Fluid control device and method of using same

Abstract

The present invention relates to an apparatus including an inlet configured to be placed in fluid communication with a source of bodily fluid and an outlet configured to be placed in fluid communication with a fluid collection device. An isolation portion can be configured to receive an initial volume of bodily fluid. A flow controller disposed in the isolation portion can be configured to transition from a first state to a second state in response to contact with the initial volume of bodily fluid. As the flow controller transitions, a negative pressure differential can be defined that is operable to draw the initial volume of bodily fluid into the isolation portion. When the flow controller is in the second state, the negative pressure differential can be substantially equalized such that (1) the isolation portion isolates the initial volume of bodily fluid and such that (2) a subsequent volume of bodily fluid can pass from the inlet to the outlet.

Description

[0001] This application is a continuation of, and claims priority to, U.S. Patent Application Serial No. 15 / 882,050, filed on June 11, 2018, entitled "Fluid Control Devices and Methods of Using the Same," which is a continuation-in-part of International Patent Application No. PCT / US2018 / 036910, filed on June 11, 2018, entitled "Fluid Control Devices and Methods of Using the Same," which claims priority to U.S. Provisional Patent Application Serial No. 62 / 517,681, filed on June 9, 2017, entitled "Fluid Control Devices and Methods of Using the Same," the disclosures of which are incorporated herein by reference in their entireties.

[0002] Cross Reference to Related Applications

[0003] This application claims priority to and the benefit of U.S. Provisional Patent Application Serial No. 62 / 517,681, filed on June 9, 2017, entitled "Fluid Control Devices and Methods of Using the Same," the disclosure of which is incorporated herein by reference in its entirety. TECHNICAL FIELD

[0004] This application also claims priority to and the benefit of U.S. Provisional Patent Application Serial No. 62 / 639,572, filed on March 7, 2018, entitled "Fluid Control Devices and Methods of Using the Same," the disclosure of which is incorporated herein by reference in its entirety. BACKGROUND

[0005] The present invention relates generally to obtaining a body fluid sample from a body source or from a body fluid container, and more particularly to fluid transfer, isolation, and / or containment devices and methods for obtaining a body fluid sample that has been reduced in contaminants, such as microorganisms left over from the skin and / or other contaminants external to the source of the body fluid.

[0006] Healthcare practitioners routinely use non- enterally obtained body fluids or body fluids stored in containers or reservoirs to perform various types of microbiological diagnostic testing and other extensive diagnostic testing on body fluid samples obtained from patients. With the development and advancement of sophisticated diagnostic technologies, the speed, accuracy (both sensitivity and specificity), and value of the information that can be provided to clinicians continues to improve. Maintaining the integrity of a body fluid sample during and / or after collection ensures that the analytical diagnostic results are representative of the patient's in vivo condition. Examples of diagnostic technologies that rely on high quality, uncontaminated, and / or pure body fluid samples include, but are not limited to, microbiological testing, molecular diagnostics, genetic sequencing (e.g., deoxyribonucleic acid (DNA), ribonucleic acid (RNA), next generation sequencing (NGS), etc.), biomarker identification, and similar technologies. When biological matter (which can include cells external to the intended source for the sample being taken) and / or other external contaminants are inadvertently included in a body fluid sample to be analyzed, there is a chance that inaccurate test results will be derived. In short, when the purity of a sample expected to be obtained from a particular body fluid source or from a container holding the collected body fluid is compromised during the specimen acquisition process or during the sample transfer process from the fluid collection, the resultant analytical test results can be inaccurate, misleading, adulterated, false positive, false negative, and / or otherwise not representative of the patient's actual in vivo condition, which in turn can inform erroneous, inaccurate, confusing, uncertain, confidence-lacking, and / or otherwise undesirable clinical decisions.

[0007] In certain instances, a patient sample (e.g., a body fluid) is tested for the presence of one or more potentially undesirable microorganisms, such as bacteria, fungi, or yeast (e.g., Candida). In some instances, the microbiological testing can include incubating the patient sample in one or more sterile and / or non-sterile vessels that can hold culture media, general additives, and / or other types of solutions that facilitate the growth of microorganisms. In other instances, the sample in the vessel can be analyzed directly (i.e., without incubation) and can not hold culture media or additives associated with incubated specimens. In yet other instances, various techniques can be employed to assist in detecting microorganisms and other types of biological matter, specific types of cells, biomarkers, proteins, antigens, enzymes, blood components, and / or the like during diagnostic testing. Examples include, but are not limited to, molecular polymerase chain reaction (PCR), magnetic resonance and other magnetic analysis platforms, automated microscopy, spatial clone isolation, flow cytometry, whole blood ("culture- free") specimen analysis (e.g., NGS) and related technologies, morphokinetic cell analysis, and / or other commonly used or developing advanced technologies used in clinical or research laboratory settings to characterize patient specimens and / or to detect, identify, classify, categorize, quantify, and / or characterize specific organisms, antibiotic sensitivities, and / or the like.

[0008] In certain instances, detection of the presence of a microorganism includes allowing the microorganism and / or organism to grow for an amount of time (e.g., a variable amount of time from less than an hour to several hours to several days, which can be longer or shorter depending on the diagnostic technique employed). The microorganism and / or organism growth can then be detected by automated methods, continuous monitoring methods, and / or other methods specific to the analysis platform and technique used for detection, identification, and / or the like.

