Device and method for collecting and dispensing body fluids

Abstract

The present invention relates to an apparatus comprising a housing defining a fluid reservoir and including a port in fluid communication with the fluid reservoir. An inlet adapter is removably couplable 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, to draw bodily fluid into the fluid reservoir via the inlet adapter. As the plunger moves, the actuator modulates the rate of movement of the plunger below a threshold. When 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, and in turn the inlet adapter can be removed to transfer the predetermined volume of bodily fluid into a sample vial external to the housing via the port.

Description

[0001] Cross-reference of related applications

[0002] This application claims priority and benefit to U.S. Provisional Patent Application Serial No. 62 / 802,999, filed February 8, 2019, entitled “Devices and Methods for BodilyFluid Collection and Distribution,” the disclosure of which is incorporated herein by reference in its entirety. Technical Field

[0003] The embodiments described herein generally relate to the acquisition of bodily fluid samples, and more specifically to apparatus and methods for acquiring and distributing bodily fluid samples with reduced contaminants. Background Technology

[0004] Healthcare professionals routinely use non-enteric body fluids to perform various types of microbial diagnostic tests and other extensive diagnostic tests on patients. With the development and advancement of advanced diagnostic technologies, the speed, accuracy (both sensitivity and specificity) and value of the information available to clinicians continue to improve. Collecting appropriate (e.g., recommended) and / or desired volumes of body fluids during and / or after collection, and maintaining the integrity of the fluid samples, helps ensure that the analytical diagnostic results represent the patient's physical condition. Examples of diagnostic technologies that rely on high-quality, uncontaminated, and / or pure body 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, and similar technologies.

[0005] One source of inaccurate results in this type of testing is the presence of biological material, which can include cells from outside the intended source used to acquire the sample and / or other external contaminants unintentionally present in the bodily fluid sample to be analyzed. In short, when the purity of a sample expected to originate from or collected from a specific bodily fluid source is compromised during the specimen acquisition process, synthetic analytical test results can be inaccurate, distorted, adulterated, false positives, false negatives, and / or otherwise fail to represent the patient's actual condition. This can, in turn, lead to erroneous, inaccurate, confusing, uncertain, unconfident, and / or otherwise undesirable clinical decisions.

[0006] Another source of false positive and / or false negative results can be an incorrect and / or inappropriate volume of patient sample for a given type of test. For example, overfilling of volume-sensitive blood culture bottles can lead to false positive results, as described in the instructions for use and / or in the manufacturer's warning labels for such culture bottles and in associated automated continuous monitoring microbial testing systems. On the other hand, insufficient volume of patient sample within the culture medium can lead to false negative results.

[0007] Therefore, there is a need for apparatus and methods for obtaining bodily fluid samples with reduced contaminants. Furthermore, there is a need for apparatus and methods that accurately measure, quantify, and / or distribute one or more sample volumes of the obtained bodily fluid into one or more sample reservoirs, for example, used in bodily fluid sample testing. Summary of the Invention

[0008] This document describes apparatus and methods for acquiring and / or dispensing a body fluid sample of an appropriate, suitable, and / or recommended volume with reduced contaminants. In some embodiments, an apparatus includes a housing, an inlet 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 inlet adapter is removably coupled to the housing, and when coupled to the housing, the inlet adapter places the port in fluid communication with a source of body fluid. The actuator includes a plunger disposed within the fluid reservoir and defining at least a portion of the fluid reservoir. A portion of the actuator is configured to be engaged by a user to move the plunger within the housing from a first position to a second position, in which the fluid reservoir has a first volume, and in the second position, the fluid reservoir has a second volume larger than the first volume. The increase in volume is operable to aspirate body fluid into the fluid reservoir via the inlet adapter. As the plunger moves from the first position to the second position, the actuator modulates the rate of movement of the plunger to below a threshold. The volume indicator is configured to transition from a first state to a second state in response to the setting of a predetermined volume of body fluid in the fluid reservoir. The inlet adapter is configured to be removed from the housing after the predetermined volume of body fluid has been transferred into the fluid reservoir to allow the predetermined volume of body fluid to be transferred via a port into a sample vial outside the housing. Attached Figure Description

[0009] Figures 1A to 1C These are schematic diagrams of a body fluid collection and dispensing device according to an embodiment, shown in the first, second, and third states, respectively.

[0010] Figure 2 This is a perspective view of a body fluid collection and dispensing device according to an embodiment.

[0011] Figures 3 to 5yes Figure 2 Top view, left side view and rear view of the body fluid collection and distribution device.

[0012] Figure 6 and Figure 7 Each is along separately Figure 3 Line 6-6 and Figure 5 The line 7-7 is cut off Figure 2 A cross-sectional view of a body fluid collection and distribution device.

[0013] Figure 8 yes Figure 2 A partial exploded perspective view of a body fluid collection and distribution device.

[0014] Figures 9 to 11 These are perspective views, top views, and left side views of the body fluid collection and dispensing device according to the embodiment.

[0015] Figures 12 to 15 These are various perspective views of fluid collection and dispensing devices according to different embodiments.

[0016] Figures 16 to 19 Each of these is a top view of the body fluid collection and dispensing apparatus according to an embodiment, shown in the first, second, third, and fourth states, respectively.

[0017] Figures 20 to 22 Each of the above is a perspective view of a body fluid collection and dispensing device according to an embodiment, shown in a first state, a second state, and a third state, respectively.

[0018] Figures 23 to 25 Each of the above is a perspective view of a body fluid collection and dispensing device according to an embodiment, shown in a first state, a second state, and a third state, respectively.

[0019] Figure 26 This is a perspective view of a body fluid collection and dispensing device according to an embodiment.

[0020] Figure 27 and Figure 28 Each is a perspective view of a body fluid collection and dispensing device according to an embodiment, shown in a first state and a second state, respectively.

[0021] Figure 29 These are perspective views of a body fluid collection and dispensing apparatus according to an embodiment, shown in various states, for example.

[0022] Figure 30 and Figure 31 These are front and rear perspective views of the body fluid collection and dispensing device according to the embodiment.

[0023] Figures 32 to 34 They are shown in the first state, the second state, and the third state, respectively. Figure 30 A cross-sectional view of a body fluid collection and distribution device.

[0024] Figure 35 It is a graph showing the relationship between vacuum and / or displacement volume and the aspiration rate of body fluids aspirated into the reservoir using various methods.

[0025] Figure 36 It is a graph showing the rate at which a reservoir with a fixed filling volume is filled using various methods.

[0026] Figure 37 It is a flowchart illustrating a method using a body fluid transfer and dispensing device according to an embodiment. Detailed Implementation

[0027] In some cases, patient samples are tested for the presence of one or more potentially harmful microorganisms, such as bacteria, fungi, or yeasts (e.g., Candida). Various techniques can be employed to assist in the detection of microorganisms and other types of biological material, specific cell types, biomarkers, proteins, antigens, enzymes, blood components, and / or similar substances during diagnostic testing. 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, morphodynamic cell analysis, and / or other commonly used or evolving advanced techniques used in clinical laboratory settings to characterize patient specimens and / or detect, identify, classify, categorize, and / or characterize specific organisms, antibiotic susceptibility, and / or similar substances.

[0028] In some cases, microbial testing may include culturing a patient sample in one or more dishes for a period of time (e.g., a variable timeframe from less than an hour to several hours to several days, which may be longer or shorter depending on the diagnostic technique employed), said dishes containing culture media, common additives, and / or other types of solutions that promote microbial growth. The microorganisms and / or organisms present in the patient sample multiply and / or grow in the culture medium over time, and can be detected by automated methods, continuous monitoring methods, and / or other methods specific to analytical platforms and techniques for detection, identification, and / or similar purposes. The presence of microorganisms and / or organisms in the culture medium (e.g., indicated by observation of carbon dioxide and / or via other detection methods) suggests the presence of the same microorganisms and / or organisms in the patient sample, which in turn suggests the presence of the same microorganisms and / or organisms in the body fluids of the patient from whom the sample was obtained. In other cases, the body fluid sample may be analyzed directly (i.e., without culturing) for the presence of microorganisms and / or organisms. Therefore, when the presence of microorganisms is determined in a sample used for testing, a patient can be diagnosed and prescribed one or more antibiotics or other treatments that are specifically designed to treat the patient or otherwise remove unwanted microorganisms and / or organisms from the patient.

[0029] However, patient samples can become contaminated during acquisition and / or may otherwise be susceptible to false positive or false negative results. For example, microorganisms from the body surface (e.g., skin-borne microorganisms) expelled during the specimen acquisition process (e.g., directly or indirectly via tissue fragments, hair follicles, sweat glands, and other skin appendages) can subsequently be transferred along with the patient sample to a culture medium, test vial, or other suitable specimen collection or transfer vessel and / or otherwise included in the specimen to be analyzed. Another possible source of contamination is the personnel who draw patient samples (e.g., physicians, hemistry doctors, nurses, technicians, etc.). Specifically, the equipment, supplies, and / or devices used during the patient sample acquisition process often include multiple fluid interfaces (e.g., but not limited to, patient to needle, needle to transfer adapter, transfer adapter to sample vessel, catheter hub to syringe, syringe to transfer adapter, needle / tube to sample vessel, and / or any other fluid interface or any combination thereof), each of which can introduce a potential point of contamination. In some cases, such contaminants can multiply in culture media and / or be identified by another non-culture-based diagnostic technique, ultimately resulting in false-positive microbial test results that do not accurately reflect the presence or absence of such microorganisms in the patient's body (i.e., in vivo).

[0030] In some cases, false positive and / or false negative results can be attributed to an incorrect and / or inappropriate volume of patient sample for a given type of test. For example, overfilling of volume-sensitive blood culture bottles can lead to false positive results, as described in the instructions for use and / or in the manufacturer's warning labels for such culture bottles and in associated automated continuous monitoring microbial testing systems. On the other hand, insufficient volume of patient sample within the culture medium can lead to false negative results (e.g., failure to identify actual microorganisms present in the patient's body).

[0031] Such inaccurate results due to contamination, adulteration, and / or other inaccurate sample volumes are a problem when attempting to diagnose or treat a wide range of suspected illnesses, diseases, infections, patient conditions, and / or other related ailments. For example, false negative results from microbiology tests can lead to misdiagnosis and / or delayed treatment of a patient's illness, which in some cases can result in death. Conversely, false positive results from microbiology tests can lead to unnecessary treatment of patients with one or more antimicrobial therapies, which can cause serious side effects, including death, and create unnecessary burdens and costs on the healthcare system due to prolonged hospital stays and / or other complications associated with incorrect treatment. The use of diagnostic imaging equipment attributable to these false results is also a problem from both a cost and patient safety perspective, as unnecessary concentrated radiation exposure associated with various imaging procedures (e.g., CT scans) has many known adverse effects on patients' long-term health. Furthermore, there is a challenge in training healthcare professionals to extract accurate, desired, and / or recommended sample volumes and / or otherwise ensure the use of accurate, desired, and / or recommended sample volumes based on the specific test to be performed.

[0032] In some embodiments, a device includes a housing, an inlet 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 inlet adapter is removably coupled to the housing, and when coupled to the housing, the inlet adapter 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. A portion of the actuator is configured to be engaged by a user to move the plunger within the housing from a first position to a second position, in which the fluid reservoir has a first volume, and in the second position, the fluid reservoir has a second volume larger than the first volume. The increase in volume is operable to aspirate bodily fluid into the fluid reservoir via the inlet adapter. As the plunger moves from the first position to the second position, the actuator modulates the rate of movement of the plunger to below a threshold. The volume indicator is configured to transition from the first state to the second state in response to the establishment of a predetermined volume of bodily fluid in the fluid reservoir. The inlet adapter is configured to be removed from the housing after a predetermined volume of body fluid has been transferred to the fluid reservoir, so as to allow the predetermined volume of body fluid to be transferred via the port to a sample bottle outside the housing.

[0033] In some embodiments, a device includes a housing, an inlet 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 inlet adapter is removably coupled to the housing, and when coupled to the housing, the inlet adapter 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 between a first position and a second position within the housing. 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 fluid reservoir has a second volume larger than the first volume. The increase in the volume of the fluid reservoir is operable to aspirate bodily fluid into the fluid reservoir via the inlet adapter. The volume indicator transitions from the first state to a second state associated with a predetermined volume of bodily fluid transferred into the fluid reservoir. The predetermined volume is smaller than the second volume of the fluid reservoir. The volume indicator is configured to at least temporarily stop the plunger from moving toward the second position when the volume indicator is in the second state.

[0034] In some embodiments, a method includes placing an inlet adapter of a fluid transfer device in fluid communication with a source of bodily fluid. The inlet adapter is removably coupled to a housing of the fluid transfer device such that a port fluidly connects the inlet adapter to a fluid reservoir defined by the housing. An actuator of the fluid transfer device is engaged 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. The movement of the plunger generates a negative pressure operable to draw bodily fluid into the fluid reservoir via the inlet adapter. A volume indicator transitions from the first state to the second state as a predetermined volume of bodily fluid is transferred into the fluid reservoir. The plunger stops in response to the transition of the volume indicator from the first state to the second state before moving to the second position. The inlet adapter is removed from the housing, and the predetermined volume of bodily fluid is transferred from the fluid reservoir to a sample vial outside the fluid transfer device via the port.

[0035] In some embodiments, a device includes a housing, an inlet 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 inlet adapter is at least temporarily coupled to the housing and in fluid communication with the port. The inlet adapter is configured to place 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 engagement member being configured to be engaged by a user to move the plunger within the housing. The actuator is configured to modulate the rate at which the plunger moves from a first position to a second position, in the first position the fluid reservoir having a first volume, and in the second position the fluid reservoir having a second volume larger than the first volume. The increase in the volume of the fluid reservoir is operable to aspirate a predetermined volume of bodily fluid into the fluid reservoir. The volume indicator is configured to transition from the first state to the second state in response to the placement of a predetermined volume of bodily fluid in the fluid reservoir.

[0036] In some embodiments, the body fluid collection and dispensing device can be configured to acquire a body fluid sample of an appropriate, suitable, and / or recommended volume with reduced contaminants. In some embodiments, the body fluid collection and dispensing device and / or a shunt device coupled thereto can shunt an initial volume of body fluid into a pre-sample reservoir. The initial volume of body fluid is isolated in or by the body fluid collection and dispensing device and / or the shunt device before allowing subsequent volumes of body fluid to flow into a fluid reservoir at least partially defined by the body fluid collection and dispensing device. In some cases, the initial volume of body fluid may include microorganisms and / or other contaminants, and isolating the initial volume can reduce or substantially prevent the presence of microorganisms and / or other contaminants in subsequent volumes of body fluid (e.g., the sample volume of body fluid). Thus, subsequent volumes of body fluid can be used for diagnostic or other tests, while the initial volume of body fluid can be discarded, re-infused into a patient, and / or used for diagnostic and / or other tests that are not sensitive to potential microorganisms and / or other contaminants.

