate collection of an appropriate, preferred, recommended, desired, and / or otherwise accurate volume of bodily fluid.

[0057] As shown in FIG. 1C, after transferring a desired amount of bodily fluid, for example, a user can remove the infusion adapter 20 from the port 11. The infusion adapter 20 and / or the amount of bodily fluid disposed therein can then be discarded and / or used for any other suitable process and / or purpose. In some cases, the user can then couple the port 11 to any suitable collection or sample reservoir, such as, for example, a culture bottle (and / or any collection device described herein). Thus, the port 11 of the housing 10 can be used to transfer fluid to the fluid reservoir 15 (e.g., function as an infusion port) and to transfer fluid from the fluid reservoir 15 (e.g., function as an outlet port).

[0058] In some cases, it may be desirable to transfer a predetermined and / or desired volume of bodily fluid to an anaerobic culture bottle, for example, for use in testing samples cultured in anaerobic media that may be relatively susceptible to false negatives as a result of insufficient sample volume. Additionally, in some embodiments, the volume indicator 50 may be configured to transition to and / or be automatically placed in a second state in response to a predetermined and / or desired volume of bodily fluid being transferred to a collection or sample reservoir (e.g., an anaerobic culture bottle). In some embodiments, the predetermined and / or desired volume of bodily fluid may be approximately 10.0 mL. In some cases, the additional amount or volume of bodily fluid contained in the fluid reservoir 15 may be dispensed to one or more additional collection and / or sample reservoirs based, at least in part, on the desired and / or predetermined volume of bodily fluid that is intended to be delivered to that particular type of collection and / or sample reservoir (e.g., in accordance with a manufacturer's instructions, instructions, and / or recommendations). Thus, the device 1 can be configured to obtain bodily fluid that is substantially free of contaminants and can be configured to distribute the obtained bodily fluid in a desired volume into one or more collection or sample reservoirs.

[0059] 2-8 show a bodily fluid collection and dispensing device 100 according to one embodiment. The bodily fluid collection and dispensing device 100 (also referred to herein as the "device") may be of any suitable shape size, and / or configuration. In some embodiments, the device 100 may have a size and / or shape that enhances and / or promotes ergonomics and / or ease of use. In some embodiments, the device 100 and / or at least a portion thereof may be similar in form and / or function to a syringe and / or similar device configured to receive and at least temporarily contain a fluid therein.

[0060] As described in further detail herein, device 100 can be operated to draw large volumes of bodily fluid into a portion of device 100 at a flow rate below a threshold flow rate. Although not shown in Figures 2-8, device 100 can include and / or be coupled to a portion of device configured to divert and at least temporarily isolate an initial volume of bodily fluid drawn from a source of bodily fluid (e.g., a patient). As described herein, diverting and isolating the initial volume of bodily fluid can reduce and / or substantially eliminate the presence of contaminants in subsequent volumes of bodily fluid drawn into a portion of device 100.

[0061] In some embodiments, the device 100 can be configured to provide one or more indications to a user regarding the volume or amount of bodily fluid transferred to a portion of the device 100. In some embodiments, after a known, predetermined, and / or desired volume of bodily fluid is drawn into a portion of the device 100, the device 100 and / or portions thereof suspend, inhibit, limit, and / or substantially prevent further use of the device 100 until a user provides an input that enables further use of the device 100. In some embodiments, the device 100 can be configured to couple to one or more sample reservoirs, bottles, containers, etc. after a volume of bodily fluid is drawn into a portion of the device 100. In such embodiments, the device 100 can be configured to dispense at least a portion of a volume of bodily fluid having a known, predetermined, and / or desired volume into at least one sample reservoir, bottle, and / or container, as described in further detail herein.

[0062] As shown in FIGS. 2-5, the device 100 includes a housing 110, a fluid reservoir 115, an injection adapter 120, an actuator 140, and a volume indicator 150. The housing 110 can be of any suitable shape, size, and / or configuration. For example, in some embodiments, the housing 110 can have an elongated and / or substantially cylindrical shape. In some embodiments, the size of the housing 110 can be based at least in part on a desired volume or amount of fluid to be contained therein, at least temporarily. The housing 110 is configured to contain, accommodate, and / or form at least a portion of the fluid reservoir 115, the actuator 140, and the volume indicator 150. The housing 110 includes a port 111 in fluid communication with the fluid reservoir 115 and configured to be physically and fluidly coupled, at least temporarily, to the injection adapter 120 (see, e.g., FIGS. 6 and 7). As described in more detail herein, in some cases, the injection adapter 120 can be removed or disconnected from the port 111, which can be physically and fluidly connected to one or more collection reservoirs, sample bottles, culture bottles, etc.

[0063] The fluid reservoir 115 is disposed within and / or formed by the housing 110. For example, in some embodiments, the fluid reservoir 115 may be formed separately from the housing 110 and inserted or disposed within a portion of the housing 110 during manufacture. In other embodiments, at least a portion of the housing 110 and at least a portion of the fluid reservoir 115 may be monolithically and / or integrally formed. In some embodiments, the housing 110 may form and / or define the fluid reservoir 115. The fluid reservoir 115 may have any suitable volume and / or may be any suitable volume. can define it. For example, in some embodiments, the fluid reservoir 115 can have a volume of about 5.0 mL to about 60.0 mL, about 10.0 mL to about 50.0 mL, about 20.0 mL to about 40.0 mL. In some embodiments, the fluid reservoir 115 can have a volume of about 20.0 mL. In other embodiments, the fluid reservoir 115 can have a volume less than about 5.0 mL or greater than about 60.0 mL. As described in more detail herein, and as shown in FIGS. 6 and 7, the fluid reservoir 115 is in fluid communication with the port 111 of the housing 110 and can therefore receive or convey a flow of fluid through the port 111.

[0064] The actuator 140 may be of any suitable shape, size, and / or configuration. For example, as shown in Figs. 5-7, the actuator 140 includes a plunger 141, one or more racks 142, a wheel 143, and one or more pinions 144. The plunger 141 is movably disposed within the fluid reservoir 115. In some embodiments, the plunger 141 may include a seal configured to form a fluid-tight seal with an inner surface of the fluid reservoir 115 (or the housing 110) and form at least a portion of the fluid reservoir 115. For example, the fluid reservoir 115 may be and / or may have a volume collectively defined by and / or between the inner surface, the seal of the plunger 141, and the port 111. In some cases, the actuator 140 may be manipulated to move the plunger 141 within the fluid reservoir 115, thereby increasing or decreasing the volume of the fluid reservoir 115.

[0065] As shown in FIGS. 6 and 7, one or more racks 142 are included with, formed by, and / or coupled to the plunger 141. As shown in the embodiment of FIGS. 2-8, the actuator 140 includes a set of two racks 142. In other embodiments, the actuator 140 can include any number of racks. The racks 142 can include and / or form a number of teeth, protrusions, ribs, etc. that extend along at least a portion of the racks 142. As shown in FIG. 5, a portion of the racks 142 can be disposed within and / or extend through one or more openings defined by the rear surface of the housing 110. As described in more detail herein, in some embodiments, such an arrangement can allow the racks 142, and thus the plunger 141, to move relative to the housing 110. Although shown as including racks 142, in other embodiments, the actuator can include any suitable features, members, and / or devices operable to move the plunger 141 relative to the housing 110.

[0066] 6, a wheel 143 of the actuator 140 is rotatably coupled to the housing 110 and fixedly coupled to one or more pinions 144. The wheel 143 may be of any suitable shape, size, and / or configuration. In some embodiments, the wheel 143 may be manipulated by a user (e.g., by the user's thumb) to rotate relative to the housing 140. The wheel 143 may have and / or include any surface features, contours, grips, etc. configured to facilitate and / or enhance contact between a user (e.g., the user's thumb) and the wheel 143.

[0067] One or more pinions 144 are fixedly coupled to the wheels 143 and are in contact with and / or configured to rotate along with the one or more racks 142. More specifically, the pinions 144 may include a set of teeth, protrusions, ribs, gears, etc. that are configured to correspond and / or mesh with the teeth, protrusions, ribs, etc. of the racks 142. In other words, the actuator 140 and / or at least a portion thereof forms and / or comprises a rack and pinion arrangement and / or configuration. The pinions 144 may achieve and / or may rotate in a desired ratio (e.g., gear ratio) with or for the wheels 143. That is, the wheel 143 and the pinion(s) 144 can have and / or define any suitable gear ratio such that an amount of rotation of the wheel 143 (e.g., generated by a user manipulating the wheel) results in a known, desired, and / or predetermined amount of rotation of the pinion 144. In some embodiments, for example, the wheel 143 can have a diameter of about 34 millimeters (mm) (about 1.34 inches (in)) and the pinion 144 can have a diameter of about 6.5 mm (about 0.26 in). In some embodiments, the pinion can have, for example, 8 teeth. In other embodiments, the pinion can have less than 8 teeth or more than 8 teeth. In some embodiments, the relationship between the rack 142, the wheel 143, and the pinion 144 can at least partially control the effective pressure (negative pressure) generated by the device 100, the sensitivity of the wheel 143, and the amount of haptic feedback associated with the actuation of the wheel 143. Furthermore, the pinion 144 can have any suitable orientation relative to the rack 142, which can then control the resulting direction associated with the movement of the plunger 141 for a given direction associated with the rotation of the wheel 143.

