Fluid control device and method of using the same

Abstract

To provide a device for procuring bodily fluid samples with reduced contaminants such as dermally residing microbes and / or other contaminants exterior to a bodily fluid source.SOLUTION: A fluid control device includes an inlet configured to be arranged in fluid communication with a bodily fluid source and an outlet configured to be arranged in fluid communication with a fluid collection device. The fluid control device has a sequestration portion that can be vented or evacuated. The fluid control device has a first state in which an initial volume of bodily fluid can flow from the inlet to the sequestration portion and a second state in which (1) the initial volume is sequestered in the sequestration portion, and (2) a subsequent volume of bodily fluid, being substantially free of contaminants, can flow through at least a part of the fluid control device and into the fluid collection device. The fluid control device can transition automatically or in response to an actuation of a part of the fluid control device after the sequestration portion receives the initial volume.SELECTED DRAWING: Figure 1

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to and the benefit of U.S. Provisional Patent Application No. 62 / 595,871, entitled "Fluid Control Devices and Methods of Using the Same," filed December 7, 2017, the disclosure of which is incorporated herein by reference in its entirety.

[0002] This application claims priority to and the benefit of U.S. Provisional Patent Application No. 62 / 687,951, filed June 21, 2018, entitled "Fluid Control Devices and Methods of Using the Same," the disclosure of which is incorporated herein by reference in its entirety. [Background technology]

[0003] The present invention relates generally to parenteral procurement of bodily fluid samples, and more particularly to fluid diversion, isolation, and / or isolation devices, and devices and methods for obtaining bodily fluid samples with reduced contaminants, such as microorganisms present on the skin and / or other contaminants external to the source of the bodily fluid.

[0004] Healthcare practitioners routinely perform a wide range of microbial and other diagnostic tests on patients using parenterally obtained bodily fluids. As advanced diagnostic technologies evolve and improve, the speed, accuracy (both sensitivity and specificity), and value of the information they can provide clinicians continue to increase. Maintaining the integrity of bodily fluid samples during and / or after collection also ensures that analytical diagnostic results represent the patient's in vivo state. Examples of diagnostic techniques that rely on high-quality, uncontaminated, and / or pure bodily fluid samples include, but are not limited to, microbial detection, molecular diagnostics, gene sequencing (e.g., deoxyribonucleic acid (DNA), ribonucleic acid (RNA), next-generation sequencing (NGS), etc.), and biomarker identification. Inaccurate test results can be derived when the bodily fluid sample being analyzed accidentally contains biological material, which may include cells from outside the intended source of the sample, and / or other external contaminants. In short, when the purity of a sample intended to be derived or collected from a particular bodily fluid source is compromised during the specimen procurement process, the resulting analytical test results may be inaccurate, distorted, spurious, false positive, false negative, and / or otherwise not representative of the patient's actual condition, which in turn may lead to poor patient status, inaccurate, confusing, uncertain, less reliable, and / or other undesirable clinical decision-making.

[0005] In some embodiments, a patient sample (e.g., a bodily fluid) is tested for the presence of one or more potentially undesirable microorganisms, such as bacteria, fungi, or yeast (e.g., Candida). In some embodiments, the microbiological testing may involve culturing the patient sample in one or more sterile and / or non-sterile containers, which may contain culture media, general additives, and / or other types of solutions conducive to microbial growth. In other embodiments, the sample in the container may be analyzed directly (i.e., not cultured) and may not contain culture media or additives associated with culturing the specimen. In still other embodiments, various technologies can be used to assist in the detection of the presence of microorganisms, as well as other types of biological material, specific cell types, biomarkers, proteins, antigens, enzymes, blood components, and / or the like during diagnostic testing. Examples include molecular polymerase chain reaction (PCR), magnetic resonance and other magnetic analysis platforms, automated microscopy, spatial clonal isolation, flow cytometry, whole blood ("no-culture") specimen analysis (e.g., NGS) and related techniques, morphological cell analysis, and / or patient testing. This includes, but is not limited to, other common or advanced and sophisticated techniques utilized in a clinical laboratory setting to characterize the body and / or detect, identify, type, classify, and / or characterize specific organisms, antibiotic susceptibility, and / or the like.

[0006] In some instances, detecting the presence of a microorganism involves allowing the microorganism and / or organism to grow for a period of time (e.g., varying from less than an hour to several hours to several days, longer or shorter depending on the diagnostic technique used), after which the growth of the microorganism and / or organism can be detected by automated continuous monitoring and / or other methods specific to the analytical platform and technique used for detection, identification, and / or the like.

[0007] In a culture test, for example, when a microorganism is present in a patient sample, the microorganism multiplies over time in the culture medium, and in some cases, automated monitoring techniques can detect the carbon dioxide produced by the growing organism. The presence of the microorganism in the culture medium (indicated by observation of carbon dioxide and / or other detection methods) suggests the presence of the equivalent microorganism in the patient sample, which in turn suggests the presence of the equivalent microorganism in the patient's bodily fluid from which the sample was obtained. Thus, when a microorganism is determined to be present in the culture medium (or, more generally, in the sample used in the test), the patient may be diagnosed and prescribed one or more antibiotics or other treatments specifically designed to treat or otherwise remove the undesirable microorganism from the patient.

[0008] However, patient samples can become contaminated during procurement and / or suffer false-negative results. For example, microorganisms from body surfaces (e.g., skin-resident microorganisms) removed during the specimen procurement process (which can include insertion of a needle into the patient, specimen procurement via a lumen-containing device such as a peripheral intravenous catheter (PIV), central line (PICC), and / or other indwelling catheter(s), syringe, or other suitable means used to collect patient samples), directly or indirectly via tissue fragments, hair follicles, sweat glands, and other skin appendage structures, can be contained in and continuously transported with the patient sample to culture media, test vials, or other appropriate specimen collection or transport containers, and / or analyzed in non-culture-based tests. Another potential source of contamination is from the person (e.g., physician, phlebotomist, nurse, technician, etc.) drawing the patient sample. Specifically, the equipment, consumables, and / or devices used during the patient sample procurement process often include multiple fluid interfaces (by way of example, but not limitation, patient-to-needle, needle-to-transfer adapter, transfer adapter-to-sample container, catheter hub-to-syringe, syringe-to-transfer adapter, needle / tubing-to-sample container, and / or any combination thereof), each of which can introduce potential contamination points. In some embodiments, such contaminants may thrive in culture media and / or be identified by another non-culture-based diagnostic technique, ultimately resulting in false-positive and / or false-negative microbiological test results that may inaccurately reflect the presence or absence of such microorganisms in the patient (i.e., in vivo).

[0009] Such inaccurate results due to contamination and / or other sources of contamination that compromise sample purity are of concern when attempting to diagnose or treat a wide range of suspected illnesses, diseases, infections, patient conditions, or other ailments of concern. For example, a false-negative result from a microbiology test can result in a misdiagnosis of a patient's illness and / or delayed treatment, and in some cases, patient death. Conversely, a false-positive result from a microbiology test can result in a patient unnecessarily receiving one or more antimicrobial therapies, potentially causing serious side effects, including death, and potentially creating unnecessary burden and costs for the healthcare system due to prolonged patient stays and / or other complications associated with incorrect treatment. The use of imaging equipment resulting from these false-positive results can also have long-term implications for patient health, as unnecessary exposure to concentrated radiation associated with various imaging procedures (e.g., CT scans) can have serious adverse effects on the patient's health. It is also a concern from both a cost and patient safety perspective, as it has many known adverse effects.

[0010] In some examples, devices and / or systems can be used to reduce the likelihood of contamination, adulteration, and / or the like of bodily fluid samples for testing. For example, some known devices can be configured to collect, divert, separate, and / or isolate or quarantine an initial volume of bodily fluid likely to contain contaminants, such as microorganisms present in the dermis or the like. However, such devices are perceived as cumbersome, unintuitive, and difficult to use, making them unsuitable or unusable as intended for target patient populations, etc. Furthermore, such devices can require training, user observation, intervention by two or more users, and / or otherwise present challenges that can lead to limited effectiveness based on variables including environment, education, clinician skill, patient condition, and / or the like. In some embodiments, such challenges complicate the collection of consistently high-quality samples, such as those that are uncontaminated, sterile, pure, etc., which in turn can affect the validity of test results.

[0011] Therefore, there is a need for a fluid diversion device and method for obtaining a bodily fluid sample that has reduced contaminants, such as microorganisms present on the skin and / or other contaminants external to the bodily fluid source. Further, there is a need for a device that is user-friendly, requires little or no user intervention and / or actuation, demonstrates consistent efficacy, and addresses challenges associated with collecting samples from patients with difficult health conditions and / or physical characteristics that affect their ability to collect a bodily fluid sample. Summary of the Invention

[0012] Described herein are devices and methods for obtaining a bodily fluid sample with reduced contaminants, such as microorganisms present on the skin and / or other contaminants external to the bodily fluid source. In some embodiments, the device includes a housing and an actuator. The housing has an inlet configured to be placed in fluid communication with a bodily fluid source, an outlet configured to be placed in fluid communication with a fluid collection device, and an isolation portion configured to receive an initial volume of bodily fluid. The actuator defines at least one fluid flow path configured to direct a flow of bodily fluid through at least a portion of the housing. The actuator is configured in a first state to establish fluid communication between the isolation portion and the outlet with the at least one fluid flow path. The outlet is configured to transition from a closed state to an open state when the actuator is in the first state to vent the isolation portion via the at least one fluid flow path and the outlet. The actuator is configured to transition from the first state to a second state after venting the isolation portion such that the at least one fluid flow path establishes fluid communication between the isolation portion and the inlet, allowing the initial volume of bodily fluid to be transferred to the isolation portion. The actuator is configured to transition from the second state to a third state after an initial volume of bodily fluid is transferred into the isolation portion to (1) isolate the initial volume of bodily fluid in the isolation portion, and (2) when the fluid collection device is coupled to the outlet and the outlet is in an open state, place the outlet in fluid communication with the inlet via at least one fluid flow path to allow a subsequent volume of bodily fluid to be transferred to the fluid collection device. [Brief explanation of the drawings]

[0013] [Figure 1] 1 is a schematic diagram of a fluid control device according to an embodiment. [Figure 2] 1A-1C are cross-sectional schematic diagrams of a fluid control device in a first state or configuration, a second state or configuration, and a third state or configuration, respectively, according to an embodiment. [Figure 3]1A-1C are cross-sectional schematic diagrams of a fluid control device in a first state or configuration, a second state or configuration, and a third state or configuration, respectively, according to an embodiment. [Figure 4] 1A-1C are cross-sectional schematic diagrams of a fluid control device in a first state or configuration, a second state or configuration, and a third state or configuration, respectively, according to an embodiment. [Figure 5] 1A and 1B are perspective and rear views, respectively, of a fluid control device according to an embodiment. [Figure 6] 1A and 1B are perspective and rear views, respectively, of a fluid control device according to an embodiment. [Figure 7] 7 is a cross-sectional view of the fluid control device shown in FIG. 6 taken along line 7-7. [Figure 8] 1A and 1B are perspective top and bottom views, respectively, of a fluid control device according to an embodiment. [Figure 9] 1A and 1B are perspective top and bottom views, respectively, of a fluid control device according to an embodiment. [Figure 10] FIG. 9 is a side cross-sectional view of the fluid control device of FIG. 8. [Figure 11] 11 is a cross-sectional view of the fluid control device of FIG. 10 taken along line 11-11. [Figure 12] FIG. 1 is a side view of a fluid control device according to an embodiment. [Figure 13] 13 is a cross-sectional view of the fluid control device illustrated in FIG. 12 taken along line 13-13 in a first state or configuration. [Figure 14] 13 is a cross-sectional view of the fluid control device illustrated in FIG. 12 taken along line 13-13 in a second state or configuration. [Figure 15] 13 is a cross-sectional view of the fluid control device illustrated in FIG. 12 taken along line 13-13 in a third state or configuration. [Figure 16] FIG. 1 is a side view of a fluid control device according to an embodiment. [Figure 17]17 is a cross-sectional view of the fluid control device illustrated in FIG. 16 taken along line 17-17 in a first state or configuration. [Figure 18] 17 is a cross-sectional view of the fluid control device illustrated in FIG. 16 taken along line 17-17 in a second state or configuration. [Figure 19] 17 is a cross-sectional view of the fluid control device illustrated in FIG. 16 taken along line 17-17 in a third state or configuration. [Figure 20] 1 is a flowchart illustrating a method of using a fluid control device to obtain a body fluid sample with reduced contamination according to an embodiment. [Figure 21] 1 is a flowchart illustrating a method of using a fluid control device to obtain a body fluid sample with reduced contamination according to one embodiment. DETAILED DESCRIPTION OF THE INVENTION

[0014] Described herein are devices and methods for collecting, diverting, directing, segregating, isolating, etc., an initial volume of bodily fluid to reduce contamination in a subsequently procured bodily fluid sample. Any of the fluid control devices described herein can be configured to accept, procur, and / or transport a flow, bolus, volume, etc. of bodily fluid. A first reservoir, channel, flow path, or portion of a device can accept an initial volume of bodily fluid flow and then substantially or completely isolate (e.g., contain, retain, bypass, isolate, segregate, vapor-lock, segregate, and / or the like) the initial volume of bodily fluid within or by the first reservoir or first portion of the device. In some embodiments, contaminants, such as microorganisms present in the dermis or the like, are contained and / or entrained in the initial volume of bodily fluid and similarly isolated within or by the first reservoir or first portion of the device. Once the initial volume is isolated, the subsequent flow of fluid can be diverted, channeled, directed, and flow-controlled (e.g., manually, automatically, and / or semi-automatically) to a second reservoir, a second portion of the device, and / or any additional flow path(s). Thus, once the initial volume is isolated, the additional and / or subsequent volume(s) of fluid flow can be prevented from producing otherwise inaccurate, distorted, misleading, false positive, false negative, or other results. Some diagnostics and / or testing may be performed substantially free of contaminants that may produce disease, etc. In some embodiments, the initial volume of bodily fluid may also be used for other tests, e.g., those less affected by the presence of contaminants, discarded as a waste volume, infused back into the patient, and / or used for other suitable clinical applications.

[0015] In some embodiments, a feature of the fluid control devices and / or methods described herein is the use of an external negative pressure source (e.g., provided by the fluid collection device or other suitable means) to (1) overcome physical patient challenges that may limit and / or prevent a pressure differential (e.g., the difference between blood pressure and ambient air pressure) sufficient to fully engage the isolation and / or diversion portion and / or shift fluid flow to the fluid collection device, (2) ensure that the isolation and / or diversion portion is properly filled with a clinically validated and / or desired volume of bodily fluid, (3) provide efficient, timely, and / or user-accepted consistency in the bodily fluid collection process, and / or (4) provide a means to manipulate and / or automatically shift fluid flow (e.g., by moving physical components of the system, or by changing, switching, engaging, and / or otherwise adopting or achieving desired fluid dynamics) to enable isolation and / or separation of an initial sample and collection of subsequent samples.

[0016] In some embodiments, the device includes a housing and an actuator. The housing has an inlet configured to be placed in fluid communication with a bodily fluid source, an outlet configured to be placed in fluid communication with a fluid collection device, and an isolation portion configured to receive an initial volume of bodily fluid. The actuator defines at least one fluid flow path configured to direct a flow of bodily fluid through at least a portion of the housing. The actuator is configured in a first state to establish fluid communication between the isolation portion and the outlet with the at least one fluid flow path. The outlet is configured to transition from a closed state to an open state when the actuator is in the first state to vent the isolation portion via the at least one fluid flow path and the outlet. The actuator is configured to transition from the first state to a second state after venting the isolation portion such that the at least one fluid flow path establishes fluid communication between the isolation portion and the inlet, allowing the initial volume of bodily fluid to be transferred to the isolation portion. The actuator is configured to transition from the second state to a third state after an initial volume of bodily fluid is transferred into the isolation portion to (1) isolate the initial volume of bodily fluid in the isolation portion, and (2) when the fluid collection device is coupled to the outlet and the outlet is in an open state, place the outlet in fluid communication with the inlet via at least one fluid flow path to allow a subsequent volume of bodily fluid to be transferred to the fluid collection device.

[0017] In some embodiments, the device includes an inlet member coupled to a housing, an outlet member coupled to the housing, and an isolation portion formed at least in part by the housing. The inlet member defines a lumen in fluid communication with the fluid flow path defined by the housing and is configured to be placed in fluid communication with a source of bodily fluid. The outlet member defines a lumen in fluid communication with the fluid flow path defined by the housing and is configured to be placed in fluid communication with a fluid collection device. The isolation portion is in fluid communication with the fluid flow path defined by the housing and is configured to transform from a first state to a second state in response to a force exerted on the portion of the housing to vent the isolation portion. The isolation portion is configured to transition from the second state to the first state in response to removal of the force to generate a suction force within the isolation portion to draw an initial volume of bodily fluid through the lumen of the inlet member and the fluid flow path into the isolation portion.

[0018] In some embodiments, a method of using a fluid control device to obtain a bodily fluid sample with reduced contamination includes exerting a force that deforms an isolation portion of the fluid control device and venting the isolation portion as a result of the deformation of the isolation portion. A force is established between the inlet member of the body control device and the isolation portion. The force exerted on the isolation portion is removed to create a suction force within the isolation portion. In response to the suction force, an initial volume of bodily fluid is transferred from the bodily fluid source through the inlet member and into the isolation portion. As a result of the initial volume of bodily fluid being disposed in the isolation portion, a subsequent volume of bodily fluid is transferred from the bodily fluid source through the inlet member to an outlet member in fluid communication with the inlet member.

[0019] In some embodiments, the fluid control device includes an inlet and an outlet. The inlet is configured to be placed in fluid communication with a bodily fluid source or an intermediate bodily fluid transfer device, and the outlet is configured to be placed in fluid communication with a fluid collection device (e.g., a sample bottle, container, reservoir, syringe, evacuated container, dish, vial, lumen-containing device, and / or any other suitable bodily fluid collection and / or transfer device). In some embodiments, the fluid control device has a first state in which an initial volume of bodily fluid can flow from the inlet to an isolation and / or diversion portion of the fluid control device (which can be formed by, in, or coupled to the fluid control device), and a second state in which (1) the initial volume is isolated in the isolation and / or diversion portion of the fluid control device, and (2) a subsequent volume of bodily fluid, substantially free of contaminants, can flow from the bodily fluid source to the fluid collection device through at least a portion of the fluid control device. The fluid control device is configured to transition from the first state to the second state automatically or in response to actuation of a portion of the fluid control device after the isolation and / or diversion portion receives the initial volume.

[0020] As used in this specification and claims, the singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise. Thus, for example, the term "element" is intended to mean a single element or a combination of elements, and "material" is intended to mean one or more materials or combinations thereof.

[0021] As used herein, the terms "about," "approximately," and / or "substantially," when used in connection with stated values and / or other geometric relationships, are intended to mean that the structure so defined is the nominal value and / or the described geometric relationship. In some instances, the terms "about," "approximately," and / or "substantially" can generally mean and / or generally assume plus or minus 10% of the described value or relationship. For example, about 0.01 includes 0.009 and 0.011, about 0.5 includes 0.45 and 0.55, about 10 includes 9-11, and about 1000 includes 900-1100. While the described values may be desirable, it is understood that some variation may occur due to, for example, manufacturing tolerances or other practical considerations (e.g., pressure or force exerted through a portion of a device, conduit, lumen, etc.). Thus, the terms "about," "approximately," and / or "substantially" may be used herein to account for such tolerances and / or considerations.

[0022] As used herein, "body fluid" can include any fluid obtained directly or indirectly from a patient's body. For example, "body fluid" can include, 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, etc., or any combination thereof.

[0023] As used herein, the terms "proximal" and "distal" refer to directions toward and away from, respectively, a user who positions the device in contact with a patient. Thus, for example, the end of the device that first touches the patient's body is the distal end, and the opposite end of the device (e.g., the end of the device that is manipulated by the user) is the proximal end of the device.

[0024] As described in further detail herein, any of the devices and methods can be used to procure a reduced-contamination bodily fluid sample, for example, by diverting a "pre-sample" volume of bodily fluid prior to collecting a "sample" volume of bodily fluid. The terms "pre-sample," "first," and / or "initial" can each be used interchangeably to describe and / or refer to a deposit, portion, or volume of bodily fluid that is transferred, diverted, and / or isolated prior to procuring a "sample" volume. In some embodiments, the terms "pre-sample," "first," and / or "initial" can refer to a predetermined, defined, desired, or given volume, portion, or amount of bodily fluid. For example, in some embodiments, the predetermined and / or desired pre-sample volume of bodily fluid can be about 0.1 milliliters (mL), about 0.2 mL, about 0.3 mL, about 0.4 mL, about 0.5 mL, about 1.0 mL, about 2.0 mL, about 3.0 mL, about 4.0 mL, about 5.0 mL, about 10.0 mL, about 20 mL, about 50 mL, and / or any volume or fraction of volume therebetween. In other embodiments, the pre-sample volume can be greater than 50 mL or less than 0.1 mL. In some specific embodiments, the predetermined and / or desired pre-sample volume can be between about 0.1 mL and about 5.0 mL. In other embodiments, the pre-sample volume can be, for example, a single drop of bodily fluid, several drops of bodily fluid, or the combined volume of any number of lumens forming a flow path (or portion thereof) from a bodily fluid source to an initial collection chamber, portion, reservoir, etc. (e.g., an isolation chamber).