[0037] In some embodiments, the body fluid collection and dispensing device may include an actuator that can be engaged and / or manipulated by a user to aspirate a volume of body fluid (e.g., after an initial volume of body fluid has been diverted). For example, one or more portions of the actuator may move within and / or relative to a fluid reservoir in the body fluid collection and dispensing device to aspirate that volume of body fluid into the fluid reservoir. In some cases, the actuator may be configured to control, modulate, and / or limit the rate of movement that can be achieved by one or more portions of the actuator, which in turn allows the user to control the volume of body fluid transferred to the fluid reservoir and / or the magnitude of the negative pressure or suction applied to or at the body fluid source (e.g., in a patient's vein).

[0038] In some embodiments, the body fluid collection and dispensing device may include a volume indicator configured to ensure that an appropriate and / or desired volume of body fluid is collected and / or transferred to a fluid reservoir defined by the body fluid collection and dispensing device. The body fluid collection and / or dispensing device may be configured to automatically divert and / or control the inflow and / or outflow of fluid into the fluid reservoir. For example, after a first metered volume or predetermined volume of body fluid has been collected, the volume indicator may be configured to transition from a first state to a second state. In some embodiments, when the volume indicator is in the second state, the volume indicator may provide an indication to the user that the metered volume and / or predetermined volume of body fluid has been placed in the fluid reservoir. Additionally or alternatively, the volume indicator may be configured to gate, control, limit, and / or substantially prevent additional amounts of body fluid from being delivered to the fluid reservoir until and / or unless the user engages and / or manipulates the volume indicator to move it away from the second state (e.g., toward the first state or a third state different from the first and second states). For example, in some cases, users can move the volume indicator away from the second state transition to deliver an additional amount of bodily fluid into the fluid reservoir.

[0039] In some embodiments, a body fluid collection and dispensing device can be configured to deliver a volume of body fluid contained in a fluid reservoir to one or more sample dishes, culture flasks, sample reservoirs and / or vials, testing instruments, and / or the like. For example, a user can manipulate the body fluid collection and dispensing device (e.g., actuators and / or other suitable parts of the device) to deliver a predetermined and / or desired volume of body fluid from the fluid reservoir to, for example, a culture flask. In some embodiments, a volume indicator can control, regulate, and / or dispense the flow of body fluid from the fluid reservoir to the culture flask. For example, in some embodiments, the volume indicator can automatically switch to a state that substantially gates and / or prevents the flow of body fluid from the fluid reservoir in response to the delivery of a predetermined and / or desired volume of body fluid to the culture flask. Thus, the body fluid collection and dispensing device can ensure that a known volume, a predetermined volume, and / or a desired volume of body fluid is delivered to the culture flask.

[0040] These concepts, features, and / or aspects, together with other concepts, features, and / or aspects, are described in further detail herein and / or specific embodiments are illustrated in the accompanying drawings.

[0041] As used in this specification and the appended claims, the singular forms “an,” “a,” and “the” include plural indicators unless the context clearly indicates otherwise. Thus, for example, the term “component” is intended to mean a single component or a combination of components, and “material” is intended to mean one or more materials or a combination thereof.

[0042] As used herein, the terms “approximately,” “approximately,” and / or “basically,” when used in conjunction with stated values ​​and / or other geometric relationships, are intended to convey that the structure thus defined is nominally the stated value and / or the described geometric relationship. In some cases, the terms “approximately,” “approximately,” and / or “basically” may generally refer to and / or generally be expected to be positive or negative 10% of the stated value or relationship. For example, approximately 0.01 would include 0.009 and 0.011, approximately 0.5 would include 0.45 and 0.55, approximately 10 would include 9 to 11, and approximately 1000 would include 900 to 1100. Although the stated values ​​are expected, it should be understood that some differences may occur due to, for example, manufacturing tolerances, physiological and / or physical characteristics, or other practical considerations (e.g., pressure or force applied through a part of the device, cannula, lumen, etc.). Therefore, the terms “approximately,” “approximately,” and / or “basically” may be used herein to account for such tolerances and / or considerations.

[0043] As described further in detail herein, any of the apparatuses and methods can be used to obtain a body fluid sample with reduced contaminants by, for example, diverting a "pre-sample" volume of body fluid before collecting a "sample" volume of body fluid. As used herein, "body fluid" can include any fluid obtained directly or indirectly from a patient's body. For example, "body fluid" includes, but is not limited to, blood, cerebrospinal fluid, urine, bile, lymph, saliva, synovial fluid, serous fluid, pleural fluid, amniotic fluid, mucus, sputum, vitreous humor, air, and / or the like or any combination thereof.

[0044] The terms “pre-sample,” “first,” and / or “initial” may be used interchangeably to describe and / or refer to the amount, portion, or volume of bodily fluids transferred, diverted, and / or isolated prior to obtaining a “sample” volume. In some embodiments, the terms “pre-sample,” “first,” and / or “initial” may 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 may be about 0.1 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 volume between these values. In other embodiments, the pre-sample volume may be greater than 50 mL or less than 0.1 mL. In some specific embodiments, the predetermined and / or desired pre-sample volume may be between about 0.1 mL and about 5.0 mL. In other embodiments, the sample pre-volume can be, for example, a drop of body fluid, several drops of body fluid, or a combination of any number of cavities that form a flow path (or part thereof) from the body fluid source to an initial collection chamber, section, reservoir, etc. (e.g., an isolation chamber).

[0045] On the other hand, the terms “sample,” “second,” and / or “subsequent,” when used in the context of body fluid volume, can refer to the volume, portion, or amount of body fluid collected after the volume of body fluid prior to transfer, diversion, isolation, and / or isolation of the sample, either randomly or by a predetermined or desired amount. For example, in some embodiments, the desired sample volume of body fluid can be from about 10 mL to about 60 mL. In other embodiments, the desired sample volume of body fluid can be less than 10 mL or greater than 60 mL. In some embodiments, for example, the sample volume can be at least partially based on one or more tests, assays, analyses, and / or treatments to be 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 certain amount of body fluid (e.g., an amount of body fluid larger than the known, predetermined, and / or desired volume of a single sample volume).

[0046] When describing the relationship between the intended volume and the collected volume of bodily fluids, it should be understood that these values ​​include appropriate tolerances, such as those described above. For example, when stating that the collected volume of bodily fluids is substantially equal to the intended volume, the collected volume and the intended volume are nominally equal within appropriate tolerances. In some cases, the tolerance can be determined by the intended use of the collected volume of bodily fluids. For example, in some cases, a blood culture test can be performed with approximately 99% accuracy when the collected volume of blood is within the range of 1.0% to 5.0% of the manufacturer's (or evidence-based best practice) recommended volume. For instance, a manufacturer's recommended volume for bodily fluid testing might be 10 mL per sample collection bottle, where a total of four or six collection bottles used (i.e., a total volume of 40 mL to 60 mL) plus or minus 5% is approximately 99% confidence. Therefore, a collected volume of 10.5 mL will provide results with over approximately 99% confidence, while a collected volume of 11 mL will provide results with less than approximately 99% confidence. In other cases, suitable tolerances can 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 still other cases, the tolerance can be greater than 10.0%. Any embodiment described herein may include and / or may be used in combination with: any suitable flow metering device and / or means configured to measure flow rate and / or otherwise measure body fluid volume within suitable tolerances. In some embodiments, the flow metering device and / or means may be arranged to minimize or eliminate tolerance accumulation that may result from a combination of one or more inaccurate measurements, one or more human errors, and / or the like.

[0047] The embodiments described herein can be configured to selectively transfer bodily fluids to one or more fluid collection devices. In some embodiments, the fluid collection device may include, but is not limited to, any suitable vessel, reservoir, bottle, adapter, tray, vial, microliter vial, nanoliter vial, container, microliter container, nanoliter container, syringe, device, diagnostic and / or testing machine and / or the like. By way of specific examples, in some cases any of the embodiments and / or methods described herein can be used to transfer sample volumes into sample reservoirs, for example, any of those detailed in U.S. Patent No. 8,197,420 (“'420 Patent”), filed December 13, 2007, entitled “Systems and Methods for Parenterally Procuring Bodily-Fluid Samples with Reduced Contamination”, and / or U.S. Patent Publication No. 2018 / 0140240 (“'240 Publication”), filed November 20, 2017, entitled “Systems and Methods for Sample Collection with Reduced Hemolysis”, the disclosure of each of which is incorporated herein by reference in its entirety. In other embodiments, the fluid collection device may be substantially similar to or identical to known sample containers, such as… (manufactured by Beckton Dickinson, Inc. (“BD”), BacT / SN or BacT / FA (manufactured by Biomerieux GmbH) and / or similar substances.

[0048] In some embodiments, the sample reservoir may be a sample or a culture flask, such as an aerobic or anaerobic culture flask. Thus, the culture flask may receive a body fluid sample, which can then be tested (e.g., via in vitro diagnostic (IVD) tests and / or any other suitable tests) to check for the presence of, for example, Gram-positive bacteria, Gram-negative bacteria, yeast, fungi, and / or any other organisms. In some cases, the culture flask may receive a body fluid sample, and the culture medium (which is disposed in the culture flask) may be tested to check for the presence of any suitable organisms. If such a test of the culture medium yields a positive result, the culture medium can subsequently be tested using a PCR-based system to identify the specific organism. Furthermore, as described in further detail herein, in some cases, the body fluid before or at the initial volume of the sample may reduce and / or substantially eliminate contaminants in the body fluid sample that could otherwise lead to inaccurate test results.

[0049] Any of the sample containers, reservoirs, bottles, trays, vials, etc., described herein may be empty of contents before receiving a sample volume of bodily fluid, or may include, for example, any suitable additives, culture media, substances, enzymes, oils, fluids, and / or the like. For example, in some embodiments, a sample reservoir may include an aerobic or anaerobic culture medium (e.g., a nutrient-rich and / or environmentally controlled culture medium that promotes growth, and / or one or more other suitable culture media) occupying at least a portion of the internal volume defined by the sample reservoir. In some embodiments, a sample reservoir may include, for example, any suitable additives or the like, such as heparin, citrate, ethylenediaminetetraacetic acid (EDTA), oxalate, SPS, and / or the like, similarly occupying at least a portion of the internal volume defined by the sample reservoir. In other embodiments, a sample reservoir may be any suitable container for collecting specimens.

[0050] While the term "culture medium" can be used to describe a substance configured to react with organisms in body fluids (e.g., microorganisms such as bacteria) and the term "additive" can be used to describe a substance configured to react with portions of body fluids (e.g., constituent cells of blood, serum, synovial fluid, etc.), it should be understood that sample reservoirs can include any suitable substance, liquid, solid, powder, lyophilized compound, gas, etc. Furthermore, when referring to "additives" within a sample reservoir, it should be understood that an additive can be a culture medium (e.g., aerobic and / or anaerobic media) contained in a culture flask, an additive contained in a culture flask and / or any other suitable reservoir such as those described above, and / or any combination of any other suitable substance and / or substance. 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 body fluid to a reservoir (or the like) that does not contain culture medium, additives, and / or any other substance before receiving a flow of body fluid.

[0051] While some embodiments are described herein as being for obtaining bodily fluids for testing one or more cultured samples, it should be understood that the embodiments are not limited to this purpose. Any of the embodiments and / or methods described herein can be used to transfer bodily fluids to any suitable device placed in fluid communication with it. Therefore, although specific examples are described herein, the devices, methods, and / or concepts are not intended to be limited to such specific examples. Furthermore, samples collected using any of the devices described herein can be used in any suitable tests such as those described above.

[0052] Any embodiment and / or part thereof described herein may be formed or constructed from one or more biocompatible materials. In some embodiments, the biocompatible material may be selected based on one or more properties of the constituent materials, such as stiffness, toughness, hardness, bioreactivity, etc. Examples of suitable biocompatible materials include metals, glass, ceramics, or polymers. Examples of suitable metals include pharmaceutical-grade stainless steel, gold, titanium, nickel, iron, platinum, tin, chromium, copper, and / or alloys thereof. Polymer materials may be biodegradable or non-biodegradable. Examples of suitable biodegradable polymers include polylactide, polyglycolic acid, polylactide-co-glycolic acid (PLGA), polyanhydride, polyorthoester, polyether ester, polycaprolactone, polyesteramide, poly(butyric acid), poly(valeric acid), polyurethane, and / or blends and copolymers thereof. Examples of non-biodegradable polymers include nylon, polyester, polycarbonate, polyacrylate, ethylene-vinyl acetate and other acyl-substituted cellulose acetate polymers, non-biodegradable polyurethane, polystyrene, polyvinyl chloride, polyvinyl fluoride, poly(vinylimidazolium), chlorosulfonate polyolefins, polyethylene oxide and / or their blends and copolymers.

[0053] 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 these components may be formed from a single number of parts having any number of segments, regions, portions, and / or characteristics, or may be formed from multiple parts or features. For example, when referring to a structure such as a wall or room, the structure may be considered as a single structure having multiple parts or multiple different substructures or the like joined together 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 continuous or discontinuous with each other. A set of substructures may also be made from multiple articles or components that are manufactured individually and then joined together (e.g., via welding, adhesives, interlocking, and / or any suitable method).

[0054] Figures 1A to 1C This is a schematic diagram of a body fluid collection and dispensing device 1 according to an embodiment. The body 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 may 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 may be similar in form and / or function to a syringe and / or similar devices configured to receive and at least temporarily contain fluid. In some embodiments, the device 1 can be manipulated to aspirate a volume of body fluid from a body fluid source (e.g., a patient) into a portion of the device 1 at a flow rate below a threshold flow rate. Although in Figures 1A to 1CNot shown, but in some embodiments, device 1 may include, be coupled to, and / or be integrated with devices that can divert and at least temporarily isolate an initial volume of bodily fluid drawn from a source of bodily fluid. In some cases, as described in detail in '420 patent, 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 aspirated into a portion of device 1.

[0055] like Figures 1A to 1C As shown, device 1 includes a housing 10, a fluid reservoir 15, an inlet 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 dimensions of the housing 10 can be at least partially based on the desired volume or amount of fluid at least temporarily contained therein. For example, in some embodiments, the housing 10 can contain and / or at least partially form the fluid reservoir 15, and the dimensions and / or volume of the housing 10 can be at least partially based on the desired volume of fluid that can be transferred into and / or out of the fluid reservoir 15.

[0056] The housing 10 is configured to include, accommodate, and / or form at least a portion of the fluid reservoir 15, the actuator 40, and the volume indicator 50. The housing 10 includes a port 11 that is in fluid communication with the fluid reservoir 15 and is physically, at least temporarily, fluidly connectable to an inlet adapter 20 (see, for example...). Figure 1A and Figure 1B In some cases, the inlet adapter 20 can be removed or detached from port 11, which can be fluidly connected to one or more external collection reservoirs, sample bottles, culture flasks, etc. (see, for example...) Figure 1C ).