[0009] In a culture test, for example, when a microorganism is present in a patient sample, the microorganism thrives in the culture medium over time, and in certain instances, automated monitoring techniques can detect carbon dioxide produced by the organism growth. The presence of the microorganism in the culture medium (as indicated by the observation of carbon dioxide and / or via other detection methods) suggests the presence of the same microorganism in the patient sample, which in turn suggests the presence of the same microorganism in the bodily fluid of the patient from which the sample was obtained. Thus, when it is determined that a microorganism is present in the culture medium (or more generally, in the sample used for testing), the patient can be diagnosed and prescribed one or more antibiotics or other treatments that are specifically designed to treat the patient or otherwise remove the undesirable microorganism from the patient.

[0010] However, patient samples can become contaminated during acquisition and / or can otherwise be susceptible to false positive or false negative results. For example, microorganisms expelled from the body surface (e.g., skin-resident microorganisms) during the specimen acquisition process (which can include insertion of a needle into a patient, specimen acquisition via a device including a lumen (e.g., a peripheral IV catheter (PIV), a central line (PICC), and / or other one or more indwelling catheter), collection with a syringe or any other suitable device for collecting a patient specimen) can subsequently be transferred into a culture medium, test bottle, or other suitable specimen collection or transfer vessel along with the patient specimen and / or included in the specimen to be analyzed for non-culture based testing, either directly or indirectly via tissue debris, hair follicles, sweat glands, and other skin appendage structures. Another potential source of contamination comes from the personnel (e.g., physicians, phlebotomists, nurses, technicians, etc.) who draw the patient specimen. In particular, the equipment, supplies, and / or devices used during the patient specimen acquisition process often include multiple fluid interfaces (e.g., but not limited to, patient to needle, needle to transfer adapter, transfer adapter to specimen vessel, catheter hub to syringe, syringe to transfer adapter, needle / tube to specimen vessel, and / or any other fluid interface or any combination thereof), each of which can introduce a potential point of contamination. In some cases, such contaminants can proliferate in the culture medium and / or can be identified by another non-culture based diagnostic technique, and ultimately result in false positive and / or false negative microorganism detection results, which can inaccurately reflect the presence or lack of such microorganisms in the patient (i.e., in vivo).

[0011] Such inaccurate results due to contamination and / or other adulteration sources compromising sample purity is a problem when attempting to diagnose or treat a wide range of suspected illnesses, diseases, infections, patient conditions, or other related maladies. For example, false negative results from microorganism testing can result in misdiagnosis and / or delayed treatment of a patient's illness, which in some cases can result in patient death. Conversely, false positive results from microorganism testing can result in a patient being unnecessarily subjected to one or more antimicrobial therapies, which can cause serious side effects to the patient including, for example, death, as well as place an unnecessary burden and expense on the healthcare system due to extended patient hospitalization and / or other complications related to the erroneous treatment. From a cost and patient safety perspective, the use of diagnostic imaging equipment attributed to these false positive results is also a problem, as unnecessary concentrated radiation exposure associated with various imaging procedures (e.g., CT scans) has many known adverse effects on a patient's long-term health.

[0012] In some instances, devices and / or systems can be used to reduce the likelihood of contamination, adulteration, and / or the like of a bodily fluid sample for testing. For example, certain known devices can be configured to collect, transfer, isolate, and / or sequester or isolate an initial volume of bodily fluid that is more likely to contain contaminants, such as skin- resident microorganisms or the like. However, certain such devices can be cumbersome, unintuitive, perceived as difficult to use, inappropriate or unavailable for a target patient population, or the like. Further, certain such devices can require training, user observation, intervention by more than one user, and / or can otherwise present challenges that can result in limited efficacy based on variables including environment, education, clinician skill, patient condition, and / or the like. In some instances, such challenges can complicate the collection of a consistently high quality sample that is uncontaminated, sterile, pure, or the like, which in turn can affect the validity of test result outcomes.

[0013] Accordingly, there is a need for fluid transfer devices and methods for obtaining a bodily fluid sample that has reduced contaminants, such as skin-resident microorganisms and / or other contaminants external to the source of the bodily fluid. Further, there is a need for devices that are user friendly, have little or no user intervention and / or actuation, demonstrate consistent efficacy, and / or address challenges associated with collecting a bodily fluid sample. SUMMARY

[0014] Described herein are devices and methods for obtaining a bodily fluid sample that has reduced contaminants, such as skin-resident microorganisms and / or other contaminants external to the source of the bodily fluid. In some embodiments, an apparatus can include an inlet configured to be placed in fluid communication with a source of bodily fluid and an outlet configured to be placed in fluid communication with a fluid collection device. The apparatus can include an isolation portion configured to be in fluid communication with the inlet to receive an initial volume of bodily fluid. A flow controller can be disposed in the isolation portion and configured to transition from a first state to a second state in response to contact with a portion of the initial volume of bodily fluid. As the flow controller transitions from the first state to the second state, a negative pressure differential can be defined between the isolation portion and the inlet operable to draw the initial volume of bodily fluid from the inlet into the isolation portion. When the flow controller is in the second state, the negative pressure differential can be substantially equalized such that (1) the isolation portion sequesters the initial volume of bodily fluid and such that (2) a subsequent volume of bodily fluid can be transferred from the inlet to the outlet. BRIEF DESCRIPTION OF DRAWINGS

[0015] FIG. 1 is a schematic illustration of a fluid control device according to an embodiment.

[0016] FIG. 2 and FIG. 3 are perspective and rear views, respectively, of a fluid control device according to an embodiment.