[0025] On the other hand, the terms "sample," "second," and / or "subsequent," when used in the context of a volume of bodily fluid, can refer to a volume, proportion, or amount of bodily fluid, either a random volume of bodily fluid collected after transferring, diverting, isolating, and / or separating a pre-sample volume of bodily fluid, or a predetermined or desired volume. For example, in some embodiments, the desired sample volume of bodily fluid can be from about 10 mL to about 60 mL. In other embodiments, the desired sample volume of bodily fluid can be less than 10 mL or greater than 60 mL. In some embodiments, for example, the sample volume can be based, at least in part, on one or more tests, evaluations, analyses, and / or processes to be performed on the sample volume.

[0026] The embodiments described herein can be configured to selectively transfer bodily fluid to one or more fluid collection device(s). In some embodiments, the fluid collection device can include, but is not limited to, a suitable vessel, container, reservoir, bottle, adapter, dish, vial, syringe, device, diagnostic and / or testing equipment, and / or the like. As a specific example, in some embodiments, any of the embodiments and / or methods described herein can be used to transfer a sample volume to a sample reservoir, as described in detail in U.S. Patent No. 8,197,420, filed December 13, 2007, entitled "Systems and Methods for Parenterally Procuring Bodily-Fluid Samples with Reduced Contamination" (the "'420 Patent"), which is incorporated herein by reference in its entirety.

[0027] In some embodiments, the sample reservoir can be a sample or culture bottle, such as, for example, an aerobic or anaerobic culture bottle. In this manner, the culture bottle can receive a bodily fluid sample, which can then be tested (e.g., via an in vitro diagnostic (IVD) test, and / or any other suitable test) for the presence of, for example, gram-positive bacteria, gram-negative bacteria, yeast, fungi, and / or other organisms. In some embodiments, the culture bottle can receive a bodily fluid sample, and the culture medium (disposed therein) can be tested for the presence of any suitable organism. If such testing of the culture medium yields a positive result, the culture medium can be subsequently tested using a PCR-based system to identify the specific organism. Additionally, as further described herein, As described in detail, in some embodiments, diverting the initial volume of the pre-sample or bodily fluid can reduce and / or substantially eliminate contaminants in the bodily fluid sample that may otherwise lead to inaccurate test results.

[0028] The sample containers, reservoirs, bottles, dishes, vials, etc. described herein may be empty prior to receiving a sample volume of bodily fluid, or may contain, for example, any suitable additives, culture media, substances, enzymes, oils, fluids, and / or the like. For example, in some embodiments, the sample reservoir may contain an aerobic or anaerobic culture medium (e.g., a nutrient-rich and / or environmentally controlled medium for promoting growth, and / or other suitable culture medium(s)) that occupies at least a portion of the internal volume defined by the sample reservoir. In some embodiments, the sample reservoir may contain any suitable additives or the like, for example, heparin, citrate, ethylenediaminetetraacetic acid (EDTA), oxalate, SPS, and / or the like, that also occupy at least a portion of the internal volume defined by the sample reservoir. In other embodiments, the sample reservoir may be any suitable container used to collect a specimen.

[0029] The term "culture medium" can be used to describe a substance configured to react with organisms in a bodily fluid (e.g., microorganisms such as bacteria), and the term "additive" can be used to describe a substance configured to react with a portion of a bodily fluid (e.g., constituent cells of blood, serum, synovial fluid, etc.), and it should be understood that the sample reservoir can contain any suitable substance, liquid, solid, powder, lyophilized compound, gas, etc. Furthermore, when referring to an "additive" in a sample reservoir, it should be understood that the additive may be a culture medium, such as aerobic and / or anaerobic culture medium, additives, and / or other suitable substances contained in a culture bottle, as described above, or a combination of substances contained in a culture bottle and / or other suitable reservoir. That is, the embodiments described herein can be used with any suitable fluid reservoir or the like containing any suitable substance. Furthermore, any of the embodiments and / or methods described herein can be used to transfer a volume of bodily fluid to a reservoir (or the like) that does not contain culture medium, additives, and / or other substances prior to receiving a flow of bodily fluid.

[0030] While some of the embodiments are described herein as being used to procure bodily fluids for one or more culture sample tests, it should be understood that the embodiments are not limited to such use. Any of the embodiments and / or methods described herein can be used to transfer a flow of bodily fluid to any suitable device placed in fluid communication therewith. Thus, while specific embodiments are described herein, the devices, methods, and / or concepts are not intended to be limited to such specific embodiments. Furthermore, samples collected through use of any of the devices described herein can be used in any suitable test, such as those described above.

[0031] The embodiments and / or portions thereof described herein can be formed or constructed of one or more biocompatible materials. In some embodiments, the biocompatible material can be selected based on one or more properties of the constituent material, such as, for example, stiffness, toughness, durometer, bioreactivity, etc. Suitable biocompatible material embodiments include metals, glasses, ceramics, or polymers. Suitable metal embodiments include pharmaceutical grade stainless steel, gold, titanium, nickel, iron, platinum, tin, chromium, copper, and / or alloys thereof. Polymeric materials can be biodegradable or non-biodegradable. Suitable biodegradable polymer embodiments include polylactides, polyglycolides, polylactide-co-glycolides (PLGA), polyanhydrides, polyorthoesters, polyetheresters, and polycaprolactones. , polyesteramides, poly(butyric acid), poly(valeric acid), polyurethanes, and / or blends and copolymers thereof. Non-biodegradable polymer embodiments include nylon, polyester, polycarbonate, polyacrylate, ethylene vinyl acetate and other acyl-substituted cellulose acetate polymers, non-degradable polyurethanes, polystyrene, polyvinyl chloride, polyvinyl fluoride, poly(vinylimidazole), chlorosulfonated polyolefins, polyethylene oxide, and / or blends and copolymers thereof.

[0032] The embodiments and / or portions thereof described herein may include components formed from one or more parts, features, structures, etc. When referring to such components, it should be understood that the component can be formed by a single part having any number of sections, regions, portions, and / or characteristics, or can be formed by multiple parts or features. For example, when referring to a structure such as a wall or chamber, the structure can be considered a single structure having multiple portions, or multiple separate substructures or the like joined to form the structure. Thus, a monolithically constructed structure can include, for example, a set of substructures. Such a set of substructures can include multiple portions that are either contiguous or discontinuous with one another. A set of substructures can also be fabricated from multiple items or components that are fabricated separately and later joined (e.g., via welding, adhesives, snaps, and / or any suitable method).

[0033] Referring now to the drawings, FIG. 1 is a schematic diagram of a fluid control device 100 according to an embodiment. Generally, the fluid control device 100 (also referred to herein as a "control device" or "device") is configured to withdraw bodily fluid from a patient. A first portion or amount (e.g., an initial amount) of the withdrawn bodily fluid is isolated from a second portion or amount (e.g., a subsequent amount) of the withdrawn bodily fluid. In some embodiments, the first portion or amount can then be used for additional testing (e.g., tests that are not sensitive to potential contaminants), discarded, and / or reinfused into the patient. In this manner, contaminants or the like can be isolated within the first portion or amount of bodily fluid, leaving a second portion or amount of bodily fluid that is substantially free of contaminants. The second portion or amount of bodily fluid can then be used as a biological sample in one or more tests for medical diagnostic and / or therapeutic purposes (e.g., blood culture tests or the like), as described in more detail herein. The first portion or amount of the bodily fluid can be discarded as waste or used in any suitable test that is unlikely to produce erroneous, inaccurate, distorted, inconsistent, or unreliable results as a result of potential contaminants contained therein. In other embodiments, the first portion or amount of the bodily fluid can be infused back into the patient.

[0034] The control device 100 includes an inlet device 110 and a housing 130 in fluid communication with and / or configured to be placed in fluid communication with the inlet device 110. The inlet device 110 can be any suitable device or set of devices configured to establish fluid communication between the housing 130 and a source of bodily fluid, such as, for example, the patient's vasculature. For example, in some embodiments, the inlet device 110 can be an intravenous (IV) catheter, a needle, a peripherally inserted central catheter (PICC), a syringe, one or more sterile tubing, and / or any other suitable lumen-containing device. In other embodiments, the inlet device 110 can be a port or the like, such as, for example, a Luer Lok®, or any other suitable coupler. In such embodiments, the inlet device 110 (e.g., a port or coupler) can be configured to couple to an access device in fluid communication with the patient (e.g., a placement or indwelling IV catheter or needle). In some embodiments, the inlet device 110 can be , may be integrally and / or monolithically formed with housing 130 (e.g., inlet device 110 may be disposed within and / or form at least a portion of housing 130, or vice versa). In other embodiments, inlet device 110 may be separate from housing 130 and placed in fluid communication therewith via an intermediate lumen-containing device, such as, for example, sterile tubing or the like. In some such embodiments, inlet device 110 (or a portion thereof) may be configured to form a fluid-tight connection, coupling, port, and / or seal with housing 130 (or a portion thereof) using any suitable connection mechanism, e.g., using fittings, couplings, and / or the like.

[0035] The housing 130 includes an inlet 132, at least one outlet 136, and an isolation and / or diversion section 134. Additionally, the housing 130 defines one or more fluid flow paths 133 between the inlet 132 and the isolation and / or diversion section 134 and / or between the inlet 132 and the outlet 136. The housing 130 of the device 100 can be of any suitable shape, size, and / or configuration. For example, in some embodiments, the housing 130 can be disposed within and / or form at least a portion of the inlet device 110. In such embodiments, any suitable portion of the housing 130 can be disposed within and / or formed by the inlet device 110, or vice versa. In other embodiments, the housing 130 can be formed separately from the inlet device 110 and can be physically and / or fluidically coupled to the inlet device 110. In some embodiments, the housing 130 can have a size based at least in part on the volume of bodily fluid at least temporarily stored within the isolation and / or diversion portion 134, for example.

[0036] The inlet 132 of the housing 130 is configured to be fluidly coupled to the inlet device 110 such that the housing 130 is placed in fluid communication with a source of bodily fluid, such as, for example, the patient's vasculature. As mentioned above, in some embodiments, the inlet 132 of the housing 130 can be physically and fluidly coupled to the inlet device 110 via a lock, coupler, port, or the like. In other embodiments, the inlet 132 can be in fluid communication with the inlet device 110 via a lumen-containing device, for example, a sterile tube or the like. In still other embodiments, the inlet 132 of the housing 130 can form the inlet device 110 and / or can be integrally or monolithically formed with the inlet device 110.

[0037] One or more fluid flow paths 133 are configured to place the inlet 132 in fluid communication with the isolation and / or diversion portion 134 and / or the outlet 136. In some embodiments, the one or more fluid flow paths 133 can be configured to control one or more parameters and / or characteristics associated with the flow of fluid therethrough. For example, in some embodiments, the fluid flow path(s) 133 can have a length and / or width corresponding to and / or associated with a volume of bodily fluid to be conveyed therethrough. In some embodiments, the fluid flow path(s) 133 and / or portions thereof can have a size, width, and / or diameter configured to adjust, increase, decrease, and / or control the pressure exerted through at least the portion 133 of the fluid flow path(s). In some embodiments, regulating, increasing, decreasing, and / or controlling the pressure through one or more portions of the housing 130 and / or control device 100 can increase the likelihood of drawing a clinically meaningful volume of bodily fluid (e.g., without undesirable consequences such as damaging, collapsing, and / or "blowing" the patient's anatomy of veins and / or the like). In other embodiments, the fluid flow path(s) 133 do not need to be pressure regulated. Furthermore, in some embodiments, the fluid flow path(s) 133 or therethrough may be configured to regulate the pressure. can be configured to at least temporarily hold, store, contain, and / or isolate at least a portion of the collected bodily fluid.

[0038] The isolation and / or diversion portion 134 (also referred to herein as the "isolation portion") is disposed, at least temporarily, in fluid communication with the inlet 132 via the fluid flow path(s) 133. As described in more detail herein, the isolation portion 134 is configured to receive an initial flow and / or volume of bodily fluid from the inlet 132 when the housing 130 and / or control device 100 are in a first state or mode of operation and, in response, can isolate (e.g., separate, segregate, contain, hold, isolate, etc.) the initial flow and / or volume of bodily fluid therein to the housing 130 and / or control device 100 transitioning to a second state or mode of operation. In some embodiments, the isolation of the initial flow and / or volume of bodily fluid can also isolate contaminants or the like, which in turn reduces contaminants in subsequent volumes of bodily fluid drawn from the patient, as described in more detail herein.

[0039] The isolated portion 134 can be of any suitable shape, size, and / or configuration. For example, in some embodiments, the isolated portion 134 can be at least partially formed by the housing 130. In other embodiments, the isolated portion 134 can be a reservoir disposed and / or located within a portion of the housing 130. In other embodiments, the isolated portion 134 can be formed and / or defined by a portion of the fluid flow path 133. That is, the housing 130 can define one or more lumens and / or include one or more lumen-defining device(s) configured to receive a flow of bodily fluid from the inlet 132, thereby defining the fluid flow path 133. In such embodiments, at least a portion of the lumen and / or a portion of the lumen-defining device(s) can form and / or define the isolated portion 134. While the isolated portion 134 is described above as being disposed within the housing 130, in other embodiments, the isolated portion 134 can be partially or entirely defined or contained within the inlet device 110. In such embodiments, at least a portion of the fluid flow path 133 may be disposed within and / or defined by the inlet device 110 .

[0040] As described above, the isolation portion 134, regardless of whether it is disposed or formed in the housing 130 or the inlet device 110, is in fluid communication with the fluid flow path 133 and is configured to receive an initial volume or amount of body fluid drawn from a body fluid source. The isolation portion 134 can have any suitable volume and / or fluid volume. For example, in some embodiments, the isolation portion 134 can have a volume and / or fluid volume of from about 0.25 mL to about 5.0 mL. In some embodiments, the isolation portion 134 can have a volume measured with respect to the amount of body fluid (e.g., the initial or first amount of body fluid) configured to be transferred into the isolation chamber 134. For example, in some embodiments, the isolation chamber 134 can have a volume sufficient to receive an initial body fluid of body fluid below microliters (e.g., a small volume such as 20 drops of body fluid, 10 drops of body fluid, 5 drops of body fluid, 1 drop of body fluid, or any suitable volume therebetween). In other embodiments, the isolation portion 134 can have a volume sufficient to receive an initial volume of body fluid, for example, up to about 5.0 mL, 10.0 mL, 15 mL, 20 mL, 30 mL, 40 mL, 50 mL, or more. In some embodiments, the isolation portion 134 can have a volume equal to, substantially equal to, and / or at least partially based on a volume of a portion of the fluid flow path 133 defined between the lumen of the inlet device 110, the lumen of the inlet 132, and between the inlet 132 and the isolation portion 134, and / or any combination thereof. In other embodiments, the isolation portion 134 is a portion of the inlet device 110, the inlet 132 of the housing 130, and the fluid flow path 1 defined between the inlet 132 and the isolation portion 134 33 can have a volume equal to, and / or at least partially based on, the individual and / or combined volumes of the flowing portions.

[0041] 1 , in some embodiments, isolation portion 134 can include any suitable arrangement, configuration, and / or feature and / or can be formed from one or more materials configured to interact with a portion of bodily fluid transported into isolation portion 134. For example, in some embodiments, housing 130 can include an absorbent and / or hydrophilic material disposed within isolation portion 134 that is configured to absorb, attract, wick, retain, expand, and / or otherwise interact with at least a portion of the body fluid, which can then isolate and / or retain at least an initial portion of the bodily fluid within isolation portion 134. Similarly, in some embodiments, isolation portion 134 and / or portions thereof can have a shape (e.g., surface area to volume ratio, capillary configuration, etc.) and / or can be formed from a material or coating (e.g., textured or pitted surface) configured to wick, attract, absorb, and / or retain bodily fluid.

[0042] In other embodiments, isolation portion 134 can include and / or form an expandable or collapsible material, or can include or form a flexible bag configured to transition between a first state (e.g., while an initial portion of the bodily fluid is being transferred to isolation portion 134) and a second state (e.g., after the initial portion of the bodily fluid has been transferred to isolation portion 134) to encourage bodily fluid to flow into isolation portion 134 and / or to retain or isolate the bodily fluid in isolation portion 134. In some embodiments, forces associated with and / or resulting from the expansion or contraction of such material can be operable to transition housing 130 and / or device 100 from a first state, position, configuration, etc. to a second state, position, configuration, etc. In some embodiments, the isolation chamber 134 and / or any other suitable portion of the housing 130 may include one or more chemicals, compounds, and / or the like configured to chemically interact with bodily fluid transferred through a portion of the housing 130, which may be operable to transition the control device 100 and / or the housing 130 between a first state and a second state (e.g., via force or any other suitable means).

[0043] In some embodiments, the housing 130 and / or the isolation portion 134 can include and / or define a vent, port, opening, and / or the like in fluid communication with the isolation portion 134 and configured to "vent" the isolation portion 134. In some embodiments, the housing 130 can include a semi-permeable member or membrane disposed within or around the vent to selectively allow the flow of air or gas through the vent while restricting or substantially preventing the flow of fluid (e.g., bodily fluids such as blood) through the vent. In some embodiments, the venting of the isolation portion 134 as an initial portion of bodily fluid is transferred to the isolation portion 134 can allow equalization of pressure between the isolation portion 134 and / or the isolation portion 134 and, for example, a fluid source and / or a portion of the fluid flow path outside the isolation portion 134, or the pressure of the surrounding environment through which the isolation portion 134 is vented. In some embodiments, pressure equalization can be a factor in determining and / or defining how bodily fluid flows through the housing 130 and / or the amount or volume of bodily fluid transferred to the isolation portion 134.

[0044] Expanding further, the venting of isolation portion 134 can allow the flow of air or gas through the openings or semi-permeable member in response to displacement by bodily fluid flow. For example, in some embodiments, isolation portion 134, fluid flow path 133, and / or at least a portion of the interior volume of housing 130 can be configured to accommodate a volume of air or gas prior to use. The housing 130 may contain an inlet 132 that contains air or gas. As bodily fluid flows through the inlet 132 and enters the fluid flow path 133, the bodily fluid displaces at least a portion of the air or gas contained therein. Additionally, in some embodiments, the housing 130 may be in a first state or configuration in which the outlet(s) 136 are sealed or isolated prior to diverting and / or isolating the initial portion of the bodily fluid. Thus, the openings and / or semi-permeable members in the isolation portion 134 enable, facilitate, encourage, promote, or draw aeration of the isolation portion 134 in response to the volume of air or gas displaced by the bodily fluid, directing and / or otherwise guiding the initial flow of bodily fluid into the isolation portion 134, as described in further detail herein with respect to certain embodiments.

[0045] In some embodiments, a quantity of air or gas disposed within the isolation portion 134 prior to use can be evacuated before bodily fluid is drawn into the isolation portion 134 through the fluid flow path(s) 133. In other words, in some embodiments, the isolation portion 134 can be pre-filled and / or evacuated (e.g., via an automatic or manual process) before accepting an initial volume of bodily fluid. For example, in some instances, air or other gaseous contents disposed within the isolation portion 134 prior to use can be evacuated in response to an external force and / or compression of the isolation portion 134, such that (after placing the inlet device 110 in communication with the bodily fluid) release of the compression increases the volume within the isolation portion 134, which in turn creates a negative pressure within the isolation portion 134 operable to draw an initial flow of bodily fluid into the isolation portion 134. As another example, the contents of the isolation portion 134 can be removed prior to contacting the inlet device 110 with a source of bodily fluid by suctioning through a vent or opening using any suitable suction system. In some such embodiments, the contents of isolated portion 134 can be removed or evacuated via a negative pressure source, such as, for example, a syringe, a vacuum container, a sample or culture bottle, a pump, and / or any other suitable source of negative pressure in a fluid, disposed in or in selective fluid communication with isolated portion 134. Additionally, in some embodiments, such a negative pressure source can be configured to accept a flow of bodily fluid via outlet 136 after an initial volume of bodily fluid has been transferred to and isolated in isolated portion 134.