[0068] The wheel 143 and pinion 144 are coupled to the housing 110 to allow them to rotate relative to the housing 110 without substantially changing their translational position relative to the housing 110. In other words, the wheel 143 and pinion 144 are configured to rotate about an axis having a substantially fixed position relative to the housing 110. With the pinion 144 in contact and / or meshing with the rack 142, rotation of the wheel causes the pinion 142 to advance along the teeth or protrusions of the rack 142. In other words, rotation of the wheel 143 causes rotation of the pinion 143 at a known, predetermined, and / or expected rotational speed, which results in the plunger 141 translating within the housing 110 and / or the fluid reservoir 115 having a known, predetermined, and / or expected translational speed. Thus, as described in further detail herein, device 100 may be similar in function to a syringe, but may be configured to regulate the rate at which fluid is drawn into fluid reservoir 115 and / or may be configured to indicate and / or control the amount or volume of bodily fluid contained in fluid reservoir 115.

[0069] The volume indicator 150 may be of any suitable shape, size, and / or configuration. For example, in some embodiments, the volume indicator 150 is a button, a knob, a dial, a lever, a pointer, and / or any other suitable indicator. The volume indicator 150 may be configured to transition or be transitioned from a first state to a second state to provide an indication related to the volume of fluid disposed in the fluid reservoir 115. For example, the volume indicator 150 may transition (e.g., automatically) from the first state to the second state in response to a known, desired, and / or predetermined volume of bodily fluid being disposed in the fluid reservoir 115. In some embodiments, the known, desired, and / or predetermined volume may be, for example, any of those described above with respect to the device 1 shown in FIGS. 1A-1C. As an example, the volume indicator 150 can transition from a first state in which the volume indicator 150 (e.g., a button or other not shown in FIGS. 2-8) is depressed or substantially disposed within the housing 110 to a second state in which the volume indicator 150 is raised relative to the housing 110 (e.g., at least a portion of the button extends out of or from the housing 110). Thus, the volume indicator 150 can indicate to a user that 10.0 mL has been disposed in the fluid reservoir 110. In response, the user can decide to continue drawing additional amounts of bodily fluid into the fluid reservoir 115 (e.g., by continuing to engage the actuator 140) or to stop or terminate the procurement process.

[0070] In some embodiments, the volume indicator 150 also indicates the volume of the fluid in the fluid reservoir 110. The volume indicator 150 may be configured to place the device 100 and / or the actuator 140, at least temporarily, in a state or configuration that limits and / or substantially prevents movement of the plunger 141. For example, as described above, the volume indicator 150 may be a button (or the like) that can be moved or transitioned to a second state such that the button is raised relative to the housing 110 (e.g., at least a portion of the button extends off or from the surface of the housing 110). In some embodiments, the volume indicator 150 may selectively engage, for example, the rack 142 and / or other suitable portion of the actuator 140 to limit and / or substantially prevent movement of the plunger 141 while the volume indicator 150 is in the second state. Thus, a user may manipulate the volume indicator 150 and / or apply a force to the volume indicator 150 operable to transition the volume indicator 150 away from the second state. In some embodiments, for example, the volume indicator 150 may transition toward the first state and / or back to the first state. In other embodiments, the volume indicator 150 may transition toward and / or to a third state that is different from the first and second states.

[0071] As shown in FIGS. 6-8, the infusion adapter 120 is configured to be at least temporarily coupled to the port 111 of the housing 110. The infusion adapter 120 may be of any suitable shape, size, and / or configuration. The infusion adapter 120 may include a lumen-containing device configured to fluidly couple with a source of bodily fluid. For example, in some embodiments, the infusion adapter 120 may include a needle or catheter configured to be inserted into a patient's vein or artery. In other embodiments, the infusion adapter 120 may include a catheter and / or other conduit configured to establish a fluid connection between the infusion adapter 120 and an intermediate device (e.g., a shunt device, a placed intravenous catheter, and / or any other suitable device).

[0072] 6 and 7, when the injection adapter 120 is coupled to the housing 110, the injection adapter 120 is fluidly coupled to the port 111. For example, in some embodiments, the port 111 of the housing 110 can include a needle or other piercing member configured to advance through a penetrable, sealable, and / or frangible portion of the injection adapter 120. For example, the injection adapter 120 can include a self-sealing port that is pierced by the needle or piercing member of the port 111 when the injection adapter 120 is coupled thereto and returns to a sealed state or the like when the injection adapter 120 is removed from the housing 110. In such embodiments, the needle and / or piercing member can be positioned to fluidly couple an interior portion of the injection adapter 120 with the fluid reservoir 115, thereby allowing fluid (e.g., bodily fluid) to be transferred from the injection adapter 120 to the fluid reservoir 115.

[0073] As shown in FIG. 8, in some cases, the injection adapter 120 can be decoupled and / or otherwise removed from the housing 110 after the desired volume of fluid has been transferred to the fluid reservoir 115. Although not shown in FIG. 8, decoupling of the injection adapter 120 from the port 111 can expose a needle and / or piercing member coupled to the port 111, which can physically and / or fluidly couple the port 111 to any suitable external device and / or reservoir. For example, in some embodiments, the port 111 can be configured to physically and / or fluidly couple to a culture bottle or other sample reservoir. In other embodiments, the port 111 can be coupled to and / or include any suitable transfer adapter, such as, for example, those described in the '783 patent.

[0074] Although not shown in FIGS. 2-8, in some embodiments, the infusion adapter 120 collects, diverts, and / or isolates an initial volume of bodily fluid received from a bodily fluid source (e.g., a patient). For example, in some embodiments, the infusion adapter 120 can have a first state or configuration in which an initial volume of bodily fluid is transferred to a first portion of the infusion adapter 120 (e.g., via a first flow path, etc.) and can transition from the first state or configuration to a second state and / or configuration in which (1) the initial volume of bodily fluid is sequestered by or within the first portion of the infusion adapter 120 and (2) a subsequent volume of bodily fluid can be transferred through the infusion adapter 120 to the fluid reservoir 115, via a second flow path, etc. Thus, the subsequent volume of bodily fluid can be substantially free of contaminants, etc. that may otherwise be included in the initial volume of bodily fluid. In other embodiments, the infusion adapter 120 can be configured to couple to a diversion device, etc., configured to divert and isolate the initial volume of bodily fluid. In still other embodiments, a diversion device, etc., can be integrated and / or included in the device 100 (e.g., disposed at least partially in the housing 110).

[0075] The collection, diversion, and / or isolation of the initial volume of bodily fluid may be performed in any suitable manner with any suitable device or combination of devices. For example, in some embodiments, the collection, diversion, and / or isolation of the initial volume of bodily fluid may be performed using any of the devices (or portions thereof), concepts, and / or methods described in the '420 patent, the '783 patent, the '241 patent, the '724 patent, the '495 patent, the '084 patent, the '240 publication, the '510 publication, the '006 publication, the '117 publication, the '074 publication, and / or the '087 publication, described above with respect to device 1 shown in Figures 1A-1C and / or incorporated herein by reference.

[0076] In some cases, a user can use device 100 to obtain bodily fluid that is substantially free of contaminants and then use device 100 to deliver at least one desired and precise (e.g., appropriate, suitable, and / or recommended) volume of the procured bodily fluid to a corresponding sample reservoir, such as, for example, an aerobic or anaerobic culture bottle. For example, as described above, a user can establish a fluid connection between fluid reservoir 115 and a bodily fluid source via infusion adapter 120 and port 111 of housing 110. In some cases, a user can engage device 100, infusion adapter 120, and / or a device coupled to infusion adapter 120 to divert and isolate an initial volume of bodily fluid. After diverting the initial volume of bodily fluid, the user may rotate wheel 143 to transition and / or move plunger 141 from a first state, configuration, and / or position (e.g., a distal position as shown in FIGS. 6 and 7) to a second state, configuration, and / or position (e.g., a proximal position not shown in FIGS. 2-8). The movement of plunger 141 from the first state or position to the second state or position may result in an increase in the volume of fluid reservoir 115, which may in turn create a negative pressure differential and / or suction force operable to draw a subsequent volume of bodily fluid into fluid reservoir 115 that is substantially free of contaminants contained in the isolated initial volume.

[0077] After drawing a predetermined volume of bodily fluid into the fluid reservoir 115, the volume indicator 150 can transition (e.g., automatically) from its first state to a second state to provide a user with an indication that the predetermined volume is contained in the fluid reservoir 115. In some cases, the predetermined volume can be based on a desired volume (e.g., 10.0 mL of bodily fluid) configured to be transferred to an aerobic culture bottle. In other embodiments, the predetermined volume can be any suitable volume. In some cases, after the predetermined volume is placed in the fluid reservoir 115, the user can stop drawing bodily fluid. In other embodiments, the user can continue to rotate the wheel 143 to draw an additional amount of bodily fluid into the fluid reservoir 115. In some embodiments, the user can engage and / or transition the volume indicator 150 to move the volume indicator 150 out of its second state, thereby transferring an additional amount of bodily fluid to the fluid reservoir 115. As noted above, in some embodiments, the positioning of the actuator 140 can be adjusted to, for example, when the plunger 141 is in the fluid reservoir. The fluid reservoir 115 may be configured to control, meter, and / or regulate the rate at which bodily fluid is transferred to the fluid reservoir 115 by controlling, limiting, and / or regulating the rate at which fluid may move within or relative to the fluid reservoir 115. Thus, the negative pressure differential and / or suction force within the fluid reservoir 115 may be regulated and / or limited. Additionally, limiting the rate of fluid transfer to the fluid reservoir 115 may enhance and / or facilitate collection of an appropriate, preferred, recommended, and / or otherwise accurate volume of bodily fluid.

[0078] After transferring a desired amount of bodily fluid, for example, a user can remove the infusion adapter 120 from the port 111. The infusion adapter 120 and / or the amount of bodily fluid disposed therein can then be discarded and / or used for any other suitable process and / or purpose. In some cases, a user can then couple the port 111 to any suitable collection or sample reservoir, such as, for example, a culture bottle (and / or any collection device described herein). Thus, the port 111 of the housing 110 can be used to transfer fluid to a fluid reservoir (e.g., function as an infusion port) and to transfer fluid from a fluid reservoir (e.g., function as an outlet port).