[0017] FIG. 4 is a cross-sectional view of the fluid control device shown in FIG. 3

[0018] FIG. 5 is a perspective view of a fluid control device according to an embodiment.

[0019] FIG. 6 is a cross-sectional view of the fluid control device shown in FIG. 5

[0020] FIG. 7 is a perspective view of a fluid control device according to an embodiment.

[0021] FIG. 8 is a cross-sectional view of the fluid control device shown in FIG. 7

[0022] FIG. 9 is a perspective view of a fluid control device according to an embodiment.

[0023] FIG. 10 and FIG. 11 are exploded and rear views, respectively, of the fluid control device of FIG. 9

[0024] FIG. 12 is a cross-sectional view of the fluid control device shown in FIG. 11

[0025] FIG. 13 is a perspective view of a fluid control device according to an embodiment.

[0026] FIG. 14 and FIG. 15 are exploded and rear views, respectively, of the fluid control device of FIG. 13

[0027] FIG. 16A and 16B are cross-sectional views of the fluid control device of FIG. 15

[0028] FIG. 17 FIG. 18 are perspective and rear views, respectively, of a fluid control device according to an embodiment.

[0029] FIG. 19 is a cross-sectional view taken along line 19-19​​​​​​​​FIG. 18 a cross-sectional view of the fluid control device shown in

[0030] FIG. 20 is a portion of the fluid control device shown in FIG. 19 is an enlarged cross-sectional view of a portion of the fluid control device shown in FIG. 17

[0031] FIG. 21 is a schematic side view of a fluid control device according to an embodiment.

[0032] FIG. 22 is a cross-sectional view of the fluid control device shown in FIG. 21

[0033] FIG. 23 is a schematic side view of a fluid control device according to an embodiment.

[0034] FIG. 24 is a cross-sectional view of the fluid control device shown in FIG. 23

[0035] FIG. 25 to FIG. 29 is a schematic cross-sectional view of a fluid control device according to various embodiments.

[0036] FIG. 30 and FIG. 31 are flow diagrams according to different embodiments each illustrating a method of transferring an initial volume of bodily fluid using a fluid control device to obtain a bodily fluid sample having reduced contaminants. DETAILED DESCRIPTION

[0037] ​​​Any of the fluid control devices described herein can be configured to receive, acquire, and / or pass a flow, bolus, volume, etc. of a body fluid. A first reservoir, channel, flow path, or portion of the device can receive an initial amount of the body fluid flow, which in turn can be substantially or completely isolated (e.g., contained or held, evaded, partitioned, sequestered, bunged, separated, and / or the like) in or by a first reservoir or first portion of the device. In some cases, contaminants such as microorganisms left over from the skin or the like can be included and / or entrained in the initial amount of body fluid, and likewise isolated in or by the first reservoir or first portion of the device. Once the initial amount is isolated, any subsequent amounts of the body fluid flow can be diverted, directed, guided, flow controlled (e.g., manually, automatically, and / or semi-automatically) to a second reservoir, second portion, and / or one or more any additional flow paths of the device. Thus, with the initial amount isolated, one or more any additional and / or subsequent amounts of the body fluid are substantially free of contaminants that would otherwise produce inaccuracies, distortions, adulterations, false positives, false negatives, etc., leading to certain diagnoses and / or tests. In certain cases, the initial amount of body fluid can also be used, for example, in other tests, such as those less affected by the presence of contaminants. In other cases, the initial amount of body fluid can be discarded as a waste volume, can be infused back into the patient, and / or can be used for any other suitable clinical application.

[0038] In some embodiments, a fluid control device includes an inlet and an outlet. The inlet is configured to be placed in fluid communication with a body fluid source or an intermediate body fluid passing device, and the outlet is configured to be placed in fluid communication with a body fluid collection device (e.g., a sample bottle, container, reservoir, syringe, vacuum container, pan, vial, device comprising an internal cavity, and / or any other suitable body fluid collection and / or passing device). The fluid control device includes an isolation portion configured to be in fluid communication with the inlet and configured to receive an initial volume of body fluid from the body fluid source. In some embodiments, the fluid control device can include a flow controller disposed in the isolation portion of the fluid control device. The flow controller is configured to transition between a first state and a second state in response to contact with a portion of the initial volume of body fluid. The fluid control device can be configured such that a negative pressure differential is defined between the isolation portion and the inlet when the flow controller transitions from the first state to the second state, the negative pressure differential operable to draw the initial volume of body fluid from the inlet into the isolation portion. The fluid control device can be configured such that the negative pressure differential is substantially equalized when the flow controller is in the second state, such that (1) the isolation portion isolates the initial volume of body fluid, and such that (2) a subsequent volume of body fluid can be passed from the inlet to the outlet.

[0039] In some embodiments, an apparatus includes an inlet configured to be placed in fluid communication with a source of bodily fluid and an outlet configured to be placed in fluid communication with a fluid collection device. An isolation portion can be in fluid communication with the inlet and configured to receive an initial volume of bodily fluid from the inlet. The isolation portion can include a selectively permeable vent configured to at least temporarily vent the isolation portion to initiate a flow of the initial volume of bodily fluid from the source of bodily fluid through the inlet and into the isolation portion. A flow controller can be disposed in the isolation portion and configured to transition from a first state to a second state in response to contact with a portion of the initial volume of bodily fluid. The transition of the flow controller can be configured to create a negative pressure differential between the isolation portion and the inlet such that the isolation portion receives the initial volume of bodily fluid. The negative pressure differential can be substantially equalized when the flow controller is in the second state such that (1) the isolation portion isolates the initial volume of bodily fluid and such that (2) a subsequent volume of bodily fluid can be passed from the inlet to the outlet.