[0046] In some embodiments, housing 130 and / or isolation portion 134 can enable and / or allow for adjustment of the negative pressure generated in and / or exerted through isolation portion 134. For example, the size, shape, material, and / or physical structure of isolation portion 134 can be configured to control the rate at which the volume of isolation portion 134 increases, which in turn can control the magnitude of the negative pressure generated within isolation portion 134. In some embodiments, a desired combination of components, size, shape, material, and / or configuration can be selected to, for example, draw bodily fluid (e.g., blood from the vasculature) from a physically impaired patient (e.g., a sick patient, a patient with low blood pressure, an obese patient, a pediatric patient, etc.), and a different combination of components, size, shape, material, and / or configuration can be selected to draw bodily fluid from a healthy patient or other non-impaired patient.

[0047] In some embodiments, fluid control device 100 can include actuator 150. Actuator 150 can be included in housing 130 (as shown in the schematic diagram of FIG. 1 ), or actuator 150 can be included in any other suitable portion of device 100. Actuator 150 can be configured to transition housing 130 from a first state (e.g., a state in which an initial portion of bodily fluid can be transferred to isolation portion 134) to a second state (e.g., after the initial portion of bodily fluid has been transferred to isolation portion 134). In some embodiments, actuator 150 can be mechanically coupled to operate a switch (that opens and / or closes fluid flow path 133). For example, in some embodiments, actuator 150 can be mechanically coupled to operate a switch (that opens and / or closes fluid flow path 133) that moves within isolation portion 134. One or more mechanical actuators that can be actuated or moved create a change in volume and / or create a pressure differential between the isolation portion 134 and, for example, a fluid source and / or a portion of the fluid flow path 133 outside the isolation portion 134.

[0048] In some embodiments, the actuator 150 can effect switching states of the control device 100 by manipulating the flow of fluid through various portions of the fluid flow path 133 in any suitable manner. For example, in some embodiments, movement of the actuator 150 can create a pressure differential between the isolation portion 134 and the ambient environment through which the isolation portion 134 is vented. For example, the mechanical actuator can be in an initial state prior to use of the control device 100, and the pressure differential between the isolation portion 134 and the bodily fluid source is based on a positive pressure associated with, for example, the patient's vasculature (i.e., blood pressure). In such embodiments, the pressure differential can be relatively small. In some such embodiments, the mechanical actuator can transition from the initial state to a subsequent state upon the initiation of flow of an initial volume of bodily fluid, whereby the transition of the mechanical actuator can vent air or gaseous contents within the isolation portion 134, creating a negative pressure differential between the isolation portion 134 and the bodily fluid source, drawing the flow of bodily fluid into the isolation portion 134. In some such embodiments, the transition of the mechanical actuator may also be configured to alter access to one or more openings to allow the flow of air or gas disposed within a portion of isolation portion 134 through the openings (not shown in FIG. 1 ). For example, in some embodiments, actuator 150 may be configured to physically block or occlude one or more openings in one or more portions of fluid flow path 133, which may be introduced or removed through the operation of one or more external control mechanisms (e.g., switches, stopcocks, levers, clamps, or push-button activated flow blocks, etc.), as described in further detail below.

[0049] In some embodiments, the amount of movement of the mechanical actuator and / or the equalization of pressure after movement of the mechanical actuator can be factors in determining and / or defining how bodily fluid flows through the control device 100 and / or the amount or volume of bodily fluid transferred to the isolation portion 134, as disclosed in detail below with respect to certain embodiments.

[0050] In other embodiments, the method of actuating the actuator can be via user intervention (e.g., an external force applied by a user). In some such embodiments, the isolation chamber 114 can include a structure or material that is activated or deactivated to assist in moving or transitioning the actuator from an initial state to a resultant state. The structure or material can be activated by any suitable mechanism, for example, by contact with a small amount of bodily fluid (or any other fluid), by the passage of a predetermined time, and / or by a change in pressure or temperature, and / or the like.

[0051] In some embodiments, the outlet(s) 136 of the housing 130 are in fluid communication with and / or configured to be disposed in fluid communication with the fluid flow path 133. The outlet 136 can be any suitable outlet, opening, port, lock, seal, coupler, adapter, etc., and is configured to be fluidly coupled to a fluid collection device 160, such as, for example, a fluid collection device 160, a syringe, an intermediate lumen-containing device, and / or any other suitable bodily fluid collection or transfer device. In some embodiments, the outlet 136 can be monolithically formed with the fluid collection device 160. In other embodiments, the outlet 136 can be at least temporarily coupled to the fluid collection device 160 via adhesives, a resistance fit, mechanical fasteners, threaded couplings, a drilled or punctured arrangement, any number of mating recesses, and / or other suitable couplings or combinations thereof. Similarly stated, the outlet 136 can be physically (e.g., In yet other embodiments, the outlet 136 can be operably coupled to the fluid collection device 160 via an intervening structure (not shown in FIG. 1), such as a flexible sterile tube.

[0052] As noted above, in some embodiments, the arrangement of at least one outlet 136 can be such that the outlet 136 is physically and / or fluidly sealed prior to coupling to the fluid collection device 160. In some embodiments, such a sealed arrangement can facilitate, direct, and / or otherwise result in an initial flow of bodily fluid into the isolation portion 134 rather than the outlet 136. In some embodiments, the fluid collection device 160 can define and / or actuate to define a negative pressure that can be applied through the outlet 136 to draw bodily fluid from a bodily fluid source, through the fluid control device 100, and into the fluid collection device 160 after an initial volume of bodily fluid has been transferred to and isolated from the isolation portion 134. In some embodiments, the fluid collection device 160 can be placed in selective fluid communication with at least a portion of the isolation portion 134 such that at least a portion of the negative pressure associated with the fluid collection device 160 is applied to or through the isolation portion 134, causing an initial volume of bodily fluid to enter the isolation portion 134 (e.g., through the use of a selectively permeable member such as an air permeable / fluid impermeable barrier or the like) without transferring that volume of bodily fluid to the fluid collection device 160.

[0053] As mentioned above, fluid collection device 160 can be any suitable device for receiving and / or at least temporarily containing bodily fluids. In some embodiments, fluid collection device 160 can be a fluid collection device for containing bodily fluids, such as, for example, those described in detail in the '420 patent incorporated by reference above. In other embodiments, fluid collection device 160 can be substantially similar to or equivalent to known sample containers, such as, for example, a Vacutainer® (manufactured by Becton, Dickinson and Company (“BD”)), BacT / ALERT® SN, or BacT / ALERT® FA (manufactured by Biomerieux, Inc.), and / or any suitable reservoir, vial, microvial, microliter vial, nanoliter vial, container, microcontainer, nanocontainer, syringe, dish, pump, and / or the like.

[0054] In some embodiments, the fluid collection device 160 can include and / or define a negative pressure condition prior to use, which can then facilitate the drawing of bodily fluid from the patient into the fluid collection device 160 via vacuum or suction through the control device 100. In embodiments in which the fluid collection device 160 is a vacuum container or the like, a user can couple the fluid collection device 160 to the outlet 136 after the initial portion of the bodily fluid has been transferred and / or isolated in the isolation portion 134, which can then limit and / or substantially prevent the initial portion of the bodily fluid (potentially including contaminants) from being transferred to the fluid collection device 160. In other embodiments, at least a portion of the negative pressure associated with the fluid collection device 160 can be used prior to the isolation of the initial volume of bodily fluid in the isolation portion 134 without drawing bodily fluid into the fluid collection device 160, e.g., to create a negative pressure differential between the isolation portion 134 and an inlet 132 operable to draw bodily fluid into the isolation portion 134.

[0055] Although outlet 136 and / or housing 130 of control device 100 are described above as being fluidly coupled to and / or otherwise disposed in fluid communication with fluid collection device 160, in other embodiments, control device 100 can be used in combination with any suitable bodily fluid collection device and / or system. For example, in some embodiments, control device 100 described herein may be used in combination with any suitable bodily fluid collection device and / or system. For example, in some embodiments, control device 100 described herein may be used in combination with any suitable bodily fluid collection device and / or system. The control device 100 may be used in any suitable fluid transfer device, such as that described in U.S. Patent Publication No. 2015 / 0342510, entitled "Suitable Bodily-Fluid Collection Device and Methods" (herein referred to as the "'510 Publication"). More specifically, the control device 100 may be used in "one-piece" or pre-assembled devices (such as those described in the '510 Publication) to receive and isolate an initial volume of bodily fluid to reduce and / or eliminate contaminants in subsequent volumes of bodily fluid.

[0056] As described above, device 100 can be used to obtain a bodily fluid sample with reduced contamination from microorganisms, such as, for example, microorganisms present on skin, and / or the like. For example, in some embodiments, a user, such as a doctor, physician, nurse, phlebotomist, technician, etc., can operate device 100 to establish fluid communication between inlet device 110 and a bodily fluid source (e.g., a patient's vein, cerebrospinal fluid (CSF) from the spinal cavity, a urine collection, and / or the like). As a particular example, in some embodiments, inlet device 110 can include a needle or the like that can be operated to pierce the patient's skin and insert at least a portion of the needle into the patient's vein, thereby placing inlet device 110 in fluid communication with the bodily fluid source (e.g., a vein, an IV catheter, a PICC, etc.).

[0057] The housing 130 can be coupled to the inlet device 110 before or after the inlet device 110 is placed in fluid communication with the bodily fluid source. In other embodiments, the inlet 132 of the housing 130 includes, forms, and / or is monolithically formed with the inlet device 110. Thus, establishing fluid communication between the inlet device 110 and the bodily fluid source by coupling or forming the inlet 132 to the inlet device 110 places the housing 130 in fluid communication with the bodily fluid source. Thus, bodily fluid can flow from the bodily fluid source (e.g., a patient's vein), through the inlet device 110, and into the housing 130.

[0058] In some embodiments, the actuator 150 of the device 100 can be configured to place the control device 100 in a first state (e.g., a state in which an initial portion of the bodily fluid can be transferred to the isolation portion 134). Thus, the actuator 150 can place the control device 100 in the first state, forming a fluid connection between the bodily fluid source and the isolation portion 134 via one or more portions of the fluid flow path 133, because the inlet 132 of the housing 130 is in fluid communication with the bodily fluid source. In other embodiments, the actuator 150 can be configured to maintain the control device 100 in a storage and / or pre-use configuration or state in which the inlet 132 of the housing 130 is isolated and / or isolated from the isolation portion 134 and one or more outlets 136. In such embodiments, the actuator 150 can be operated to transition the control device 100 from a storage configuration and / or state to the first state, for example, after the inlet device 110 has established fluid communication with the bodily fluid source.

[0059] As described above, the fluid flow path 133 of the housing 130 establishes fluid communication between the inlet 132 and the isolation portion 134 and / or the outlet 136. In some embodiments, the housing 130 and / or the actuator 150 are arranged such that when a volume of bodily fluid is transferred into and / or through the inlet 132, an initial portion of the volume of bodily fluid (also referred to herein as an "initial volume" or "first volume") flows from the inlet 132, through at least a portion of the fluid flow path 133, and into the isolation portion 134. That is, in some embodiments, the control device 100 can be placed in a first or initial state (e.g., via the actuator 150) such that an initial portion or volume of bodily fluid can flow into or through at least a portion of the fluid flow path 133 and into the isolation portion 134. do.

[0060] For example, in some embodiments, the actuator 150 can be in a first configuration, state, mode, and / or position when the control device 100 is in an initial state. The first configuration of the actuator 150 can be, for example, a configuration in which the actuator 150 allows fluid communication between the inlet 132 and the isolation portion 134 via at least a portion of the fluid flow path 133, and in which the actuator 150 blocks, isolates, and / or isolates the inlet 132 from the outlet 136 or the fluid collection device 160. For example, when in the first configuration, the actuator 150 can define an opening, aperture, orifice, conduit, channel, flow path, or the like to permit fluid flow from the inlet 132 toward the isolation portion 134, and can block or occlude the opening, aperture, orifice, conduit, channel, flow path, or the like to block fluid flow from the inlet 132 toward the outlet 136 or the fluid collection device 160. In some embodiments, the first configuration of the actuator 150 can be a rest or initial configuration (e.g., a pre-use configuration) of the actuator 150. That is, the actuator 150 (and control device 100) can be in the first configuration (and first state) to allow fluid flow from the inlet device 110 toward the isolation portion 134 without user intervention. In other embodiments, the actuator 150 can be placed in and / or transitioned to the first configuration upon manipulation by a user.

[0061] In some embodiments, when control device 100 is in an initial state, isolation portion 134 is vented and outlet 136 is isolated (e.g., via actuator 150). In this manner, bodily fluid entering fluid flow path 133 displaces a volume of air or gas disposed therein, and venting isolation portion 134 allows the volume of air or gas to vent through isolation portion 134, which then urges, draws, and / or otherwise diverts an initial portion of bodily fluid into isolation portion 134 before the bodily fluid flows to outlet 136. In some embodiments, venting isolation portion 134 can be achieved by any other suitable method. In some embodiments, for example, actuator 150 can be in its initial configuration or the like before inlet device 110 is placed in fluid communication with a source of bodily fluid. For example, the isolation portion 134 can be compressed (e.g., pre-compressed or vented by a user and / or during manufacture or the like) to expel its contents prior to contacting the inlet device 110 with a source of bodily fluid (e.g., the patient's vasculature), and any air or gas disposed in the isolation portion 134 is released into the surrounding environment. In such embodiments, the actuator 150 can be switched from an initial or venting configuration to a first position that allows bodily fluid to flow from the inlet 132 toward the now-empty or vented isolation portion 134. In some embodiments, the initial or venting configuration of the actuator 150 can be different from the first configuration. In other embodiments, the initial or venting configuration can be equivalent to the first configuration.

[0062] In some cases, transitioning the actuator 150 from the initial or venting configuration to the first configuration (e.g., while the control device 100 is in the first state) after venting or evacuating the isolation portion 134 can serve to establish an operable negative pressure differential through the inlet device 110 and at least a portion of the fluid flow path 133 to draw bodily fluid into the isolation portion 134. In some embodiments, evacuating the contents of the isolation portion 134 before establishing contact with the source of bodily fluid can remove air or gaseous bubbles that could potentially be introduced into the source of bodily fluid and / or the bodily fluid sample. In other embodiments, the device 100 can be stored prior to use with a fluid or gas disposed in the isolation portion 134 configured to maintain a sterile environment within the isolation portion 134. In such embodiments, applying a vacuum to the isolation portion 134 before establishing contact with the source of bodily fluid can evacuate such fluid or gas. Additionally, when the actuator 150 is vented, When in the open and / or first configuration, the actuator 150 can decouple, block, isolate, and / or otherwise isolate the outlet 136 from the inlet 132 of the housing 130. Isolating the outlet 136 from the source of bodily fluid can, for example, prevent negative pressure within the fluid collection device 160 from drawing bodily fluid into the fluid collection device 160 before drawing and isolating the initial volume of bodily fluid in the isolation portion 134.

[0063] In some embodiments, negative pressure can be introduced into the isolation portion 134, including any intermediate portion of the actuator 150 in the first position, and the flow path 133 connecting the isolation portion 134 to the inlet 132 and / or inlet device 110, using any suitable user-mediated or non-user-mediated method. In other embodiments, the isolation portion 134 and the flow path 133 can be evacuated, vented, and / or placed under reduced or negative pressure (also referred to herein as "pre-filling") during manufacturing or the like. The negative pressure can then draw or encourage fluid flow toward and into the isolation portion 134. For example, in some embodiments, the isolation portion 134, the connecting fluid flow path 133, and / or the inlet device 110 can be positioned at a relatively lower elevation than the bodily fluid source (e.g., the patient's vasculature) to use gravity to aid fluid flow. A vent or seal in communication with the isolation portion 134 can be configured to allow unidirectional flow of air or gas (but not liquid, such as bodily fluid) from the isolation portion 134. In some embodiments, negative pressure associated with the fluid collection device 160 (e.g., a vacuum container, syringe, etc.) can be used to draw bodily fluid into the isolation portion 134 without drawing the bodily fluid into the fluid collection device 160 until an initial portion or volume of the bodily fluid has been isolated.

[0064] Although not shown in FIG. 1 , in some embodiments, control device 100 and / or housing 130 can include members, devices, mechanisms, features, etc. configured to regulate the magnitude of negative pressure to which isolation chamber 134 is exposed. For example, in some embodiments, the housing can include a valve, a membrane, a porous material, a restrictor, an orifice, and / or any other suitable member, device, and / or feature configured to regulate pressure. In some embodiments, regulating and / or controlling the magnitude of pressure to which isolation chamber 134 is exposed can, in turn, regulate the magnitude of pressure applied to the bodily fluid and / or the patient's veins. In some embodiments, such pressure regulation can, for example, reduce the likelihood of hemolysis of a blood sample and / or collapsing a vein (e.g., this is particularly important in vulnerable patients requiring microbiological and / or other diagnostic tests associated with use of control device 100). Additionally, regulating the negative pressure can, for example, at least partially control the rate at which control device 100 transitions between a first configuration or state and a second configuration or state. In some embodiments, regulating the negative pressure can function like a timer. For example, the time between the introduction of the negative pressure differential and the transition of the control device 100 from the first state to the second state can be known, predetermined, calculated, and / or controlled. Thus, in some embodiments, adjusting the negative pressure can at least partially control the amount or volume of bodily fluid transferred into the isolation chamber 134 (i.e., can control the volume of the initial amount of bodily fluid).

[0065] The initial portion and / or amount of bodily fluid can be any suitable volume of bodily fluid, as described above. For example, in some embodiments, the control device 100 can remain in the first state until a predetermined and / or desired volume (e.g., the initial volume) of bodily fluid has been transferred to the isolation portion 134. In some embodiments, the initial volume can be related to and / or based at least in part on the volume of the isolation portion 134. In other embodiments, the initial volume can be related to and / or based at least in part on the amount or volume of bodily fluid that can be absorbed by an absorbent material, a swelling material, a hydrophilic material, a wicking material, and / or other suitable material disposed in the isolation portion 134. Similarly, the initial volume can be related to and / or based at least in part on an amount or volume of bodily fluid sufficient to fully wet or saturate a semipermeable member or membrane configured to vent isolation portion 134 (e.g., isolation portion 134 has been transitioned from a "vented" state to a "sealed" state or the like). In still other embodiments, control device 100 can be configured to transfer a volume of bodily fluid (e.g., an initial volume) into isolation portion 134 until a pressure differential between isolation portion 134 and fluid flow path 133 is established and / or the source of bodily fluid is brought to a state of substantial equilibrium and / or otherwise reduced below a desired threshold. In some embodiments, the pressure differential can be established automatically or through direct or indirect intervention (e.g., by a user).

[0066] In some embodiments, the initial volume can be measured at the time of procurement by using any suitable method, such as, for example, a graduated isolation portion 134 or graduated tubing that may be associated with or part of one or more portions of the fluid flow path 133 connecting the inlet 132 to the isolation portion 134. When the initial volume of collected fluid reaches a predetermined value, the actuator 150 can transition from a first configuration to a second configuration, thereby stopping further fluid flow of bodily fluid into the isolation portion 134 and transitioning the control device 100 from the first state to the second state. After the initial volume of bodily fluid is transferred and / or diverted to the isolation portion 134, the initial volume is sequestered, separated, held, contained, isolated, etc. within the isolation portion 134 by transitioning the actuator 150 to the second configuration. As described in further detail herein, in some embodiments, contaminants, for example, microorganisms or the like present in the dermis removed during a venipuncture event, may be entrained and / or contained in the initial volume of bodily fluid and thus sequestered in the isolation portion 134 when the initial volume is sequestered therein.

[0067] Once the initial volume has been transferred and / or diverted to the isolation portion 134, the device 100 may transition (or be transitioned) to a second state in which subsequent volume(s) of bodily fluid may flow through at least a portion of the flow path 133 fluidly from the inlet 132 to the outlet 136. In some embodiments, the control device 100 may passively and / or automatically (e.g., without user intervention) transition from the first state to the second state once the initial volume of bodily fluid has been sequestered in the isolation portion 134. For example, in some embodiments, filling the isolation portion 134 to volume and / or completely saturating, wetting, and / or impregnating an absorbent or similar material disposed in the isolation portion 134 may be such that further transfer of bodily fluid into the isolation portion 134 is limited and / or substantially prevented.

[0068] In some embodiments, as described above, the control device 100 can be transitioned from a first state to a second state by switching or actuating the actuator 150. The actuator 150 can be configured to switch from a first configuration (e.g., position, state, operating mode, arrangement, etc.) to a second configuration, allowing fluid flow toward the isolation portion 134 while blocking fluid flow toward one or more of the outlets 136 or fluid collection device 160, such that the isolation portion 134 is isolated and / or blocked and fluid is allowed to flow toward the outlets 136 or fluid collection device 160.