[0079] In some cases, it may be desirable to transfer a predetermined and / or desired volume of bodily fluid to an anaerobic culture bottle, for example, for use in testing samples cultured in anaerobic media that may be relatively susceptible to false negatives as a result of insufficient sample volume. Additionally, in some embodiments, the volume indicator 150 may be configured to transition to and / or be automatically placed in a second state in response to a predetermined and / or desired volume of bodily fluid being transferred to a collection or sample reservoir (e.g., an anaerobic culture bottle). In some embodiments, the predetermined and / or desired volume of bodily fluid may be approximately 10.0 mL. In some cases, the additional amount or volume of bodily fluid contained in the fluid reservoir 115 may be dispensed to one or more additional collection and / or sample reservoirs based, at least in part, on the desired and / or predetermined volume of bodily fluid that is intended to be delivered to that particular type of collection and / or sample reservoir (e.g., in accordance with a manufacturer's instructions, instructions, and / or recommendations). Thus, device 100 can be configured to obtain bodily fluid that is substantially free of contaminants and can be configured to distribute the obtained bodily fluid in a desired volume to one or more collection or sample reservoirs.

[0080] Although device 100 is particularly shown in Figures 2-8, in other embodiments, any suitable changes in form may be made without departing from the functionality described above. For example, Figures 9-11 show bodily fluid collection and dispensing device 200 according to one embodiment. Bodily fluid collection and dispensing device 200 (also referred to herein as "device" 200) includes a housing 210, a fluid reservoir 215, an infusion adapter 220, an actuator 240, and a volume indicator 250. Device 200 is substantially similar in form and / or function to device 100 described above with reference to Figures 2-8. However, device 200 may differ in the placement and / or configuration of housing 210. For example, device 100 includes housing 110 configured to extend from a distal end portion of device 100 to a proximal end portion of device 100 (e.g., adjacent infusion adapter 120). 9-11, housing 210 extends from a distal end portion of device 200 toward a proximal end portion of 200, but is shorter than housing 110 of device 100. More specifically, housing 210 is configured to stop at a position along the length of the device proximally adjacent volume indicator 250. In other aspects, device 200 may be substantially similar to device 100, and thus will not be further detailed herein.

[0081] Although actuator 140 of device 100 is particularly shown in Figures 2-8 and described above, in other embodiments, the bodily fluid collection and dispensing device may include an actuator having any suitable configuration and / or arrangement without substantially departing from the function of actuator 140 described above (unless otherwise noted). More specifically, actuator 140 may include , configured to transition and / or move the plunger 141 between a first state and / or position (e.g., a distal position) to a second state and / or position (e.g., a proximal position) while limiting and / or regulating the speed at which the plunger 141 can move within and / or relative to the fluid reservoir 115. In other embodiments, the bodily fluid collection device can include an actuator having any suitable arrangement and / or configuration that can similarly transition and / or move the plunger while controlling, limiting and / or regulating the speed at which the plunger can be moved.

[0082] For example, Figure 12 illustrates a bodily fluid collection and dispensing device 300 according to one embodiment. The bodily fluid collection and dispensing device 300 (also referred to herein as "device" 300) may be substantially similar, at least in form and / or function, to devices 1, 100, and / or 200 described above. However, device 300 may differ in the arrangement and / or configuration of housings and actuators, while still being configured to, among other things, control, restrict, meter, and / or regulate the rate of transfer of fluid to and / or from device 300.

[0083] As shown in FIG. 12, device 300 includes at least housing 310, fluid reservoir 315, and actuator 340. Housing 310 includes infusion port 311 and outlet port 312. Housing 310 may be similar in form and / or function to housing 110 described above. Thus, housing 310 includes, contains, and / or at least partially houses fluid reservoir 315 and actuator 340. Infusion port 311 is configured to receive a flow of fluid (e.g., from a bodily fluid source). In some embodiments, infusion port 311 can be coupled to an infusion adapter, for example, similar to infusion adapter 120 described above. In other embodiments, infusion port 311 can be positioned to fluidly couple with a needle, catheter, and / or lumen defining device at least partially disposed in a patient. In still other embodiments, infusion port 311 can be positioned to fluidly couple with a flow diverter and / or flow diverter device, such as any of those described herein.

[0084] 12, in some embodiments, the injection port 311 and / or the housing 310 can form and / or define a channel, conduit, and / or flow passage configured to position the injection port 311 in fluid communication with a desired portion of the fluid reservoir 315. For example, the injection port 315 shown in FIG. 12 can be located on or at a distal end portion of the housing 310 and can include a channel, conduit, and / or flow passage (not shown) that can position the injection port 311 in fluid communication with a proximal end portion of the housing 310 and / or a proximal end portion of the fluid reservoir 315. In other embodiments, the injection port 311 can be located at any suitable location on or along the housing 310.

[0085] The outlet port 312 of the housing 310 is fluidly coupled to a portion of the fluid reservoir 315, as described in further detail herein. In some embodiments, the outlet port 312 can be located, for example, on, at, or near the proximal end portion of the housing 310. For example, as shown in FIG. 12, the outlet port 312 can be located at the proximal end portion of the housing 310 and can be located substantially opposite the inlet port 311.

[0086] The outlet port 312 is configured to be physically and / or fluidly coupled to a collection device, such as any of those described herein. For example, as shown at 12, the outlet port 312 can be physically and fluidly coupled to a sample or culture bottle. In some embodiments, the outlet port 312 can include a shielded needle and / or other suitable piercing member configured to pierce a portion of the collection device to establish a fluid connection therebetween. In other embodiments, the outlet port 312 can include any suitable features, members, devices, etc. configured to establish a fluid connection between the outlet port 312 and a collection device.

[0087] The actuator 340 of the device is substantially similar in form and / or function to the actuator 140 described above with respect to the device 100. For example, the actuator 340 may include a wheel configured to be rotated by a user to move the plunger within and / or relative to the housing 310 and / or fluid reservoir 315 (e.g., moved between a first state and / or position and a second state and / or position). However, the actuator 340 may differ from the actuator 140 by the position and / or orientation of the wheel. For example, as shown in 12, the wheel may be configured to rotate about an axis that is substantially perpendicular to the axis about which the wheel 143 of the actuator 140 rotates. In some embodiments, the arrangement of the actuator 340 may be such that the plunger and / or a seal included in or on the plunger may be disposed in a proximal position within the fluid reservoir 315 when the plunger is in a first state and / or position, and disposed in a distal position within the fluid reservoir 315 when the plunger is in a second state (as shown in 12). Additionally, the actuator 340 may be configured to control, limit, meter, and / or adjust the rate at which the plunger moves within or relative to the fluid reservoir 315, as described in detail above with respect to the device 100.

[0088] 12, the inlet port 311 of the housing 310 and the outlet port 312 of the housing 310 are each in fluid communication with a portion of the fluid reservoir 315 proximal to the plunger and / or a seal on the plunger. In some cases, the wheel can be operable to draw a volume of fluid into the fluid reservoir 315 (e.g., proximal to the plunger or its seal) through the inlet port 311 by manipulating the plunger from a first state or position to a second state or position, and the wheel can be operable to convey at least a portion of the volume of fluid from the fluid reservoir 315 via the outlet port 312 by manipulating the plunger from the second state or position to the first state or position. Thus, as described above with respect to the devices 1, 100 and / or 200, the device 100 can be configured to obtain bodily fluid that is substantially free of contaminants and can be configured to distribute the obtained bodily fluid in a desired volume into one or more collection or sample reservoirs.

[0089] 13 illustrates another embodiment of a bodily fluid collection and dispensing device 400. The bodily fluid collection and dispensing device 400 (also referred to herein as "device" 400) may be substantially similar, at least in form and / or function, to devices 100, 200, and / or 300 described above. However, device 400 may differ in the placement and / or configuration of actuators, while still being configured to, among other things, control, restrict, meter, and / or regulate the rate of transfer of fluid to and / or from device 400.

[0090] 13, device 400 includes at least a housing 410, a fluid reservoir 415, and an actuator 440. Housing 410 includes an inlet port 411 configured to convey a flow of fluid (e.g., bodily fluid) to fluid reservoir 415, and an outlet port 412 configured to convey a flow of fluid (e.g., bodily fluid) from fluid reservoir 415. In some embodiments, housing 410 may be substantially similar in form and / or function to housing 310 described above. Accordingly, housing 410 will not be described in further detail herein.

[0091] The actuator 440 of the device is at least substantially similar in function to the actuators 140 and / or 340 described above. For example, the actuator 440 may move a plunger within and / or between the housing 410 and / or the fluid reservoir. The actuator 440 may include an engagement member 443 (e.g., similar to wheels 143, 243, and / or 343) configured to be rotated by a user to move the plunger relative to the fluid reservoir 415 (e.g., to move between a first state and / or position and a second state and / or position). However, the actuator 440 may differ by including a plunger including and / or disposed as a lead screw, a worm gear, and / or any other threaded member configured to engage with a corresponding internal portion of the engagement member 443. Thus, rotating the engagement member 443 may transition and / or move the plunger relative to and / or within the fluid reservoir 415. Additionally, the actuator 440 may be configured to control, limit, meter, and / or regulate the rate at which the plunger moves in or relative to the fluid reservoir 415, as described in detail above with respect to the device 100. Thus, as described above with respect to any of devices 1, 100, 200 and / or 300, device 400 can be configured to obtain bodily fluid that is substantially free of contaminants and can be configured to distribute the obtained bodily fluid in a desired volume to one or more collection or sample reservoirs.