[0040] In some embodiments, a method of obtaining a reduced contaminant bodily fluid sample using a flow control device can include establishing fluid communication between a source of bodily fluid and an inlet of the flow control device. An isolation portion of the flow control device can be vented to create a first negative pressure differential between the isolation portion and the inlet. The isolation portion can receive a portion of an initial volume of bodily fluid from the inlet in response to the first negative pressure differential. A flow controller can be disposed in the isolation portion and the flow controller can transition from a first state to a second state in response to the flow controller being placed in contact with the portion of the initial volume of bodily fluid. The transition of the flow controller can be configured to create a second negative pressure differential between the isolation portion and the inlet such that the isolation portion receives the initial volume of bodily fluid from the inlet. The initial volume of bodily fluid can be isolated in the isolation portion and a subsequent volume of bodily fluid can be passed from the inlet to an outlet in fluid communication with a fluid collection device when the flow controller is placed in the second state.

[0041] In some embodiments, a fluid control device includes an inlet and an outlet. The inlet is configured to be placed in fluid communication with a source of bodily fluid or an intermediate bodily fluid transfer device, and the outlet is configured to be placed in fluid communication with a bodily fluid collection device (e.g., a sample bottle, a container, a reservoir, a syringe, a vacuum container, a pan, a vial, a device comprising an internal cavity, 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 into an isolation and / or transfer portion of the fluid control device (which can be formed by or in the fluid control device or coupled to the fluid control device) and a second state in which (1) the initial volume of bodily fluid is isolated in the isolation and / or transfer portion of the fluid control device and (2) a subsequent volume of bodily fluid substantially free of contaminants can flow from the source of bodily fluid through at least a portion of the fluid control device into the fluid collection device. The fluid control device is configured to transition from the first state to the second state after the isolation and / or transfer portion receives the initial volume.

[0042] In some embodiments, a fluid collection device can include, can define, and / or can be actuated to create a negative pressure condition within the fluid collection device, which in turn can facilitate the drawing of bodily fluid from a source of bodily fluid (e.g., a patient) into the fluid collection device via a vacuum or suction. In embodiments in which the fluid collection device is a vacuum container or the like, the container can include a vacuum seal or the like that can transition from a sealed state to an unsealed state. In certain instances, after an initial portion of bodily fluid is transferred and / or isolated, a user can couple the vacuum container to an outlet of a fluid control device, such as those described herein, which in turn can limit and / or substantially prevent the initial portion of bodily fluid (potentially containing contaminants) from being transferred into the container (e.g., fluid collection device).

[0043] In some embodiments, a fluid control device includes an inlet device and a diverter. The inlet device is configured to be placed in fluid communication with a source of bodily fluid. The diverter includes an inlet configured to fluidically couple the diverter to the inlet device and an outlet configured to fluidically couple the diverter to a sample reservoir. The diverter defines an isolation chamber (or portion). The diverter has a first state in which an initial volume of bodily fluid can flow from the inlet device into the isolation chamber and a second state in which (1) the isolation chamber isolates the initial volume and (2) a subsequent volume of bodily fluid substantially free of contaminants can flow through the inlet device and the diverter, out of the outlet of the diverter, and into the sample reservoir. In some embodiments, the diverter is configured to automatically transition from the first state to the second state after the isolation chamber receives the initial volume, while in other embodiments, the transition can be achieved manually or via any suitable measure.

[0044] As used in the specification and claims, the singular forms “a,” “an” and “the” include plural referents unless the context clearly dictates otherwise. Thus, for example, the term “a member” is intended to mean a single member or a combination of members, “a material” is intended to mean a single material or a combination of materials, and the like.

[0045] As used herein, the terms “about,” “approximately” and / or “substantially” when used in conjunction with a recited value and / or geometric relationship are intended to convey that the structure so defined is nominally the recited value and / or described geometric relationship. In some instances, the terms “about,” “approximately” and / or “substantially” can generally mean and / or can generally be expected to be plus or minus 10% of the recited value or relationship. For example, about 0.01 would include 0.009 and 0.011, about 0.5 would include 0.45 and 0.55, about 10 would include 9 to 11, and about 1000 would include 900 to 1100. While the recited value would be desirable, it should be understood that some variance will occur due to, for example, manufacturing tolerances or other practical considerations (e.g., pressure or force exerted by a portion of a device, a catheter, a lumen, etc.). Accordingly, the terms “about,” “approximately” and / or “substantially” can be used herein to account for such tolerances and / or considerations. Similarly, in certain instances, the term “substantially” can be used herein to account for tolerances and / or other practical considerations when comparing similar or analogous components, features, characteristics, etc. For example, when the pressure of two components is nominally equal or the same within practical or functional tolerances, it can be said that the pressure differential between the two components is “substantially” equal.

[0046] As used herein, “bodily fluid” can include any fluid, tissue or biological material (e.g., as a component of or in addition to a fluid) obtained directly from a patient’s body or indirectly from a patient (e.g., via an intermediate collection device, container, biopsy needle, scalpel and / or the like). For example, “bodily fluid” can include, but is not limited to, blood (e.g., whole blood or a component of blood, such as platelets or other components), cerebrospinal fluid, urine, bile, lymphatic fluid, saliva, synovial fluid, serous fluid, pleural fluid, amniotic fluid, mucus, sputum, vitreous humor, air and / or the like, any type of tissue (e.g., tumors, organs, muscle, tendons) and / or any combination thereof.