[0057] Fluid reservoir 15 is disposed within and / or formed by housing 10. For example, in some embodiments, fluid reservoir 15 may be formed independently of housing 10 during manufacturing and inserted into or disposed within a portion of housing 10. In other embodiments, at least a portion of housing 10 and at least a portion of fluid reservoir 15 may be formed integrally and / or as an integral part thereof. Fluid reservoir 15 may have and / or may define any suitable volume. For example, in some embodiments, fluid reservoir 15 may have a volume between about 5.0 mL and about 60.0 mL, between about 10.0 mL and about 50.0 mL, between about 20.0 mL and about 40.0 mL, or about 30.0 mL. In some embodiments, fluid reservoir 15 may have a volume of about 20.0 mL, about 25.0 mL, or about 30 mL. In other embodiments, fluid reservoir 15 may have a volume less than about 5.0 mL or greater than about 60.0 mL. Fluid reservoir 15 is in fluid communication with port 11 of housing 10, and can therefore receive or deliver fluid flow via port 11, as described in further detail herein. Although in Figures 1A to 1C Not shown, but in some embodiments, device 1 may include a pre-sample reservoir that is fluidly isolated from fluid reservoir 15 and configured to receive an initial volume of body fluid transferred into housing 10.

[0058] Actuator 40 can be of any suitable shape, size, and / or configuration. For example, in some embodiments, 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 housing 10. In some embodiments, the syringe-like plunger (referred to herein as a "plunger" for simplicity) may include a seal that forms a fluid-tight seal with the inner surface of fluid reservoir 15 (or the inner surface of housing 10 defining a portion of fluid reservoir 15). Thus, the plunger of actuator 40 may form and / or define at least a portion of fluid reservoir 15. For example, fluid reservoir 15 may be and / or may have a volume defined by the inner surface of housing 10, port 11, and plunger of actuator 40 and / or a volume defined between the inner surface of housing 10, port 11, and plunger of actuator 40.

[0059] Actuator 40 can be manipulated 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 can cause a decrease in pressure (e.g., negative pressure, vacuum, suction, etc.) within fluid reservoir 15, which can be operated to draw fluid (e.g., bodily fluid) into fluid reservoir 15 through port 11. Conversely, decreasing the volume of fluid reservoir 15 can cause an increase in pressure within fluid reservoir 15, which can be operated to discharge fluid from fluid reservoir 15 through port 11, as described in further detail herein.

[0060] In some embodiments, the actuator 40 is arranged such that the actuator 40 and / or a portion thereof are configured to control and / or modulate the rate of change of the volume of the fluid reservoir 15. For example, in some embodiments, a first portion of the actuator 40 may be engaged and / or manipulated by a user to change and / or move a second portion of the actuator 40, the second portion of which includes, for example, a plunger. In some embodiments, the first portion of the actuator 40 (e.g., an engagement portion or the like) may be directly or indirectly coupled to the second portion of the actuator 40 (e.g., at least the plunger of the actuator 40) and may be configured to use at least a portion of the force applied by a user of the first portion of the actuator 40 and / or convert it into a known, predetermined, and / or modulated force to change and / or move the second portion of the actuator 40. In other words, in some embodiments, the actuator 40 and / or one or more portions thereof may be configured to control and / or modulate the rate of change of the volume of the fluid reservoir 15, which in turn may control and / or modulate the flow rate of fluid inflow into and / or outflow from the fluid reservoir 15. In some implementations, such control and / or modulation can enable the user to have increased control over the flow rate into and / or out of the fluid reservoir 15, which can allow the user to more accurately control the volume of fluid transferred into and / or out of the fluid reservoir 15, as described in further detail herein.

[0061] For example, in some embodiments, the first portion of actuator 40 may be one or more wheels, turntables, pinions, levers, pneumatic or hydraulic actuators, rods, etc., which may be directly or indirectly coupled to the second portion of actuator 40 (e.g., plunger 40). In some embodiments, the first portion of actuator 40 may be coupled to the second portion of actuator 40 via one or more racks, tracks, channels, flow paths, energy storage members and / or biasing members (e.g., one or more springs), kinematic linkage mechanisms and / or the like. In some embodiments, the direct or indirect coupling between the first portion of actuator 40 (e.g., engagement portion or member) and the second portion of actuator 40 (e.g., plunger) may be selected and / or designed to modulate the transmission of energy and / or force therebetween. For example, in some embodiments, the first portion of actuator 40 may be a wheel indirectly coupled to the second portion of actuator 40 via one or more racks and pinions. In such an implementation, the force applied to the second part of the actuator 40 can be modulated, tuned, and / or controlled, for example, by increasing or decreasing the gear ratio between the wheel, pinion, and / or rack.

[0062] In other embodiments, the transfer of energy and / or force can be modulated and / or controlled via any suitable mechanism, such as increasing and / or decreasing the size and / or shape of tracks, channels, flow paths, 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 kinematic linkage; increasing or decreasing the flow rate of a gas or fluid; and / or via any other suitable mechanism or method, such as any of those described herein. While specific examples and / or methods for controlling and / or modulating the rate of change of the volume of fluid reservoir 15 and / or the flow rate of fluid flowing into and / or out of fluid reservoir 15 have been described, in other embodiments, the transfer and distribution device can control and / or modulate the rate of change of the volume of the fluid reservoir, which includes any suitable manner and is not intended to be limited to the specific examples and / or methods described herein.

[0063] The volume indicator 50 can be of any suitable shape, size, and / or configuration. For example, in some embodiments, the volume indicator 50 is a button, knob, dial, lever, pointer, and / or any other suitable indicator. The volume indicator 50 can be configured to transition from a first state to a second state or to transition from a first state to a second state to provide an indication associated with the volume of fluid disposed in the fluid reservoir 15. For example, the volume indicator 50 can transition from the first state (e.g., automatically) in response to the placement of a known volume, desired volume, and / or predetermined volume of bodily fluid in the fluid reservoir 15. In some embodiments, the known volume, desired volume, and / or predetermined volume of bodily fluid can be at least partially based on the volume of such bodily fluid (e.g., blood) suitable for one or more tests or suitable for similar tests configured to be performed on or used with the bodily fluid, such as blood culture tests and / or similar tests. In some embodiments, the known volume, desired volume, and / or predetermined volume can be, 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 volume fraction therebetween. In other embodiments, the known volume, desired volume, and / or predetermined volume can be less than 1.0 mL or greater than 20.0 mL.

[0064] As an example, the known volume, desired volume, and / or predetermined volume could be 10.0 mL. Therefore, the volume indicator 50 can switch and / or transition from a first state to a second state in response to 10.0 mL of bodily fluid being transferred to and / or disposed in the fluid reservoir 15. In some embodiments, the volume indicator 50 can transition from a first state to a second state in which the volume indicator 50 (e.g., a button or the like) is pressed or substantially disposed within the housing 10, and in the second state, the volume indicator 50 is raised relative to the housing 10 (e.g., at least a portion of the button extends out of or from the housing 10). When the volume indicator 50 is in the second state, it can provide the user with an indication that 10.0 mL of bodily fluid has been disposed in the fluid reservoir 10. In response, the user can decide whether to continue aspirating an additional amount of bodily fluid into the fluid reservoir 15 (e.g., by continuing to engage the actuator 40) or to stop or end the aspiration process.

[0065] In some embodiments, the volume indicator 50 may also be configured to at least temporarily place the device 1 and / or actuator 40 in a state or configuration that restricts and / or substantially prevents at least a portion of the movement 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 selectively engage, for example, any suitable portion of the actuator 40 to restrict and / or substantially prevent the movement of the plunger when the volume indicator 50 is in the second state. Thus, a user may manipulate the volume indicator 50 and / or may apply a force to the volume indicator 50 that is operable to transition the volume indicator 50 away from the second state. In some embodiments, for example, the volume indicator 50 may transition toward and / or return to a first state. In other embodiments, the volume indicator 50 may transition toward and / or transition to a third state different from the first and second states.

[0066] The inlet adapter 20 is configured to be at least temporarily coupled to port 11 of housing 10. The inlet adapter 20 can be of any suitable shape, size, and / or configuration. The inlet adapter 20 may include a lumen-containing device configured to be in fluid communication with a source of bodily fluid. For example, in some embodiments, the inlet adapter 20 may include a needle or catheter configured to be inserted into a patient's vein or artery. In other embodiments, the inlet adapter 20 may include a catheter and / or other cannula configured to establish fluid communication between the inlet adapter 20 and a source of bodily fluid and / or an intervening device (e.g., a shunt device, a placed intravenous catheter, and / or any other suitable device).

[0067] like Figure 1A and Figure 1BAs shown, when the inlet adapter 20 is coupled to the housing 10, the inlet adapter 20 is fluidly coupled to the port 11. In some embodiments, the port 11 of the housing 10 may include a needle or other piercing member configured to advance through a puncturable portion, a sealable portion, and / or a brittle portion of the inlet adapter 20. For example, the inlet adapter 20 may include a self-sealing port or the like, which is pierced by the needle or piercing member of the port 11 when coupled to the inlet adapter 20 and returns to a sealed or similar state when the inlet adapter 20 is removed from the housing 10. In such embodiments, the needle and / or piercing member may place an internal portion of the inlet adapter 20 in fluid communication with the fluid reservoir 15, thereby allowing fluid (e.g., bodily fluids) to transfer from the inlet adapter 20 to the fluid reservoir 15. In other embodiments, the inlet adapter 20 and the port 11 may include and / or may together form a Luer-type connection and / or any other suitable physical and / or fluid interface.

[0068] like Figure 1C As shown, in some cases, after the desired volume of fluid has been transferred to the fluid reservoir 15, the inlet adapter 20 can be detached from and / or otherwise removed from the housing 10. In some embodiments, detachment of the inlet adapter 20 from the port 11 may expose the needle and / or puncture member coupled to the port 11, which in turn allows the port 11 to be physically and / or fluidly coupled to any suitable external device and / or reservoir. For example, in some embodiments, the port 11 may be configured to be physically and / or fluidly coupled to a culture flask or other sample reservoir. In other embodiments, the port 11 may be coupled to and / or may include any suitable transfer adapter, such as those described in U.S. Patent No. 10,123,783 (referred to herein as the "'783 Patent"), filed March 3, 2015, entitled "Apparatus and Methods for Disinfection of a Specimen Container," the disclosure of which is incorporated herein by reference in its entirety.

[0069] In some embodiments, the inlet adapter 20 may be configured to collect, divert, and / or isolate an initial volume of bodily fluid received from a source of bodily fluid (e.g., a patient). For example, in some embodiments, the inlet adapter 20 may have a first state or configuration in which the initial volume of bodily fluid is transferred to a first portion of the inlet adapter 20 (e.g., via a first flow path or the like), and the inlet adapter 20 may 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 inlet adapter 20, and (2) subsequent volumes of bodily fluid can be transferred through the inlet adapter 20 to the fluid reservoir 15 via a second flow path or the like. Thus, subsequent volumes of bodily fluid may be substantially free of contaminants or the like, which may otherwise be contained in the initial volume of bodily fluid. In other embodiments, the inlet adapter 20 may be configured to be coupled to a diversion device or the like, which is configured to divert and isolate the initial volume of bodily fluid. In some other embodiments, a diversion device or the like may be integrated and / or included in device 1 (e.g., at least partially disposed in housing 10).

[0070] The collection, diversion, and / or isolation of an initial volume of bodily fluid can be performed by any suitable device or combination of devices in any suitable manner. For example, in some embodiments, the following patents may be used: '420 patent, '240 publication and / or '783 patent; U.S. Patent Publication No. 2015 / 0342510 ("'510 publication") entitled "Sterile Bodily-Fluid Collection Device and Methods" filed June 2, 2015; U.S. Patent No. 8,535,241 ("'214 patent") entitled "Fluid Diversion Mechanism for Bodily-Fluid Sampling" filed October 12, 2012; U.S. Patent No. 9,060,724 ("'724 patent") entitled "Fluid Diversion Mechanism for Bodily-Fluid Sampling" filed May 29, 2013; and U.S. Patent No. 9,060,724 ("'724 patent") entitled "Syringe-Based Fluid Diversion Mechanism for Bodily-Fluid" filed December 2, 2013. U.S. Patent No. 9,155,495 (“'495 Patent”) entitled “Sampling”; U.S. Patent Publication No. 2016 / 0361006 (“'006 Publication”) filed June 13, 2016, entitled “Devices and Methods for Syringe-Based Fluid Transfer for Bodily-Fluid Sampling”; U.S. Patent No. 9,950,084 (“'084 Patent”) filed September 6, 2016, entitled “Apparatus and Methods for Maintaining Sterility of a Specimen Container”; U.S. Patent Publication No. 2018 / 0353117 (“'117 Publication”) filed June 11, 2018, entitled “Fluid Control Devices and Methods of Using the Same”; and U.S. Patent Publication No. 2018 / 0353117 (“'117 Publication”) filed September 12, 2018, entitled “Fluid Control Devices and Methods of Using the Same”. US Patent Publication No. for "Same".The invention relates to any apparatus (or part thereof), concept, and / or method described in U.S. Patent Publication No. 2019 / 0076074 (“'074 Publication”); and / or any device (or part thereof), concept, and / or method described in U.S. Patent Publication No. 2019 / 0175087 (“'087 Publication”), filed December 7, 2018, entitled “Fluid Control Devices and Methods of Using the Same,” the disclosure of each patent being incorporated herein by reference in its entirety.

[0071] In some cases, a user can use device 1 to obtain a quantity of substantially contaminated bodily fluid and then use device 1 to divert at least one desired and accurate (e.g., appropriate, suitable, and / or recommended) volume of the obtained bodily fluid to a corresponding sample reservoir, such as an aerobic or anaerobic culture flask. For example, as described above, the user can establish fluid communication between the fluid reservoir 115 and the bodily fluid source via inlet adapter 20 and port 11 of housing 10. In some cases, the user can engage device 1, inlet adapter 20, and / or a device connected to inlet adapter 20 to divert and isolate the initial volume of bodily fluid. In other cases, the user can divert and isolate the initial volume of bodily fluid via a connected or separate diversion device. In still other cases, the user does not need to divert the initial volume of bodily fluid.

[0072] After establishing fluid communication with the body fluid source, the user can engage and / or manipulate the actuator 40 to change the actuator 40 from a first state to a second state or toward a second state. For example, the actuator 40 can be engaged and / or manipulated to move the plunger of the actuator 40 from a first position to a second position (or toward a second position), in which the fluid reservoir 15 has a first volume ( Figure 1A In the second position, the fluid reservoir 15 has a second volume larger than the first volume. Figure 1B The movement of the plunger from the first position to the second position can cause an increase in the volume of the fluid reservoir 15, which in turn can generate a negative pressure differential and / or suction force operable to draw a certain volume of body fluid into the fluid reservoir 15. In some cases, diverting the initial volume of body fluid can ensure that the volume of body fluid transferred to the fluid reservoir 15 is substantially free of contaminants, which can cause false results during testing.

[0073] After a predetermined volume of body fluid is aspirated into the fluid reservoir 15, the volume indicator 50 can be read from its first state ( Figure 1A (For example, automatically) it transitions to its second state ( Figure 1BThe actuator 40 is configured to provide the user with an indication that a predetermined volume is contained in the fluid reservoir 15. In some cases, the predetermined volume may be based on a desired volume (e.g., 10.0 mL of body fluid) configured to be transferred to an aerobic culture flask. In other embodiments, the predetermined volume may be any suitable volume. In some cases, the user may stop collecting body fluid after the predetermined volume has been set in the fluid reservoir 15. In other embodiments, the user may continue to engage and / or manipulate the actuator 40 to aspirate additional amounts of body fluid into the fluid reservoir 15. For example, in some embodiments, the user may engage and / or change the volume indicator 50 to move the volume indicator 50 away from its second state, thereby enabling additional amounts of body fluid to be transferred into the fluid reservoir 15.