[0092] 14 illustrates another embodiment of a bodily fluid collection and dispensing device 500. The bodily fluid collection and dispensing device 500 (also referred to herein as "device" 500) may be substantially similar, at least in form and / or function, to devices 1, 100, 200, 300 and / or 400 described above. However, device 500 may differ in the placement and / or configuration of actuators, while still being configured to, among other things, control, restrict, meter and / or regulate the rate of transfer of fluid to and / or from device 500.

[0093] 14, device 500 includes at least a housing 510, a fluid reservoir 515, and an actuator 540. Housing 510 includes an inlet port 511 configured to convey a flow of fluid (e.g., bodily fluid) to fluid reservoir 515, and an outlet port 512 configured to convey a flow of fluid (e.g., bodily fluid) from fluid reservoir 515. In some embodiments, housing 510 may be substantially similar in form and / or function to housings 10, 110, 210, 310, and / or 410 described above. Accordingly, housing 510 will not be described in further detail herein.

[0094] The actuator 540 of the device is at least substantially similar in function to the actuator 140 described above with respect to the device 100. While the actuator 140 is described above as including a wheel 143 configured to rotate one or more pinions 144 to translate and / or move the plunger 141, the actuator 540 includes a lever 546 configured to engage a rack 542 coupled to, contained within, and / or formed by the plunger 541. In the embodiment shown in FIG. 14, a user can engage a portion of the plunger 541 to move the plunger 541 between a first state and / or position (FIG. 14) and a second state and / or position within and / or relative to the housing 510 and / or fluid reservoir 515. As described in detail above with respect to device 100, further, in some cases, lever 546 may engage rack 542 of plunger 541 to control, limit, meter, and / or adjust the speed at which plunger 541 moves within or relative to fluid reservoir 515. In some cases, a user may apply a desired amount of force to lever 546 while moving plunger 541 to further adjust the speed at which plunger 541 is moved and / or the ease associated with the movement of plunger 541. Thus, as described above with respect to any of devices 1, 100, 200, 300 and / or 400, device 500 may be configured to obtain bodily fluid that is substantially free of contaminants and to distribute the obtained bodily fluid in a desired volume into one or more collection or sample reservoirs.

[0095] 15 illustrates a bodily fluid collection and distribution device 600 according to another embodiment. Device 600 (also referred to herein as "device" 600) may be substantially similar, at least in form and / or function, to devices 1, 100, 200, 300, 400 and / or 500 described above. However, device 600 may differ in the placement and / or configuration of actuators, while still being configured to, among other things, control, restrict, meter and / or regulate the rate of transfer of fluid to and / or from device 600.

[0096] 15, device 600 includes at least a housing 610, a fluid reservoir 615, and an actuator 640. Housing 610 includes an inlet port 611 configured to convey a flow of fluid (e.g., bodily fluid) to fluid reservoir 615, and an outlet port 612 configured to convey a flow of fluid (e.g., bodily fluid) from fluid reservoir 615. In some embodiments, housing 610 may be substantially similar in form and / or function to housings 10, 110, 210, 310, and / or 410 described above. Accordingly, housing 610 will not be described in further detail herein.

[0097] The actuator 640 of the device is at least substantially similar in function to the actuator 140 described above with respect to the device 100. While the actuator 140 is described above as including a wheel 143 configured to rotate one or more pinions 144 to transition and / or move the plunger 141, the actuator 640 is configured to be operable to generate, create, and / or generate a negative pressure differential and / or suction force to move the plunger of the actuator 640. For example, as shown in FIG. 15, the actuator 640 includes a bulb 647 in fluid communication with a portion of the fluid reservoir 615. In use, the bulb 647 can be squeezed by a user to transition the actuator 640 and / or its plunger between a first state and a second state. More specifically, in response to the bulb 647 being squeezed by a user, air and / or other contents within the bulb 647 can be released to the surrounding environment or atmosphere (e.g., via a one-way valve or the like, not shown in FIG. 15). After expelling the contents, the user can release bulb 647, causing bulb 647 to return to an uncompressed state. The volume within bulb 647 then increases, resulting in a negative pressure differential and / or suction force being applied within fluid reservoir 615 or a portion thereof in communication with bulb 647. The negative pressure differential and / or suction force is then sufficient to move the plunger within fluid reservoir 615.

[0098] In some embodiments, the configuration of bulb 647 is such that the amount or degree of negative pressure differential and / or suction force applied within or to fluid reservoir 615 is limited and / or controlled. In some cases, bulb 647 is squeezed multiple times to move the plunger a desired amount or distance (e.g., from a first state or position to a second state or position). Thus, actuator 640 may be configured to control, limit, meter, and / or regulate the rate at which the plunger moves within or relative to fluid reservoir 615, as described in detail above with respect to device 100. Thus, device 600 may be configured to obtain bodily fluid that is substantially free of contaminants, and may be configured to dispense the obtained bodily fluid into one or more collection or sample reservoirs in a desired volume, as described above with respect to any of devices 1, 100, 200, 300, 400, and / or 500.

[0099] Although the volume indicator 150 of the device 100 is particularly shown in FIGS. 2-8 and described above, in other embodiments, the bodily fluid collection and dispensing device may include a volume indicator having any suitable configuration and / or arrangement without substantially departing from the functionality of the volume indicator 150 described above (unless otherwise noted). More specifically, the volume indicator 150 is configured to transition and / or move from a first state to a second state in response to a known, desired, and / or predetermined volume of bodily fluid being disposed within the fluid reservoir 115. Further, in some embodiments, the volume indicator 150 may be configured to transition and / or move from a first state to a second state in response to a known, desired, and / or predetermined volume of bodily fluid being disposed within the fluid reservoir 115. Thus, the volume indicator 115 may be configured to selectively suspend, limit, and / or prevent additional amounts of bodily fluid from being transferred to the fluid reservoir 115 while the volume indicator 115 is in the second state. In other embodiments, the bodily fluid collection device may include a volume indicator having any suitable arrangement and / or configuration capable of indicating and / or controlling a volume of bodily fluid disposed therein, capable of being disposed therein, and / or configured to be dispensed from the fluid reservoir, similarly transitioning and / or moving between at least the first and second states.

[0100] 16-19, for example, illustrate a bodily fluid collection and dispensing device 700 according to one embodiment, shown in a first state, a second state, a third state, and a fourth state, respectively. The bodily fluid collection and dispensing device 700 (also referred to herein as "device" 700) may be at least substantially similar in form and / or function to device 100 described above. However, device 700 may differ in the placement and / or configuration of a volume indicator, among other things, while providing an indication of the volume of fluid (e.g., bodily fluid) within device 700 and / or the device, and / or being configured to control, restrict, and / or dispense at least a portion of the volume of fluid within device 700.

[0101] As shown in Figures 16-19, device 700 includes at least a housing 710, a fluid reservoir 715, an actuator 740, and a volume indicator 750. Housing 710 includes a port 711 configured to convey a flow of fluid (e.g., bodily fluid) to and / or from fluid reservoir 715. In some embodiments, housing 710 may be substantially similar in form and / or function to housings 10 and / or 110 described above. In some embodiments, housing 710 may be similar to a housing of a syringe or the like. Accordingly, certain portions and / or aspects of housing 710 will not be described in further detail herein.

[0102] Actuator 740 may be of any suitable shape, size, and / or configuration. In some embodiments, actuator 740 may include at least a plunger configured to transition and / or move within and / or relative to fluid reservoir 715. In some embodiments, for example, actuator 740 is similar, at least in form and / or function, to any of actuators 40, 140, 240, 340, 440, 540, and / or 640 described above. In other embodiments, actuator 740 may be similar to an actuator of a syringe and / or the like. Accordingly, certain portions and / or aspects of actuator 740 are not described in further detail herein.

[0103] As described in detail above with reference to device 100, the volume indicator 750 of device 700 may be of any suitable shape, size, and / or configuration and may be configured to provide an indication of a volume of fluid (e.g., bodily fluid) in the fluid reservoir 715 and / or to control, restrict, and / or dispense at least a portion of the volume of fluid in the fluid reservoir 715. As shown in FIGS. 16-19 , the volume indicator 750 includes an indicator member 751 (e.g., an arm, an arrow, a rod, a dial, and / or any other suitable indicator). Further, in some embodiments, a portion of the housing 710 (e.g., a surface such as an exterior surface) may define a track 752 within which at least a portion of the indicator member 751 is disposed. The indicator member 751 is configured to rotate relative to the housing 710 to move a portion of the indicator member 751 through one or more portions of the track 752 that are based at least in part on the position of the plunger within the housing 710 (and thus the volume of fluid in the fluid reservoir 715). Further, based on the portion of the track 752 on which the portion of the indicating member 751 is located, the indicating member 751 may be configured to indicate and / or display a housing that is associated with and / or indicative of a known, predetermined, and / or desired volume of fluid disposed within the fluid reservoir 715. 710 or device 700.

[0104] For example, the indicating member 751 may be aligned with indicia such as "pediatric" and a portion of the indicating member 751 may be disposed on a first portion of the track 752 (e.g., the pediatric portion of the track 752) when the volume indicator 750 is in a first state (FIG. 16). The indicating member 751 may be aligned with indicia such as "anaerobic" and a portion of the indicating member 751 may be disposed on a second portion of the track 752 (e.g., the anaerobic portion of the track 752) when the volume indicator 750 is in a second state (FIG. 17). The indicating member 751 may be aligned with indicia such as "aerobic" and a portion of the indicating member 751 may be disposed on a third portion of the track 752 (e.g., the aerobic portion of the track 752) when the volume indicator 750 is in a third state (FIGS. 18 and 19).