[0069] In some embodiments, control device 100 can be transitioned from a first state to a second state through various passive or active mechanisms, or a combination of passive and active mechanisms. Similarly, actuator 150 can be transitioned from a first state to a second state through various passive or active mechanisms, or based on one or more other changing parameters, such as during the procurement of bodily fluid from a user, or through active user intervention, or through a combination of passive and active mechanisms. The actuator 150 may have a configuration, state, and / or position (e.g., a storage state, a venting state, a first state, a second state, etc.). In some embodiments, for example, the actuator 150 may assume various states based on a passive mechanism that does not require or involve user intervention. For example, the actuator 150 may transition between states in response to the passage of time, a change in volume, a change in a physical property such as saturation of a hydrophilic material in the isolation portion 134, a change in the amount of negative pressure applied to draw or push fluid flow toward or into the isolation portion 134, and / or the like. The actuator 150 may also utilize other changing parameters, such as changes in applied gravity, to draw fluid into an appropriately positioned isolation portion 134.

[0070] In some embodiments, the actuator 150 can be actively transitioned from the first state to the second state through user intervention. In other words, the actuator 150 can be manually transitioned by a user who directly controls the direction of bodily fluid flow with the actuator 150, thereby transitioning the control device 100 from the first state to the second state. As described above, the actuator 150 can switch from the first state to the second state based on any suitable criteria (e.g., the amount of bodily fluid collected in the isolation portion 134, a pressure differential that encourages fluid flow into the isolation portion 134, etc.), or any other suitable indication or at the discretion of the user. Thus, when the criteria are met, the user can operate the actuator 150 (e.g., a switch, valve, port, stopcock, etc.) to transition the actuator 150 from the first state to the second state.

[0071] The fluid collection device 160 can be at least fluidly coupled to the outlet 136 before or after the housing 130 is placed in the second state. Similarly, in some embodiments, the fluid collection device 160 can be at least fluidly coupled to the outlet 136 before or after the actuator 150 transitions from the first configuration or state to the second configuration or state. The positioning of the outlet 136 can be such that the outlet 136 remains sealed until an initial volume of bodily fluid is sequestered in the isolation portion 134, regardless of whether a fluid collection device is coupled to the outlet 136. Thus, when the fluid collection device 160 is fluidly coupled to the outlet 136 and the housing 130 is in the second state (e.g., an initial volume of bodily fluid is isolated within or by the isolation portion 134, and the actuator 150 is in the second configuration or state, establishing fluid communication between the inlet 132 and the outlet 136), subsequent volume(s) of bodily fluid can flow from the inlet 132, through the fluid flow path 133, the actuator 150, and the outlet 136 to the fluid collection device 160. Thus, as described above, isolating the initial volume of bodily fluid in the isolation portion 134 prior to collecting or procuring one or more sample volumes of bodily fluid reduces and / or substantially eliminates the amount of contaminants in the one or more sample volumes. Further, in some embodiments, the arrangement of the control device 100 and / or the actuator 150 can be such that the control device 100 and / or the actuator 150 cannot transition to the second state before collecting and isolating the initial volume in the isolation portion 134.

[0072] 2-4 illustrate (in cross-section) at least a portion of a fluid control device 200 according to an embodiment. As described above with respect to control device 100, fluid control device 200 (also referred to herein as a "control device" or "device") is configured to withdraw and isolate a first portion or amount (e.g., an initial amount) of bodily fluid from a patient, and then withdraw a second portion or amount (e.g., a subsequent amount) of bodily fluid, e.g., for use in sampling and / or testing the bodily fluid. By isolating the first portion or amount of bodily fluid, contaminants such as microorganisms present on skin removed during venipuncture or the like are likewise isolated, leaving a second portion or amount of bodily fluid that is substantially free of contaminants. In some embodiments, portions and / or aspects of control device 200 are similar to those described above with reference to FIG. 1. They are substantially similar in form and / or function to corresponding parts and / or aspects of control device 100. Accordingly, such similar parts and / or aspects will not be described in further detail herein.

[0073] 2-4, the control device 200 includes a housing 230 similar in structure and / or function to the housing 130 of the fluid control device 100 described above, and an actuator 250 similar in structure and / or function to the actuator 150 described above with respect to the fluid control device 100. The diagrams of FIGS. 2-4 show the actuator 250 in various configurations and / or positions (e.g., a venting position, a first position, and a second position), as described in further detail herein.

[0074] The housing 230 can be any suitable device or set of devices configured to (1) receive a flow of bodily fluid, (2) store and isolate a first or initial volume of bodily fluid, and (3) direct or divert a subsequent flow of bodily fluid to a fluid collection device, as described in further detail herein. The housing 230 can be of any suitable shape, size, and / or configuration. For example, in some embodiments, the housing 230 can be formed of a relatively rigid material, such as plastic or the like, and can be configured to retain its shape and / or form when exposed to changes in pressure and / or inlet or outlet flow of fluid. In other embodiments, the housing 230 can be made of a flexible material that can withstand compression and / or other similar forces used to expel the contents of the isolation portion 234 prior to use, as described above with respect to the housing 130 of the fluid control device 100.

[0075] As shown in FIGS. 2-4 , housing 230 includes inlet 232 and outlet 236. Inlet 232 is in fluid communication with and / or configured to be placed in fluid communication with an inlet device (not shown). Generally, inlet device can be any suitable device or set of devices configured to establish fluid communication between housing 230 and a source of bodily fluid, such as, for example, the patient's vasculature, as described above with respect to control device 100. Outlet 236 is in fluid communication with and / or configured to be placed in fluid communication with a fluid collection device (not shown in FIGS. 2-4 ), such as a fluid collection device, syringe, culture bottle, and / or the like. The fluid collection device can be similar to any of the fluid collection devices described above with reference to control device 100.

[0076] Housing 230 includes and / or defines one or more fluid flow paths 233 and isolation and / or diversion portions 234. Fluid flow path(s) 233 can be of any suitable arrangement and are configured to selectively establish fluid communication between inlet 232 and isolation and / or diversion portion 234 and / or between inlet 232 and outlet 236. Isolation and / or diversion portion 234 (also referred to herein as “isolation portion”) can be of any suitable shape, size, and / or configuration and is configured to receive an initial volume of bodily fluid, which may include contaminants or other undesirable materials, and, after receiving the initial volume, isolates the initial volume of bodily fluid and contaminants and / or other undesirable materials within isolation portion 234, as described in further detail herein.

[0077] As mentioned above, in some embodiments, actuator 250 can be associated with, included in, and / or coupled to housing 230, as shown in Figures 2-4. Actuator 250 can be any suitable member, device, mechanism, etc. configured to transition between at least two different operating states to selectively control the flow of fluid through housing 230. For example, actuator 250 included in device 100 can be any suitable member, device, mechanism, etc. configured to transition between at least two different operating states to selectively control the flow of fluid through housing 230. As described above with respect to actuator 150, actuator 250 can be a switch, valve, port, membrane, movable channel, clamp, and / or the like configured to manipulate the flow of fluid (either directly or indirectly) through housing 230.

[0078] The actuator 250 can be formed monolithically or as an integral part of the housing 230, or can be formed separately and operably coupled to at least the housing 230. In the embodiment shown in FIGS. 2-4 , the actuator 250 can be a three-way valve, port, stopcock, and / or the like, and its configuration can be changed to form pathways, conduits, and / or channels to allow fluid to flow in selected directions. The actuator 250 can include lumens, channels, openings, flow paths, and / or the like that can be aligned with or adjacent to various portions of the fluid flow path 233 to control the flow of fluid through the housing 230. The actuator 250 is configured to be arranged in different configurations that allow fluid flow through selected portions of the actuator 250 and the fluid flow path 233 while preventing fluid flow through other portions of the fluid flow path 233.

[0079] The configuration of actuator 250 can be switched, modified, and / or manipulated either by passive methods, active user intervention, or a combination of active and passive methods, as described above with respect to actuator 150. For example, in some embodiments, actuator 250 can be a rotary valve driven by a spring or damper mechanism such that actuator 250 can be switched between various positions, each of which switches in a position occurring over a predetermined time period, or when certain criteria, such as a predetermined pressure differential and / or the like, are met. For example, actuator 250 can be a push button, toggle, switch, lever, dial, etc., that, when engaged by a user, can transition actuator 250 from a first state or position to a second state or position. As described in further detail herein, in some embodiments, actuator 250 can be configured to establish fluid communication between inlet 232 and isolation portion 234 when in a first state, configuration, and / or position, and to establish fluid communication between inlet 232 and outlet 236 when in a second state, configuration, and / or position.

[0080] In some embodiments, actuator 250 can be configured in any other suitable form. For example, instead of a three-way valve (e.g., a rotary valve, a port, and / or the like), actuator 250 can be a two-way valve in a Y- or T-configuration or any other suitable path selector that allows selection between an open flow path connecting inlet 232 with isolation portion 234 and an open flow path connecting inlet 232 with outlet 234.

[0081] In some embodiments, actuator 250 can be an opening / closing mechanism for existing channels, pathways, and / or conduits, thus not forming new channels or conduits, but allowing or blocking access to one or more existing channels or conduits. For example, actuator 250 can be configured to open (or block) at least a portion of fluid flow path 233 connecting isolation portion 234 to inlet 232, while blocking (or opening) at least a portion of fluid flow path 233 connecting outlet 236 to inlet 232. In some embodiments, actuator 250 can be configured as a rotary valve (as shown in FIGS. 2-4), a linear valve (e.g., a plunger) with a series of seals, and / or any other suitable valve.

[0082] The operation of the actuator 250 in opening and blocking one or more flow paths can be configured to be either sequential or simultaneous. , actuator 250 can be designed so that only a certain number of flow paths are open in any particular configuration. For example, actuator 250 can be designed so that only one of isolation portion 234 or outlet 236 can be fluidly connected to inlet 232 in any given configuration. In some other embodiments, actuator 250 can enable fluid communication between multiple portions of housing 230. For example, in some embodiments, actuator 250 can be designed to establish fluid communication substantially simultaneously between inlet 232 and isolation portion 234, as well as between inlet 232 and outlet 236. In some such embodiments, actuator 250 can enable selection of fluid flow paths through one or more control mechanisms other than blocking or occluding (e.g., by manipulating a pressure differential or other mechanism that urges fluid flow in a particular direction). In some embodiments, actuator 250 may operate by physically allowing or blocking access to particular fluid flow paths, such that opening of a first fluid flow path (e.g., a fluid flow path connecting inlet 232 with isolation portion 234) automatically results in blocking of another fluid flow path (e.g., a fluid flow path connecting inlet 232 and outlet 236), and vice versa. However, in some embodiments, allowing and / or blocking of particular fluid flow paths may allow for flexibility in user discretion or control in selecting one or more fluid flow paths.

[0083] In some embodiments, actuator 250 can be arranged in a storage and / or venting configuration, as described above with respect to actuator 150 of control device 100. For example, FIG. 2 shows actuator 250 in a storage and / or venting configuration prior to use for obtaining bodily fluid. As described above, in the storage and / or venting configuration, actuator 250 can fluidly isolate inlet 232 from isolation portion 234 and outlet 236. Although not shown in FIG. 2 , in some embodiments, outlet 236 can be substantially sealed prior to use. In some embodiments, a user can transition outlet 236 to an open configuration and / or the like, which can allow the removal, effusion, or exhaustion of air or other gaseous contents disposed in isolation portion 234 (e.g., via outlet 236) before isolation portion 234 was placed in fluid communication with inlet 232. For example, venting the contents of isolation portion 234 can evacuate the volume within isolation portion 234, thereby allowing bodily fluid to be drawn into the volume. In some embodiments, venting can create a negative pressure within isolated portion 234 that can be operable to draw or encourage the flow of bodily fluid from a source of bodily fluid (e.g., the patient's vasculature) into isolated portion 234 when actuator 250 places isolated portion 234 in fluid communication with inlet 232. In some embodiments, venting, filling, and / or venting of isolated portion 234 can be responsive to a fluid collection device being coupled to outlet 236. For example, in some such embodiments, the fluid collection device can define a negative pressure or the like that can draw air or gas from isolated portion 234 through actuator 250 (during the venting configuration) and through outlet 236.

[0084] While FIG. 2 illustrates that isolation portion 234 can be vented via outlet 236, in other embodiments, housing 230 can include and / or define any suitable opening(s), outlet(s), vent(s), port(s), etc. that are in communication with isolation portion 234 and configured to allow venting of contents placed in isolation portion 234 prior to use of device 200 (not shown in FIGS. 2-4 ). In some embodiments, access to these vents or the like can be controlled by actuator 250 and / or any other suitable device. In other embodiments, isolation portion 234 is not vented prior to use of control device 200. In such embodiments, actuator 250 can be stored in a storage configuration (as shown in FIG. 2 ) and / or in a configuration in which inlet 232 is in fluid communication with isolation portion 234.

[0085] As shown in FIG. 3 , after venting the isolation portion 234 and / or when the control device 200 is otherwise ready for use, the actuator 250 can be placed in a first configuration or position to establish fluid communication between the inlet 232 and the isolation portion 234. For example, in some embodiments, the actuator 250 can be a rotary valve or the like that can be switched from the storage and / or vent configuration ( FIG. 2 ) to the first configuration ( FIG. 3 ) by turning and / or rotating the actuator 250 (e.g., by rotating the actuator 250 90 degrees clockwise). The clockwise rotation or similar switch in the position of the actuator 250 can be implemented by any suitable mechanism. For example, the rotary valve actuator 250 can be rotated for a predetermined period of time driven by a spring-loaded mechanism (e.g., a torsion spring that can provide a steady torque to rotate the actuator 250). In some embodiments, a damper fluid can be used to control the rotational speed of the actuator 250. In other embodiments, actuator 250 can be switched between configurations and / or positions using a push button mechanism, a lever, a switch, a slider, a toggle, a pressure-dependent release mechanism, an external force-dependent (e.g., gravity-dependent) mechanism, and / or other suitable switching means. Similarly, any suitable mechanism can be used to control the rate at which actuator 250 switches from one position to the next.

[0086] Once the initial volume of bodily fluid has been transferred to the isolation portion 234, the actuator 250 can be switched from a first configuration and / or position ( FIG. 3 ) to a second configuration and / or position ( FIG. 4 ). When in the second configuration and / or position, the actuator 250 is configured to establish fluid communication between the inlet 232 and the outlet 236, as shown in FIG. 4 . Furthermore, the actuator 250 can be configured to isolate the isolation portion 234 such that the isolation portion 234 is not in fluid communication with the inlet 232 and is not in fluid communication with the outlet 236. Thus, as described above with reference to the control device 100, the initial volume of bodily fluid within the isolation portion 234 is isolated. Furthermore, in some examples, the initial volume of bodily fluid may include contaminants and / or undesirable substances, which are also sequestered in the isolation portion 234. Thus, when the actuator 250 is in the second configuration and / or position, the subsequent volume of bodily fluid drawn from the patient can be substantially free of contaminants and can be transferred to one or more fluid collection devices (e.g., a fluid collection device or the like).

[0087] As described above, the actuator 250 can be switched between the first and second configurations and / or positions using a mechanically actuated mechanism (e.g., a button is pressed, a turn control is actuated, a lever is actuated, a clamp is actuated, a switch is actuated) or any other suitable mechanism (e.g., pressure-dependent, volume-dependent, and / or time-dependent, etc.). For example, in some embodiments, the actuator 250 can be switched in response to a force applied by a user. In such embodiments, the user can visually inspect the housing 230 to determine whether an initial volume of bodily fluid has been transferred to the isolation portion 234. If the user confirms that the initial volume of bodily fluid is in the isolation portion 234, the user can then apply a force to the actuator 250 to transition the actuator 250 from the first configuration and / or position to the second configuration and / or position.

[0088] In other embodiments, actuator 250 can be configured to transition from a first configuration and / or position to a second configuration and / or position in response to one or more criteria being met. For example, in some embodiments, actuator 250 transitions from a first configuration and / or position to a second configuration and / or position in response to pressure equalization between isolation portion 234 and inlet 232. The actuator 250 can be configured to transition from a first configuration and / or position to a second configuration and / or position. In other embodiments, the actuator 250 can be configured to transition from a first configuration to a second configuration in response to a desired volume to be transferred to the isolation portion 234. In yet other embodiments, the actuator 250 can be configured to transition from the first configuration to the second configuration after a predetermined time has elapsed. For example, in some embodiments, if the volumetric flow rate of the bodily fluid is known or can be determined, the time it takes for the desired volume of bodily fluid to enter the isolation portion 234 can likewise be determined. Thus, as described above, the actuator 250 can be transitioned between one or more configurations and / or positions automatically and / or in response to direct or indirect user input.

[0089] 5-7 show various views of a fluid control device 300 according to an embodiment. As described above with reference to control devices 100 and 200, fluid control device 300 (also referred to herein as a "control device" or "device") is configured to withdraw and isolate a first portion or amount (e.g., an initial amount) of bodily fluid from a patient such that the subsequently withdrawn amount, portion, and / or volume of bodily fluid is substantially free of contaminants. In some embodiments, portions and / or aspects of control device 300 are substantially similar in form and / or function to corresponding portions and / or aspects of control devices 100 and / or 200 described above with reference to FIGS. 1 and 2-4, respectively. Accordingly, such similar portions and / or aspects will not be described in further detail herein.

[0090] As shown in FIG. 5, control device 300 includes inlet device 310, housing 330 in fluid communication with and / or configured to be placed in fluid communication with inlet device 310, and actuator 350. Inlet device 310 can be any suitable device(s), such as, for example, an IV catheter, a sharp catheter, or a sharp needle, and / or any other suitable lumen-containing device. For example, in the embodiment shown in FIGS. 5-7, inlet device 310 is a butterfly needle or other suitable access device having a body 311, a needle 314, and a flexible tube 320. Generally, inlet device 310 can be any suitable device or set of devices configured to establish fluid communication between housing 330 and a source of bodily fluid, such as, for example, the patient's vasculature.

[0091] 7 , body 311 defines a lumen 312 extending therethrough, needle 314 defines a lumen 315 extending therethrough, and flexible tube 320 defines a lumen 321 extending therethrough. Needle 314 is coupled to a distal end portion of body 311, for example, such that lumen 315 of needle 314 is in fluid communication with lumen 312 of body 311. Similarly, flexible tube 320 is coupled to a proximal end portion of body 311, for example, such that lumen 321 of flexible tube 320 is in fluid communication with lumen 312 of body 311. Thus, the lumen 315 of the needle 314, the lumen 312 of the body 311, and the lumen 321 of the flexible tube 320 collectively define a fluid flow path extending through the inlet device 310. Furthermore, the inlet device 310 can be similar and / or substantially equivalent to the inlet device 110 described in detail above with reference to Figure 1. Accordingly, the inlet device 310 will not be described in further detail herein.

[0092] Housing 330 can be any suitable device or set of devices configured to (1) receive a flow of bodily fluid, (2) store and isolate a first or initial volume of bodily fluid, and (3) direct or divert a subsequent flow of bodily fluid to a fluid collection device, as described in further detail herein. In the embodiment shown in Figures 5-7, housing 330 includes an inlet 332, a first outlet 336, and The housing 330 includes a second outlet 337 and defines a fluid flow path 333 and an isolation portion 334. The housing 330 can be of any suitable shape, size, and / or configuration. For example, in the embodiment shown in FIGS. 5-7, the housing 330 forms a Y-connector, and / or the like. In some embodiments, the housing 330 can be formed of a relatively rigid material, such as plastic or the like, and can be configured to retain its shape and / or form when exposed to changes in pressure and / or inlet or outlet flow of fluid.

[0093] 7 , the housing 330 includes and / or receives a portion of an actuator 350, which may be configurable to switch between a first configuration in which the actuator 350 establishes fluid communication between the inlet 332 and a first outlet 336 and a second configuration in which the actuator 350 establishes fluid communication between the inlet 332 and a second outlet 337, as described in further detail below. The inlet 332 of the housing 330 is coupled to a flexible tube 320 (e.g., the flexible tube 320 is a flexible inlet tube for the housing 330), which defines a lumen configured to place the inlet 332 in fluid communication with the inlet device 310. The first outlet 336 is coupled to a first flexible outlet tube 338 (also referred to herein as the “first outlet tube”), which defines a lumen 339 configured to receive a first, or initial, volume of bodily fluid flowing through the housing 330. The first outlet tube 338 is also coupled to a vent portion 335 having a vent material 342 that can selectively vent the lumen 339 of the first outlet tube 338. Accordingly, as described in further detail herein, at least a portion of the lumen 339 can form, for example, an isolation portion 334 (also referred to herein as an "isolation portion"), and / or the like. The second outlet 337 is in fluid communication with a second flexible outlet tube 347 (also referred to herein as a "second outlet tube") and defines a lumen 348 configured to fluidly connect the second outlet tube 347 with one or more fluid collection devices (not shown).