[0074] In some embodiments, the arrangement of the actuator 40 can be configured to control, meter, and / or modulate the rate at which bodily fluid is transferred into the fluid reservoir 15 (e.g., by controlling, limiting, and / or modulating the rate at which the plunger can move within or relative to the fluid reservoir 15). Thus, negative pressure differentials and / or suction within the fluid reservoir 15 can be modulated and / or limited. Furthermore, limiting the rate at which fluid is transferred into the fluid reservoir 15 can enhance and / or facilitate the collection of bodily fluid at an appropriate, suitable, recommended, desired, and / or otherwise accurate volume.

[0075] like Figure 1C As shown, for example, after transferring the desired amount of bodily fluid, the user can remove the inlet adapter 20 from port 11. The inlet adapter 20 and / or the volume 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 connect port 11 to any suitable collection or sample reservoir, such as a culture flask (and / or any collection device described herein). Thus, port 11 of housing 10 can be used to transfer fluid into fluid reservoir 15 (e.g., acting as an inlet port) and to transfer fluid out of fluid reservoir 15 (e.g., acting as an outlet port).

[0076] In some cases, for example, it may be desirable to transfer a predetermined and / or desired volume of body fluid into an anaerobic culture flask for testing samples cultured in anaerobic medium, which can be relatively sensitive to false negatives due to insufficient sample volume. Furthermore, in some embodiments, the volume indicator 50 may be configured to transition to its second state and / or may be automatically placed in its second state in response to the transfer of a predetermined and / or desired volume of body fluid into a collection reservoir or sample reservoir (e.g., an anaerobic culture flask). In some embodiments, the predetermined and / or desired volume of body fluid may be about 10.0 mL. In some cases, additional amounts or volumes of body fluid contained in the fluid reservoir 15 may be dispensed into one or more additional collection reservoirs and / or sample reservoirs, based at least in part on the desired and / or predetermined volume of body fluid expected to be delivered to a particular type of collection reservoir and / or sample reservoir (e.g., as directed, instructed, and / or recommended by the manufacturer). Therefore, the device 1 can be configured to obtain substantially contaminant-free body fluid and to dispense the obtained body fluid into one or more collection or sample reservoirs in a desired volume.

[0077] Figures 2 to 8 A body fluid collection and dispensing device 100 according to an embodiment is shown. The body fluid collection and dispensing device 100 (also referred to herein as the “device”) can 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 fluid.

[0078] As described in further detail herein, device 100 can be manipulated to aspirate a volume of bodily fluid into a portion of device 100 at a flow rate below a threshold. Although in Figures 2 to 8 Not shown, but device 100 may include a portion of and / or be coupled to a device configured to divert and at least temporarily isolate an initial volume of bodily fluid aspirated 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 aspirated into a portion of device 100.

[0079] In some embodiments, device 100 may be configured to provide a user with one or more indications regarding the volume or amount of bodily fluid that has been transferred to that portion of device 100. In some embodiments, after a known volume, predetermined volume, and / or desired volume of bodily fluid has been aspirated into that portion of device 100, device 100 and / or a portion thereof may be configured to suspend, disable, limit, and / or substantially prevent further use of device 100 until the user provides input enabling further use of device 100. In some embodiments, device 100 may be configured to be coupled to one or more sample reservoirs, bottles, containers, etc., after a certain volume of bodily fluid has been aspirated into that portion of device 100. In such embodiments, device 100 may be configured to dispense at least a portion of the volume of bodily fluid having a known volume, predetermined volume, and / or desired volume into at least one sample reservoir, bottle, and / or container, as further described in detail herein.

[0080] like Figures 2 to 5 As shown, device 100 includes a housing 110, a fluid reservoir 115, an inlet 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 dimensions of the housing 110 can be at least partially based on the desired volume or amount of fluid at least temporarily contained therein. The housing 110 is configured to include, house, 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 that is in fluid communication with the fluid reservoir 115 and is configured to be physically, at least temporarily, fluidly coupled to the inlet adapter 120 (see, for example...). Figure 6 and Figure 7 In some cases, the inlet adapter 120 may be removed or detached from port 111, which may be physically fluidly connected to one or more collection reservoirs, sample bottles, culture flasks, etc., as described in further detail herein.

[0081] A fluid reservoir 115 is disposed within and / or formed by a housing 110. For example, in some embodiments, the fluid reservoir 115 may be formed independently of the housing 110 during manufacturing and inserted into or disposed within a portion of the housing 110. In other embodiments, at least a portion of the housing 110 and at least a portion of the fluid reservoir 115 may be formed integrally and / or as an integral part thereof. In some embodiments, the housing 110 may form and / or define the fluid reservoir 115. The fluid reservoir 115 may have and / or define any suitable volume. For example, in some embodiments, the fluid reservoir 115 may have a volume between about 5.0 mL and about 60.0 mL, between about 10.0 mL and about 50.0 mL, or between about 20.0 mL and about 40.0 mL. In some embodiments, the fluid reservoir 115 may have a volume of about 20.0 mL. In other embodiments, the fluid reservoir 115 may have a volume less than about 5.0 mL or greater than about 60.0 mL. Figure 6 and Figure 7 As shown, fluid reservoir 115 is in fluid communication with port 111 of housing 110, and can therefore receive or deliver fluid flow via port 111, as described in further detail herein.

[0082] Actuator 140 can be any suitable shape, size, and / or configuration. For example, such as Figures 5 to 7 As shown, 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 a fluid reservoir 115. In some embodiments, the plunger 141 may include a seal that forms a fluid-impermeable seal with the inner surface of the fluid reservoir 115 (or housing 110) and is configured to form at least a portion of the fluid reservoir 115. For example, the fluid reservoir 115 may be and / or may have a volume defined by the inner surface, the seal of the plunger 141, and the port 111, and / or a volume defined between the inner surface, the seal of the plunger 141, and the port 111. In some cases, actuator 140 may be manipulated to move the plunger 141 within the fluid reservoir 115, which may in turn increase or decrease the volume of the fluid reservoir 115.

[0083] like Figure 6 and Figure 7 As shown, one or more racks 142 are included in, formed by, and / or coupled to the plunger 141. Figures 2 to 8 In the illustrated embodiment, actuator 140 includes a set of two racks 142. In other embodiments, actuator 140 may include any number of racks. Racks 142 include and / or form a plurality of teeth, protrusions, ribs, etc., extending along at least a portion of rack 142. Figure 5As shown, a portion of the rack 142 may be disposed in one or more openings defined by the rear surface of the housing 110 and / or may extend through one or more openings defined by the rear surface of the housing 110. In some embodiments, this arrangement may allow the rack 142 (and therefore the plunger 141) to move relative to the housing 110, as described in further detail herein. Although shown as including the rack 142, in other embodiments, the actuator may include any suitable features, components, and / or means operable to move the plunger 141 relative to the housing 110.

[0084] The wheel 143 of the actuator 140 is rotatably coupled to the housing 110 and fixedly coupled to one or more pinions 144, such as... Figure 6 As shown. Wheel 143 can be any suitable shape, size and / or configuration. In some embodiments, wheel 143 can be manipulated by a user (e.g., by the user's thumb) to rotate relative to housing 140. Wheel 143 may have and / or may include any surface features, contours, grips and / or the like configured to facilitate and / or enhance contact between the user (e.g., the user's thumb) and wheel 143.

[0085] One or more pinions 144 are fixedly coupled to wheel 143 and contact one or more racks 142 and / or configured to rotate along one or more racks 142. More specifically, the one or more pinions 144 may include a set of teeth, protrusions, ribs, gears and / or the like corresponding to the teeth, protrusions, ribs, etc. of one or more racks 142 and / or configured to mesh with the teeth, protrusions, ribs, etc. of one or more racks 142. In other words, actuator 140 and / or at least a portion thereof forms and / or has a rack and pinion arrangement and / or configuration. Pinions 144 may have any suitable size and / or diameter to achieve and / or cause a desired ratio (e.g., gear ratio) with or relative to wheel 143. That is, wheel 143 and one or more pinions 144 may have and / or may define any suitable gear ratio such that the amount of rotation of wheel 143 (e.g., generated by a user operating the wheel) causes a known, desired and / or predetermined amount of rotation of one or more pinions 144. In some embodiments, for example, wheel 143 may have a diameter of about 34 millimeters (mm) (about 1.34 inches (in.)) and one or more pinions 144 may have a diameter of about 6.5 millimeters (about 0.26 inches). In some embodiments, one or more pinions may have, for example, eight (8) teeth. In other embodiments, one or more pinions may have fewer than eight teeth or more than eight teeth. In some embodiments, the relationship between one or more racks 142, wheel 143 and one or more pinions 144 may at least partially control the effective pressure (negative pressure) generated by device 100, the sensitivity of wheel 143, the amount of tactile feedback associated with actuating wheel 143 and / or the like. Furthermore, pinion 144 may have any suitable orientation relative to rack 142, which in turn may control the resulting direction associated with the movement of plunger 141 with respect to a given direction associated with rotating wheel 143.

[0086] Wheel 143 and one or more pinions 144 are coupled to housing 110 and are allowed to rotate relative to housing 110 without substantially changing their translational position relative to housing 110. In other words, wheel 143 and one or more pinions 144 are configured to rotate about an axis having a substantially fixed position relative to housing 110. When one or more pinions 144 are in contact and / or meshing with one or more racks 142, the rotation of the wheel causes one or more pinions 142 to advance along the teeth or protrusions of one or more racks 142. In other words, the rotation of wheel 143 causes one or more pinions 143 to rotate at a known, predetermined, and / or expected rotational speed, which in turn causes plunger 141 to translate within housing 110 and / or fluid reservoir 115 at a known, predetermined, and / or expected translational speed. Therefore, the device 100 may be at least functionally similar to a syringe, but may be configured to modulate the rate at which fluid is drawn into the fluid reservoir 115 and / or to provide indication and / or control of the amount or volume of bodily fluid contained in the fluid reservoir 115, as described in further detail herein.

[0087] The volume indicator 150 can be of any suitable shape, size, and / or configuration. For example, in some embodiments, the volume indicator 150 is a button, knob, dial, lever, pointer, and / or any other suitable indicator. The volume indicator 150 can be configured to transition from a first state to a second state or to transition from a first state to a second state to provide an indication associated with the volume of fluid disposed in the fluid reservoir 115. For example, the volume indicator 150 can transition from the first state (e.g., automatically) in response to the disposal of a known volume, desired volume, and / or predetermined volume of bodily fluid in the fluid reservoir 115. In some embodiments, the known volume, desired volume, and / or predetermined volume can be, for example, as referenced above. Figures 1A to 1C Any of those described in the illustrated device 1. For example, the volume indicator 150 can transition from a first state to a second state, in which the volume indicator 150 (e.g., Figures 2 to 8 A button (not shown) is pressed or substantially positioned within the housing 110, and in the second state, 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 provide the user with an indication that 10.0 mL of bodily fluid has been deposited in the fluid reservoir 110. In response, the user can decide whether to continue aspirating an additional amount of bodily fluid into the fluid reservoir 115 (e.g., by continuing to engage the actuator 140) or to stop or terminate the aspiration process.

[0088] In some embodiments, the volume indicator 150 may also be configured to at least temporarily place the device 100 and / or actuator 140 in a state or configuration that restricts and / or substantially prevents movement of the plunger 141 within the fluid reservoir 110. 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 out of or from the surface of the housing 110). In some embodiments, the volume indicator 150 may selectively engage, for example, one or more racks 142 and / or any other suitable portion of the actuator 140 to restrict and / or substantially prevent movement of the plunger 141 when the volume indicator 150 is in the second state. Thus, a user may manipulate the volume indicator 150 and / or may apply a force to the volume indicator 150 that is operable to transition the volume indicator 150 away from the second state. In some embodiments, for example, the volume indicator 150 may transition toward a first state and / or return to a 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.

[0089] like Figures 6 to 8 As shown, the inlet adapter 120 is configured to be at least temporarily coupled to port 111 of housing 110. The inlet adapter 120 can be of any suitable shape, size, and / or configuration. The inlet adapter 120 may include a device comprising a lumen configured to be in fluid communication with a source of bodily fluids. For example, in some embodiments, the inlet adapter 120 may include a needle or catheter configured to be inserted into a patient's vein or artery. In other embodiments, the inlet adapter 120 may include a catheter and / or other cannula configured to establish fluid communication between the inlet adapter 120 and an intervening device (e.g., a shunt device, a placed intravenous catheter, and / or any other suitable device).

[0090] like Figure 6 and Figure 7As shown, when the inlet adapter 120 is coupled to the housing 110, the inlet adapter 120 is fluidly coupled to the port 111. For example, in some embodiments, the port 111 of the housing 110 may include a needle or other puncture member configured to advance through a puncturable portion, a sealable portion, and / or a brittle portion of the inlet adapter 120. For example, the inlet adapter 120 may include a self-sealing port or the like, which is punctured by the needle or puncture member of the port 111 when coupled to the inlet adapter 120 and returns to a sealed or similar state when the inlet adapter 120 is removed from the housing 110. In such embodiments, the needle and / or puncture member may place an internal portion of the inlet adapter 120 in fluid communication with the fluid reservoir 115, thereby allowing fluid (e.g., bodily fluids) to transfer from the inlet adapter 120 to the fluid reservoir 115.

[0091] like Figure 8 As shown, in some cases, after the desired volume of fluid has been transferred into the fluid reservoir 115, the inlet adapter 120 can be detached from and / or otherwise removed from the housing 110. Although in Figure 8 Not shown, but in some embodiments, disengaging the inlet adapter 120 from port 111 can expose the needle and / or puncture member coupled to port 111, which in turn allows port 111 to be physically and / or fluidly coupled to any suitable external device and / or reservoir. For example, in some embodiments, port 111 may be configured to be physically and / or fluidly coupled to a culture flask or other sample reservoir. In other embodiments, port 111 may be coupled to and / or may include any suitable transfer adapter, such as those described in the '783 patent.

[0092] Although Figures 2 to 8Not shown, but in some embodiments, the inlet adapter 120 may be configured to collect, divert, and / or isolate an initial volume of bodily fluid received from a source of bodily fluid (e.g., a patient). For example, in some embodiments, the inlet adapter 120 may have a first state or configuration in which the initial volume of bodily fluid is transferred to a first portion of the inlet adapter 120 (e.g., via a first flow path or the like), and the inlet adapter 120 may 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 inlet adapter 120 and (2) subsequent volumes of bodily fluid can be transferred through the inlet adapter 120 to the fluid reservoir 115 via a second flow path or the like. Thus, subsequent volumes of bodily fluid may be substantially free of contaminants or the like, which may otherwise be contained in the initial volume of bodily fluid. In other embodiments, the inlet adapter 120 may be configured to connect to a diversion device or the like, which is configured to divert and isolate an initial volume of bodily fluid. In still other embodiments, the diversion device or the like may be integrated and / or included in the device 100 (e.g., at least partially disposed within the housing 110).