[0105] In use, a user can operate the actuator 740 to draw a flow of fluid (e.g., bodily fluid) through the port 711 of the housing 710 and into the fluid reservoir 715. In some cases, the volume indicator 750 can be in a first state ( FIG. 16 ), and a user can operate the actuator 740 to draw a predetermined volume of fluid (e.g., a relatively small volume) suitable for testing a sample drawn from a pediatric patient into the fluid reservoir 715 until a portion of the indicating member 751 reaches an end of a first portion of the track 752. In some embodiments, the indicating member 751 reaching an end of the first portion of the track 752 can limit and / or substantially prevent an additional amount and / or volume of bodily fluid from being drawn into the fluid reservoir 715 until the volume indicator 750 transitions from the first state to the second state.

[0106] In some cases, volume indicator 750 can be placed in a second state ( FIG. 17 ) and a user can operate actuator 740 to draw a predetermined volume of fluid suitable for anaerobic culture testing (e.g., a volume greater than a pediatric volume) into fluid reservoir 715 until a portion of indicating member 751 reaches an end of a second portion of track 752. In some embodiments, indicating member 751 reaching an end of a second portion of track 752 can limit and / or substantially prevent additional amounts and / or volumes of bodily fluid from being drawn into fluid reservoir 715 until volume indicator 750 transitions from the second state to a third state.

[0107] In some cases, the volume indicator 750 can be placed in a third state (FIGS. 18 and 19), and a user can operate the actuator 740 to draw a predetermined volume of fluid suitable for aerobic culture testing (e.g., a volume greater than the anaerobic volume) into the fluid reservoir 715 until the portion of the indicating member 751 reaches the end of the third portion of the track 752 (e.g., the fourth state shown in FIG. 19). In some embodiments, the indicating member 751 reaching the end of the portion of the track 752 can limit and / or substantially prevent an additional amount and / or volume of bodily fluid from being drawn into the fluid reservoir 715. In other words, the end of the third portion of the track 752 can be a stop or limit to or on the range of motion of the actuator 740 relative to the housing 710. In some cases, a user can operate the actuator 740 to transfer a volume of bodily fluid from the fluid reservoir 715 to one or more sample or culture bottles (or the like) based at least in part on the amount or volume of bodily fluid contained in the fluid reservoir. Thus, the volume indicator 750 can provide an indication related to the amount or volume of bodily fluid disposed within the fluid reservoir 715 and can provide a means for distributing the bodily fluid to one or more collection devices based on at least a partial volume of the bodily fluid disposed in the fluid reservoir.

[0108] 20-22 are diagrams showing different configurations of the first, second, and third states, respectively. 8 illustrates a bodily fluid collection and dispensing device 800 according to an embodiment. The bodily fluid collection and dispensing device 800 (also referred to herein as "device" 800) may be at least substantially similar in form and / or function to devices 100 and / or 700 described above. However, device 800 may differ in the placement and / or configuration of volume indicators while being configured to, among other things, provide an indication of the volume of fluid (e.g., bodily fluid) within device 800 and / or the device and / or to control, restrict, and / or dispense at least a portion of the volume of fluid within device 800.

[0109] 20-22, device 800 includes at least a housing 810, a fluid reservoir 815, an actuator 840, and a volume indicator 850. Housing 810 includes a port 811 configured to convey a flow of fluid (e.g., bodily fluid) to and / or from fluid reservoir 815. In some embodiments, housing 810 may be substantially similar in form and / or function to housing 110 described above. In some embodiments, housing 810 may be similar to a housing of a syringe or the like. Accordingly, certain portions and / or aspects of housing 810 will not be described in further detail herein.

[0110] Actuator 840 may be of any suitable shape, size, and / or configuration. In some embodiments, actuator 840 may include at least plunger 841 configured to transition and / or move within and / or relative to fluid reservoir 815. In some embodiments, for example, actuator 840 is similar, at least in form and / or function, to any of actuators 40, 140, 240, 340, 440, 540, 640, and / or 740 described above. In other embodiments, actuator 840 may be similar to actuators such as syringes. Accordingly, certain portions and / or aspects of actuator 840 are not described in further detail herein.

[0111] In the embodiment shown in FIGS. 20-22, the volume indicator 850 may include two indicating members 851 disposed on the plunger 841 and configured to move along corresponding tracks 848 (e.g., ridges, protrusions, paths, etc.) formed by and / or extending from the plunger 841. In some embodiments, the indicating members 851 may be configured to selectively engage corresponding tracks 842 of the plunger 841. For example, in some embodiments, each track 842 may have a different shape and / or contour such that the track 842 contacts the indicating members 851 after a predetermined and / or desired amount of movement of the plunger 841. More specifically, in some embodiments, the first track 842 may be configured to engage and / or move with the first indicating member 851 in response to the plunger 841 being moved a first amount or distance, and the second track 842 does not engage with the second indicating member 851 ( FIG. 21 ). In some embodiments, the movement and / or engagement of the first indicating member 851 provides an indication to the user that a first predetermined and / or known volume of bodily fluid has been disposed within the fluid reservoir 815. In some cases, the user can continue to move the plunger 841 an additional amount (e.g., a second amount or distance), which can cause the second track 842 to engage and / or move into contact with the second indicating member 851 ( FIG. 22 ). In this manner, movement of the second indicating member 851 can provide an indication to the user that a second predetermined and / or known volume of bodily fluid has been disposed within the fluid reservoir 815.

[0112] 23-25 ​​illustrate another embodiment of a bodily fluid collection and dispensing device 900, shown in a first, second, and third condition, respectively. The bodily fluid collection and dispensing device 900 (also referred to herein as "device" 900) may be at least substantially similar in form and / or function to devices 1, 100, 700, and / or 800 described above. However, , device 900 may be configured to, among other things, provide an indication of the volume of fluid (e.g., bodily fluid) within device 900 and / or the device, and / or to control, restrict, and / or dispense at least a portion of the volume of fluid within device 900, while the placement and / or configuration of the volume indicator may vary.

[0113] As shown in FIGS. 23-25, the device 900 includes at least a housing 910, a fluid reservoir 915, an actuator 940, and a volume indicator 950. The housing 910 includes a port 911 configured to convey a flow of fluid (e.g., bodily fluid) to and / or from the fluid reservoir 915. In some embodiments, the housing 910 may be substantially similar in form and / or function to the housings 110, 710, and / or 810 described above. In some embodiments, the housing 910 may be similar to a housing of a syringe, or the like. Additionally, the actuator 940 may be similar in form and / or function to any of the actuators 40, 140, 240, 340, 440, 540, 640, 740, and / or 840 described above. In other embodiments, the actuator 940 may be similar to an actuator of a syringe, or the like. Accordingly, certain portions and / or aspects of the housing 910 and / or actuator 940 will not be described in further detail herein.

[0114] In the embodiments shown in Figures 23-25, the volume indicator 950 can include an indicating member 951 configured to move along a portion of the actuator 940. In some embodiments, the portion of the actuator 940 can be configured to selectively engage the indicating member 951 in response to the actuator 940 moving a first amount or distance. More specifically, in some embodiments, the volume indicator 950 can be in a first state or position when the actuator 950 is in a first state or position, as shown in Figure 23, the volume indicator 950 can transition to a second state or position when the actuator 950 is disposed in a second state or position, as shown in Figure 24, and the volume indicator 950 can transition to a third state or position when the actuator 950 is disposed in a third state or position, as shown in Figure 25. As described above with respect to any of devices 1, 100, 200, 300, 400, 500, 600, 700, and / or 800, in this manner, the volume indicator 950 can be configured to provide an indication to the user related to and / or indicative of the volume of bodily fluid drawn into the fluid reservoir 915 in response to moving the actuator 940 a known or predetermined amount.

[0115] For example, Figure 26 illustrates a bodily fluid collection and dispensing device 1000 according to one embodiment. The bodily fluid collection and dispensing device 1000 (also referred to herein as "device" 1000) may be substantially similar, at least in form and / or function, to at least the devices 1, 100, 700, 800, and / or 900 described above. However, device 1000 may differ in the placement and / or configuration of volume indicators while being configured, among other things, to provide an indication of the volume of device 1000 and / or fluid (e.g., bodily fluid) within the device and / or to control, restrict, and / or dispense at least a portion of the volume of fluid within device 1000.

[0116] 26, the device 1000 includes at least a housing 1010, a fluid reservoir 1015, an actuator 1040, and a volume indicator 1050. The housing 1010 includes an inlet port 1011 configured to deliver a flow of fluid (e.g., bodily fluid) to the fluid reservoir 1015, and at least one outlet port 1012 configured to deliver a desired volume or portion of the bodily fluid disposed within the fluid reservoir 1015. In some embodiments, the housing 1010 may be substantially similar in form and / or function to the housings 110, 710, 810, and / or 910 described above. In some embodiments, the housing 1010 may be similar to a housing of a syringe, or the like. Additionally, the actuator 1040 may include a volume indicator 1050. The actuator 1040 may be similar, at least in form and / or function, to any of the actuators 40, 140, 240, 340, 440, 540, 640, 740, 840, and / or 940 described above. In other embodiments, the actuator 1040 may be similar to an actuator such as a syringe. Accordingly, certain portions and / or aspects of the housing 1010 and / or actuator 1040 are not described in further detail herein.