[0094] In some embodiments, one or more portions of the fluid flow path(s) 333 can include at least one feature, characteristic, dimension, etc. that can adjust, modify, increase, decrease, and / or at least partially control the pressure applied through the fluid flow path(s) 333. For example, in some embodiments, the portion of the fluid flow path 333 associated with and / or defined by the first outlet 336 can be offset and / or misaligned from the portion of the fluid flow path 333 associated with and / or defined by the inlet 332, which in turn forms and / or defines a reduced diameter and / or other suitable constraint therebetween. Similarly, the portion of the fluid flow path 333 associated with and / or defined by the second outlet 337 can be offset and / or misaligned from the portion of the fluid flow path 333 associated with and / or defined by the inlet 332, which in turn forms and / or defines a reduced diameter and / or other suitable constraint therebetween. Thus, the constraint can be configured to reduce, modify, and / or limit the pressure applied through the fluid flow path(s) 333. In other embodiments, portions of the fluid flow path 333 may have an increased diameter and / or any other suitable feature configured to increase the pressure differential (e.g., either a positive pressure differential or a negative pressure differential).

[0095] Actuator 350 is included in and / or coupled to housing 330. Actuator 350 can be any suitable member, device, mechanism, and / or the like configured to selectively allow fluid flow from inlet 332 to first outlet 336 or from inlet 332 to second outlet 337. For example, in some embodiments, actuator 350 is configured to transition between at least a first configuration, state, position, etc. and a second configuration, state, position, etc. to selectively control fluid flow through housing 330. As described above with respect to actuators 150 and / or 250 associated with devices 100 and / or 200, respectively, actuators 350 may be configured to transition between at least a first configuration, state, position, etc. and a second configuration, state, position, etc. to selectively control fluid flow through housing 330. As such, actuator 350 can be a switch, valve, port, and / or the like that can directly manipulate and / or establish one or more fluid flow paths, or that can indirectly manipulate and / or establish one or more fluid flow paths. For example, in some embodiments, actuator 350 is a push-button-activated switch or valve that defines a lumen 358 such that when actuator 350 is in a first configuration, state, position, etc. (referred to for simplicity as the "first state"), lumen 358 fluidly connects inlet 332 to first outlet 336, and when actuator 350 is in a second configuration, state, position, etc. (referred to for simplicity as the "second state"), lumen 358 fluidly connects inlet 332 to second outlet 337. Actuator 350 can be configured to switch from one position to another through user intervention or through the action of any suitable passive force. For example, actuator 350 can be switched by manual or mechanical action (e.g., engaging and / or applying a force to a button, stopcock, switch, toggle, slider, etc.), by one or more internal or external forces and / or changes in the magnitude of such forces (e.g., changes in the magnitude of a negative pressure differential and / or the like), by the passage of a predetermined amount of time, or through any suitable combination of active and / or passive mechanisms.

[0096] As mentioned above, the state of control device 300 can be based, at least in part, on the state of actuator 350. For example, when actuator 350 is in a first state, control device 300 is also in a first state such that inlet 332 is in fluid communication with first outlet 336, and when actuator 350 is in a second state, control device 300 is also in a second state such that inlet 332 is in fluid communication with second outlet 337. As described in detail above with reference to devices 100 and / or 200, device 300 shown in FIGS. 5-7 can be used to divert a first, or initial, volume of bodily fluid such that a subsequently obtained bodily fluid sample is less contaminated from microorganisms present on the skin, for example, and / or the like. For example, in some embodiments, a user, such as a doctor, physician, nurse, phlebotomist, technician, etc., can operate device 300 by inserting at least a portion of needle 314 into a patient's vein (e.g., a venipuncture event) and / or otherwise establish fluid communication between needle 314 and the patient. Upon fluid communication with the patient, bodily fluid can flow from a bodily fluid source (e.g., the patient's vein), through inlet device 310, and into housing 330.

[0097] In some embodiments, the actuator 350 can be placed in a storage configuration or the like before the inlet device 310 is placed in fluid communication with a patient. In such embodiments, the storage configuration can be such that the lumen 358 defined by the actuator 350 is isolated and / or otherwise not in fluid communication with the fluid flow path 333 or the inlet 332 of the housing 330. However, once the inlet device 310 is inserted into a patient, a user can engage the actuator 350 to transition the actuator 350 from the storage configuration or state to a first state (shown in FIG. 7 ). In other embodiments, the actuator 350 can be in the first state when the inlet device 310 is inserted into a patient.

[0098] As described above, first outlet conduit 338 is coupled to vent portion 335, which can be configured to vent lumen 339 of first outlet conduit 338 (e.g., isolation portion 334) when housing 330 is in a first, or initial, state. In this manner, a pressure differential (e.g., a negative pressure differential) between lumen 339 of first outlet conduit 338 and, for example, lumen 315 of needle 314, can encourage and draw fluid to flow through fluid flow path 333, through lumen 358 defined by actuator 350, and through first outlet 336 in response to the negative pressure differential (e.g., based at least in part on venting first outlet conduit 338). That is, when the control device 300 and the actuator 350 are in a first, or initial state, the flow of bodily fluid is diverted or directed from the inlet 332 to the first outlet 336 and into the isolated portion 334 (defined or formed by the first outlet conduit 338).

[0099] Thus, a first or initial amount of bodily fluid can be transferred into the lumen 339 of the first outlet tube 338. In some embodiments, the first outlet tube 338 can be bent, flexed, and / or positioned such that the flow of bodily fluid into the lumen 339 of the first outlet tube 338 is assisted and / or enhanced by gravity. For example, in some embodiments, the end of the first flexible outlet tube 338 (e.g., the end coupled to and / or including the vent 335) can be positioned at a lower position (e.g., at a lower elevation) in the housing 330, thereby facilitating the flow of bodily fluid toward the vent 335. Although not shown in FIGS. 5-7 , in some embodiments, the first outlet tube 338 and / or the vent 335 can be selectively in fluid communication with the second outlet tube 347. For example, in some embodiments, the vent material 342 can be a gas-permeable and fluid-impermeable barrier or the like. In such embodiments, second outlet conduit 347 can be fluidly coupled to a fluid collection device and / or any other suitable negative pressure source capable of exerting negative pressure through operable isolation portion 334, for example, to draw a first or initial volume of bodily fluid into vent material 342 and isolation portion 334. In other embodiments, first outlet conduit 338 can be fluidly coupled to a negative pressure source without being coupled to second outlet conduit 347. For example, in some embodiments, first outlet conduit 338 can be placed in fluid communication with a vacuum or suction pump, a vacuum container, and / or any other suitable negative pressure source.

[0100] In some embodiments, the first, or initial, amount of bodily fluid is a volume sufficient to wet or saturate the vent material 342. As described above with reference to control device 100, the vent material 342 can be configured to transition from an open, or vented, state or configuration to a closed, or sealed configuration in response to being wetted or saturated (e.g., fully saturated). In this manner, transferring the first, or initial, volume of bodily fluid into the lumen 339 of the first outlet conduit 338 (e.g., isolation portion 334) seals the vent material 342, which in turn allows the pressure within the lumen 339 to equalize with, for example, the pressure within the fluid flow path 333 and / or the lumen 321 of the flexible tube 320. In some embodiments, the first, or initial, volume of bodily fluid can be a volume sufficient to completely fill the lumen 339 of the first outlet conduit 338, either completely saturating or not saturating the vent material 342. In such embodiments, first outlet conduit 338 may include, for example, a valve or selectively permeable membrane configured to limit and / or substantially prevent the exit of bodily fluid from first outlet conduit 338. In some embodiments, such a valve or membrane may be automatically actuated, user-actuated, and / or a combination thereof. In some embodiments, a portion of actuator 350 may form and / or function as such a valve.

[0101] The configuration of the first outlet conduit 338 (e.g., isolation portion 334) can be such that the lumen retains and / or isolates an initial volume or amount of bodily fluid therein. As described in detail above, contaminants, for example, microorganisms or the like present in the dermis dislodged during a venipuncture event, can be entrained and / or contained in the initial volume of bodily fluid and thus isolated in the first outlet conduit 338. In some embodiments, completely filling the lumen 339 of the first outlet conduit 338 and / or saturating the vent material 342 can place the actuator 350 in a second position and / or the device 300 in a second state or configuration, after which any subsequent volume of bodily fluid will flow through the fluid flow path 333 to the second outlet 337. In some embodiments, the first outlet The tube 338 can be at least partially transparent, allowing a user to visualize when the initial volume has been transferred into the first outlet tube 338. In such embodiments, a user can engage the actuator 350 to transition the actuator 350 to a second state once the user confirms (e.g., visually) that the desired initial volume has been placed in the first outlet tube 338. As described above, the transition of the actuator 350 from the first state to the second state can result in (1) the first outlet tube 338 being isolated (e.g., blocked or sealed by a portion of the actuator 350) and (2) a lumen 358 defined by the actuator 350 establishing fluid communication between the second outlet 337 and the inlet 332. Isolating an initial amount or volume of bodily fluid within the first outlet tube 338 (e.g., isolation portion 334) prior to collecting or procuring one or more sample volumes of the bodily fluid reduces and / or substantially eliminates the amount of contaminants in the one or more sample volumes.

[0102] As described in detail above, the second outlet 337 is in fluid communication with one or more fluid collection device(s) (e.g., via the second outlet tubing 347) such that subsequent volume(s) of bodily fluid can flow from the inlet 332 through the fluid flow path 333, the lumen 358 of the actuator 350, the second outlet 336, and the second outlet tubing 347 into the fluid collection device(s) (not shown). In some embodiments, the fluid collection device(s) can be any suitable device, such as a reservoir, a syringe, a container, or the like. For example, in some embodiments, the fluid collection device can include and / or define a reservoir or device. For example, the reservoir or device can be a reservoir or device that includes and / or defines a negative pressure, such as a disposable collection tube(s), a vacuum-based collection tube(s), a syringe(s), a blood culture bottle(s), and / or the like. In some embodiments, the fluid collection device can be fluidly connected to the second outlet 337 via the second outlet conduit 347 after the actuator 350 and / or device 300 are in the second state (e.g., after an initial volume of bodily fluid has been sequestered in the isolation portion 334). Thus, the negative pressure defined by the fluid collection device can be operable to draw a sample volume of bodily fluid from the patient, through the inlet device 310, through the housing 330 and the actuator 350, and into the fluid collection device. Furthermore, with the initial volume of bodily fluid sequestered within the first outlet conduit 338 (e.g., the isolation portion 334), the sample volume of bodily fluid can be substantially free of contaminants, and / or the like. Although the fluid collection device is described as being fluidly connected to the second outlet conduit 347 after the actuator 350 is in its second state, in other embodiments, the fluid collection device can be fluidly connected to the second outlet conduit 347 before the actuator 350 is placed in its second state.In yet other embodiments, the negative pressure associated with the fluid collection device can be operable to draw a first or initial portion of the bodily fluid into the lumen 339 of the first outlet tube 338 (e.g., the isolation portion 334) without drawing the bodily fluid into the fluid collection device before the actuator 350 and / or the device 300 are placed in the second state.

[0103] In some embodiments, one or more components, including the diversion section, actuator, outlet conduit, and / or isolation and / or diversion section, can be incorporated into the inlet device, or vice versa. For example, FIGS. 8-11 illustrate a fluid control device 400 (also referred to herein as a "control device" or "device") according to an embodiment. As described above with reference to control devices 100, 200, and / or 300, control device 400 is configured to withdraw and isolate a first portion or amount (e.g., an initial amount) of bodily fluid from a patient, such that the subsequently withdrawn amount, portion, and / or volume of bodily fluid is substantially free of contaminants. In some embodiments, portions and / or aspects of control device 400 are similar to corresponding portions and / or components of control devices 100, 200, and / or 300 described above with reference to FIGS. 1, 2-4, and 5-7, respectively. are substantially similar in aspect and / or function, and therefore, such similar parts and / or aspects will not be described in further detail herein.

[0104] 8 and 9, the control device 400 includes an inlet device 410, as described in further detail below, and a housing 430 that is at least partially incorporated into the inlet device 410. Generally, the inlet device 410 can be any suitable device or set of devices configured to establish fluid communication between a source of bodily fluid, such as a patient's vasculature, and one or more fluid collection devices, such as a fluid collection device, a syringe, a vacuum container, and / or the like (as described in detail above).

[0105] As shown in FIGS. 8-11 , the arrangement of control device 400 is such that housing 430 is incorporated into and / or forms a part of inlet device 410. Inlet device 410 can be any suitable device(s), such as, for example, an IV catheter, a sharp catheter, or a sharp needle, and / or any other suitable lumen-containing device. For example, in the embodiment shown in FIGS. 8-11 , inlet device 410 is a butterfly needle or other suitable access device having needle 414, housing 430, and outlet or outlet tubing 447. Thus, needle 414 of inlet device 410 is in fluid communication with one or more fluid flow paths defined by housing 430, which in turn are in fluid communication with outlet or outlet tubing 447. Thus, needle 414 can receive a flow of bodily fluid that can be selectively transferred through housing 430 to outlet or outlet tubing 447, as described in further detail herein.

[0106] Housing 430 can be any suitable device or set of devices configured to (1) receive a flow of bodily fluid (e.g., from needle 414), (2) store and isolate a first or initial volume of bodily fluid, and (3) direct or divert a subsequent flow of bodily fluid to a fluid collection device, as described in further detail herein. Housing 430 includes and / or defines a set of isolation and / or diversion portions 434, a set of fluid flow paths 433, 464, and 468, and an outlet or outlet tube 447. In the embodiment shown in FIGS. 8-11 , the set of isolation and / or diversion portions 434 includes two isolation and / or diversion portions 434 (also referred to herein as “isolation portions 434”). In other embodiments, the set of isolation portions 434 can include any suitable number of isolation and / or diversion portions (e.g., less than two or more than two). As described in more detail herein, each isolation portion 434 can include and / or be configured to function at least in part as an actuator 450 that can be manipulated by a user to urge, encourage, and / or draw bodily fluids into or toward the corresponding isolation portion 434.

[0107] As shown in FIGS. 8-11, the control device 400 can be configured as and / or similar to a butterfly needle. The set of isolation portions 434 of the housing 430 can be housed within and / or form the "wings" of the butterfly needle. In other words, the inlet device 410 can be modified to include the housing 430 as its main body portion (e.g., similar to the main body 311 of the inlet device 310), and thus the isolation portions 434 can form what would otherwise be the wings (butterfly needle) of the inlet device 410. In some embodiments, one or more portions of the housing 430 can be formed of a relatively rigid material, such as plastic, and can be configured to retain their shape and / or form when exposed to changes in pressure and / or inlet or outlet flow of fluid. Conversely, other portions of the housing 430 (e.g., the isolation portions 434 or the wing portions) can be formed of a relatively flexible material (e.g., molded rubber, flexible plastic, etc.) and can be configured to elastically deform in response to compressive forces. Thus, a portion (e.g., isolation portion 434) can be configured to change shape and / or formation in response to an applied force, which in turn results in a change in volume of isolation portion 434. As described in further detail herein, the change in volume within the isolation and / or diverting portion can result in a pressure differential that can be operable to draw bodily fluid into isolation portion 434. Note that while isolation portion 434 is shown in FIGS. 8-11 as forming wings of inlet device 410, in other embodiments, isolation and / or diverting portion(s) 434 can be external to inlet device 410, such that tubing or fluid connections (not shown) can be used to connect one or more outlets of housing 430 to external isolation and / or diverting portion(s) 434.

[0108] As shown in FIG. 10 , fluid flow path 433 extends through housing 430 to fluidly couple to the lumen of needle 414 and the lumen of outlet or outlet tube 447. Fluid flow path 433 thus establishes fluid communication between needle 414 and outlet or outlet tube 447. Additionally, housing 430 includes fluid flow path 464 branching from fluid flow path 433, as well as fluid flow path 468 in fluid communication with fluid flow path 464 and isolated portion 434. For example, in some embodiments, fluid flow paths 464 and 468 can form T- or Y-shaped flow paths extending from fluid flow path 433 (e.g., a central flow path) and terminating at isolated portion 434, as shown in FIGS. 10 and 11 . Thus, housing 430 can receive an initial flow of bodily fluid from needle 414, for example, and selectively allow fluid to flow through at least a portion of fluid flow paths 433, 464, and / or 468 to isolated portion 434, as described in further detail herein. Although not shown in FIGS. 8-11 , housing 430 may include one or more actuators, valves, and / or flow controllers (other than actuator 450 shown in FIGS. 8-11 ) that can selectively allow or block fluid flow, for example, from fluid flow path 433 to fluid flow path 464, thereby isolating and / or isolating isolation portion 434. As described above with reference to actuators 150, 250, and / or 350, the actuator(s) associated with housing 430 and / or device 400 may be switches, valves, ports, and / or the like that can directly or indirectly manipulate and / or control the flow of fluid through housing 430.

[0109] In some embodiments, housing 430 can be configured to divert, direct, and / or otherwise facilitate fluid flow based on forces (e.g., passive or active forces) applied to and / or experienced by portions of housing 430. For example, in some embodiments, housing 430 can be configured to divert, direct, and / or otherwise facilitate fluid flow based on one or more pressure differentials generated by any suitable method. Specifically, as described above, isolation portion 434 and / or portions thereof can form and / or include actuator(s) 450 (also referred to herein as “actuator portion(s)”). Actuator portion 450 of each isolation portion 434 can be configured to deform in response to an external force (e.g., applied by a user), which can in turn result in compression of isolation portion 434. Compression can be performed manually by a user performing a pinching or pushing action with actuator portion 450 of isolation portion 434 before contacting needle 414 with a source of bodily fluid (e.g., by puncturing a patient's vasculature to draw blood).

[0110] In some embodiments, compression of isolation portion 434 can result in venting of isolation portion 434 and expulsion of air and / or other contents disposed within isolation portion 434. In some embodiments, venting can occur by venting one of needle 414 or exit tube 447. At least one of the vents may be configured to allow air or gas to vent from the isolated portion 434. In other embodiments, the housing 430 may include at least one vent, opening, port, valve, or the like configured to allow air or gas to vent from the isolated portion 434. In such embodiments, the vent(s) or the like may be configured to allow unidirectional flow of air and / or gas from the isolated portion 434 while restricting and / or preventing the flow of air or gas into the isolated portion 434. Additionally, such a vent or the like may permit air or gas to vent from the isolated portion 434 while restricting and / or preventing the flow of fluid (e.g., liquid) from or to the isolated portion 434. In still other embodiments, the isolated portion 434 may be evacuated, vented, and / or filled in any suitable manner, including, for example, by exposure to an external negative pressure source.

[0111] In some embodiments, venting of isolation portion 434 can be before or after placing needle 414 in fluid communication with a bodily fluid source. Following venting, control device 400 can be in a charged and / or primed state when needle 414 is inserted into a portion of a patient (i.e., placed in communication with a source of bodily fluid). In this state, the force applied to actuator portion 450 can be maintained, and isolation portion 434 can be in a deformed, compressed, folded, and / or vented configuration (as described above). Once needle 414 is in fluid communication with a bodily fluid source, the force can be removed from actuator portion 450 (e.g., a user can release the pinched, squeezed, and / or otherwise applied compressive force to actuator portion 450). In response, isolation portion 434 can return to an undeformed, uncompressed, and / or unfolded configuration, which in turn results in an increase in volume within isolation portion 434 (e.g., placing device 400 and / or housing 430 in a first state). The increase in volume within isolation portion 434 creates a negative pressure within isolation portion 434 that can draw, urge, and / or promote the flow of bodily fluid preferentially and / or through a portion of fluid flow path 433, via fluid flow paths 464 and 468, and into isolation portion 434. Thus, isolation portion 434 can receive an initial or first volume of bodily fluid drawn from a bodily fluid source (e.g., a patient).

[0112] 8-11 , device 400 may also include one or more actuators, membranes, valves, ports, etc. (other than actuator 450) disposed within or along fluid flow paths 433, 464, and / or 468 to actively or passively allow or block flow in particular directions (as described in detail above). In some embodiments, at least a portion of housing 430 and / or isolation portion 434 may have and / or include a shape, material, configuration, and / or device configured to promote the flow of bodily fluid toward isolation portion 434. For example, in some embodiments, isolation portion 434 and / or portions thereof may include and / or be formed of an absorbent material, a hydrophilic material, a wicking material, a textured or pitted surface, and / or any other suitable means for absorbing, attracting, and / or retaining bodily fluid, as described in detail above with reference to device 100. Additionally, in some embodiments, the size, shape, and / or configuration of fluid flow paths 433, 464, and 468 and / or portions thereof can be configured to control, modulate, regulate, restrict, direct, etc., the flow of fluid and / or the negative pressure applied therethrough. For example, in some embodiments, the size and / or diameter of fluid flow paths 464 and 468 can be smaller than the size and / or diameter of fluid flow path 433, which can in turn reduce, restrict, and / or regulate the amount of negative pressure (generated within isolation portion 434) applied to, within, and / or through fluid flow path 433.