[0093] The collection, diversion, and / or isolation of an initial volume of bodily fluid can be performed by any suitable device or combination of devices in any suitable manner. For example, in some embodiments, the above references can be used. Figures 1A to 1C The apparatus 1 shown herein and / or any apparatus (or part thereof), concept and / or method described above by reference incorporated herein by reference in the '420, '783, '241, '724, '495, '084, '240, '510, '006, '117, '074 and / or '087 publications shall be used to perform the collection, transfer and / or isolation of an initial volume of bodily fluid.

[0094] In some cases, a user can use device 100 to obtain a quantity of substantially contaminated bodily fluid, and then use device 100 to divert at least one desired and accurate (e.g., appropriate, suitable, and / or recommended) volume of the obtained bodily fluid to a corresponding sample reservoir, such as an aerobic or anaerobic culture flask. For example, as described above, the user can establish fluid communication between the fluid reservoir 115 and the bodily fluid source via inlet adapter 120 and port 111 of housing 110. In some cases, the user can engage device 100, inlet adapter 120, and / or devices connected to inlet adapter 120 to divert and isolate an initial volume of bodily fluid. After diverting the initial volume of bodily fluid, the user can rotate wheel 143 to move plunger 141 from a first state, configuration, and / or position (e.g., as...). Figure 6 and Figure 7 The distal position shown is transformed and / or moved to a second state, configuration and / or position (e.g., Figures 2 to 8 (Proximal position not shown). Movement of plunger 141 from the first state or position to the second state or position can cause an increase in the volume of fluid reservoir 115, which in turn can generate a negative pressure differential and / or suction force operable to draw subsequent volumes of body fluid (substantially free of contaminants otherwise contained in the isolated initial volume) into fluid reservoir 115.

[0095] After a predetermined volume of bodily fluid has been aspirated into fluid reservoir 115, volume indicator 150 can transition from its first state (e.g., automatically) to its second state to provide the user with an indication that a predetermined volume is contained in fluid reservoir 115. In some cases, the predetermined volume may be based on a desired volume (e.g., 10.0 mL of bodily fluid) configured for transfer to an aerobic culture flask. In other embodiments, the predetermined volume may be any suitable volume. In some cases, the user may stop collecting bodily fluid after the predetermined volume has been set in fluid reservoir 115. In other embodiments, the user may continue to rotate wheel 143 to aspirate additional amounts of bodily fluid into fluid reservoir 15. In some embodiments, the user may engage and / or rotate volume indicator 150 to move volume indicator 150 away from its second state, thereby enabling the transfer of additional amounts of bodily fluid into fluid reservoir 115. As described above, in some embodiments, the arrangement of the actuator 140 can be configured, for example, to control, meter, and / or modulate the rate at which bodily fluid is transferred into the fluid reservoir 115, either within or relative to the fluid reservoir 115, by controlling, limiting, and / or modulating the rate at which the plunger 141 moves. Thus, negative pressure differentials and / or suction within the fluid reservoir 115 can be modulated and / or limited. Furthermore, limiting the rate at which fluid is transferred into the fluid reservoir 115 can enhance and / or facilitate the collection of appropriate, suitable, recommended, and / or otherwise accurate volumes of bodily fluid.

[0096] For example, after transferring the desired amount of bodily fluid, the user can remove the inlet adapter 120 from port 11. The inlet adapter 120 and / or the volume 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 connect port 111 to any suitable collection or sample reservoir, such as a culture flask (and / or any collection device described herein). Thus, port 111 of housing 110 can be used to transfer fluid into a fluid reservoir (e.g., acting as an inlet port) and to transfer fluid out of a fluid reservoir (e.g., acting as an outlet port).

[0097] In some cases, for example, it may be desirable to transfer a predetermined and / or desired volume of body fluid into an anaerobic culture flask for testing samples cultured in anaerobic medium, which can be relatively sensitive to false negatives due to insufficient sample volume. Furthermore, in some embodiments, the volume indicator 150 may be configured to transition to its second state and / or may be automatically placed in its second state in response to the transfer of a predetermined and / or desired volume of body fluid into a collection reservoir or sample reservoir (e.g., an anaerobic culture flask). In some embodiments, the predetermined and / or desired volume of body fluid may be about 10.0 mL. In some cases, additional amounts or volumes of body fluid contained in the fluid reservoir 115 may be dispensed into one or more additional collection reservoirs and / or sample reservoirs, based at least in part on the desired and / or predetermined volume of body fluid expected to be delivered to a particular type of collection reservoir and / or sample reservoir (e.g., as indicated, instructed, and / or recommended by the manufacturer). Therefore, the device 100 can be configured to obtain substantially contaminant-free body fluid and to dispense the obtained body fluid into one or more collection or sample reservoirs in a desired volume.

[0098] Although Figures 2 to 8 The device 100 is specifically shown, but in other embodiments, any suitable changes in form may be made without departing from the described function. For example, Figures 9 to 11 A body fluid collection and dispensing device 200 according to an embodiment is shown. The body fluid collection and dispensing device 200 (also referred to herein as “device” 200) includes a housing 210, a fluid reservoir 215, an inlet adapter 220, an actuator 240, and a volume indicator 250. Device 200 is substantially similar in form and / or function to the above-referenced device. Figures 2 to 8 The device 100 is described. However, the device 200 may differ in the arrangement and / or configuration of the housing 210. For example, the housing 110 included in the device 100 is configured to extend from the distal end portion of the device 100 to the proximal end portion of the device 100 (e.g., adjacent to the inlet adapter 120). Figures 9 to 11 As shown, housing 210 extends from the distal end portion of device 200 toward the proximal end portion of device 200, but is shorter than housing 110 of device 100. More specifically, housing 210 is configured to stop along the length of the device in a position proximal to the volume indicator 250. In other respects, device 200 may be substantially similar to device 100, and therefore will not be described in further detail here.

[0099] Although Figures 2 to 8 The actuator 140 of device 100 is specifically shown, but in other embodiments, the fluid collection and dispensing device may include actuators with any suitable configuration and / or arrangement without substantially departing from the function of the actuator 140 described above (unless otherwise explicitly described). More specifically, the actuator 140 is configured to switch and / or move the plunger 141 between a first state and / or position (e.g., distal position) and a second state and / or position (e.g., proximal position) while controlling, limiting, and / or modulating the rate at which the plunger 141 can move within and / or relative to the fluid reservoir 115. In other embodiments, the fluid collection device may include actuators with any suitable arrangement and / or configuration that can similarly switch and / or move the plunger while controlling, limiting, and / or modulating the rate at which the plunger can move.

[0100] For example, Figure 12 A body fluid collection and dispensing apparatus 300 according to an embodiment is shown. The body fluid collection and dispensing apparatus 300 (also referred to herein as “apparatus” 300) may be substantially similar in form and / or function to the apparatuses 1, 100, and / or 200 described above. However, the apparatus 300 may differ in the arrangement and / or configuration of the housing and actuators, while still being configured to, among other things, control, limit, meter, and / or modulate the rate at which fluid is transferred into and / or out of the apparatus 300.

[0101] like Figure 12As shown, device 300 includes at least a housing 310, a fluid reservoir 315, and an actuator 340. Housing 310 includes an inlet port 311 and an outlet port 312. Housing 310 may be similar in form and / or function to housing 110 described above. Therefore, housing 310 includes, contains, and / or at least partially accommodates the fluid reservoir 315 and actuator 340. Inlet port 311 is configured to receive a fluid flow (e.g., from a bodily fluid source). In some embodiments, inlet port 311 may be coupled to an inlet adapter similar to, for example, inlet adapter 120 described above. In other embodiments, inlet port 311 may be placed in fluid communication with a needle, catheter, and / or device defined by a lumen, at least partially disposed within a patient's body. In still other embodiments, inlet port 311 may be placed in fluid communication with a shunt and / or shunt device (such as any of those described herein).

[0102] Although Figure 12 Not shown, but in some embodiments, the inlet port 311 and / or housing 310 may form and / or define channels, cannulas, and / or flow paths, configured to place the inlet port 311 in fluid communication with a desired portion of the fluid reservoir 315. For example, Figure 12 The inlet port 315 shown may be located on or at the distal end portion of the housing 310, and the inlet port 315 may include a channel, cannula, and / or flow path (not shown) that may place the inlet port 311 in fluid communication with the proximal end portion of the housing 310 and / or the proximal end portion of the fluid reservoir 315. In other embodiments, the inlet port 311 may be located on or along the housing 310 at any suitable location.

[0103] The outlet port 312 of the housing 310 is in fluid communication with a portion of the fluid reservoir 315, as described in further detail herein. In some embodiments, the outlet port 312 may be located, for example, on, or near a proximal end portion of the housing 310. Figure 12 As shown, the outlet port 312 can be located at the near end portion of the housing 310 and can be substantially opposite to the inlet port 311.

[0104] The outlet port 312 is configured to be physically and / or fluidly connected to a collection device, such as any of those described herein. For example, as Figure 12As shown, the outlet port 312 can be physically and fluidly coupled to a sample or culture flask. In some embodiments, the outlet port 312 may include a sheathed needle and / or other suitable puncture member configured to puncture a collection device to establish fluid communication therebetween. In other embodiments, the outlet port 312 may include any suitable feature, component, device, and / or like configured to establish fluid communication between the outlet port 312 and the collection device.

[0105] The actuator 340 of the device is substantially similar in form and / or function to the actuator 140 described above with reference to the device 100. For example, the actuator 340 may include a wheel configured to be rotated by a user to move a plunger within and / or relative to the housing 310 and / or fluid reservoir 315 (e.g., between a first state and / or position and a second state and / or position). However, the actuator 340 may differ from the actuator 140 in the position and / or orientation of the wheel. For example, as Figure 12 As shown, the wheel can be configured to rotate about an axis substantially perpendicular to the axis of rotation of the wheel 143 of the actuator 140. In some embodiments, the actuator 340 is arranged such that the plunger and / or a seal included in or on the plunger is positioned proximal to the fluid reservoir 315 when the plunger is in a first state and / or position (e.g., Figure 12 (As shown) and when the plunger is in the second state, it can be in a distal position within the fluid reservoir 315. Furthermore, the actuator 340 can be configured to control, limit, meter, and / or modulate the rate of movement of the plunger within or relative to the fluid reservoir 315, as described in detail above with reference device 100.

[0106] Although Figure 12 Not shown, but the inlet port 311 and outlet port 312 of housing 310 are each in fluid communication with a portion of fluid reservoir 315 near the plunger and / or the plunger's seal. In some cases, manipulating the wheel to move the plunger from a first state or position to a second state or position can be operable to draw a volume of fluid into fluid reservoir 315 (e.g., near the plunger or its seal) via inlet port 311, and manipulating the wheel to move the plunger from a second state or position to a first state or position can be operable to deliver at least a portion of the volume of fluid from fluid reservoir 315 via outlet port 312. Thus, device 100 can be configured to obtain substantially contaminated bodily fluid and to dispense the obtained bodily fluid in a desired volume into one or more collection or sample reservoirs, as described above with reference to devices 1, 100, and / or 200.

[0107] Figure 13 A body fluid collection and dispensing apparatus 400 according to another embodiment is shown. The body fluid collection and dispensing apparatus 400 (also referred to herein as "apparatus" 400) may be substantially similar in form and / or function to the apparatuses 100, 200, and / or 300 described above. However, the apparatus 400 may differ in the arrangement and / or configuration of its actuators while still being configured to, among other things, control, limit, meter, and / or modulate the rate at which fluid is transferred into and / or out of the apparatus 400.

[0108] like Figure 13 As shown, the device 400 includes at least a housing 410, a fluid reservoir 415, and an actuator 440. The housing 410 includes an inlet port 411 and an outlet port 412, the inlet port 411 being configured to deliver a fluid (e.g., bodily fluid) flow into the fluid reservoir 415, and the outlet port 412 being configured to deliver a fluid (e.g., bodily fluid) flow out of the fluid reservoir 415. In some embodiments, the housing 410 may be substantially similar in form and / or function to the housing 310 described above. Therefore, the housing 410 will not be described in further detail here.

[0109] The actuator 440 of the device is at least functionally substantially similar to at least the aforementioned actuators 140 and / or 340. For example, 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 a plunger within and / or relative to the housing 410 and / or fluid reservoir 415 (e.g., between a first state and / or position and a second state and / or position). However, actuator 440 may differ by including a plunger that includes and / or is arranged as a lead screw, worm gear, and / or any other threaded member configured to engage a corresponding internal portion of engagement member 443. Thus, rotation of engagement member 443 may cause the plunger to change and / or move relative to and / or within the fluid reservoir 415. Furthermore, actuator 440 can be configured to control, limit, meter, and / or modulate the rate of movement of the plunger within or relative to fluid reservoir 415, as described in detail for reference device 100 above. Therefore, device 400 can be configured to obtain substantially contaminant-free bodily fluid and to dispense the obtained bodily fluid in a desired volume into one or more collection or sample reservoirs, as described in any of reference devices 1, 100, 200, and / or 300 above.

[0110] Figure 14A body fluid collection and dispensing apparatus 500 according to yet another embodiment is shown. The body fluid collection and dispensing apparatus 500 (also referred to herein as “apparatus” 500) may be substantially similar in form and / or function to the apparatuses 1, 100, 200, 300, and / or 400 described above. However, the apparatus 500 may differ in the arrangement and / or configuration of its actuators while still being configured to, among other things, control, limit, meter, and / or modulate the rate at which fluid is transferred into and / or out of the apparatus 500.

[0111] like Figure 14 As shown, the device 500 includes at least a housing 510, a fluid reservoir 515, and an actuator 540. The housing 510 includes an inlet port 511 and an outlet port 512, the inlet port 511 being configured to deliver a fluid (e.g., bodily fluid) flow into the fluid reservoir 515, and the outlet port 512 being configured to deliver a fluid (e.g., bodily fluid) flow out of the fluid reservoir 515. In some embodiments, the housing 510 may be substantially similar in form and / or function to the housings 10, 110, 210, 310, and / or 410 described above. Therefore, the housing 510 will not be described in further detail here.

[0112] The actuator 540 of the device is at least functionally substantially similar to the actuator 140 described above for reference device 100. While the actuator 140 is described above as including a wheel 143 configured to rotate one or more pinions 144 to shift and / or move the plunger 141, the actuator 540 includes a lever 546 configured to engage a rack 542 coupled to, included in, or on the plunger 541 and / or otherwise formed by the plunger 541. Figure 14 In the illustrated embodiment, the user can engage a portion of the plunger 541 such that the plunger 541 is in a first state and / or position within the housing 510 and / or fluid reservoir 515 and / or relative to the housing 510 and / or fluid reservoir 515. Figure 14Movement between a second state and / or position. Furthermore, in some cases, lever 546 may engage rack 542 of plunger 541 to control, limit, meter, and / or modulate the rate of movement of plunger 541 within or relative to fluid reservoir 515, as described in detail with reference device 100 above. In some cases, the user may apply a desired force to lever 546 while moving plunger 541 to further modulate the rate of movement of plunger 541 and / or the ease of movement associated with moving plunger 541. Thus, device 500 may be configured to obtain substantially contaminated bodily fluid and to dispense the obtained bodily fluid in a desired volume into one or more collection or sample reservoirs, as described in any of reference devices 1, 100, 200, 300, and / or 400 above.