[0117] 26 may be substantially similar, at least in function, to the volume indicators 50, 150, 750, 850, and / or 950 of devices 100, 700, 800, and / or 900, respectively. While the volume indicators 750, 850, and 950 are described above as including an indicating member that transitions in response to movement of at least a portion of an actuator, the volume indicator 1050 shown in FIG. 26 may be and / or include, such as a switch that can transition between one or more states and / or configurations to control and / or dispense one or more volumes of bodily fluid drawn into the fluid reservoir 1015. For example, in some embodiments, the switch of the volume indicator 1050 may be a first state and / or configuration in which the device 1000 is configured or enabled for a desired amount of bodily fluid into the fluid reservoir 1015. In some cases, after placing a desired amount of bodily fluid in the fluid reservoir 1015, the user may transition the volume indicator 1050 to a second state and / or configuration in which a first known and / or predetermined volume of bodily fluid may be delivered and / or dispensed to one or more collection devices. In some cases, the second state may be effective and / or enable the user to deliver and / or dispense a large volume of bodily fluid that is associated with and / or otherwise suitable for aerobic culture testing (through one of the outlets 1012) or anaerobic culture testing (e.g., through the outlets 1012). Thus, the device 1000 may be configured to provide an indication related to the volume placed in the fluid reservoir 1015 and / or to deliver and / or dispense a known and / or predetermined volume of bodily fluid to one or more collection devices based at least in part on the type of testing and / or analysis to be performed.

[0118] 27 and 28, for example, depict a bodily fluid collection and dispensing device 1100 according to one embodiment, shown in a first state and a second state, respectively. The bodily fluid collection and dispensing device 1100 (also referred to herein as "device" 1100) may be substantially similar, at least in form and / or function, to devices 1, 100, 700, 800, 900 and / or 1000 described above. However, device 1100 may differ in the placement and / or configuration of volume indicators while being configured, among other things, to provide an indication of the volume of fluid (e.g., bodily fluid) within device 1100 and / or the device, and / or to control, restrict and / or dispense at least a portion of the volume of fluid within device 1100.

[0119] 27 and 28, the device 1100 includes at least a housing 1110, a fluid reservoir 1115, an actuator 1140, and a volume indicator 1150. The housing 1110 includes a port 1111 configured to convey a flow of fluid (e.g., bodily fluid) to and / or from the fluid reservoir 1115. In some embodiments, the housing 1110 may be substantially similar in form and / or function to the housings 10, 110, 710, 810, 910, and / or 1010 described above. In some embodiments, the housing 1110 may be similar to a housing of a syringe or the like. Additionally, the actuator 1140 may be similar in form and / or function to any of the actuators 40, 140, 240, 340, 440, 540, 640, 740, 840, 940, and / or 1040 described above. In other embodiments, the actuator 1140 may be similar to an actuator such as a syringe, etc. Accordingly, certain portions and / or aspects of the housing 1110 and / or the actuator 1140 are not described in further detail herein.

[0120] The volume indicator 1150 of the device 1100 shown in Figures 27 and 28 may be substantially similar, at least in function, to the volume indicators 50, 150, 750, 850, 950 and / or 1050 of the devices 1, 100, 700, 800, 900 and / or 1000, respectively. For example, while the volume indicator 1050 is shown as a switch, in the embodiment shown in Figures 27 and 28, the volume indicator 1150 is arranged and / or configured as a dial or the like that can be transitioned between one or more states and / or configurations to control and / or dispense one or more volumes of bodily fluid drawn into the fluid reservoir 1115. Thus, the volume indicator 1150 may function in a manner similar to the volume indicator 1050 shown and described above with respect to Figure 26.

[0121] Although devices 1, 100, 200, 300, 400, 500, 600, 700, 800, 900, 1000, and / or 1100 are shown and described above as including a single fluid reservoir, in other embodiments, the bodily fluid collection and dispensing device can include any number of fluid reservoirs configured to receive a volume of bodily fluid based at least in part on one or more tests intended to be performed on the bodily fluid. For example, FIG. 29 illustrates a bodily fluid collection and dispensing device 1200 according to one embodiment. The bodily fluid collection and dispensing device 1200 (also referred to herein as "device 1200") can be substantially similar, at least in form and / or function, to any of the devices described above. However, device 1200 can differ by including at least two fluid reservoirs, each configured to receive a predetermined and / or desired volume of bodily fluid.

[0122] As shown in FIG. 29 , the device 1200 includes at least a housing 1210, a fluid reservoir 1215, an actuator 1240, and a volume indicator 1250. The housing 1210 includes a port 1211 configured to convey a flow of fluid (e.g., bodily fluid) to and / or from the fluid reservoir 1215. In some embodiments, the housing 1210 may be substantially similar in form and / or function to any of the housings described above. In some embodiments, the housing 1210 may be similar to a housing such as a syringe. Additionally, the actuator 1240 may be similar in at least form and / or function to any of the actuators described above. In other embodiments, the actuator 1240 may be similar to an actuator such as a syringe. Accordingly, certain portions and / or aspects of the housing 1210 and / or the actuator 1240 are not described in further detail herein.

[0123] As shown in FIG. 29, the actuator 1240 can include a first portion configured to be disposed and / or engaged with a first fluid reservoir and a second portion configured to be disposed and / or engaged with a second fluid reservoir. Additionally, the volume indicator 1250 of the device 1200 can be configured to selectively engage one or more portions of the actuator 1240 to control, restrict, and / or selectively enable the first portion of the actuator 1240 or the second portion of the actuator 1240 to move within and / or relative to the corresponding fluid reservoir 1215. Thus, the volume indicator 1250 can selectively control the flow of a predetermined and / or known volume of bodily fluid into one or more fluid reservoirs 1215. In some embodiments, the volume indicator 1250 can similarly control and / or distribute a desired portion of the bodily fluid to any number of collection devices. In some cases, the volume indicator 1250 can be configured to distribute a predetermined volume of bodily fluid to a collection device based at least in part on a test or analysis performed on the bodily fluid.

[0124] Although the infusion adapter 120 of the bodily fluid collection and dispensing device 100 has been described above as including and / or being coupled to a device configured to receive, divert, and / or isolate an initial volume of bodily fluid from a bodily fluid source, in other embodiments, the bodily fluid collection and dispensing device may further include an infusion adapter 120. can include a flow diverter having any suitable configuration and / or arrangement without substantially departing from the functionality of the flow diverter devices described above. For example, Figures 30-34 show a bodily fluid collection and distribution device 1300 according to one embodiment. The bodily fluid collection and distribution device 1300 (also referred to herein as "device" 1300) may be substantially similar, at least in form and / or function, to at least device 1 described above with respect to Figures 1A-1C and / or device 100 described above with respect to Figures 2-8. However, device 1300 may differ by including a flow diverter and / or flow diverting device or mechanism within the housing of device 1300 and / or otherwise integrated into device 1300.

[0125] As shown in FIGS. 30-34 , the device 1300 includes at least a housing 1310, a fluid reservoir 1315, an infusion adapter 1320, an actuator 1340, a volume indicator 1350, and a flow diverter 1370. The housing 1310 includes a port 1311 configured to convey a flow of fluid (e.g., bodily fluid) to and / or from the fluid reservoir 1315. In some embodiments, the housing 1310 may be substantially similar in form and / or function to any of the housings described above. In some embodiments, the infusion adapter 1320 may be substantially similar in form and / or function to the infusion adapter 120 described above with respect to FIGS. 2-8. In some embodiments, the actuator 1340 may be similar at least in form and / or function to any of the actuators described above. In some embodiments, the volume indicator 1350 may be substantially similar in form and / or function to the volume indicator 150 described above with respect to FIGS. 2-8, for example. Accordingly, certain portions and / or aspects of the housing 1310, injection adapter 1320, actuator 1340, and / or volume indicator 1350 will not be described in further detail herein.

[0126] As described above, the flow diverter 1370 can be configured to (1) receive an initial volume of bodily fluid drawn from a bodily fluid source (e.g., a patient) and (2) isolate the initial volume of bodily fluid such that a subsequent volume of bodily fluid drawn into the fluid reservoir 1315 is substantially free of contaminants contained in the subsequent volume. The flow diverter 1370 of the device 1300 can be of any suitable shape, size, and / or configuration. As shown in FIGS. 32-34 , the flow diverter 1370 is disposed within the housing 1310, and more specifically, within a portion of the actuator 1340. In some embodiments, the flow diverter 1370 can include a pre-sample reservoir 1372 configured to receive a plunger or seal included within and / or coupled to the actuator 1340. The flow diverter 1370 further includes a needle 1371 or other conduit configured to penetrate and / or at least temporarily extend through a seal 1373 disposed within a plunger of the actuator 1340.

[0127] The flow diverter 1370 is configured to transition between a first state and a second state in response to the actuator 1340 transitioning and / or moving relative to the housing 1310. For example, the flow diverter 1370 may be in the first state when the actuator 1340 is in a first or distal position within the fluid reservoir 1315, as shown in FIG. 32. More specifically, when the flow diverter 1370 is in the first state, the needle 1371 may be positioned to extend through the seal 1373 to fluidly couple a pre-sample reservoir 1372 of the flow diverter 1370 with the injection adapter 1320. Thus, when a user operates the device 1300 to draw bodily fluid from a bodily fluid source (e.g., a patient), the pre-sample reservoir 1372 may receive an initial volume of bodily fluid.

[0128] 33, a user can manipulate the actuator 1340 to transition the flow diverter 1370 from a first state to a second state. In some embodiments, manipulating the actuator 1340 can include, for example, moving a portion or plunger of 1340 within the pre-sample reservoir 1372, which in turn displaces the pre-sample reservoir. 33 , the needle 1371 may also be withdrawn from the seal 1373 and placed in the pre-sample reservoir 1372. Thus, an initial volume of bodily fluid may be transferred to the pre-sample reservoir 1372 via the infusion adapter 1320 and the seal 1373, as shown in FIG. 33 . In some embodiments, after receiving the initial volume of bodily fluid in the pre-sample reservoir 1372, the flow diverter 1370 may be configured to isolate the initial volume therein. Once isolated, the user may continue to manipulate the actuator 1340 to draw subsequent volumes of bodily fluid into the fluid reservoir 1315 ( FIG. 34 ), as described in detail above with respect to the device 1 and / or 100. Thus, the device 1300 may perform in a substantially similar manner as the device 1 and / or 100. Additionally, in some cases, the isolated initial volume of bodily fluid may be transported out of the fluid reservoir 1372 of the diverter 1370 for reinjection into the body or for any suitable testing that is not susceptible to erroneous results due to contamination.