[0113] In some embodiments, the flow of bodily fluid into isolation portion 434 can be terminated gradually or abruptly by any suitable active or passive mechanism. For example, flow into isolation portion 434 can be terminated in response to a desired initial volume of bodily fluid being disposed in isolation portion 434. In some embodiments, for example, the flow of bodily fluid into isolation portion 434 can be stopped in response to equalization of a pressure differential that would otherwise have been sufficient to draw the initial volume into isolation portion 434. In some embodiments, the flow of bodily fluid into isolation portion 434 can be stopped when the negative pressure is insufficient to draw the bodily fluid, for example, into fluid flow paths 464 and / or 468. For example, as described above, the size, shape, diameter, and / or configuration of any of fluid flow paths 433, 464, and / or 468 can be selected, designed, matched, and / or otherwise modified to regulate the fluid flow and / or negative pressure therein. Thus, in some embodiments, the cross-sectional area of fluid flow path 464 can be smaller than the cross-sectional area of fluid flow path 433. Thus, in some embodiments, the flow of bodily fluid into isolation portion 434 can be stopped when the negative pressure is insufficient to draw bodily fluid through fluid flow path 464 (e.g., whether or not there is substantial pressure equalization). In other embodiments, fluid flow paths 433, 464, and / or 468, and / or any suitable portion thereof, can include absorbent materials, semipermeable membranes, valves, and / or the like configured to transition to a sealing or closed configuration in response to an initial volumetric flow therethrough. In some embodiments, the valves, membranes, materials, and / or seals, etc., can be time-based (as described above) or the like. In some embodiments, the flow of bodily fluid into isolation portion 434 can be stopped when isolation portion 434 is completely filled. For example, in some embodiments, isolation portion 434 and / or at least a portion thereof can be at least partially transparent, allowing a user to visually determine when isolation portion 434 is completely filled.In other embodiments, isolation portion 434 and / or any suitable portion of device 400 may provide an indication (e.g., a visual indication, an audible indication, a tactile indication, etc.) when the desired initial volume is positioned in isolation portion 434.

[0114] With the initial volume of bodily fluid disposed in the isolated portion 434, the device 400 can be transitioned from the first state to the second state to allow the bodily fluid to flow from the needle 414, through at least a portion of the fluid flow path 433, and to the outlet or outlet tube 447. While not shown in FIGS. 8-11 , the outlet and / or outlet tube 447 can be connected to a fluid collection device as described herein (e.g., a syringe, a vacuum-based collection tube or container, a sample bottle, a culture bottle, etc.). Furthermore, when the device 400 is placed in the second state, the initial volume of bodily fluid, which may contain contaminants, and / or the like, is isolated in the isolated portion 434. For example, in some embodiments, equalization of a negative pressure otherwise operable to draw bodily fluid into the isolated portion 434 can cause a subsequent volume of bodily fluid to flow through the fluid flow path 433 without entering the fluid flow path 464. In other embodiments, the isolated portion 434 and / or the initial volume of bodily fluid contained therein can be isolated in any suitable manner, as described above. Thus, with the initial volume of bodily fluid sequestered in the sequestering portion 434 being substantially free of contaminants, a subsequent volume of bodily fluid can be drawn from the patient into a collection device (eg, a fluid collection device).

[0115] 8-11, in some embodiments, device 400 may include an actuator, valve, switch, and / or any other suitable flow controller or mechanism configured to transition device 400 from a first state to a second state. For example, in some embodiments, device 400 may include a valve or flow controller having one or more fluid flow paths. In such embodiments, the valve and / or flow controller may be actuated in response to a user engaging an actuator, such as a dial, switch, button, rotor, slider, and / or the like. In embodiments in which device 400 is configured as a butterfly needle and / or the like, a user can configure a valve and / or flow controller to be shifted by shifting, moving, rotating, and / or otherwise engaging at least one of the wings of the butterfly needle. For example, in some embodiments, at least one of the wings of the butterfly needle (e.g., including isolation portion 434 formed thereby) can be rotated about housing 430, which can in turn rotate a valve or other flow controller configured to control the flow of bodily fluid from needle 414 to either fluid flow path 464 (and isolation portion 434) or fluid flow path 433 (and outlet conduit 447). In other embodiments, a valve or flow controller or the like can be actuated and / or shifted in any other suitable manner, as described herein.

[0116] Although control device 400 is described above as being evacuated and / or vented in response to a force (e.g., a compressive force) applied to isolation portion 434, in other embodiments, the isolation portion can be pre-filled and / or vented or evacuated in any suitable manner. For example, FIGS. 12-15 illustrate a fluid control device 500 (also referred to herein as a "control device" or "device") according to an embodiment. As described above with reference to control devices 100, 200, 300, and / or 400, control device 500 is configured to withdraw and isolate a first portion or amount (e.g., an initial amount) of bodily fluid from a patient such that the subsequently withdrawn amount, portion, and / or volume of bodily fluid is substantially free of contaminants. In some embodiments, portions and / or aspects of control device 500 are substantially similar in form and / or function to corresponding portions and / or aspects of control devices 100, 200, 300, and / or 400 described above. Accordingly, such similar portions and / or aspects will not be described in further detail herein.

[0117] As shown in FIGS. 12-15 , control device 500 includes housing 530 and actuator 550. Housing 530 can be any suitable device or set of devices configured to (1) receive a flow of bodily fluid, (2) store and isolate a first or initial volume of bodily fluid (or receive a device or container configured to store and isolate a first volume), and (3) direct or divert a subsequent flow of bodily fluid to a fluid collection device, as described in further detail herein. Housing 530 can be any suitable shape, size, and / or configuration. For example, in some embodiments, housing 530 can be similar to any of the housings described herein.

[0118] Housing 530 includes an inlet 532 and an outlet 536. Inlet 532 of housing 530 can be physically and fluidly coupled (directly or indirectly) to any suitable device configured to fluidly connect inlet 532 with a bodily fluid source. For example, in some embodiments, inlet 532 can be coupled to an inlet device (e.g., similar to those described herein), a needle, flexible tubing, and / or any other lumen-containing device. Outlet 536 is configured to be in fluid communication with and / or be placed in fluid communication with a fluid collection device (not shown in FIGS. 12-15 ), such as a fluid collection device, syringe, culture bottle, and / or the like. The fluid collection device can be similar to any of the fluid collection devices described above with reference to control device 100.

[0119] The housing 530 defines an interior volume 531 that is configured to define and / or form one or more fluid flow paths 533. As described in further detail herein, in some embodiments, the device 500 includes a fluid flow path 533 that is connected to an inlet 532 and an outlet 533. 36. Additionally, the interior volume 531 of the housing 530 is configured to receive at least a portion of the actuator 550 and at least a portion of an isolation and / or diversion portion or device 534 (referred to herein as an "isolation device" 534). For example, as shown in FIG. 13, the housing 530 can have and / or define an open end portion configured to allow access to the interior volume 531 of the housing 530.

[0120] Although isolation portions 134, 234, 334, and / or 434 are described herein as being formed by a portion of housing 130, 230, 330, and / or 430, respectively, in the embodiments shown in Figures 12-15, isolation device 534 can be formed independently of housing 530 and configured to be inserted into interior volume 531 through one of the ends of housing 530. Additionally, devices 100, 200, 300, and / or 400 are described above in the embodiments shown in Figures 12-15 as including and / or implementing various methods for venting and / or evacuating isolation portions 134, 234, 334, and / or 434, respectively, to reduce pressure therein, and isolation device 534 can be a pre-filled or evacuated container, such as a Vacutainer® or other negative pressure vessel configured to receive a fluid.

[0121] In some embodiments, the isolation device 534 can be pre-filled or pre-evacuated before being inserted into the housing 530. For example, in some instances, the isolation device 534 can be pre-filled and / or evacuated during manufacturing. Furthermore, in some embodiments, the control device 500 can be compatible with any suitable isolation device 534, such as, for example, known vacuum containers (e.g., Vacutainers® and / or the like), custom vacuum containers, and / or any other suitable device. As described in further detail herein, reduced or negative pressure within the pre-filled isolation device 534 can be operable to draw an initial volume of bodily fluid through at least a portion of the control device 500 and into the isolation device 534. Thus, the isolation device 534 can be similar, at least in function, to the isolation portions 134, 234, 334, and / or 434 described herein.

[0122] As described above, actuator 550 is configured to be at least partially disposed within interior volume 531 of housing 530. For example, in some embodiments, at least a portion of actuator 550 can be inserted into interior volume 531 through one of the ends of housing 530 (e.g., the end opposite isolation device 534). Actuator 550 can be any suitable member, device, mechanism, etc. configured to transition between at least two different operating states so as to selectively control fluid flow through housing 530. For example, as described above with respect to actuators 150, 250, 350, and / or 450, actuator 550 can be a switch, valve, port, membrane, movable channel, clamp, plunger, movable member, and / or the like configured to manipulate (directly or indirectly) the flow of fluid through housing 530.

[0123] 12-15, the actuator 550 is a movable member or plunger that defines a fluid flow path 554 configured to be at least temporarily placed in fluid communication with the inlet 532. Additionally, the actuator 550 has or includes a set of seals 552 and an outlet member 555. For example, as shown in FIG. 13, the actuator 550 may include a set of seals 552 disposed around an outer surface or portion of the actuator 550. , which defines at least a portion of the interior volume 531 and which is configured to contact the interior surface of the housing 530. More specifically, each seal 552 can be positioned at a desired and / or predetermined location along the actuator 550 and can be in contact with at least a portion of the exterior surface of the actuator 550 and at least a portion of the interior surface of the housing 530 such that each seal 552 forms a substantially fluid-tight seal therebetween.

[0124] 13 , the exit member 555 is included in and / or coupled to the actuator 550 and is in fluid communication with the fluid flow path 554. More specifically, the exit member 555 can define a lumen (not shown) that is in fluid communication with the fluid flow path 554. For example, in some embodiments, the exit member 555 can be a needle or sheathed needle, a coupler, an engagement member, and / or any other suitable lumen-defining or housing member. As described in further detail herein, the exit member 555 is configured to engage and / or otherwise establish fluid communication with the isolation device 534 when the isolation device 534 is inserted into the interior volume 531 of the housing 530, such that the lumen defined by the exit member 555 establishes fluid communication between the fluid flow path 554 of the actuator 550 and the isolation device 534.

[0125] As described above with reference to actuators 150, 250, 350, and / or 450, actuator 550 is configured to selectively control, direct, divert, and / or enable fluid flow through at least a portion of device 500 to transition between two or more states and / or configurations. For example, in some embodiments, actuator 550 can have a first state and / or configuration in which a first portion of interior volume 531 of housing 530 fluidly connects inlet 532 with fluid flow path 554 of actuator 550 (see, e.g., FIGS. 13 and 14). Furthermore, actuator 550 can have and / or be arranged in a second portion and / or configuration in which (1) fluid flow path 554 of actuator is isolated from inlet 532, and (2) a second portion of interior volume 531 (e.g., fluid flow path 533) connects inlet 532 with outlet 536 (see, e.g., FIG. 15), as described in further detail herein.

[0126] In some embodiments, the device 500 can be in a first state and / or configuration prior to use (e.g., during shipping, storage, and / or before the device 500 is placed in fluid communication with a source of bodily fluid, such as a patient). For example, in some embodiments, as shown in FIG. 13 , the actuator 550 can be positioned in its first state and / or configuration such that the inlet 532 is in fluid communication with a fluid flow path 554 defined by the actuator 550. Furthermore, in some implementations, the isolation device 534 can be outside the housing 530 when the device 500 is in the first state or configuration, or can be inserted into the housing 530 such that fluid communication is not yet established between the isolation device 534 and the exit member 555. (See, e.g., FIG. 13 ). In some embodiments, the isolation device 534 can be in a sealed or closed state prior to being engaged by the exit member 555 or being engaged therewith (e.g., when the device 500 is in the first state and / or configuration). As described in detail above, isolation device 534 can be a vacuum container and / or any other suitable container, vessel, and / or reservoir having a reduced or negative pressure. In this manner, when device 500 is in a first state and / or configuration, the interior volume of isolation device 534 (which defines and / or has an interior volume at a reduced or negative pressure) is isolated and / or fluidly isolated from device 500.

[0127] The actuator 550 also controls the first state of the device 500 when the device 500 is in the first state. 13, the actuator 550 can be in a position such that a first seal 552 is disposed on a first side of the inlet 532 and a second seal 552 (e.g., an adjacent seal) is disposed on a second side within the inlet 532. Similarly, the actuator 550 can be disposed such that the first seal 552 is disposed on a first side of a portion of the actuator 550 and the second seal 552 is disposed on a second side of the portion of the actuator 550 such that a fluid flow path 554 can extend through the portion of the actuator 550. In other words, the portion of the actuator 550 through which the fluid flow path 554 extends is disposed between the first seal 552 and the second seal 552. Thus, when the actuator 550 is in a first state and / or configuration, the portion of the internal volume 531 defined between the first seal 552 and the second seal 552 fluidly connects the inlet 532 to a fluid flow path 554 defined by the actuator 550, as shown in FIG. 13 .

[0128] In some embodiments, device 500 can be placed in fluid communication with a bodily fluid source when device 500 is in the first state and / or configuration. For example, in some embodiments, inlet 532 can be placed in fluid communication with an inlet device (e.g., such as those described herein), a needle, a lumen-containing device, and / or any other suitable device. For example, in some instances, inlet 532 can be coupled to a flexible tube or the like, which is in turn fluidly coupled to an inlet device (not shown), such as a butterfly needle. In some embodiments, the inlet device can be in fluid communication with the bodily fluid source (e.g., can be at least partially inserted into a patient and / or otherwise in fluid communication with a bodily fluid source outside the patient's body). Thus, as described in detail above, inlet 532 can be placed in fluid communication with a bodily fluid source. Further, when the actuator 550 is in a first state, position, and / or configuration, the portion of the interior volume 531 of the housing 530 defined between the first seal 552 and the second seal 552 fluidly connects the inlet 532 to the fluid flow path 554 and the outlet member 555 of the actuator 550.

[0129] In some embodiments, device 500 can be placed in and / or transitioned to a second state or configuration when inlet 532 is placed in fluid communication with a source of bodily fluid. For example, as shown in FIG. 14 , device 500 can be in the second state and / or configuration when isolation device 534 engages and / or is engaged by outlet member 555 of actuator 550. More specifically, in some examples, a user can advance, push, move, and / or otherwise insert isolation device 534 into housing 530 such that outlet member 555 engages, penetrates, punctures, ruptures, and / or otherwise opens a surface or port of isolation device 534, thereby placing device 500 in the second state and / or configuration. When the isolation device 534 engages the exit member 555 (e.g., when the exit member 555 penetrates or pierces a port or frangible surface of the isolation device 534), the lumen of the exit member 555 is placed in fluid communication with the interior volume of the isolation device 534. Thus, reduced or negative pressure within the isolation device 534 creates or otherwise results in a suction force acting through the lumen of the exit member 555.

[0130] 14 , when the isolation device 534 is moved relative to the housing 530 (e.g., when the device 500 is placed in a second state and / or configuration), the actuator 550 can remain in its first state, position, and / or configuration. As described in detail above with reference to devices 100, 200, 300, and / or 400, a negative pressure differential or suction force created by establishing fluid communication between the isolation device 534 and the exit member 555 flows through the inlet 532 of the device 500 and through a portion of the interior volume 531 defined between the first seal 552 and the second seal 552. The actuator 550 can be operable to draw bodily fluid from a bodily fluid source (e.g., a patient) into the isolation device 534 through the fluid flow path 554 and the outlet member 555 of the actuator 550. Thus, the isolation device 534 can receive an initial volume of bodily fluid from the bodily fluid source (e.g., a patient). Thus, using a pre-filled isolation device 534 can be substantially similar, at least in function, to venting and / or evacuating the isolation devices (or portions) 134, 234, 334, and / or 434 described above. Furthermore, in some embodiments, such an arrangement can enable the use of multiple isolation devices 534 by replacing a complete isolation device 534 with a new, sealed and evacuated isolation device 534 (e.g., a new Vacutainer® or the like).

[0131] Once the initial volume of bodily fluid has been transferred to the isolation device 534, the device 500 can be placed and / or transitioned to a third state or configuration. For example, in some embodiments, the actuator 550 can be switched or transitioned from a first state, position, and / or configuration (FIGS. 13 and 14) to a second state, position, and / or configuration (FIG. 15) to place the device 500 in a third state and / or configuration. In the embodiment shown in FIGS. 12-15, the actuator 550 can be switched and / or transitioned in response to a force applied by a user to a portion of the actuator 550, which moves the actuator 550 relative to the housing 530. In some embodiments, the actuator 550 can be moved relative to the housing 530 in a direction substantially opposite the direction the isolation device 534 was inserted into the housing 530. In other embodiments, the actuator 550 can be switched, transitioned, moved, and / or reconfigured in any suitable manner, such as any of those described herein.

[0132] 15 , when in the second state, position, and / or configuration, the actuator 550 can allow fluid communication to be established between the inlet 532 and the outlet 536. Furthermore, the actuator 550 can be configured to isolate the fluid flow path 554 from the inlet 532 and the outlet 536 of the housing 530, which in turn isolates the initial volume of bodily fluid from the inlet 532 and the outlet 536. In some embodiments, the initial volume of bodily fluid can include contaminants and / or undesirable substances that are similarly isolated within the isolation device 534 and / or from the inlet 532 and the outlet 536. In some implementations, the isolation device 534 can be removed from the housing 530 when the actuator 550 is transitioned to the second state, position, and / or configuration. In other implementations, the isolation device 534 can be removed from the housing 530 after receiving the initial volume, but before the actuator 550 is transitioned to the second state, position, and / or configuration. In still other implementations, the isolation device 534 need not be removed from the housing 530 (e.g., it can remain engaged with the outlet member 555). In such implementations, isolating the fluid flow path 554 from the inlet 532 and the outlet 536 in turn isolates the isolation device 534, and / or the initial volume disposed therein, from at least the inlet 532 and the outlet 536.

[0133] As described in detail above with reference to devices 100, 200, 300, and / or 400, when actuator 550 is in the second configuration and / or position, for example, a portion of interior volume 531 defined between second seal 552 and third seal 552 defines a fluid flow path 533 that fluidly connects inlet 532 with outlet 536, as shown in FIG. 15 . Thus, a subsequent volume of bodily fluid drawn from the patient, substantially free of contaminants, can be transported from inlet 532 through the portion of interior volume 531 (e.g., fluid flow path 533) and outlet 536 to one or more fluid collection devices coupled to outlet 536. In some embodiments, the fluid collection device(s) may be a reservoir, a syringe, a cap, a syringe ... The device 500 can be any suitable device, such as a container, and / or any of the fluid collection devices described herein. Accordingly, the device 500 can be configured to obtain one or more volumes of bodily fluids (e.g., used for bodily fluid sampling or the like) that are substantially free of contaminants.

[0134] While device 500, and more specifically actuator 550, are described above as transitioning, switching, moving, and / or reconfiguring in response to a force applied by a user to portions of actuator 550, in other embodiments, the actuator can transition between states in any suitable manner and / or in response to any suitable force. For example, FIGS. 16-19 illustrate a fluid control device 600 (also referred to herein as a "control device" or "device") according to an embodiment. As described above with reference to control devices 100, 200, 300, 400, and / or 500, control device 600 is configured to withdraw and isolate a first portion or amount (e.g., an initial amount) of bodily fluid from a patient such that the subsequently withdrawn amount, portion, and / or volume of bodily fluid is substantially free of contaminants. In some embodiments, portions and / or aspects of control device 600 are substantially similar in form and / or function to corresponding portions and / or aspects of at least control device 500 described above with reference to FIGS. 12-15. Accordingly, such similar portions and / or aspects will not be described in further detail herein.

[0135] As shown in FIGS. 16-19 , control device 600 includes housing 630 and actuator 650. Housing 630 can be any suitable device or set of devices configured to (1) receive a flow of bodily fluid, (2) store and isolate a first or initial volume of bodily fluid (or receive a device or container configured to store and isolate a first volume), and (3) direct or divert a subsequent flow of bodily fluid to a fluid collection device, as described in further detail herein. Housing 630 can be any suitable shape, size, and / or configuration. For example, in some embodiments, housing 630 can be substantially similar to housing 530 described above with reference to FIGS. 12-15 .

[0136] Housing 630 includes inlet 632 and outlet 636 and defines an interior volume 631. As described above with respect to inlet 532, inlet 632 of housing 630 can be physically and fluidly coupled (directly or indirectly) to any suitable device configured to fluidly connect inlet 632 with a bodily fluid source. As described above with reference to device 600, outlet 636 is configured to be in fluid communication with and / or to be placed in fluid communication with a fluid collection device (not shown in FIGS. 16-19 ), such as a fluid collection device, syringe, culture bottle, and / or the like. Interior volume 631 of housing 630 is configured to define and / or form one or more fluid flow paths 633. As described above with reference to device 500, device 600 can be controlled, operated, and / or implemented such that fluid flow paths 633 establish fluid communication with inlet 632 and outlet 636. The interior volume 631 of the housing 630 is configured to receive at least a portion of an isolation and / or diversion portion or device 634 (referred to herein as an "isolation device" 634). The isolation device 634 can be similar to or substantially equivalent to the isolation device 534 described above, and therefore, the isolation device 634 will not be described in further detail herein.