[0113] Figure 15 A body fluid collection and dispensing apparatus 600 according to yet another embodiment is shown. The body fluid collection and dispensing apparatus 600 (also referred to herein as “apparatus” 600) may be substantially similar in form and / or function to the apparatuses 1, 100, 200, 300, 400, and / or 500 described above. However, the apparatus 600 may differ in the arrangement and / or configuration of its actuators while still being configured to, among other things, control, limit, meter, and / or modulate the rate at which fluid is transferred into and / or out of the apparatus 600.

[0114] like Figure 15 As shown, the device 600 includes at least a housing 610, a fluid reservoir 615, and an actuator 640. The housing 610 includes an inlet port 611 and an outlet port 612, the inlet port 611 being configured to deliver a fluid (e.g., bodily fluid) flow into the fluid reservoir 615, and the outlet port 612 being configured to deliver a fluid (e.g., bodily fluid) flow out of the fluid reservoir 615. In some embodiments, the housing 610 may be substantially similar in form and / or function to the housings 10, 110, 210, 310, and / or 410 described above. Therefore, the housing 610 will not be described in further detail here.

[0115] The actuator 640 of the device is at least functionally substantially similar to the actuator 140 described above for reference device 100. While the actuator 140 is described above as including a wheel 143 configured to rotate one or more pinions 144 to shift and / or move the plunger 141, the actuator 640 is configured to generate, produce, and / or create a negative pressure differential and / or suction force operable to move the plunger of the actuator 640. For example, as... Figure 15As shown, actuator 640 includes a ball 647 in fluid communication with a portion of fluid reservoir 615. In use, ball 647 can be squeezed by a user to switch actuator 640 and / or its plunger between a first state and a second state. More specifically, in response to ball 647 being squeezed by a user, air and / or other contents within ball 647 can be released to the surrounding environment or atmosphere (e.g., via a one-way valve or the like). Figure 15 (Not shown in the image). After the contents are expelled, the user can release the ball 647 to allow it to return to its uncompressed state. Instead, the volume within the ball 647 increases, which causes a negative pressure differential and / or suction to be applied to the portion of the fluid reservoir 615 communicating with the ball 647. The negative pressure differential and / or suction is then sufficient to move the plunger within the fluid reservoir 615.

[0116] In some embodiments, the configuration of the sphere 647 limits and / or controls the amount or magnitude of the negative pressure differential and / or suction applied in or on the fluid reservoir 615. In some cases, the sphere 647 is squeezed multiple times to move the plunger by a desired amount or distance (e.g., from a first state or position to a second state or position). Thus, the actuator 640 can be configured to control, limit, meter, and / or modulate the rate of movement of the plunger within or relative to the fluid reservoir 615, as described in detail for reference device 100 above. Thus, device 600 can be configured to obtain substantially contaminated bodily fluid and to dispense the obtained bodily fluid in a desired volume into one or more collection or sample reservoirs, as described in any of reference devices 1, 100, 200, 300, 400, and / or 500 above.

[0117] Although Figures 2 to 8The volume indicator 150 of device 100 has been specifically shown and described above. However, in other embodiments, the body fluid collection and dispensing device may include a volume indicator with any suitable configuration and / or arrangement without substantially departing from the function of the volume indicator 150 described above (unless otherwise explicitly described). More specifically, the volume indicator 150 is configured to transition from a first state to a second state in response to the placement of a known volume, desired volume, and / or predetermined volume of body fluid in the fluid reservoir 115. Additionally, in some embodiments, the volume indicator 150 may be configured to selectively suspend, limit, and / or prevent the transfer of additional amounts of body fluid into the fluid reservoir 115 while the volume indicator 115 is in the second state as described above. In other embodiments, the body fluid collection device may include a volume indicator with any suitable arrangement and / or configuration that may similarly transition and / or move between at least a first state and a second state to indicate and / or control the volume of body fluid disposed within the fluid reservoir, permitted to be disposed within the fluid reservoir, and / or configured to be dispensed from the fluid reservoir.

[0118] For example, Figures 16 to 19 A body fluid collection and dispensing device 700 according to an embodiment is shown in a first state, a second state, a third state, and a fourth state, respectively. The body fluid collection and dispensing device 700 (also referred to herein as “device” 700) may be substantially similar in form and / or function to at least the device 100 described above. However, the device 700 may differ in the arrangement and / or configuration of the volume indicator while still being configured to, among other things, provide indication of the volume of fluid (e.g., body fluid) within the device 700 and / or control, limit, and / or dispense at least a portion of the volume of fluid within the device 700.

[0119] like Figures 16 to 19 As shown, the device 700 includes at least a housing 710, a fluid reservoir 715, an actuator 740, and a volume indicator 750. The housing 710 includes a port 711 configured to deliver fluid (e.g., bodily fluids) into and / or out of the fluid reservoir 715. In some embodiments, the housing 710 may be substantially similar in form and / or function to the housings 10 and / or 110 described above. In some embodiments, the housing 710 may be similar to the housing of a syringe and / or the like. Therefore, certain parts and / or aspects of the housing 710 are not described in further detail herein.

[0120] Actuator 740 can be of any suitable shape, size, and / or configuration. In some embodiments, actuator 740 may include at least a plunger configured to change and / or move within and / or relative to fluid reservoir 715. For example, in some embodiments, actuator 740 is at least similar in form and / or function to any of the 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. Therefore, certain parts and / or aspects of actuator 740 are not described in further detail herein.

[0121] The volume indicator 750 of device 700 can be of any suitable shape, size and / or configuration, and can be configured to provide indication of the volume of fluid (e.g., bodily fluid) within fluid reservoir 715 and / or control, limit and / or distribute at least a portion of the volume of fluid within fluid reservoir 715, as described in detail above with reference to device 100. Figures 16 to 19 As shown, the volume indicator 750 includes an indicating member 751 (e.g., an arm, arrow, rod, dial, and / or any other suitable indicator). Furthermore, in some embodiments, a portion of the housing 710 (e.g., a surface such as an outer surface) may define a track 752 within which at least a portion of the indicating member 751 is disposed. The indicating member 751 is configured to rotate relative to the housing 710 to move a portion of the indicating member 751 through one or more portions of the track 752, at least partially based on the position of the plunger within the housing 710 (and therefore, the volume of fluid within the fluid reservoir 715). Furthermore, based on the portion of the track 752 in which the indicating member 751 is disposed, the indicating member 751 may be aligned with one or more marks on the housing 710 or device 700 and / or may point to one or more marks on the housing 710 or device 700, which are associated with and / or indicate a known volume, predetermined volume and / or desired volume of fluid disposed in the fluid reservoir 715.

[0122] For example, when the volume indicator 750 is in the first state ( Figure 16 When the volume indicator 750 is in the second state, the indicator member 751 can be aligned with a mark such as "PEDIATRIC", and a portion of the indicator member 751 can be disposed in the first portion of the track 752 (e.g., the pediatric portion of the track 752); when the volume indicator 750 is in the second state ( Figure 17When the volume indicator 750 is in the third state, the indicator member 751 can be aligned with a mark such as "ANAEROBIC" (anaerobic), and this part of the indicator member 751 can be located in the second part of the track 752 (e.g., the anaerobic part of the track 752); and when the volume indicator 750 is in the third state ( Figure 18 and Figure 19 When in the track 752, the indicator member 751 can be aligned with a mark such as “AEROBIC”, and this part of the indicator member 751 can be set in the third part of the track 752 (e.g., the aerobic part of the track 752).

[0123] In use, the user can manipulate actuator 740 to draw fluid (e.g., bodily fluid) through port 711 of housing 710 into fluid reservoir 715. In some cases, volume indicator 750 can be in a first state ( Figure 16 In this embodiment, the user can manipulate actuator 740 to aspirate a predetermined volume (e.g., a relatively small volume) of fluid suitable for testing a sample drawn from a pediatric patient into fluid reservoir 715 until that portion of indicating member 751 reaches the end of the first portion of track 752. In some embodiments, the reaching of the end of the first portion of track 752 by indicating member 751 can limit and / or substantially prevent additional amounts and / or volumes of bodily fluid from being aspirated into fluid reservoir 715 until volume indicator 750 transitions from a first state to a second state.

[0124] In some cases, the volume indicator 750 can be placed in the second state ( Figure 17 In this embodiment, the user can manipulate actuator 740 to aspirate a predetermined volume of fluid suitable for anaerobic culture testing (e.g., a volume larger than a pediatric volume) into fluid reservoir 715 until that portion of indicating member 751 reaches the end of the second portion of track 752. In some embodiments, the reaching of the end of the second portion of track 752 by indicating member 751 can limit and / or substantially prevent additional amounts and / or volumes of bodily fluid from being aspirated into fluid reservoir 715 until volume indicator 750 transitions from a second state to a third state.

[0125] In some cases, the volume indicator 750 can be placed in the third state ( Figure 18 and Figure 19 In this system, the user can manipulate actuator 740 to draw a predetermined volume of fluid (e.g., a volume larger than that of anaerobic culture) suitable for aerobic culture testing into fluid reservoir 715 until that portion of indicator member 751 reaches the end of the third portion of track 752 (e.g., as shown in the image). Figure 19(as shown in the fourth state). In some embodiments, the end of the portion of the indicating member 751 reaching the track 752 may limit and / or substantially prevent additional amounts and / or volumes of bodily fluid from being aspirated into the fluid reservoir 715. In other words, the end of the third portion of the track 752 may be a stop or limitation on the range of motion of the actuator 740 relative to the housing 710. In some cases, a user may manipulate the actuator 740 to transfer a volume of bodily fluid from the fluid reservoir 715 to one or more sample or culture flasks (or the like) based at least in part on the amount or volume of bodily fluid contained in the fluid reservoir. Therefore, the volume indicator 750 may provide an indication associated with the amount or volume of bodily fluid disposed in the fluid reservoir 715 and may provide measures for dispensing bodily fluid into one or more collection devices based at least in part on the volume of bodily fluid disposed in the fluid reservoir.

[0126] Figures 20 to 22 A body fluid collection and dispensing apparatus 800 according to yet another embodiment is shown in a first, second, and third state, respectively. The body fluid collection and dispensing apparatus 800 (also referred to herein as "apparatus" 800) may be substantially similar in form and / or function to at least the aforementioned apparatus 100 and / or 700. However, apparatus 800 may differ in the arrangement and / or configuration of the volume indicator while still being configured to, among other things, provide indication of the volume of fluid (e.g., body fluid) within apparatus 800 and / or control, limit, and / or dispense at least a portion of the volume of fluid within apparatus 800.

[0127] like Figures 20 to 22 As shown, the device 800 includes at least a housing 810, a fluid reservoir 815, an actuator 840, and a volume indicator 850. The housing 810 includes a port 811 configured to deliver fluid (e.g., bodily fluid) into and / or out of the fluid reservoir 815. In some embodiments, the housing 810 may be substantially similar in form and / or function to the housing 110 described above. In some embodiments, the housing 810 may be similar to the housing of a syringe and / or the like. Therefore, certain parts and / or aspects of the housing 810 are not described in further detail herein.

[0128] Actuator 840 can be of any suitable shape, size, and / or configuration. In some embodiments, actuator 840 may include at least a plunger 841 configured to change and / or move within and / or relative to fluid reservoir 815. For example, in some embodiments, actuator 840 is similar in form and / or function to any of the actuators 40, 140, 240, 340, 440, 540, 640, and / or 740 described above. In other embodiments, actuator 840 may be similar to an actuator of a syringe and / or the like. Therefore, certain parts and / or aspects of actuator 840 are not described in further detail herein.

[0129] exist Figure 20 and Figure 22 In the illustrated embodiment, the volume indicator 850 may include two indicator members 851 configured to move along corresponding tracks 848 (e.g., ridges, protrusions, paths, and / or the like) disposed on, formed by, and / or otherwise extending from the plunger 841. In some embodiments, the indicator 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 profile, such that the track 842 is to contact the indicator member 851 after the plunger 841 has moved a predetermined amount and / or a desired amount of time. More specifically, in some embodiments, the first track 842 may be configured to engage the first indicator member 851 and / or move the first indicator member 851 in response to a first amount or distance of movement of the plunger 841, while the second track 842 does not engage the second indicator member 851. Figure 21 In some embodiments, movement and / or engagement of the first indicating member 851 provides the user with an indication that a first predetermined volume and / or a known volume of bodily fluid is present in the fluid reservoir 815. In some cases, the user may continue to move the plunger 841 by an additional amount (e.g., a second amount or distance), which in turn may cause the second track 842 to engage and / or move into contact with the second indicating member 851. Figure 22 Thus, moving the second indicating member 851 can provide the user with an indication that a second predetermined volume and / or a known volume of bodily fluid is provided in the fluid reservoir 815.

[0130] Figures 23 to 25A body fluid collection and dispensing apparatus 900 according to yet another embodiment is shown in a first, second, and third state, respectively. The body fluid collection and dispensing apparatus 900 (also referred to herein as "apparatus" 900) may be substantially similar in form and / or function to at least the aforementioned apparatuses 1, 100, 700, and / or 800. However, apparatus 900 may differ in the arrangement and / or configuration of the volume indicator while still being configured to, among other things, provide indication of the volume of fluid (e.g., body fluid) within apparatus 900 and / or control, limit, and / or dispense at least a portion of the volume of fluid within apparatus 900.

[0131] like Figures 23 to 25 As shown, 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 allow fluid (e.g., bodily fluids) to flow into and / or out of 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 the housing of a syringe and / or the like. Furthermore, the actuator 940 may be at least 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 the actuator of a syringe and / or the like. Therefore, certain parts and / or aspects of the housing 910 and / or actuator 940 are not described in further detail here.

[0132] exist Figure 23 and Figure 25 In the illustrated embodiment, the volume indicator 950 may include an indicator member 951 configured to move along a portion of the actuator 940. In some embodiments, a portion of the actuator 940 may be configured to selectively engage the indicator member 951 in response to a first amount or distance of movement of the actuator 940. More specifically, in some embodiments, the volume indicator 950 may be in a first state or position when the actuator 950 is in a first state or position, such as... Figure 23 As shown; when the actuator 950 is placed in the second state or position, the volume indicator 950 can switch to the second state or position, such as... Figure 24 As shown; and when the actuator 950 is placed in the third state or position, the volume indicator 950 can switch to the third state or position, as shown. Figure 25As shown. Thus, the volume indicator 950 can be configured to provide the user with an indication associated with the volume of bodily fluid aspirated into the fluid reservoir 915 and / or an indication of the volume of bodily fluid aspirated into the fluid reservoir 915 in response to a known or predetermined amount of movement of the actuator 940, as described in any of the above-described reference devices 1, 100, 200, 300, 400, 500, 600, 700 and / or 800.