[0129] The devices described herein are configured to limit, control, measure, and / or regulate the rate at which bodily fluid is drawn into the fluid reservoir of the device. In some cases, limiting, controlling, and / or regulating the rate of fluid movement may in turn limit, control, measure, and / or regulate the degree of vacuum in the fluid reservoir and / or the volume displaced by the actuator or its plunger.

[0130] For example, FIG. 35 is a graph 1400 illustrating the relationship and / or expected, calculated, and / or theoretical relationship between vacuum and / or displaced volume and retraction speed to draw bodily fluid into a reservoir using various methods, such as any of the methods described herein. More specifically, graph 1400 illustrates the vacuum and / or displaced volume as a function of retraction speed (e.g., speed at which the actuator is moved) at a fixed fluid flow, injection size, and fluid viscosity. As shown, curve 1401 illustrates the maximum vacuum using a 20 mL displacement at a sealed volume. Curve 1402 illustrates the vacuum resulting from a "fast retract" where the 20 mL displacement is quickly performed and held, allowing bodily fluid to flow into the displaced volume. Curve 1403 illustrates the vacuum resulting from a "normal retract" where the plunger is maintained approximately 1.0 mL ahead of the fluid flow until the 20 mL displacement. Curve 1404 shows the vacuum resulting from a "slow retract" where the plunger moves at a rate substantially equal to the fill rate of bodily fluid up to a displacement of 20 mL. Curve 1405 shows the vacuum resulting from a maximum displacement rate using any of the devices described herein. As shown by curve 1405 of graph 1400, the devices described herein control, limit, meter, and / or regulate the amount of vacuum and / or the displacement rate within a fluid reservoir, even if actuated as quickly as possible.

[0131] 36 is a graph 1500 illustrating the rate at which a reservoir having a constant fill volume can be filled using various methods. More specifically, curves 1501, 1502, and 1503 show the fill rates of fluids of different viscosities using the same procurement method (e.g., using a diversion and collection device) with a 3.0 mL displacement. For example, curve 1501 represents the fill rate of a fluid simulating blood (e.g., VATA, etc.), curve 1502 represents the fill rate of a fluid with a viscosity of about 4.0 centipoise (cP), and curve 1503 represents the fill rate of a fluid with a viscosity of about 8.0 cP. Curves 1504, 1505, and 1506 show the fill rates of VATA, a 4.0 cP fluid, and an 8.0 cP fluid, respectively, using a 1.0 mL syringe and 1.0 mL displacement. Curves 1507 and 1508 show the fill rates of 4.0 cP and 8.0 cP fluids, respectively, using a 3.0 mL syringe and 1.0 mL displacement.

[0132] 37 is a flow chart illustrating a method 1600 of using a fluid transfer and distribution device, according to one embodiment. The device may be similar and / or substantially the same as any of the devices (or any combination of devices) described herein, for example, the device may include a housing, a fluid reservoir, an injection adapter, an actuator, and a volume indicator, for example, as described above with respect to device 1 shown in Figures 1A-1C.

[0133] The method 1600 includes placing an injection adapter of a fluid transfer device in fluid communication with a bodily fluid source when the injection adapter is removably coupled to the housing such that a port in the housing fluidly couples the injection adapter to a fluid reservoir defined by the housing (1601). The injection adapter may be any suitable member, mechanism, device, etc., such as any of those described herein. For example, in some implementations, the injection adapter may be substantially similar in form and / or function to the injection adapter 20 described with respect to FIGS. 1A-1C. In some embodiments, the injection adapter may be and / or include a needle, catheter, cannula, conduit, etc. that may be in fluid communication with a bodily fluid source (e.g., a patient). The injection adapter may be configured to be removably coupled to the housing such that a fluid connection is established between the injection adapter and the fluid reservoir via the port.

[0134] The actuator is engaged to move a plunger disposed therein and defining at least a portion of the fluid reservoir from a first position to a second position, such that the movement of the plunger is operable to generate a negative pressure to draw bodily fluid through the infusion adapter and into the fluid reservoir (1602). The actuator may be any suitable member, mechanism, device, etc., such as any of those described herein. For example, in some implementations, the actuator may be substantially similar in form and / or function to actuator 40 described with respect to FIGS. 1A-1C. In this manner, the actuator may be operated to move the plunger within the housing, thereby increasing the volume of the fluid reservoir as the plunger moves from the first position to the second position and drawing a volume of bodily fluid into the fluid reservoir. As described in detail above, in some implementations, the actuator may be configured to control, meter, and / or regulate the rate at which bodily fluid is transferred to the fluid reservoir, thereby increasing the likelihood that a user will draw a desired and precise volume of bodily fluid into the fluid reservoir, for example, as described above with respect to device 1.

[0135] When the predetermined volume of bodily fluid is transferred to the fluid reservoir, the volume indicator transitions (1603) from the first state to the second state. The volume indicator may be any suitable member, mechanism, device, etc., such as any of those described herein. For example, in some implementations, the volume indicator may be substantially similar in form and / or function to the volume indicator 50 described above with respect to FIGS. 1A-1C. In some implementations, the predetermined volume of bodily fluid may be a recommended and / or desired volume of bodily fluid for use in testing the bodily fluid. For example, in some cases, the predetermined volume of bodily fluid may be 10.0 mL. As described above, the volume indicator may be configured to automatically transition from the first state to the second state when the predetermined volume of bodily fluid is in the fluid reservoir.

[0136] In response to the volume indicator transitioning from the first state to the second state, the plunger is stopped (1604) before the plunger moves (or is positioned) at the second position. For example, in some implementations, when the volume indicator is in the second state, a portion of the volume indicator can directly or indirectly block, restrict, and / or substantially prevent further transition of the actuator (e.g., further movement of the plunger to the second position). In such embodiments, the predetermined volume of bodily fluid is less than the volume of the fluid reservoir when the plunger is in the second position. Thus, a user can, for example, prevent bodily fluid from continuing to be transferred to the fluid reservoir by transitioning the volume indicator out of its second state (e.g., toward the first state or to a third state different from the first and second states). You can choose.

[0137] The injection adapter is removed from the housing (1605). For example, a user can transfer a desired volume of bodily fluid (e.g., a predetermined volume of fluid) to the fluid reservoir, and once placed therein, the user can remove and / or disconnect the injection adapter from the housing, as described above with respect to any of the devices 1, 100, 200, and / or other devices described herein. In some implementations, removing the injection adapter from the housing allows the user to access a port in the housing, which allows the user to transfer at least a portion of the bodily fluid in the fluid reservoir to one or more more external fluid reservoirs. In some implementations, the injection adapter can be configured to divert an initial volume of bodily fluid that is isolated within the injection adapter (e.g., in a pre-sample reservoir) when the injection adapter is removed from the housing. In such a case, the injection adapter (and the initial volume contained therein) can be discarded. In other examples, the initial volume of bodily fluid isolated in the injection adapter can be used for tests that are relatively less sensitive to contamination, can be re-injected into the patient, and / or can be used for any other suitable purpose.

[0138] A predetermined volume of bodily fluid is transferred from the fluid reservoir through the port to a sample bottle external to the fluid transfer device (1606). For example, in some cases, a user can couple the port to any suitable collection or sample reservoir, such as, for example, a culture bottle (and / or any collection device described herein). Thus, the port of the housing can be used to transfer fluid to the fluid reservoir (e.g., function as an inlet port) and to transfer fluid from the fluid reservoir (e.g., function as an outlet port). For example, in some cases, a user can engage an actuator to move the plunger toward a first position (e.g., in a direction opposite to the direction the plunger moved when moving from the first position toward the second position) and then expel a predetermined volume of bodily fluid from the fluid reservoir through the port to an external sample bottle. In other examples, the external sample bottle can be expelled and / or a negative pressure operable to draw a predetermined volume of bodily fluid into the external sample bottle. In some cases, a user can transition a volume indicator from a second state prior to transferring a predetermined volume of bodily fluid to the external sample bottle. In other examples, the user need not transition the volume indicator from its second state.

[0139] Various embodiments of the bodily fluid collection devices described herein can enable collection of two (or more) sets of bodily fluid (e.g., blood) samples from a single venipuncture. The current standard of care requires that certain tests (e.g., blood cultures) be performed using samples procured from different, separate bodily fluid access points (e.g., two separate venipunctures, catheter + venipuncture, and / or any combination thereof). The embodiments described herein can facilitate procurement of multiple samples for certain diagnostic tests (e.g., blood culture tests) from a single bodily fluid access point (e.g., venipuncture) and can reduce the annual number of venipunctures required to procure these samples by a factor of two. This benefits both patients and healthcare professionals alike. Reducing the number of venipunctures (and / or other bodily fluid access procedures) can significantly reduce the risk of needlestick injury to healthcare professionals and reduce patient-related complications resulting from these procedures (e.g., hematoma, thrombosis, phlebitis, infection, etc.).

[0140] Additionally, reducing the number of fluid access procedures (e.g., venipuncture) reduces the utilization of consumables, labor, and waste associated with these procedures. The cost savings realized by the healthcare system are significant and represent an opportunity to become increasingly efficient in the consumption of resources and improve patient outcomes through improved sample integrity. Improved sample integrity can improve patient diagnostics. The accuracy of the analysis is improved, facilitating the development and implementation of treatment plans. The fluid collection devices also significantly reduce the occurrence of false positives from post-collection analysis. The fluid collection devices described herein can also streamline the fluid collection process, reducing the number of manual steps and "touch points," thereby reducing the opportunity for external contamination. The devices described herein can also minimize the risk of needlestick injury and infection for laboratory technicians and / or phlebotomists.