[0047] As used herein, the words “proximal” and “distal” refer to directions close to and away from, respectively, a user who places a device in contact with a patient. Thus, for example, the end of a device that first touches the patient’s body will be the distal end, while the opposite end of the device (e.g., the end of the device manipulated by the user) will be the proximal end of the device.

[0048] As described in further detail herein, either of the devices and methods can be used to obtain a reduced contaminant body fluid sample, for example, by diverting a "pre-sample" volume of body fluid prior to collecting a "sample" volume of body fluid. Each of the terms "pre-sample," "first," and / or "initial" can be used interchangeably to describe and / or refer to an amount, portion, or volume of body fluid that is passed, diverted, and / or isolated prior to obtaining a "sample" volume. In some embodiments, the terms "pre-sample," "first," and / or "initial" can refer to a predetermined, defined, desired, or given volume, portion, or amount of body fluid. For example, in some embodiments, a predetermined and / or desired pre-sample volume of body fluid can be about 0.01 milliliter (mL), about 0.1 mL, about 0.2 mL, about 0.3 mL, about 0.4 mL, about 0.5 mL, about 1.0 mL, about 2.0 mL, about 3.0 mL, about 4.0 mL, about 5.0 mL, about 10.0 mL, about 20 mL, about 50 mL, and / or any volume or fraction of a volume therebetween. In other embodiments, a pre-sample volume can be greater than 50 mL or less than 0.1 mL. In some particular embodiments, a predetermined and / or desired pre-sample volume can be between about 0.1 mL and about 5.0 mL. In other embodiments, a pre-sample volume can be, for example, a drop of body fluid, a few drops of body fluid, a combined volume of any number of lumens that form, for example, a flow path (or portion thereof) from a body fluid source to an initial collection chamber, portion, reservoir, etc. (e.g., an isolation chamber).

[0049] On the other hand, the terms "sample," "second," and / or "subsequent" when used in the context of a volume of body fluid can refer to a volume, portion, or amount of body fluid that is a random volume or a predetermined or desired volume of body fluid collected after passing, diverting, isolating, and / or sequestering a pre-sample volume of body fluid. For example, in some embodiments, a desired sample volume of body fluid can be about 10 mL to about 60 mL. In other embodiments, a desired sample volume of body fluid can be less than 10 mL or greater than 60 mL. In some embodiments, for example, a sample volume can be based at least in part on one or more tests, assays, analyses, and / or processes to be performed on the sample volume.

[0050] Embodiments described herein can be configured to selectively transfer bodily fluid to one or more fluid collection devices. In some embodiments, the fluid collection devices can include, but are not limited to, any suitable vessel, container, reservoir, bottle, adapter, dish, vial, syringe, device, diagnostic and / or testing machine, and / or the like. By way of specific example, in certain instances, any of the embodiments and / or methods described herein can be used to transfer a sample volume into a fluid collection device, such as any of those described in detail in U.S. Patent No. 8,197,420 entitled "Systems and Methods for Parenterally Procuring Bodily-Fluid Samples with Reduced Contamination," filed on December 13, 2007 ("the '420 patent"), the disclosure of which is incorporated by reference herein in its entirety.

[0051] Any of the sample containers, reservoirs, bottles, dishes, vials, and / or the like described herein can be free of contents prior to receiving a sample volume of bodily fluid or can include, for example, any suitable additives, media, and / or the like. For example, in some embodiments, the sample reservoirs can include, for example, any suitable additives and / or the like. The additives can be any suitable substance, enzyme, oil, fluid, compound, chemical, and / or the like that occupies at least a portion of the interior volume defined by the sample reservoir. Specific examples can include, but are not limited to, heparin, citrate, acid citrate dextrose (ACD), ethylenediaminetetraacetic acid (EDTA), oxalate, sodium poly-m-cresol sulfonate (SPS), and / or the like. In other embodiments, the sample reservoirs can contain, for example, an aerobic or anaerobic culture medium. Generally, the culture medium is a nutrient-rich and / or environmentally controlled medium (and / or any other suitable medium) that promotes growth that occupies at least a portion of the interior volume defined by the sample reservoir. In use, the sample reservoir (e.g., culture bottle) can receive a sample of bodily fluid, which in turn can be tested (e.g., via in vitro diagnostic (IVD) testing and / or any other suitable testing) to check for the presence of, for example, gram-positive bacteria, gram-negative bacteria, yeast, fungi, and / or any other organism. If the testing of the culture medium yields a positive result, the culture medium can then be tested using various methods (e.g., PCR-based systems) to identify the specific organism. As described in further detail herein, in some instances, the transfer of the sample pre- or initial volume of bodily fluid can reduce and / or substantially eliminate contaminants in the sample of bodily fluid that would otherwise result in inaccurate test results.

[0052] While the term“medium” can be used to describe a substance configured to react with a biological organism in a bodily fluid (e.g., a microorganism such as a bacterium), and the term“additive” can be used to describe a substance configured to react with a component of a bodily fluid (e.g., a constituent cell of blood, synovial fluid, etc.), it should be understood that a sample container can include any suitable substance, liquid, solid, powder, lyophilized compound, gas, etc. Further, when referring to an“additive” within a sample reservoir, it should be understood that the additive can be and / or can include a medium (e.g., an aerobic or anaerobic medium), an additive, and / or any other suitable substance and / or any combination of substances, media, etc. contained within the sample reservoir. That is, the embodiments described herein can be used with any suitable sample reservoir and / or the like containing any suitable substance. Further, any of the embodiments and / or methods described herein can be used to pass a volume of bodily fluid to a sample reservoir and / or the like that does not contain a medium, additive, and / or any other substance prior to receiving a flow of bodily fluid.