[0137] 17-19, the actuator 650 of the device 600 is configured to be at least partially disposed within the interior volume 631 of the housing 630. The actuator 650 may be configured to selectively control the flow of fluid through the housing 630. Actuator 650 may be any suitable member, device, mechanism, etc. configured to transition between at least two different operational states. For example, as described above with respect to actuator 550, actuator 650 may be a switch, valve, port, membrane, moveable channel, clamp, plunger, moveable member, and / or the like configured to manipulate (directly or indirectly) the flow of fluid through housing 630.

[0138] 16-19, actuator 650 is a movable member or plunger and defines a fluid flow path 654 configured to be disposed, at least temporarily, in fluid communication with inlet 632. Additionally, actuator 650 has or includes a set of seals 652 and an outlet member 655. For example, as shown in FIG. 17, actuator 650 may include three seals 652 disposed about an outer surface or portion of actuator 650, defining at least a portion of interior volume 631, and configured to contact an inner surface of housing 630. As described in detail above with reference to actuator 550, each seal 652 may be disposed at a desired and / or predetermined location along actuator 650 and may contact at least a portion of the outer surface of actuator 650 and at least a portion of the inner surface of housing 630 such that each seal 652 forms a substantially fluid-tight seal therebetween.

[0139] 17 , the exit member 655 is included in and / or coupled to the actuator 650 and is in fluid communication with the fluid flow path 654. More specifically, the exit member 655 can define a lumen (not shown) that is in fluid communication with the fluid flow path 654. For example, the exit member 655 can be a member defining or housing a needle or sheathed needle, a coupler, an engagement member, and / or any other suitable lumen. As described above with respect to the exit member 655, the exit member 655 is configured to engage and / or otherwise establish fluid communication with the isolation device 634 when the isolation device 634 is inserted into the interior volume 631 of the housing 630, such that the lumen defined by the exit member 655 establishes fluid communication between the fluid flow path 654 of the actuator 650 and the isolation device 634.

[0140] As described above with reference to actuator 550, actuator 650 is configured to selectively control, direct, divert, and / or enable fluid flow through at least a portion of device 600 to transition between two or more states and / or configurations. For example, in some embodiments, actuator 650 can have a first state and / or configuration in which a first portion of interior volume 631 of housing 630 fluidly connects inlet 632 with fluid flow path 654 of actuator 650 (see, e.g., FIGS. 17 and 18 ). Furthermore, actuator 650 can have and / or be arranged such that (1) fluid flow path 654 of actuator is isolated from inlet 632, and (2) a second portion of interior volume 631 (e.g., fluid flow path 633) connects inlet 632 with outlet 636 (see, e.g., FIG. 19 ). In some embodiments, some aspects and / or functions of actuator 650 can be similar to corresponding aspects and / or functions of actuator 550. Such aspects and / or functions will not be described in further detail herein and should be considered to be similar in at least form and / or function unless expressly stated otherwise.

[0141] In some embodiments, device 600 can be in a first state and / or configuration prior to use (e.g., during shipping, storage, and / or before device 600 is placed in fluid communication with a source of bodily fluid, such as a patient). For example, in some embodiments, as shown in FIG. 17 , actuator 650 is positioned in its first state and / or configuration such that inlet 632 is in fluid communication with a fluid flow path 654 defined by actuator 650. As described above with reference to device 500, isolation device 634 can be outside of housing 630 when device 600 is in the first state or configuration, or can be inserted into housing 630 such that fluid communication is not yet established between isolation device 634 and exit member 655 (see, e.g., FIG. 17 ). In this manner, when device 600 is in the first state and / or configuration, the interior volume of isolation device 634 (which may define an interior volume at reduced or negative pressure, and / or otherwise) is isolated and / or fluidly isolated from device 600.

[0142] Actuator 650 can also be in its first state and / or configuration when device 600 is in the first state such that inlet 632 and a portion of actuator 650 through which fluid flow path 654 extends are disposed between first seal 652 and second seal 652 (e.g., adjacent seals 652 (see, e.g., FIG. 17 )), respectively. Thus, as described in detail above with reference to device 500, when actuator 650 is in the first state and / or configuration, a portion of interior volume 631 defined between first seal 652 and second seal 652 fluidly connects inlet 632 to fluid flow path 654 defined by actuator 650. In some examples, device 600 can be disposed in fluid communication with a source of bodily fluid when device 600 is in the first state and / or configuration. For example, in some embodiments, inlet 632 can be disposed in fluid communication with an inlet device (e.g., such as those described herein), a needle, a lumen-containing device, and / or any other suitable device, as described above with respect to device 500. Accordingly, when actuator 650 is in a first state, position, and / or configuration, the portion of interior volume 631 of housing 630 defined between first seal 652 and second seal 652 places inlet 632 in fluid communication with fluid flow path 654 and outlet member 655 of actuator 650.

[0143] In some embodiments, device 600 can be placed in and / or transitioned to a second state or configuration when inlet 632 is placed in fluid communication with a source of bodily fluid. For example, as shown in FIG. 18 , device 600 can be in the second state and / or configuration when isolation device 634 engages and / or is engaged by outlet member 655 of actuator 650. More specifically, in some examples, a user can advance, push, move, and / or otherwise insert isolation device 634 into housing 630 such that outlet member 655 engages, penetrates, punctures, ruptures, and / or otherwise opens a surface or port of isolation device 634, thereby placing device 600 in the second state and / or configuration. When the isolation device 634 engages the exit member 655 (e.g., when the exit member 655 penetrates or pierces a port or frangible surface of the isolation device 634), the lumen of the exit member 655 is placed in fluid communication with the interior volume of the isolation device 634. Thus, reduced or negative pressure within the isolation device 634 creates or otherwise results in a suction force acting through the lumen of the exit member 655.

[0144] 18 , when isolation device 634 is moved relative to housing 630 (e.g., when device 600 is placed in a second state and / or configuration), actuator 650 can remain in its first state, position, and / or configuration. As described in detail above with reference to devices 100, 200, 300, 400, and / or 500, a negative pressure differential or suction force created by establishing fluid communication between isolation device 634 and exit member 655 can be operable to draw bodily fluid from a bodily fluid source (e.g., a patient) through inlet 632 of device 600, through the portion of interior volume 631 defined between first seal 652 and second seal 652, through fluid flow path 654 and exit member 655 of actuator 650, and into isolation device 634. Thus, isolation device 634 can be configured as described above with reference to isolation device 534. An initial volume of bodily fluid can be received from a bodily fluid source (eg, a patient) in a manner substantially similar to that described above.

[0145] Once the initial volume of bodily fluid has been transferred to the isolation device 634, the device 600 can be placed and / or transitioned to a third state or configuration. While the actuator 550 is described above as being moved, for example, in a direction opposite to the direction in which the isolation device 534 was inserted into the housing 530, in the embodiment shown in Figures 16-19, the actuator 650 can be configured to transition from its first state, position, and / or configuration in response to continued movement of the isolation device 634 relative to the housing 630 (e.g., in a second direction). In other words, in some embodiments, isolation device 634 can be moved a first distance in a predetermined direction relative to housing 630 to transition device 600 from a first state ( FIG. 17 ) to a second state ( FIG. 18 ), and can be moved a second distance in a predetermined direction relative to housing 630 to transition actuator 650 from its first state or position to a second state or position, which can then transition device 600 from the second state ( FIG. 18 ) to a third state ( FIG. 19 ). Thus, as described above with reference to actuator 650, when actuator 650 is in the second state, position, and / or configuration, as shown in FIG. 19 , actuator 650 can allow fluid communication to be established between inlet 632 and outlet 636. Furthermore, actuator 650 can be configured to isolate fluid flow path 654 from inlet 632 and outlet 636 of housing 630, which in turn isolates an initial volume of bodily fluid from inlet 632 and outlet 636. Additionally, in some embodiments, the initial volume of bodily fluid may include contaminants and / or undesirable materials that are also isolated within isolation device 634 and / or from inlet 632 and outlet 636 .

[0146] As described in detail above with reference to device 500, when actuator 650 is in the second configuration and / or position, for example, a portion of interior volume 631 defined between second seal 652 and third seal 652 defines a fluid flow path 633 that fluidly connects inlet 632 with outlet 636, as shown in FIG. 19 . Thus, a subsequent volume of bodily fluid drawn from the patient, substantially free of contaminants, can be transported from inlet 632 through the portion of interior volume 631 (e.g., fluid flow path 633) and outlet 636 to one or more fluid collection devices coupled to outlet 636. Thus, device 600 can be configured to obtain one or more volumes of bodily fluid (e.g., to be used for bodily fluid sampling or the like) that are substantially free of contaminants.

[0147] 20, a flowchart illustrating a method 10 of diverting an initial volume of bodily fluid to obtain a bodily fluid sample with reduced contamination using a fluid control device such as those described herein, according to an embodiment, is shown. The fluid control device (also referred to herein as a "control device") includes an inlet device and a housing, and may also include one or more actuators associated with the housing and / or the inlet device. In some embodiments, the control device can be similar and / or substantially equivalent to any of control devices 100, 200, 300, 400, 500, and / or 600 described herein.

[0148] The method 10 includes, at 11, establishing fluid communication between a bodily fluid source and a fluid control device. In some embodiments, for example, the bodily fluid source can be a fluid source within the patient's body. More specifically, in some embodiments, the bodily fluid source can be a vein and / or vasculature within the patient's body. As noted above, the inlet device can be any suitable device configured to establish fluid communication with a bodily fluid source, such as, for example, an intravenous catheter, a butterfly needle, and / or the like. In other embodiments, the inlet device The device can be any suitable coupler, port, etc. configured to fluidly couple to a bodily fluid source. Thus, in some embodiments, establishing fluid communication between the bodily fluid source and the control device can include placing the control device in fluid communication with the inlet device.

[0149] In some embodiments, the device can be in a storage and / or pre-use state and / or configuration prior to use. For example, in some embodiments, one or more actuators can be in a pre-use state and / or configuration. In some embodiments, such state and / or configuration can be such that at least a portion of the control device is isolated, thereby maintaining sterility of such portion. In some embodiments, prior to establishing contact with a source of bodily fluid, the control device can be vented using an appropriate procedure, as described herein. The venting procedure can include venting one or more isolation and / or diversion portions associated with the device, i.e., one or more isolation and / or diversion portions defined by the housing and / or inlet device. The control device can be disposed in a venting configuration to perform the venting procedure. In some embodiments, one or more actuators can be in a pre-use state and / or configuration and / or disposed in a venting state and / or configuration that enables venting and / or isolation and / or diversion portions of the device. In such embodiments, once sufficiently vented, the one or more actuators can be transitioned from the venting configuration to a first position, and / or the like. In some embodiments, the one or more actuators can be transitioned before, during, and / or after establishing contact between the bodily fluid source and the inlet device. In some embodiments, venting and / or filling of the isolation and / or diversion section(s) can be the result of fluidly connecting the isolation and / or diversion section(s) with one or more external negative pressure sources. In some embodiments, for example, such an external negative pressure source can be a fluid collection device such as those described herein. In other embodiments, the external negative pressure source can be any suitable member, device, and / or source.

[0150] Upon establishing fluid communication with the bodily fluid source, at 12, an initial volume of bodily fluid is transferred from the bodily fluid source to one or more isolation and / or diversion portions when the device is in a first state (e.g., with or without the actuator in a first state or position). In some embodiments, the control device is in the first state and / or configuration prior to use. Thus, establishing fluid communication with the bodily fluid source automatically establishes fluid communication with the isolation and / or diversion portions. In other embodiments, transitioning the actuator from a pre-use and / or venting state or configuration to the first state and / or configuration can be operable to place the control device in the first state to allow the initial volume of bodily fluid to be transferred to one or more isolation and / or diversion portions. In some embodiments, the initial volume of bodily fluid can be transferred and / or drawn into the isolation and / or diversion portion(s) in response to a negative pressure differential. In some such embodiments, the negative pressure differential can result from fluidly connecting the isolation and / or diversion portions to a negative pressure source, such as a fluid collection device (as described above). Thus, the negative pressure can be operable to draw bodily fluid into the isolation and / or diversion portion without transferring the bodily fluid to the fluid collection device before the initial volume is transferred and isolated in the isolation and / or diversion portion.

[0151] As described in detail herein, the initial volume can be any suitable volume of bodily fluid. For example, in some embodiments, the initial volume can be as small as one drop of bodily fluid (or a relatively small number of drops of bodily fluid). In other embodiments, the initial volume can be, for example, up to about 30 mL, 40 mL, 50 mL, or more. Furthermore, as described in detail above with reference to certain embodiments, the initial volume can be any suitable volume of bodily fluid. The initial volume can be based at least in part on and / or related to the amount of bodily fluid that can be contained and / or sequestered in the bypass portion. In some embodiments, the initial volume can be a volume that is sufficient to entrain and / or contain substantially all of the undesirable microorganisms that can be removed, etc., when fluid communication between the bodily fluid source and the inlet device is established.

[0152] In 13, in response to an initial volume of bodily fluid being placed in the isolation and / or diversion portion, the device transitions (e.g., automatically, passively, or in response to actuation) from a first state to a second state so as to isolate the initial volume of bodily fluid in the isolation and / or diversion portion. In some embodiments, the device can be transitioned from a first state to a second state in response to one or more associated actuators transitioning from the first state and / or configuration to the second state and / or configuration. The transition of the one or more actuators from the first state and / or configuration to the second state and / or configuration can be in response to any suitable passive or active input, such as those described above with reference to actuators 150, 250, 350, 450, 550, and / or 650.

[0153] In some embodiments, an initial volume of bodily fluid can fill the isolation and / or diversion portion, preventing additional volumes of bodily fluid from entering and / or being contained and / or contained in the isolation and / or diversion portion. In such embodiments, a completely filled isolation and / or diversion portion can form a fluid lock or the like, for example, that prevents additional amounts of bodily fluid from entering the isolation and / or diversion portion and / or prevents bodily fluid from exiting the isolation and / or diversion portion. In some embodiments, the isolation and / or diversion portion can include a hydrophilic material or the like (e.g., as described above with respect to housing 130) that can absorb and / or retain (e.g., sequester) the bodily fluid contained in the isolation and / or diversion portion. In some embodiments, the isolation and / or diversion portion can retain and / or sequester the initial volume of bodily fluid in any suitable manner, as described herein. For example, in some embodiments, a fully filled or saturated isolation and / or diversion portion may automatically activate, transition, switch, and / or otherwise reconfigure the actuator (e.g., to transition the actuator from a first state to a second state), which then isolates the isolation and / or diversion portion. In other embodiments, active user intervention can transition the actuator from a first state to a second state, regardless of the extent of the volume of bodily fluid transferred to the isolation and / or diversion portion, so as to isolate the isolation and / or diversion portion. In still other embodiments, the transition of the actuator can be based on any other suitable input, device, mechanism, etc. For example, in some embodiments, the actuator can be time-dependent or pressure-dependent, for example.

[0154] Once the device transitions to a second state (e.g., actively or passively) and the actuator transitions to a second position (e.g., actively or passively), a subsequent volume of bodily fluid is transferred from the bodily fluid source to a fluid collection device (e.g., such as any of those described herein) in fluid communication with the device at 14. As described in detail above, the isolation of the initial volume of bodily fluid in the isolation and / or diversion portion similarly isolates any contaminants in the isolation and / or diversion portion. Thus, the subsequent amount of bodily fluid transferred to the fluid collection device is substantially free of contaminants.

[0155] 21, a flow chart illustrating a method 20 of diverting an initial volume of bodily fluid to obtain a bodily fluid sample with reduced contamination using a fluid control device such as those described herein, according to an embodiment. The fluid control device (also referred to herein as a "device") includes an inlet device and a housing, and may also include one or more actuators associated with the housing and / or the inlet device. In some embodiments, the control device may be similar to and / or substantially equivalent to, for example, control device 400 described above with reference to FIGS.

[0156] Method 20 includes, at 21, exerting a force that deforms an isolation portion of a fluid control device. For example, in some embodiments, the control device (e.g., control device 400) can be arranged as and / or similarly arranged as a butterfly needle with one or more isolation portions housed within and / or formed by the "wings" of a butterfly needle (see, e.g., FIGS. 8 and 9). In such embodiments, the isolation portion can be formed of a relatively flexible and / or movable material that is configured to deform in response to an external force (e.g., applied by a user), which can in turn result in compression of the isolation portion.

[0157] At 22, the isolation portion is vented as a result of the deformation. For example, in some embodiments, a compressive force can be applied to a portion of the isolation portion, which can expel air and / or other contents disposed within the isolation portion. In some embodiments, as described above with reference to control device 400, the venting can occur through at least one of an inlet member or an outlet member of the control device, or the control device can include at least one vent, opening, port, valve, etc. configured to allow air or gas to vent from the isolation portion.

[0158] At 23, fluid communication between the portal member of the control device and the bodily fluid source is established. Establishing fluid communication between the portal member and the bodily fluid source can occur before or after venting the isolation portion. In some embodiments, the portal member can be a needle configured to be inserted into a patient. In other embodiments, the portal member can be coupled to any suitable intervening device configured to establish fluid communication with a bodily fluid source.

[0159] At 24, the force on the isolation portion is removed such that a suction force is generated within the isolation portion. For example, in some embodiments, following venting of the isolation portion and establishing fluid communication between the portal member and the bodily fluid source, the control device can be in a primed and / or primed state in which the isolation portion can remain deformed, compressed, collapsed, and / or vented. Once fluid communication is established between the portal member and the bodily fluid source, the force can be removed from the isolation portion. For example, in some instances, a user can apply force by squeezing a portion of the isolation portion, and the force can be removed to allow the isolation portion to return to an undeformed, uncompressed, and / or uncollapsed configuration, which can then result in an increase in volume within the isolation portion.

[0160] As described in detail herein, in some embodiments, an increase in the volume inside the isolation portion can create a suction force (e.g., a reduced pressure or negative pressure condition) within the isolation portion. At 25, in response to the suction, an initial volume of bodily fluid is transferred from the bodily fluid source through the inlet member and into the isolation portion. Thus, the suction and / or negative pressure within the isolation portion can draw, urge, and / or facilitate the flow of bodily fluid into and / or through one or more fluid flow paths from the bodily fluid source to the isolation portion (as described in detail above).

[0161] At 26, as a result of the initial volume of bodily fluid being placed in the isolation portion, a subsequent volume of bodily fluid is transferred from the bodily fluid source through the inlet member to an outlet member in fluid communication with the inlet member. For example, in some embodiments, as described herein, the flow of bodily fluid into the isolation portion can be terminated gradually or abruptly by any suitable active or passive mechanism. In some embodiments, once the initial volume of bodily fluid is placed in the isolation portion, the bodily fluid is transferred to the inlet member. The control device can be transitioned from a first state to a second state to allow bodily fluid to flow from the inlet member to the outlet member. In some embodiments, when the control device is placed in the second state, an initial volume of bodily fluid, which may contain contaminants and / or the like, can be sequestered in the isolation portion. Thus, a subsequent volume of bodily fluid, substantially free of contaminants, can be drawn from the bodily fluid source, through the inlet member, and into the outlet member. Furthermore, as described in detail herein, the outlet member can be configured to couple to any suitable fluid collection device. Thus, method 20 can be used to divert an initial volume of bodily fluid to obtain a bodily fluid sample with reduced contamination.

[0162] While various embodiments have been described above, it should be understood that they have been presented by way of example only, and not by way of limitation. While the above-described schematic diagrams and / or embodiments show particular components disposed in particular orientations or locations, the arrangement of the components may be changed. While embodiments have been particularly shown and described, it will be understood that various changes in form and detail may be made.

[0163] For example, although inlet devices 110, 310, and / or 410 are described above as including or coupled to a needle or the like configured to pierce a patient's skin and place the needle lumen in fluid communication with the patient's vein, in other embodiments, the fluid control device can include any suitable inlet device. For example, in some embodiments, the inlet device can include a trocar or the like and a catheter. The trocar is configured to pierce a patient's skin and then be withdrawn from the patient, leaving the catheter of the inlet device positioned within the patient. In other embodiments, the inlet device need not pierce a patient's skin. For example, in some embodiments, the inlet device can include a needle or catheter that can be positioned in a dish, well, sample volume, container, reservoir, etc. In still other embodiments, the inlet device can be and / or include a coupler or port configured to couple to an indwelling needle or intravenous catheter. In other embodiments, such a coupler or port can be configured to couple to any suitable source of bodily fluid (or a port thereof), such as, for example, a syringe, reservoir, container, etc.