[0133] For example, Figure 26 A body fluid collection and dispensing apparatus 1000 according to an embodiment is shown. The body fluid collection and dispensing apparatus 1000 (also referred to herein as "apparatus" 1000) may be substantially similar in form and / or function to at least the aforementioned apparatuses 1, 100, 700, 800, and / or 900. However, apparatus 1000 may differ in the arrangement and / or configuration of the volume indicator while still being configured to, among other things, provide indication of the volume of fluid (e.g., body fluid) within apparatus 1000 and / or control, limit, and / or dispense at least a portion of the volume of fluid within apparatus 1000.

[0134] like Figure 26 As shown, 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 and at least one outlet port 1012, the inlet port 1011 being configured to deliver a fluid (e.g., bodily fluid) flow into the fluid reservoir 1015, and the at least one outlet port 1012 being configured to deliver a desired volume or portion of the bodily fluid disposed in 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 the housing of a syringe and / or the like. Furthermore, the actuator 1040 may be at least similar 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, actuator 1040 may be similar to an actuator of a syringe and / or the like. Therefore, certain parts and / or aspects of housing 1010 and / or actuator 1040 will not be described in further detail here.

[0135] Figure 26 The volume indicator 1050 of the illustrated device 1000 may be substantially similar, at least functionally, to the volume indicators 50, 150, 750, 850, and / or 950 of devices 100, 700, 800, and / or 900, respectively. While volume indicators 750, 850, and 950 are described above as including an indicating member that changes in response to movement of at least a portion of an actuator, Figure 26 The volume indicator 1050 shown may be and / or may include a switch or the like, which can switch between one or more states and / or configurations to control and / or dispense one or more volumes of bodily fluid aspirated into the fluid reservoir 1015. For example, in some embodiments, the switch of the volume indicator 1050 may be in a first state and / or configuration, wherein the device 1000 is configured or enabled to dispose of a desired amount of bodily fluid into the fluid reservoir 1015. In some cases, after disposing of a desired amount of bodily fluid into the fluid reservoir 1015, the user may switch the volume indicator 1050 to a second state and / or configuration, wherein a first known volume and / or predetermined volume of bodily fluid may be delivered and / or dispensed into one or more collection devices. In some cases, the second state may enable and / or allow the user to deliver and / or dispense a certain volume of body fluid associated with an aerobic or anaerobic culture test and / or otherwise suited for an aerobic culture test (e.g., via one of outlets 1012) or for an anaerobic culture test (e.g., via another outlet 1012). Therefore, the device 1000 may be configured to provide, at least in part, an indication associated with the volume disposed in the fluid reservoir 1015 and / or deliver and / or dispense known and / or predetermined amounts of body fluid into one or more collection devices based on the type of test and / or analysis to be performed.

[0136] For example, Figure 27 and Figure 28 A body fluid collection and dispensing device 1100 according to an embodiment is shown in a first state and a second state, respectively. The body fluid collection and dispensing device 1100 (also referred to herein as “device” 1100) may be substantially similar in form and / or function to at least the aforementioned devices 1, 100, 700, 800, 900, and / or 1000. However, the device 1100 may differ in the arrangement and / or configuration of the volume indicator while still being configured to, among other things, provide indication of the volume of fluid (e.g., body fluid) within the device 1100 and / or control, limit, and / or dispense at least a portion of the volume of fluid within the device 1100.

[0137] like Figure 27 and Figure 28As shown, 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 allow fluid (e.g., bodily fluids) to flow into and / or out of 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 the housing of a syringe and / or the like. Additionally, the actuator 1140 may be at least 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 the actuator of a syringe and / or the like. Therefore, certain parts and / or aspects of the housing 1110 and / or actuator 1140 will not be described in further detail here.

[0138] Figure 27 and Figure 28 The volume indicator 1150 of the illustrated device 1100 may be substantially similar in function to the volume indicators 50, 150, 750, 850, 950, and / or 1050 of devices 1, 100, 700, 800, 900, and / or 1000, respectively. For example, although the volume indicator 1050 is shown as a switch, in Figure 27 and Figure 28 In the illustrated embodiment, the volume indicator 1150 is arranged and / or configured as a turntable or the like, which can switch between one or more states and / or configurations to control and / or dispense one or more volumes of bodily fluid aspirated into the fluid reservoir 1115. Therefore, the volume indicator 1150 can be configured in accordance with the above references. Figure 26 It functions in a manner similar to that of the volume indicator 1050 shown and described.

[0139] While devices 1, 100, 200, 300, 400, 500, 600, 700, 800, 900, 1000, and / or 1100 are shown and described as comprising a single fluid reservoir, in other embodiments, the body fluid collection and dispensing device may include any number of fluid reservoirs configured to receive a volume of body fluid, at least in part, based on one or more tests to be performed on the body fluid. For example, Figure 29A body fluid collection and dispensing apparatus 1200 according to an embodiment is shown. The body fluid collection and dispensing apparatus 1200 (also referred to herein as "apparatus" 1200) may be substantially similar to any of the apparatuses described above, at least in form and / or function. However, the apparatus 1200 may differ by including at least two fluid reservoirs, each of which is configured to receive a predetermined volume and / or a desired volume of body fluid.

[0140] like Figure 29 As shown, 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 deliver fluid (e.g., bodily fluid) into and / or out of 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 the housing of a syringe and / or the like. Additionally, the actuator 1240 may be at least similar in form and / or function to any of the actuators described above. In other embodiments, the actuator 1240 may be similar to the actuator of a syringe and / or the like. Therefore, certain parts and / or aspects of the housing 1210 and / or actuator 1240 are not described in further detail herein.

[0141] like Figure 29 As shown, actuator 1240 may include a first portion and a second portion, the first portion being disposed in and / or configured to engage the first fluid reservoir, and the second portion being disposed in and / or configured to engage the second fluid reservoir. Furthermore, volume indicator 1250 of device 1200 may be configured to selectively engage one or more portions of actuator 1240 to control, limit, and / or selectively enable the first portion or the second portion of actuator 1240 to move within and / or relative to a corresponding fluid reservoir 1215. Thus, volume indicator 1250 can selectively control the inflow of a predetermined and / or known volume of bodily fluid into one or more of the fluid reservoirs 1215. In some embodiments, volume indicator 1250 may similarly control and / or dispense desired portions of bodily fluid into any number of collection devices. In some cases, the volume indicator 1250 can be configured to dispense a predetermined volume of body fluid into a collection device, at least in part based on a test or analysis to be performed on the body fluid.

[0142] While the inlet adapter 120 of the body fluid collection and distribution device 100 has been described above as including and / or coupled to a device configured to receive, divert, and / or isolate an initial volume of body fluid from a body fluid source, in other embodiments, the body fluid collection and distribution device may include a diverter having any suitable configuration and / or arrangement without substantially departing from the function of the diverter described above. For example, Figures 30 to 34 A body fluid collection and dispensing device 1300 according to an embodiment is shown. The body fluid collection and dispensing device 1300 (also referred to herein as “device 1300”) may be substantially similar in form and / or function to at least the above-mentioned references. Figures 1A to 1C The described device 1 and / or the above references Figure 2 and Figure 8 The device 100 is described. However, the device 1300 may vary by including a shunt and / or shunt device or mechanism within the housing of the device 1300 and / or otherwise integrated into the device 1300.

[0143] like Figures 30 to 34 As shown, the device 1300 includes at least a housing 1310, a fluid reservoir 1315, an inlet adapter 1320, an actuator 1340, a volume indicator 1350, and a diverter 1370. The housing 1310 includes a port 1311 configured to deliver fluid (e.g., bodily fluid) into and / or out of 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 inlet adapter 1320 may be substantially similar in form and / or function to the aforementioned references. Figure 2 and Figure 8 The described inlet adapter 120. In some embodiments, the actuator 1340 may be similar 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, for example, the one described above. Figures 2 to 8 The volume indicator 150 is described. Therefore, certain parts and / or aspects of the housing 1310, inlet adapter 1320, actuator 1340 and / or volume indicator 1350 are not described in further detail herein.

[0144] As described above, the shunt 1370 can be configured to (1) receive an initial volume of body fluid aspirated from a body fluid source (e.g., a patient) and (2) isolate the initial volume of body fluid such that subsequent volumes of body fluid aspirated into the fluid reservoir 1315 are substantially free of contaminants otherwise contained in the initial volume. The shunt 1370 of the device 1300 can be of any suitable shape, size, and / or configuration. Figures 32 to 34As shown, the shunt 1370 is disposed within the housing 1310 and more specifically within a portion of the actuator 1340. In some embodiments, the shunt 1370 may include a pre-sample reservoir 1372 configured to receive a plunger or seal included in and / or coupled to the actuator 1340. The shunt 1370 also includes a needle 1371 or other cannula configured to pierce and / or at least temporarily extend through a seal 1373 disposed within the plunger of the actuator 1340.

[0145] The shunt 1370 is configured to switch between a first state and a second state in response to a change and / or movement of the actuator 1340 relative to the housing 1310. For example, when the actuator 1370 is in a first position or a distal position within the fluid reservoir 1315, the shunt 1370 may be in the first state, such as... Figure 32 As shown. More specifically, when the shunt 1370 is in the first state, the needle 1371 can extend through the seal 1373 to place the sample pre-reservoir 1372 of the shunt 1370 in fluid communication with the inlet adapter 1320. Thus, when the user operates the device 1300 to draw body fluid from a source of body fluid (e.g., a patient), the sample pre-reservoir 1372 can receive an initial volume of body fluid.

[0146] like Figure 33 As shown, a user can manipulate actuator 1340 to switch shunt 1370 from a first state to a second state. In some embodiments, manipulating actuator 1340 may include, for example, moving a plunger or portion of actuator 1340 within pre-sample reservoir 1372, which in turn creates a negative pressure differential and / or suction within pre-sample reservoir 1372. In some embodiments, needle 1371 may also be withdrawn from seal 1373 and positioned within pre-sample reservoir 1372. Thus, an initial volume of bodily fluid can be transferred through inlet adapter 1320 and seal 1373 into pre-sample reservoir 1372, as... Figure 33 As shown. In some embodiments, after receiving an initial volume of body fluid in the pre-sample reservoir 1372, the shunt 1370 can be configured to isolate the initial volume therein. Once the initial volume of body fluid is isolated, the user can continue to manipulate the actuator 1340 to aspirate subsequent volumes of body fluid into the fluid reservoir 1315. Figure 34 As described in detail above with reference devices 1 and / or 100, device 1300 can therefore be performed in a manner substantially similar to that of device 1 and / or 100. Furthermore, in some cases, the isolated initial volume of bodily fluid can be diverted from the fluid reservoir 1372 of the diverter 1370 for reinfusion into the body or for any suitable test in which erroneous results are not easily obtained due to contamination.

[0147] The apparatus described herein is configured to limit, control, meter, and / or modulate the rate at which bodily fluids are drawn into the apparatus's fluid reservoir. In some cases, limiting, controlling, and / or modulating the rate of fluid transfer similarly limits, controls, meters, and / or modulates the magnitude of the vacuum within the fluid reservoir and / or the magnitude of the volume displaced by its actuator or plunger.

[0148] For example, Figure 35 Figure 1400 shows the relationship between vacuum and / or displacement volume and the aspiration rate of bodily fluid being aspirated into a reservoir using various methods (e.g., any of those described herein), and / or the expected, calculated, and / or theoretical relationship. More specifically, Figure 1400 shows vacuum and / or displacement volume as a function of aspiration rate (e.g., the speed of actuator movement) with a constant fluid flow rate, inlet size, and fluid viscosity. As shown, line 1401 shows the maximum vacuum using a 20 mL displacement in a closed volume. Line 1402 shows the vacuum caused by “rapid aspiration,” where a 20 mL displacement is rapidly executed and maintained, allowing bodily fluid to flow into the displacement volume. Line 1403 shows the vacuum caused by “normal aspiration,” where the plunger is maintained at approximately 1.0 mL before fluid flow until a displacement of 20 mL is achieved. Line 1404 shows the vacuum caused by “slow aspiration,” where the plunger moves at a rate substantially equal to the rate at which the bodily fluid is filled until a displacement of 20 mL is achieved. Line 1405 illustrates the vacuum caused by the maximum displacement rate when using any of the devices described herein. As shown by line 1405 in graph 1400, the devices described herein control, limit, meter, and / or modulate the amount of vacuum and / or displacement rate within the fluid reservoir, even when actuated as quickly as possible.

[0149] Figure 36 Figure 1500 shows the rates at which a reservoir with a fixed filling volume is filled using various methods. More specifically, lines 1501, 1502, and 1503 show the filling rates of fluids with different viscosities at a displacement of 3.0 mL using the same acquisition method (e.g., using a diversion and collection device). For example, line 1501 shows the filling rate of a fluid simulating blood (e.g., VATA or the like); line 1502 shows the filling rate of a fluid with a viscosity of approximately 4.0 centipoise (cP); and line 1503 shows the filling rate of a fluid with a viscosity of approximately 8.0 cP. Lines 1504, 1505, and 1506 show the filling rates of VATA, a 4.0 cP fluid, and an 8.0 cP fluid, respectively, using a 1.0 mL syringe and a 1.0 mL displacement. Lines 1507 and 1508 show the filling rates of a 4.0 cP fluid and an 8.0 cP fluid, respectively, using a 3.0 mL syringe and a 1.0 mL displacement.

[0150] Figure 37 This is a flowchart illustrating a method 1600 using a fluid transfer and dispensing apparatus according to an embodiment. The fluid transfer and dispensing apparatus (also referred to herein as an apparatus) may be similar to and / or substantially the same as any apparatus (or combination of apparatuses) described herein. For example, an apparatus may include a housing, a fluid reservoir, an inlet adapter, an actuator, and a volume indicator, as referenced above, for example... Figures 1A to 1C The device 1 shown is described.

[0151] Method 1600 includes, at 1601, placing the inlet adapter of the fluid transfer device in fluid communication with a source of bodily fluid, such that a port of the housing fluidly connects the inlet adapter to a fluid reservoir defined by the housing. The inlet adapter can be any suitable component, mechanism, device, etc., such as any of those described herein. For example, in some embodiments, the inlet adapter may be substantially similar in form and / or function to the references above. Figures 1A to 1C The described inlet adapter 20. In some embodiments, the inlet adapter may be and / or may include a needle, catheter, cannula, endoscope, and / or the like that is in fluid communication with a source of bodily fluid (e.g., a patient). The inlet adapter may be configured to be removably coupled to the housing such that fluid communication is established between the inlet adapter and the fluid reservoir via a port.

[0152] At position 1602, the actuator is engaged 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, such that the movement of the plunger generates a negative pressure operable to draw bodily fluid into the fluid reservoir via an inlet adapter. The actuator can be any suitable component, mechanism, device, etc., such as any of those described herein. For example, in some embodiments, the actuator may be substantially similar in form and / or function to the references above. Figures 1A to 1C The actuator 40 is described. Thus, the actuator can be manipulated to move the plunger within the housing, which in turn increases the volume of the fluid reservoir and draws a certain volume of bodily fluid into the fluid reservoir as the plunger moves from a first position to a second position. As described in detail above, in some embodiments, the actuator can be configured to control, meter, and / or modulate the rate at which bodily fluid is transferred into the fluid reservoir, which in turn increases the likelihood that the user will draw the desired and accurate volume of bodily fluid into the fluid reservoir, as described above, for example, with reference to device 1.