[0053] While some embodiments are described herein as being used to acquire bodily fluid for one or more culture sample testing, it should be understood that embodiments are not limited to such use. Any of the embodiments and / or methods described herein can be used to pass a flow of bodily fluid to any suitable device placed in fluid communication therewith. Thus, while particular examples are described herein, the devices, methods, and / or concepts are not intended to be limited to such particular examples.

[0054] Embodiments described herein and / or portions thereof can be formed or constructed from one or more biocompatible materials. In some embodiments, the biocompatible material can be selected based on one or more properties of the constituent material, e.g., stiffness, toughness, hardness, bioreactivity, etc. Examples of suitable biocompatible materials include metals, glasses, ceramics, or polymers. Examples of suitable metals include medical grade stainless steel, gold, titanium, nickel, iron, platinum, tin, chromium, copper, and / or alloys thereof. The polymeric material can be biodegradable or non-biodegradable. Examples of suitable biodegradable polymers include polylactide, polyglycolide, polylactide-co-glycolide (PLGA), poly anhydrides, polyorthoesters, polyetheresters, polycaprolactone, polyesteramides, poly(butyric acid), poly(valeric acid), polyurethanes, and / or blends and copolymers thereof. Examples of non-biodegradable polymers include nylon, polyesters, polycarbonates, polyacrylates, polymers of ethylene-vinyl acetate and other acyl substituted cellulose acetates, non-degradable polyurethanes, polystyrene, polyvinylchloride, polyvinylfluoride, poly(vinylimidazole), chlorosulfolane polyolefins, polyethylene oxide, and / or blends and copolymers thereof.

[0055] Embodiments described herein and / or portions thereof can include components formed from one or more parts, features, structures, etc. When referring to such components, it will be understood that the components can be formed from a single part having any number of segments, regions, portions, and / or features, or can be formed from multiple parts or features. For example, when referring to a structure such as a wall or chamber, the structure can be considered to be a single structure having multiple portions or a plurality of different sub-structures or the like that are coupled to form the structure. Thus, a structure that is integrally constructed can include, for example, a set of sub-structures. Such a set of sub-structures can include multiple portions that are continuous with one another or discontinuous with one another. A set of sub-structures can also be made from multiple articles or components that are separately produced and then joined together (e.g., via welding, adhesive, or any suitable method).

[0056] Referring now to the drawings, FIG. 1 is a schematic illustration of a fluid control device 100 according to embodiments. Generally, the fluid control device 100 (also referred to herein as a "control device" or "device") is configured to draw bodily fluid from a patient. A first portion or amount (e.g., an initial amount) of the drawn bodily fluid is isolated from a second portion or amount (e.g., a subsequent amount) of the drawn bodily fluid. In this way, contaminants or the like can be isolated within the first portion or amount, while the second portion or amount 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 the purposes of medical diagnosis and / or treatment (e.g., a blood culture test or the like), as described in greater detail herein. The first portion or amount of bodily fluid can be discarded as waste, or can be used in any suitable test (e.g., a test that is less likely to produce false, inaccurate, skewed, inconsistent, and unreliable results due to the inclusion of potential contaminants therein). In other cases, the first portion or amount of bodily fluid can be transfused into the patient and / or used for any other suitable purpose.

[0057] The control device 100 can be any suitable shape, size, and / or configuration. For example, in some embodiments, the control device 100 can have a size that is based at least in part on a volume of bodily fluid that is at least temporarily stored, e.g., in an isolation, diversion, sequestration, and / or storage portion of the control device 100. As described in further detail herein, the control device 100 can be configured to transition between operational modes such that (1) a first portion or amount of bodily fluid is selectively flowed through at least a first portion of the fluid control device and is subsequently isolated therein, and such that (2) a second portion or amount of bodily fluid is selectively flowed through at least a second portion of the fluid control device into a fluid collection device or the like. In some embodiments, the control device 100 can be configured to transition between operational modes automatically (e.g., based on a pressure differential, time, an electronic signal or instruction, a saturation of a membrane or member, an absorbent and / or barrier material, etc.) or via and / or in response to an intervention (e.g., a user intervention, a mechanical intervention, or the like).

[0058] The control device 100 includes an inlet 132, at least one outlet 136, and an isolation and / or diversion portion 134 (also referred to herein as an “isolation portion”). Additionally, the control device 100 defines one or more fluid flow paths 133 between the inlet 132 and the isolation portion 134 and / or between the inlet 132 and the one or more outlets 136.

[0059] The inlet 132 of the control device 100 is configured to be placed in fluid communication with a source of bodily fluid. In some embodiments, the inlet 112 can be coupled to and / or can include an inlet device, such as an intravenous (IV) catheter, a needle, a peripherally inserted central catheter (PICC), a syringe, a port, a coupler, one or more sterile tubing, and / or any other suitable lumen-containing device and / or intermediate transfer device. In some embodiments, the inlet can be a port, a valve, and / or the like, such as a Luer or any other suitable coupler. In some embodiments, the inlet (e.g., a port or coupler) can be configured to be coupled to an access or inlet device that is in fluid communication with a patient (e.g., a placed or indwelling IV catheter or needle) or other source of bodily fluid. In some other embodiments, for example, the inlet (e.g., a port or coupler) can be configured to be coupled to a corresponding port or coupler of a collection reservoir that holds collected bodily fluid. In some embodiments, the inlet 132 can be physically and fluidly coupled to an access or inlet device via a lock, a coupler, a port, or the like. In other embodiments, the inlet 132 can be in fluid communication with an access or inlet device via an intermediate lumen-containing device, such as a sterile tube or the like. In still other embodiments, the inlet 132 of the control device 100 can form and / or can be integrally or monolithically formed with an access or inlet device.