[0141] While various embodiments have been described above, it should be understood that they are presented by way of example only, and not by way of limitation. Where the schematic diagrams and / or embodiments above show particular components disposed in particular orientations or positions, the arrangement of the components may be altered. Although embodiments have been specifically shown and described, it will be understood that various changes in form and detail may be made. Although various embodiments have been described as having particular combinations of features, concepts, and / or components, other embodiments may have any combination or subcombination of any of the features, concepts, and / or components from any of the embodiments described herein. Furthermore, any of the features, concepts, and / or components from any of the embodiments described herein may be incorporated into any suitable known device. For example, any of the features, concepts, and / or components, and / or any combination thereof, may be incorporated into a known syringe and / or any other suitable fluid collection device.

[0142] The specific configurations of the various components can also be varied. For example, the size and specific shapes of the various components can differ from the embodiments shown while still providing the functionality described herein. More specifically, the size and shape of the various components can be specifically selected for a desired rate and / or volume of flow of bodily fluid into the fluid reservoir. For example, the circumference, diameter, and / or cross-sectional area of ​​any fluid flow path described herein can be designed and / or specifically selected to accommodate the flow or diversion of a fluid (e.g., bodily fluid), gas (e.g., air), or any suitable combination thereof, at a desired flow rate. In other words, the components of the fluid control devices described herein include components that are constructed separately and later attached together, and can be selected individually or together to meet desired sample procurement criteria, such as, for example, the magnitude of pressure differential, the desired flow rate of bodily fluid through portions of the device, the ability to adjust the pressure and / or flow rate, and / or the like. Similarly, the size and / or shape of the various components can be specifically selected for a desired or intended use. For example, in some embodiments, devices such as those described herein can be configured for use with or with an apparently healthy adult patient. In such embodiments, the device may include a sequestration chamber having a first volume (e.g., about 0.5 ml to about 5.0 ml). In other embodiments, devices as described herein may be configured for use with or on, for example, very sick and / or pediatric patients. In such embodiments, the device may include a sequestration chamber having a second volume that is less than the first volume (e.g., less than about 0.5 ml). Thus, the size, shape, and / or configuration of the embodiments and / or components thereof may be adapted for a given application unless the context clearly dictates otherwise.

[0143] Where the methods and / or events described above indicate that certain events and / or procedures occur in a particular order, the order of the certain events and / or procedures may be modified, such modifications being in accordance with variations of the invention. Additionally, certain events and / or procedures may be performed simultaneously in parallel processes, where possible, or may be performed sequentially as described above. Certain steps may be partially completed or omitted before proceeding to a subsequent step.

Claims

1. a housing defining a fluid reservoir and including a port in fluid communication with the fluid reservoir; an infusion adapter removably connectable to the housing, the infusion adapter, when connected to the housing, placing the port in fluid communication with a source of bodily fluid; an actuator including a plunger disposed therein defining at least a portion of the fluid reservoir, the portion of the actuator configured to be engaged by a user to move the plunger within the housing from a first position in which the fluid reservoir has a first volume to a second position in which the fluid reservoir has a second volume greater than the first volume, the increase in volume operable to draw bodily fluid through the infusion adapter and into the fluid reservoir, the actuator adjusting a speed of movement of the plunger below a threshold as the plunger moves from the first position to the second position; a volume indicator configured to transition from a first state to a second state in response to a predetermined volume of bodily fluid being disposed in the fluid reservoir; an injection adapter configured to be removed from the housing after a predetermined volume of bodily fluid has been transferred to the fluid reservoir, allowing the predetermined volume to be transferred via the port to a sample bottle outside of the housing.

2. The apparatus of claim 1 , wherein the predetermined volume is less than the second volume.

3. The device of claim 2 , wherein the volume indicator is configured to at least temporarily stop the plunger from moving toward the second position when in the second state.

4. The apparatus of claim 1 , wherein the predetermined volume is equal to the second volume.

5. The device of claim 1 , wherein the predetermined volume is from about 10 milliliters (mL) to about 30 mL.

6. 2. The device of claim 1, wherein the predetermined volume is 10 mL.

7. 2. The device of claim 1, wherein a portion of the actuator is moved through a first range of motion when engaged by the user, and the actuator is configured to move the plunger through a second range of motion that is different from the first range of motion.

8. 10. The device of claim 1, wherein adjusting the actuation speed of the plunger below a threshold value reduces the flow rate of bodily fluid into the fluid reservoir, thereby increasing accuracy associated with the predetermined volume of bodily fluid transferred to the fluid reservoir.

9. 2. The device of claim 1, wherein the predetermined volume of bodily fluid is a first predetermined volume of bodily fluid, and the volume indicator is configured to transition to a third state in response to a second predetermined volume of bodily fluid being transferred to the fluid reservoir, the second predetermined volume being greater than the first predetermined volume.

10. a housing defining a fluid reservoir and including a port in fluid communication with the fluid reservoir; an infusion adapter removably connectable to the housing, the infusion adapter, when connected to the housing, placing the port in fluid communication with a source of bodily fluid; An actuator including a plunger disposed therein that defines at least a portion of the fluid reservoir. and an actuator configured to move the plunger within the housing between a first position and a second position, wherein when the plunger is in the first position, the fluid reservoir has a first volume, and when the plunger is in the second position, the second volume is greater than the first volume, such that an increase in the volume of the fluid reservoir is operable to draw bodily fluid into the fluid reservoir through the infusion adapter; and a volume indicator configured to transition from a first state to a second state associated with a predetermined volume of bodily fluid to be transferred to the fluid reservoir, the predetermined volume being less than the second volume of the fluid reservoir, the volume indicator configured to at least temporarily stop the plunger from moving toward the second position when in the second state.

11. 11. The device of claim 10, wherein a portion of the actuator is moved through a first range of motion when engaged by the user, the actuator being configured to move the plunger through a second range of motion different from the first range of motion.

12. The apparatus of claim 10 , wherein the actuator is configured to regulate a speed of movement of the plunger below a threshold value as the plunger moves from the first position to the second position.

13. 11. The device of claim 10, wherein the injection adapter is configured to be removed from the housing after the predetermined volume of bodily fluid has been transferred to the fluid reservoir so as to allow the predetermined volume to be transferred to a sample bottle outside the housing via the port.

14. 11. The device of claim 10, wherein the bodily fluid is blood, the sample bottle is a blood culture bottle containing anaerobic culture media, and the predetermined volume of bodily fluid is a volume of blood associated with an anaerobic blood culture test.

15. 11. The device of claim 10, wherein the bodily fluid is blood, the sample bottle is a blood culture bottle containing an aerobic culture medium, and the predetermined volume of bodily fluid is a volume of blood associated with an aerobic blood culture test.

16. The device of claim 10, wherein the predetermined volume is from about 10 milliliters (mL) to about 30 mL.

17. The device of claim 10 , wherein the volume indicator is configured to transition from the first state to the second state in response to the predetermined volume of bodily fluid being transferred to the fluid reservoir.

18. 11. The device of claim 10, wherein after the predetermined volume of bodily fluid has been transferred to the fluid reservoir, the volume indicator is configured to transition to a third state in which the plunger can be placed in the second position.

19. 20. The device of claim 18, wherein the predetermined volume of bodily fluid is a first predetermined volume of bodily fluid and the second volume of the fluid reservoir when the plunger is in the second position is a second predetermined volume that is greater than the first predetermined volume.

20. 1. A method comprising: placing an infusion adapter of a fluid transfer device in fluid communication with a source of bodily fluid, the infusion adapter being removably connectable to a housing of the fluid transfer device, the port being fluidly connecting the injection adapter to a fluid reservoir defined by the housing; engaging an actuator to move a plunger disposed therein defining at least a portion of the fluid reservoir from a first position toward a second position, the movement of the plunger creating a negative pressure operable to draw bodily fluid through the infusion adapter and into the fluid reservoir; transitioning a volume indicator from a first state to a second state when a predetermined volume of bodily fluid is transferred to the fluid reservoir; in response to the volume indicator transitioning from the first state to the second state, stopping the plunger before it moves to the second position; Removing the injection adapter from the housing; and transferring the volume of bodily fluid from the fluid reservoir through the port to a sample bottle external to the fluid transfer device.

21. 21. The method of claim 20, wherein engaging the actuator includes moving a portion of the actuator through a first range of motion, the actuator being configured to move the plunger through a second range of motion that is different from the first range of motion.

22. 21. The method of claim 20, wherein the actuator is configured to adjust a speed of movement of the plunger below a threshold value as the plunger moves from the first position to the second position.

23. 21. The method of claim 20, wherein the bodily fluid is blood, the sample bottle is a blood culture bottle containing anaerobic culture media, and the predetermined volume of bodily fluid is a volume of blood associated with an anaerobic blood culture test.

24. 21. The method of claim 20, wherein the bodily fluid is blood, the sample bottle is a blood culture bottle containing an aerobic culture medium, and the predetermined volume of bodily fluid is a volume of blood associated with an aerobic blood culture test.

25. 21. The method of claim 20, wherein the predetermined volume is from about 10 milliliters (mL) to about 30 mL.

26. and transitioning the volume indicator to a third state to permit placement of the plunger in the second position after the predetermined volume of bodily fluid has been transferred to the fluid reservoir.

21. The method of claim 20.

27. 27. The method of claim 26, wherein the predetermined volume of bodily fluid is a first predetermined volume of bodily fluid and the second volume of the fluid reservoir when the plunger is in the second position is a second predetermined volume that is greater than the first predetermined volume.

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