[0153] At point 1603, when a predetermined volume of body fluid is transferred to the fluid reservoir, the volume indicator transitions from the first state to the second state. The volume indicator can be any suitable component, mechanism, device, etc., such as any of those described herein. For example, in some embodiments, the volume indicator may be substantially similar in form and / or function to the references above. Figures 1A to 1C The volume indicator 50 is described. In some embodiments, the predetermined volume of body fluid may be a recommended and / or desired volume of body fluid for testing body fluid. For example, in some cases, the predetermined volume of body fluid may be 10.0 mL. As described above, when the predetermined volume of body fluid is in the fluid reservoir, the volume indicator may be configured to automatically transition from a first state to a second state.

[0154] At 1604, before the plunger moves to (or is positioned in) the second position, the plunger stops in response to the transition of the volume indicator from the first state to the second state. For example, in some embodiments, when the volume indicator is in the second state, a portion of the volume indicator may directly or indirectly block, limit, and / or substantially prevent further transitions of the actuator (e.g., further movement of the plunger toward the second position). In such embodiments, when the plunger is in the second position, the predetermined volume of the bodily fluid is less than the volume of the fluid reservoir. Therefore, the user can choose to continue transferring bodily fluid into the fluid reservoir, for example, by transitioning the volume indicator from its second state (e.g., toward a third state different from the first and second states).

[0155] At 1605, the inlet adapter is removed from the housing. For example, a user may transfer a desired volume of bodily fluid (e.g., a predetermined volume of fluid) into a fluid reservoir, and once the desired volume of bodily fluid is in the fluid reservoir, the user may remove the inlet adapter from the housing and / or detach the inlet adapter from the housing, as described in reference devices 1, 100, 200 above and / or any other device described herein. In some embodiments, removing the inlet adapter from the housing may allow the user access to a port of the housing, which in turn may allow the user to transfer at least a portion of the bodily fluid in the fluid reservoir to one or more external fluid reservoirs. In some embodiments, the inlet adapter may be configured to divert an initial volume of bodily fluid (e.g., in a pre-sample reservoir) isolated within the inlet adapter when it is removed from the housing. In this case, the inlet adapter (and the initial volume contained therein) may be discarded. In other cases, the initial volume of bodily fluid isolated within the inlet adapter may be used in tests with relatively low sensitivity to contamination, may be reinfused into a patient, and / or may be used for any other suitable purpose.

[0156] At point 1606, a predetermined volume of bodily fluid is transferred via a port from a fluid reservoir to a sample bottle external to the fluid transfer device. For example, in some cases, the user can connect the port to any suitable collection or sample reservoir, such as a culture flask (and / or any collection device described herein). Thus, the port of the housing can be used to transfer fluid into the fluid reservoir (e.g., acting as an inlet port) and to transfer fluid out of the fluid reservoir (e.g., acting as an outlet port). For example, in some cases, the user can engage an actuator to move a plunger toward a first position (e.g., in a direction opposite to the direction of plunger movement when the plunger moves from the first position toward a second position), which in turn can discharge a predetermined volume of bodily fluid from the fluid reservoir into the external sample bottle via the port. In other cases, the external sample bottle can be evacuated and / or a negative pressure can be defined, which can be operable to aspirate a predetermined volume of bodily fluid into the external sample bottle. In some cases, the user can change the volume indicator from its second state before transferring the predetermined volume of bodily fluid into the external sample bottle. In other cases, the user does not need to switch the volume indicator from its second state.

[0157] Various embodiments of the fluid collection devices described herein can allow the collection of two (or more) sets of fluid (e.g., blood) samples from a single venipuncture. Current standards of care require that certain tests (e.g., blood cultures) be performed using samples obtained from different, separate fluid access points (e.g., via two separate venipunctures, via catheter + venipuncture, and / or any combination thereof). The embodiments described herein can facilitate the acquisition of multiple samples for a specific diagnostic test (e.g., blood culture test) from a single fluid access point (e.g., venipuncture), potentially reducing the number of venipunctures required to obtain these samples per year to half. This benefits both patients and healthcare professionals. The reduction in the number of venipunctures (and / or other fluid access procedures) can significantly reduce the risk of needlestick injuries to healthcare professionals and reduce patient-related complications arising from these procedures (e.g., hematoma, thrombosis, phlebitis, infection, etc.).

[0158] Furthermore, reducing the number of fluid access procedures (e.g., venipuncture) reduces the utilization of supplies, labor, and waste associated with these procedures. The cost reductions achieved by the healthcare system are substantial and represent an opportunity to drive increasingly efficient resource consumption and enhanced patient outcomes due to improved sample integrity. Improved sample integrity can lead to greater accuracy in diagnosing patients, which in turn facilitates the development and implementation of one or more treatment plans. Fluid collection devices also significantly reduce the occurrence of false positives from post-collection analysis. The fluid collection devices described herein also simplify the fluid collection process and reduce the number of manual steps and “touchpoints,” thereby reducing the chance of external contamination. The devices described herein also minimize the risk of needlestick injuries and infections to laboratory technicians and / or blood collection personnel.

[0159] Although various embodiments have been described above, it should be understood that they have been presented by way of example only and not limitation. Where certain components are arranged in certain orientations or positions as indicated by the above schematic diagrams and / or embodiments, modifications to the arrangement of components are possible. While embodiments have been specifically shown and described, it should be understood that various changes in form and detail are possible. Although various embodiments have been described as having specific combinations of features, concepts, and / or components, other embodiments having any combination or sub-combination of any features, concepts, and / or components from any embodiment described herein are also possible. Furthermore, any feature, concept, and / or component from any embodiment described herein can be incorporated into any suitable known device. For example, any feature, concept, and / or component and / or any combination thereof can be incorporated into a known syringe and / or any other suitable fluid collection device.

[0160] The specific configuration of the various components can also be varied. For example, the size and specific shape of the various components may differ from the illustrated embodiments while still providing the functionality described herein. More specifically, the size and shape of the various components can be specifically selected for the desired rate and / or volume of bodily fluid flowing into the fluid reservoir. For example, the perimeter, 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 movement of fluids (e.g., bodily fluids), gases (e.g., air), or any suitable combination thereof at a desired flow rate. In other words, the components of the fluid control device described herein, including those constructed separately and subsequently attached together, can be selected individually or together to meet desired sample acquisition criteria, such as the magnitude of the pressure differential, the desired flow rate of bodily fluid through the various parts of the device, the ability to modulate pressure and / or flow rate, and / or similar parameters. Similarly, the size and / or shape of the various components can be specifically selected according to the desired or intended use. For example, in some embodiments, devices such as those described herein can be configured for use with or on a seemingly healthy adult patient. In such embodiments, the device may include an isolation chamber having a first volume (e.g., about 0.5 ml to about 5.0 ml). In other embodiments, devices such as those described herein may be configured for use with or on, for example, critically ill patients and / or pediatric patients. In such embodiments, the device may include an isolation chamber having a second volume smaller than the first volume (e.g., less than about 0.5 ml). Therefore, the dimensions, shape, and / or arrangement of embodiments and / or their components may be adapted to a given purpose unless the context clearly indicates otherwise.

[0161] Where the methods and / or events described above indicate that certain events and / or procedures occur in a certain order, the order of certain events and / or procedures may be modified, and these modifications are variations of the invention. Furthermore, certain events and / or procedures may, where possible, be executed simultaneously in parallel processing and sequentially as described above. Certain steps may be performed partially or omitted before proceeding to subsequent steps.

Claims

1. A device for collecting and dispensing bodily fluids, comprising: A housing that defines a fluid reservoir and includes a port in fluid communication with the fluid reservoir; An inlet adapter, which is removably connected to the housing, wherein when the inlet adapter is connected to the housing, the inlet adapter places the port in fluid communication with a source of bodily fluid; An actuator comprising a plunger disposed within the fluid reservoir and defining at least a portion of the fluid reservoir, a portion of the actuator being configured to be engaged by a user to move the plunger within the housing from a first position to a second position, in the first position the fluid reservoir having a first volume, and in the second position the fluid reservoir having a second volume larger than the first volume, the increase in volume enabling the aspiration of bodily fluids into the fluid reservoir via the inlet adapter, the actuator modulating the rate of movement of the plunger to below a threshold as the plunger moves from the first position to the second position, the actuator comprising a track having at least a first shoulder and a second shoulder; and A volume indicator, coupled to the housing, has a first indicator position in which a portion of the volume indicator is configured to contact a first shoulder along an actuator track as the plunger moves proximally, thereby stopping the plunger in response to the fluid reservoir receiving a first predetermined volume of body fluid associated with the first culture test method. The volume indicator also has a second indicator position, in which a portion of the volume indicator is configured to contact a second shoulder along the actuator track as the plunger moves proximally, thereby stopping the plunger in response to the fluid reservoir receiving a second predetermined volume of body fluid associated with the second culture test method, the second predetermined volume being greater than the first predetermined volume. The inlet adapter is configured to be removed from the housing after the first predetermined volume or the second predetermined volume of body fluid has been transferred into the fluid reservoir, so as to allow the first predetermined volume or the second predetermined volume of body fluid to be transferred via the port into a sample bottle outside the housing.

2. The device for collecting and dispensing bodily fluids according to claim 1, wherein, At least one of the first predetermined volume of body fluid and the second predetermined volume of body fluid is between 10 mL and 30 mL.

3. The device for collecting and dispensing bodily fluids according to claim 1, wherein, The first predetermined volume of body fluid is 10 mL.

4. The device for collecting and dispensing bodily fluids according to claim 1, wherein, When engaged by a user, a portion of the actuator moves through a first range of motion, and the actuator is configured to cause the plunger to move through a second range of motion different from the first range of motion.

5. The device for collecting and dispensing bodily fluids according to claim 1, wherein, Modulating the plunger's movement rate below a threshold reduces the flow rate of bodily fluid into the fluid reservoir, thereby improving the accuracy of associating the first predetermined volume of bodily fluid and the second predetermined volume of bodily fluid transferred into the fluid reservoir.

6. The apparatus for collecting and dispensing bodily fluids according to claim 1, wherein, The first culture test is an aerobic culture test, and the second culture test is an anaerobic culture test.

7. A device for collecting and dispensing bodily fluids, comprising: A housing that defines a fluid reservoir and includes a port in fluid communication with the fluid reservoir; An inlet adapter, which is removably connected to the housing, wherein when the inlet adapter is connected to the housing, the inlet adapter places the port in fluid communication with a source of bodily fluid; An actuator including a plunger disposed within the fluid reservoir and defining at least a portion of the fluid reservoir, the actuator being configured to move the plunger within the housing between a first position and a second position, wherein the fluid reservoir has a first volume when the plunger is in the first position and a second volume larger than the first volume when the plunger is in the second position, the increase in the volume of the fluid reservoir enabling the aspiration of bodily fluids into the fluid reservoir via the inlet adapter, the actuator including a track having at least a first shoulder and a second shoulder; and A volume indicator, coupled to the housing, has a first indicator position in which a portion of the volume indicator is configured to contact a first shoulder along the actuator's track as the plunger moves proximally, thereby stopping the plunger in response to the fluid reservoir receiving a first predetermined volume of body fluid associated with the first culture test method. The volume indicator also has a second indicator position in which a portion of the volume indicator is configured to contact a second shoulder along the actuator track as the plunger moves proximally, so as to stop the plunger from moving proximally toward the second position when a second predetermined volume of body fluid associated with the second culture test method is placed in the fluid reservoir, the second predetermined volume being greater than the first predetermined volume.

8. The apparatus for collecting and dispensing bodily fluids according to claim 7, wherein, A portion of the actuator moves through a first range of motion when engaged by a user, and the actuator is configured to cause the plunger to move through a second range of motion different from the first range of motion.

9. The apparatus for collecting and dispensing bodily fluids according to claim 7, wherein, The actuator is configured to modulate the movement rate of the plunger to below a threshold as the plunger moves from the first position to the second position.

10. The apparatus for collecting and dispensing bodily fluids according to claim 7, wherein, The inlet adapter is configured to be removed from the housing after a first predetermined volume or a second predetermined volume of body fluid has been transferred into the fluid reservoir, so as to allow the first predetermined volume or the second predetermined volume of body fluid to be transferred via the port into a sample bottle outside the housing.

11. The apparatus for collecting and dispensing bodily fluids according to claim 10, wherein, The body fluid is blood, the sample bottle is a blood culture bottle containing aerobic culture medium, and the first predetermined volume of the body fluid is the volume of blood associated with an aerobic blood culture test.

12. The apparatus for collecting and dispensing bodily fluids according to claim 10, wherein, The body fluid is blood, the sample bottle is a blood culture bottle containing anaerobic culture medium, and the second predetermined volume of the body fluid is the volume of blood associated with the anaerobic blood culture test.

13. The apparatus for collecting and dispensing bodily fluids according to claim 7, wherein, At least one of the first predetermined volume and the second predetermined volume is between 10 mL and 30 mL.

14. A method for collecting and distributing bodily fluids, comprising: The inlet adapter of the fluid transfer device is placed in fluid communication with a source of bodily fluid, the inlet adapter being removably connected to the housing of the fluid transfer device such that the port fluidly connects the inlet adapter to a fluid reservoir defined by the housing; Engage the actuator 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, the movement of the plunger generating a negative pressure that can draw bodily fluids into the fluid reservoir via the inlet adapter; When the volume indicator is in the first indicator position, the plunger stops moving proximally. In the first indicator position, a portion of the volume indicator is configured to contact the first shoulder along a track formed by the actuator in response to the fluid reservoir receiving a first predetermined volume of body fluid associated with the first culture test. Change the volume indicator from the first indicator position to the second indicator position; When the volume indicator is in the second indicator position, the plunger is stopped before it moves proximally to the second position. In the second indicator position, a portion of the volume indicator is configured to contact the second shoulder along a track formed by the actuator in response to the fluid reservoir receiving a second predetermined volume of body fluid associated with the second culture test, the second predetermined volume of body fluid being greater than the first predetermined volume. Remove the inlet adapter from the housing; as well as At least one of a first predetermined volume of body fluid and a second predetermined volume of body fluid is transferred from the fluid reservoir via the port to a sample bottle outside the fluid transfer device.

15. The method for collecting and distributing bodily fluids according to claim 14, 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 different from the first range of motion.

16. The method for collecting and distributing bodily fluids according to claim 14, wherein, The actuator is configured to modulate the movement rate of the plunger to below a threshold as the plunger moves from the first position to the second position.

17. The method for collecting and distributing bodily fluids according to claim 14, wherein, The body fluid is blood, the sample bottle is a blood culture bottle containing aerobic culture medium, and the first predetermined volume of the body fluid is the volume of blood associated with an aerobic blood culture test.

18. The method for collecting and distributing bodily fluids according to claim 14, wherein, The body fluid is blood, the sample bottle is a blood culture bottle containing anaerobic culture medium, and the second predetermined volume of the body fluid is the volume of blood associated with an anaerobic blood culture test.

19. The method for collecting and distributing bodily fluids according to claim 14, wherein, At least one of the first predetermined volume of body fluid and the second predetermined volume of body fluid is between 10 mL and 30 mL.

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