[0060] The isolation portion 134 of the control device 100 is at least temporarily placed in fluid communication with the inlet 132 via one or more fluid flow paths 133. As described in further detail herein, the isolation portion 134 is configured to (1) receive a flow and / or volume of bodily fluid from the inlet 110 and (2) isolate (e.g., separate, divert, sequester, contain, hold, partition, etc.) the flow and / or volume of bodily fluid therein.

[0061] The isolation portion 134 can have any suitable shape, size, and / or configuration. For example, in some embodiments, the isolation portion 134 can be at least partially formed by a body portion (not shown) of the control device 100. In other embodiments, the isolation portion 134 can be a reservoir placed and / or disposed within a portion of the control device 100. In other embodiments, the isolation portion 134 can be formed by and / or defined by a portion of the fluid flow path 133. That is, the control device 100 can define one or more lumens and / or can include one or more lumen-defining devices 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 one or more lumen-defining devices can form and / or can define the isolation portion 134. FIG. 1 The isolation portion 134 can have any suitable volume and / or fluid capacity. For example, in some embodiments, the isolation portion 134 can have a volume and / or fluid capacity of between about 0.25 milliliters (mL) to about 5.0 mL. In some embodiments, the isolation portion 134 can have a volume that is measured in volumes of bodily fluid as small as one microliter or less (e.g., as small as 20 drops of bodily fluid, 10 drops of bodily fluid, 5 drops of bodily fluid, one drop of bodily fluid, or any suitable volume therebetween). In other embodiments, the isolation portion 134 can have a volume of, for example, up to about 5.0 mL, 10.0 mL, 15.0 mL, 20.0 mL, 30.0 mL, 40.0 mL, 50.0 mL, or more. In some embodiments, the volume of the isolation portion 134 can be equal to and / or based at least in part on the volume of a lumen of an access or inlet device coupled to and / or included in the control device 100, a lumen of the inlet 132, and a portion of the fluid flow path 133 defined between the inlet 132 and the isolation portion 134, and / or any combination thereof. In other embodiments, the volume of the isolation portion 134 can be equal to and / or based at least in part on the individual and / or combined volume of a portion of an access or inlet device, the inlet 132 of the control device 100, and the portion of the fluid flow path 133 defined between the inlet 132 and the isolation portion 134.

[0062]

[0063] ​Although not shown in FIG. 1 In some embodiments, the isolation portion 134 can include one or more passive or active flow controllers (e.g., shapes, sizes, flow paths, materials configured to interact with fluids, actuators, plungers, pistons, valves, flow restrictors, seals, vents, etc.) that can be actuated, engaged, manipulated, and / or controlled to push, draw, direct, and / or divert fluids (e.g., bodily fluids, air or other gases, and / or the like) into and / or out of the isolation portion 134. For example, in some embodiments, the isolation portion 134 can include any suitable arrangement, configuration, and / or feature and / or can be formed of one or more materials configured to interact with a portion of bodily fluid that is transferred into the isolation portion 134. In some embodiments, the control device 100 can include a bibulous and / or hydrophilic material disposed within the isolation portion 134. Accordingly, when bodily fluid is transferred into the isolation portion 134, the bibulous and / or hydrophilic material can absorb, attract, retain, swell, and / or otherwise interact with at least a portion of the bodily fluid, which in turn can isolate and / or retain at least an initial portion of the bodily fluid within the isolation portion 134, as described in further detail herein.

[0064] In other embodiments, the isolation portion 134 can include and / or be formed of an expandable or collapsible material configured to transition between a first state (e.g., when an initial portion of bodily fluid is transferred into the isolation portion 134) and a second state (e.g., after the initial portion of bodily fluid is transferred into the isolation portion 134). In some embodiments, a force associated with and / or resulting from the expansion or collapse of such a material can be operable to transition the control device 100 and / or any suitable portion of the control device 100 from a first state, mode, position, configuration, etc. to a second state, mode, position, configuration, etc. In some embodiments, the isolation portion 134 and / or any other suitable portion of the control device 100 can include one or more chemicals, compounds, and / or the like configured to chemically interact with bodily fluid transferred through a portion of the control device 100, which can be operable to transition the control device 100 between a first state and a second state (e.g., via a force or any other suitable measure).

[0065] In some embodiments, the isolation portion 134 can have a geometry and / or can be formed of a material, or can have a coating of a material configured to wick, attract, absorb, and / or retain bodily fluid. For example, in some embodiments, the geometry of the isolation portion 134 and / or at least a portion thereof can have a geometry configured to enhance wicking, such as a relatively high surface area to volume ratio. In other embodiments, the isolation portion 134 can have a relatively small volume and an elongated perimeter or circumference configured to enhance capillary action (e.g., wicking) or the like. For example, in some embodiments, the isolation portion 134 can include and / or be formed of one or more structures (e.g., a series of capillaries) configured to have a relatively high surface area to volume ratio to draw fluid into the isolation portion 134. In some embodiments, forces associated with these one or more structures (e.g., intermolecular forces acting between the surface of the fluid and the structure) can be operable to wick, attract, absorb, and / or retain bodily fluid transferred and isolated in the isolation portion 134. In some embodiments, the isolation portion 134 can include a textured or pitted inner surface configured to facilitate absorption, attraction, and / or wicking of bodily fluid. Similarly, in some embodiments, the inner surface of the isolation portion 134 can have and / or can include a coating or the like (e.g., a hydrophilic coating or the like) configured to facilitate wicking, absorption, attraction, and / or the like.