[0164] Thus, while embodiments are described above as withdrawing and isolating an initial volume of bodily fluid to isolate contaminants, such as microorganisms present in the dermis, in other embodiments, the inlet device can be coupled to any suitable bodily fluid source, and the device can be configured to isolate an initial volume of bodily fluid withdrawn from that bodily fluid source to isolate contaminants that may be present within the source and / or any interface of a container or reservoir containing the bodily fluid. For example, in some embodiments, the needle of the inlet device can be configured to pierce a port or surface of the reservoir to place the needle in fluid communication with the interior volume of the container or device. In such embodiments, the devices described herein can be used to isolate an initial volume of bodily fluid from the bodily fluid source, and then isolate contaminants or the like that may be present at the punctured interface, port, or surface. Thus, the devices and methods described herein can be used to obtain reduced-contamination bodily fluid samples from any suitable bodily fluid source. Additionally, although some such contaminants are described herein as being microorganisms present on the skin, it should be understood that the contaminant may be any contaminant, for example, that is external to the source of the bodily fluid and / or is otherwise foreign to the bodily fluid, or that is or includes any component (e.g., microorganism, virus, molecule, particle, element, etc.).

[0165] As another example, the control devices 100, 200, 300, 400, 500, and / or Although 600 has been described as transferring bodily fluid to the device via a particular passive or active mechanism or means for creating a negative pressure differential between two or more portions of the device, in other embodiments, the negative pressure differential can be created and / or otherwise result from any suitable means. By way of example, in some embodiments, the outlet of the control device can be coupled to a syringe, a pump, and / or the like. In other embodiments, the control device can include a pre-filled isolation chamber (e.g., similar to isolation devices 534 and / or 634), a vented isolation chamber, a manually actuated device configured to create negative pressure, an energy source, and / or any other suitable means for defining and / or creating a pressure differential within a portion of the control device.

[0166] Any fluid control device and / or method described herein uses an external negative pressure source (e.g., provided by the fluid collection device, and / or other suitable means) to (1) overcome physical patient challenges that may limit and / or prevent a pressure differential (e.g., the difference between blood pressure and ambient air pressure) sufficient to fully engage the isolation chamber and / or transition fluid flow to the fluid collection device, (2) ensure that the isolation chamber is properly filled with a clinically validated and / or desired volume of bodily fluid, (3) provide efficient, timely, and / or user-accepted consistency in the bodily fluid collection process, and / or (4) provide a means to manipulate and / or automatically transition fluid flow (e.g., by moving physical components of the system, or by changing, switching, engaging, and / or otherwise adopting or achieving desired fluid dynamics) to enable isolation and / or separation of an initial sample and collection of subsequent samples.

[0167] In some embodiments, a method of using a fluid control device using an external negative pressure source can include the ordered steps of establishing fluid communication between a bodily fluid source (e.g., a patient's vein or the like) and an inlet of the fluid control device. The outlet of the fluid control device is then placed in fluid communication with and / or otherwise engaged with the negative pressure source. Such a negative pressure source can be a sample reservoir, a syringe, a vacuum container, an intermediate transfer device, and / or the like. The fluid control device can be in a first state or mode of operation when the outlet is coupled to the negative pressure source such that a negative pressure differential is applied across at least a portion of the fluid control device, which can be operable to draw an initial volume of bodily fluid into an isolation chamber of the fluid control device. Once the initial volume of bodily fluid is placed in the isolation chamber, the fluid control device is transitioned, either automatically or through user intervention, from the first state or mode of operation to a second state or mode of operation such that (1) the initial volume is isolated in the isolation chamber and (2) fluid communication is established between the inlet and the outlet. The isolation of the initial volume can be such that contaminants entrained in the initial volume of flow are similarly isolated within the isolation chamber. With the initial volume of bodily fluid isolated within the isolation chamber, and fluid communication established between the inlet and outlet, a subsequent volume of substantially uncontaminated bodily fluid can be collected in one or more sample reservoirs.

[0168] In some embodiments, any of the fluid control devices described herein can be formed from any suitable components that can be manufactured, sterilized, and packaged as separate parts or components. In such embodiments, a user can, for example, open one or more packages containing one or more components, assemble the components to form the fluid control device, and use the fluid control device as described above. For example, in some embodiments, devices 500 and 600 can be manufactured, sterilized, and packaged separately from isolation devices 534 and 634, respectively. In other embodiments, any of the fluid control devices described herein can be formed from any suitable components that can be manufactured, sterilized, assembled, and packaged as an assembly or integrated device. For example, in some embodiments, devices 500 and 600 can be sterilized, assembled, and / or packaged with one or more isolation devices 534 and / or 634, respectively. In such embodiments, a user can, for example, open a package containing such an assembled or integrated device and use the device described above without further assembly of components. In some embodiments, any control device can be formed entirely or at least partially monolithically.

[0169] In some embodiments, any of the control devices can be physically and / or fluidly coupled to a collection device (e.g., a sample reservoir, syringe, blood culture bottle, collection vial, fluid transfer container, and / or any other suitable reservoir, collection device, and / or transfer device) by a user before or during use, as described in detail above. In other embodiments, any control device can be physically coupled, attached, formed, and / or otherwise joined to a fluid collection device during the manufacturing process. This can be done prior to sterilization, so that the collection path(s) and connection interface(s) (e.g., if the control device couples to a fluid collection device) maintain a closed system, mechanical flow diversion device within a sterile environment, immune to touchpoint contamination from external sources.

[0170] In some embodiments, pre-assembly of the control device and collection device can be such that a user is initially forced to segregate, isolate, and / or isolate at least a portion of an initial bodily fluid volume or flow before transferring a sample volume to the pre-assembled fluid collection device. For example, the control device can include an actuator configured to isolate an outlet from other portions of the control device, thereby isolating the collection device from such portions of the control device. Furthermore, after transferring the initial volume of bodily fluid, actuation of the actuator can result in isolation of the initial volume of bodily fluid and fluid coupling of the outlet to an additional portion (e.g., an inlet) of the control device. In some embodiments, pre-assembling the control device and collection device (e.g., during manufacturing) can enforce compliance with a sample acquisition protocol that, for example, requires isolation of an initial volume of bodily fluid before collecting a sample volume of bodily fluid.

[0171] In some embodiments, coupling, mating, and / or attachment (e.g., during manufacturing) of the fluid control device to the fluid collection device can be performed such that the control device can be removed after use (physically decoupled, removed with a specific "key," and / or other approaches used to separate the control device from the fluid collection device) to allow access to the fluid collection device. After decoupling, the collection device can be placed in an incubator and / or any other type of analytical machine, accessed for analysis, and / or otherwise further processed. In some embodiments, such decoupling can be blocked, restricted, and / or substantially prevented before use, and unblocked or enabled after use. In other embodiments, the fluid control device and fluid collection device can be (at least partially) permanently coupled and / or monolithically formed to prevent such decoupling.

[0172] Any of the embodiments described herein can be used in combination with any suitable fluid transfer, fluid collection, and / or fluid storage device, such as, for example, the fluid reservoir described in the '420 patent, the transfer device described in the '510 publication, and / or the transfer adapter described in U.S. Patent No. 10,123,783, entitled "Apparatus and Methods for Disinfection of a Specimen Container," filed March 3, 2015. In embodiments, any embodiment described herein may be implemented in conjunction with any of the techniques disclosed in, for example, U.S. Patent No. 8,535,241, entitled "Fluid Diversion Mechanism for Bodily-Fluid Sampling," filed October 12, 2012; U.S. Patent No. 9,060,724, entitled "Fluid Diversion Mechanism for Bodily-Fluid Sampling," filed May 29, 2013; U.S. Patent No. 9,155,495, entitled "Syringe-Based Fluid Diversion Mechanism for Bodily-Fluid Sampling," filed December 2, 2013; U.S. Patent Publication No. 2016 / 0361006, entitled "Devices and Methods for Syringe-Based Fluid Transfer for Bodily-Fluid Sampling," filed June 13, 2016; U.S. Patent Publication No. 2016 / 0361006, entitled "Devices and Methods for Syringe-Based Fluid Transfer for Bodily-Fluid Sampling," filed November 20, 2017; No. 2018 / 0140240, entitled "Apparatus and Methods for Maintaining Sterility of a Specimen Container," filed September 6, 2016, the disclosures of each of which are incorporated herein by reference in their entirety.

[0173] Although various embodiments have been described as having certain combinations of features, concepts, and / or components, other embodiments are possible having any combination or subcombination of any of the features, concepts, and / or components from any of the embodiments described herein. For example, as described above, any of devices 100, 200, 300, and / or 400 can be arranged and / or configured such that, in some embodiments, the fluid collection device provides a negative pressure or pressure differential that can be operable to draw bodily fluid into isolation and / or diversion portions 134, 234, 334, and / or 434, respectively. In some embodiments, the device can include parallel fluid flow paths or the like, and the inlet of the device (or the housing of the device) can be arranged in fluid communication with the isolation and / or diversion portions and in parallel with the fluid collection device. In some embodiments, fluid diversion can be controlled by the automatic or passive (e.g., non-user-mediated) methods described above, while additional control mechanisms for user intervention (e.g., control switches, valves, ports) can be available to add and / or control various parameters of fluid diversion, such as volume, diversion rate, and / or the like. In some embodiments, negative pressure generated by the fluid collection device can be operable to draw bodily fluid through the inlet, and the device can include any suitable means for pre-directing and / or diverting an initial flow of bodily fluid through an isolation and / or diversion portion to direct and / or divert a subsequent flow of bodily fluid into the fluid collection device, such as, for example, any of the actuators described herein.

[0174] The specific configurations of the various components can also be varied. For example, the size and specific shape of the various components can differ from the embodiments shown while still providing the functionality described herein. More specifically, the size and shape of the various components can be specifically selected for a desired rate and / or volume of bodily fluid flow into the fluid reservoir. For example, the circumference, diameter, and / or cross-sectional area of any fluid flow path described herein can be designed and / or specifically selected to accommodate the flow or diversion of a fluid (e.g., bodily fluid), gas (e.g., air), or any suitable combination thereof, at a desired flow rate. In other words, the components of the fluid control devices described herein include components that are constructed separately and later attached together, e.g., The various components can be individually or jointly selected to meet desired sample procurement criteria, such as, for example, the magnitude of the pressure differential, the desired flow rate of bodily fluid through portions of the device, the ability to adjust the pressure and / or flow rate, and / or the like. Similarly, the size and / or shape of the various components can be specifically selected for a desired or intended use. For example, in some embodiments, devices such as those described herein can be configured for use with or with apparently healthy adult patients. In such embodiments, the device can 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 can be configured for use with or with, for example, very sick and / or pediatric patients. In such embodiments, the device can include an isolation chamber having a second volume that is less than the first volume (e.g., less than about 0.5 ml). Thus, the size, shape, and / or arrangement of an embodiment and / or its components can be adapted for a given application unless the context clearly dictates otherwise.

[0175] Although not shown, any of the devices described herein can include an opening, port, coupler, septum, luer lock, gasket, valve, threaded connector, standard fluid interface, etc. (referred to as a "port" for simplicity) in fluid communication with the isolation chamber. In some such embodiments, the port can be configured to couple to any suitable device, reservoir, pressure source, etc. For example, in some embodiments, the port can be configured to couple to a reservoir, which can then allow a larger volume of bodily fluid to be diverted and / or transferred to the isolation chamber. In some embodiments, the port can be coupled to a negative pressure source such as a vacuum container, pump, syringe, and / or the like to collect some or all of the bodily fluid in the isolation chamber, channel, reservoir, etc., and use that volume of bodily fluid (e.g., a pre-sample volume) for additional clinical and / or in vitro diagnostic testing. In other embodiments, the port can be coupled to any suitable pressure source or infusion device configured to infuse the initial volume of bodily fluid isolated within the isolation chamber back into the patient and / or bodily fluid source (e.g., in the case of pediatric patients, very ill patients, patients with low blood volume, and / or the like).

[0176] In some embodiments, the port can be configured to accept a probe, sampling tool, testing device, and / or the like that can be used to perform one or more tests on the initial volume (e.g., tests that are not sensitive to potential contamination) while the initial volume is placed or isolated in the isolation chamber. In other embodiments, the isolation channel, chamber, and / or reservoir can be configured with additional diagnostic testing components (e.g., paper tests) incorporated into the chamber so that the initial body fluid can be used for that testing. In still other embodiments, the isolation chamber, channel, and / or reservoir can be designed, sized, and configured to be removable and compatible with testing devices and / or to provide access to other types of body fluid testing commonly performed on patients with a particular suspected condition. As an example, patients suspected of sepsis typically have blood samples drawn for lactate testing, procalcitonin testing, and blood culture testing. All of the fluid control devices described herein can be configured such that the isolation chamber, channel, reservoir, etc. can be removed (e.g., after receiving an initial volume of bodily fluid), and the bodily fluid contained therein can be used for these additional testing purposes before or after a next isolation sample is collected for microbiological testing.

[0177] Although not shown, in some embodiments, the fluid control device may include one or more lumens, channels, passages, etc. that are configured to selectively allow for "bypass" flow of bodily fluids. An initial amount or volume of bodily fluid can flow from the inlet through a lumen, channel, flow path, etc., bypassing the isolation chamber and into the collection device. In some embodiments, the fluid control device can include, for example, an actuator having at least three states. First, bodily fluid can flow from the inlet to the isolation chamber; second, bodily fluid can flow from the inlet to the outlet after the initial volume has been isolated in the isolation chamber; and third, bodily fluid can flow from the inlet through a bypass flow path to the outlet. In other embodiments, the control device can include a first actuator configured to transition the device between the first and second states, as described in detail above with reference to certain embodiments, and can include a second actuator configured to transition the device to a bypass configuration, or the like. In still other embodiments, the control device can include any suitable device, feature, component, mechanism, actuator, controller, etc. configured to selectively place the fluid control device in a bypass configuration or state.

[0178] While the methods and / or events described above indicate that certain events and / or procedures occur in a particular order, the order of the certain events and / or procedures may be altered, such alterations being in accordance with variations of the present invention. Additionally, certain events and / or procedures may be performed simultaneously in a parallel process, where possible, or sequentially as described above. Certain steps may be partially completed or omitted before proceeding to a subsequent step. For example, while the devices are described herein as transitioning from a first state to a second state in a discrete operation or the like, it should be understood that the devices described herein may be configured to transition from the first state to the second state automatically and / or passively, and such transition may occur over a period of time. In other words, the transition from the first state to the second state may be relatively gradual, such that, in some instances, the control device begins transitioning from the first state to the second state as the final portion of the initial volume of bodily fluid is being transferred to the isolation chamber. In some embodiments, the rate of change when transitioning from the first state to the second state may be selectively controlled to achieve one or more desired characteristics associated with the transition. Furthermore, in some such embodiments, the entry of the final portion of the initial volume can limit and / or substantially prevent bodily fluid already disposed in the isolation chamber from escaping therefrom. Thus, although the transition from the first state to the second state can occur over a given period of time, the isolation chamber can nevertheless isolate the volume of bodily fluid disposed therein.

[0179] Although the embodiments and / or methods are described above as transitioning from a first state and / or configuration in which an initial volume of bodily fluid flows from the inlet to or toward the isolation and / or diversion portion, and a second state and / or configuration in which a subsequent volume of bodily fluid flows from the inlet to an outlet or fluid collection device, in other embodiments, the fluid control device can have any suitable number of states and / or configurations therebetween. For example, some of the fluid control devices are described herein as having a first state in which an actuator allows an initial volume of bodily fluid to flow from the inlet to the isolation and / or diversion portion of the control device while blocking the flow of bodily fluid to the outlet or fluid collection device, and a second state in which the actuator blocks the flow of bodily fluid to or from the isolation and / or diversion portion and allows a subsequent volume of bodily fluid to flow from the inlet to the outlet or fluid collection device. However, in some embodiments, the control device and / or the actuator included therein can be temporarily placed in one or more intermediate states and not allow fluid flow to the isolation and / or diversion portion or outlet. In other words, such an actuator can be transitioned to a state or configuration different from and / or in addition to the first state or second state.

[0180] For example, assume a first state that allows fluid flow to the isolation and / or diversion portion. Between assuming a first state and a second state that allows fluid flow to the outlet, the actuator can assume or be switched to intermediate positions that block flow of the fluid flow path between the inlet and both the isolation and / or diversion section and the outlet. In some such embodiments, drawing of bodily fluid can be stopped from flowing to the isolation and / or diversion section or the outlet by placing the actuator in one or more intermediate states and / or configurations. In some examples, from the intermediate state, the actuator can assume or switch to a first configuration to continue drawing fluid into the isolation and / or diversion section, or can assume or switch to a second configuration to draw fluid into the outlet and / or fluid collection device. In some embodiments, enabling for one or more intermediate states and / or configurations can allow a user to adjust the negative pressure applied to or through the inlet. In other embodiments, transitioning the actuator through one or more intermediate states between the first and second states can limit and / or substantially prevent the actuator from accidentally transitioning from the first state to the second state before collecting an initial volume of bodily fluid, which could otherwise result in contaminants being transferred into the sample volume of bodily fluid.

Claims

1. a body having an inlet configured to be placed in fluid communication with a source of bodily fluid and an outlet configured to be coupled to a fluid collection device; a reservoir at least partially disposed within the body; an actuator coupled to the body and defining a fluid flow path, the actuator configured to transition from a first state in which the fluid flow path places the reservoir in fluid communication with the inlet to a second state in which the fluid flow path places the outlet in fluid communication with the inlet to facilitate flow of bodily fluid from the inlet into the reservoir; a pressure control device in fluid communication with the reservoir, the pressure control device configured to adjust the magnitude of a pressure differential in the reservoir to control a rate at which the actuator transitions from the first state to the second state, such that the reservoir receives a first volume of bodily fluid before the actuator enters the second state; The device is configured such that, in the second state, the actuator is operable such that suction introduced into the outlet draws a second volume of bodily fluid from the inlet, through the fluid flow path, and into the actuator.

2. The device of claim 1 , wherein the actuator is configured to automatically transition between the first state and the second state.

3. The device of claim 1 , wherein the actuator is configured to rotate to transition between the first state and the second state.

4. 10. The device of claim 1, wherein the actuator is configured to transition from the first state to the second state in response to the reservoir receiving the first volume of bodily fluid.

5. The device of claim 4 , wherein the first volume is based at least in part on a flow rate of the bodily fluid from the inlet to the reservoir.

6. The apparatus of claim 1 , wherein the pressure control device places the reservoir in fluid communication with the outlet.

7. The apparatus of claim 6 , wherein the outlet is configured to transition from a closed state to an open state in response to being coupled to the fluid collection device.

8. The apparatus of claim 7 , wherein the pressure control device is configured to vent gas from the reservoir to the outlet when the outlet is in the open state.

9. The device of claim 1 , wherein the actuator is configured such that in the second state, the fluid flow path is isolated from the reservoir.

10. The device of claim 1 , wherein the actuator is configured such that in the second state, the fluid flow path is disconnected from the reservoir.

11. a body having an inlet configured to be placed in fluid communication with a source of bodily fluid and an outlet configured to be coupled to a fluid collection device; a reservoir at least partially disposed within the body; an actuator coupled to the body and defining a fluid flow path, the fluid flow path configured, in a first state, to fluidly connect the reservoir to the inlet to facilitate flow of bodily fluid into the reservoir; an actuator configured such that in a second state, (1) the reservoir contains a first volume, and (2) the fluid flow path fluidly connects the inlet to the outlet, whereby suction applied to the outlet draws a second volume of bodily fluid into the fluid collection device while bypassing the first volume of bodily fluid contained within the reservoir; a pressure control device in fluid communication with the reservoir; The pressure control device is configured to adjust the magnitude of the pressure differential along the fluid flow path prior to entering the second state to control the rate of the flow of bodily fluid into the reservoir.

12. The device of claim 11 , wherein the actuator is configured to isolate the reservoir from the fluid flow path in the second state.

13. The device of claim 11 , wherein the body at least partially defines the reservoir.

14. 12. The device of claim 11, wherein the outlet is configured to transition from a closed state to an open state in response to the suction force being applied to the outlet.

15. 15. The apparatus of claim 14, wherein the pressure control device places the reservoir in fluid communication with the outlet, the pressure control device configured to vent gas from the reservoir to the outlet when the outlet is in the open state.

16. The apparatus of claim 11 , wherein the actuator is configured to transition automatically from the first state to the second state.

17. The device of claim 11 , wherein the actuator is configured to rotate to transition between the first state and the second state.

18. 12. The device of claim 11, wherein the actuator is configured to transition from the first state to the second state in response to the reservoir receiving the first volume of bodily fluid.

19. 20. The device of claim 18, wherein the first volume of bodily fluid is based at least in part on a flow rate of the bodily fluid from the inlet to the reservoir.

20. 12. The apparatus of claim 11, wherein the pressure control device is configured to adjust a pressure differential within the reservoir to control a rate at which the actuator transitions from the first state to the second state.

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