[0066] In some embodiments, the isolation portion 134 can include and / or can house one or more mechanical actuators that can move within the isolation portion 134 or can be moved within the isolation portion 134 to create a volume change and / or a pressure differential between the isolation portion 134 and, for example, a source of fluid outside of the isolation portion 134 and / or a portion of the fluid flow path 133. In other embodiments, movement of the mechanical actuators can create a pressure differential between the isolation portion 134 and the ambient environment into which the isolation portion 134 vents. For example, the mechanical actuators can be in an initial state prior to use of the control device 100, in which a pressure differential between the isolation portion 134 and a source of bodily fluid is based on a positive pressure (i.e., blood pressure) associated with, for example, a vasculature of a patient. In such cases, the pressure differential can be relatively small. In some such cases, the mechanical actuators can transition from the initial state to a subsequent state at the beginning of flow of an initial volume of bodily fluid, such that the transition of the mechanical actuators can expel air or gaseous contents within the isolation portion 134 and create a negative pressure differential between the isolation portion 134 and the source of bodily fluid, thereby drawing flow of the bodily fluid into the isolation portion 134. In some such embodiments, the transition of the mechanical actuators can also be configured to modify one or more openings (e.g., the one or more openings 136) of the isolation portion 134 to facilitate flow of the bodily fluid into the isolation portion 134. FIG. 1Access (not shown) is provided to allow air or gas within the components disposed in the isolation portion 134 to flow through one or more openings. In some embodiments, the amount of movement of the mechanical actuator and / or pressure equalization after movement of the mechanical actuator may be factors that determine and / or define how bodily fluids flow through the control device 100 and / or the amount or volume of bodily fluids to be delivered to the isolation portion 134, as disclosed in detail below with respect to specific embodiments.

[0067] In some embodiments, one or more flow controllers can be activated and / or operated in any suitable manner. FIG. 1 (Not shown in the image). For example, in some embodiments, the method of activating one or more flow controllers may be passive (e.g., automatic and requiring no user intervention, as described in detail below with reference to specific embodiments). In other embodiments, the method of activating one or more flow controllers may be active (e.g., in response to a generated energy source and / or negative pressure) and / or via user intervention (e.g., an external force applied by the user). In some such embodiments, the isolation portion 134 may include a structure or substance that is activated or deactivated to move or assist in moving the actuator from an initial state to a final state. The structure or substance may be activated by any suitable mechanism (e.g., by contact with a small amount of bodily fluid (or any other fluid), by the elapsed time, by a change in pressure or temperature, by expansion or contraction of volume, and / or similar methods). In some embodiments, the initial state may be a state in which one or more flow controllers or a portion thereof have a higher potential energy, and activation of the flow controllers causes the potential energy to be converted into kinetic energy. As some examples, activation of the substance may be the remodeling of a dry chemical, which produces a gaseous substance that moves the plunger. In other embodiments, activation may include dissolving a substance, which in turn allows the energy storage component to release energy to move a plunger (e.g., a spring that releases tension to move the plunger). Specific example embodiments are described in further detail below.

[0068] In some embodiments, the control device 100 and / or the isolation portion 134 may include and / or define one or more openings in fluid communication with the isolation portion 134. FIG. 1As described above, in some embodiments, the walls or structures of the control device 100 can include and / or define openings (e.g., vents, ports, apertures, orifices, etc., referred to herein as "openings") in fluid communication with the isolation portion 134 that are built into or defined by the body of the isolation portion 134. In some embodiments, the openings can be uncovered. In other embodiments, one or more devices that selectively control the flow of fluids and / or gases can be disposed within and / or can cover the openings. For example, in some embodiments, the openings can include mechanical ports, valves, membranes, vents, gates, and / or the like FIG. 1 As described above, in some embodiments, the walls or structures of the control device 100 can include and / or define openings (e.g., vents, ports, apertures, orifices, etc., referred to herein as "openings") in fluid communication with the isolation portion 134 that are built into or defined by the body of the isolation portion 134. In some embodiments, the openings can be uncovered. In other embodiments, one or more devices that selectively control the flow of fluids and / or gases can be disposed within and / or can cover the openings. For example, in some embodiments, the openings can include mechanical ports, valves, membranes, vents, gates, and / or the like FIG. 1 As described above, in some embodiments, the walls or structures of the control device 100 can include and / or define openings (e.g., vents, ports, apertures, orifices, etc., referred to herein as "openings") in fluid communication with the isolation portion 134 that are built into or defined by the body of the isolation portion 134. In some embodiments, the openings can be uncovered. In other embodiments, one or more devices that selectively control the flow of fluids and / or gases can be disposed within and / or can cover the openings. For example, in some embodiments, the openings can include mechanical ports, valves, membranes, vents, gates, and / or the like FIG. 1 As described above, in some embodiments, the walls or structures of the control device 100 can include and / or define openings (e.g., vents, ports, apertures, orifices, etc., referred to herein as "openings") in fluid communication with the isolation portion 134 that are built into or defined by the body of the isolation portion 134. In some embodiments, the openings can be uncovered. In other embodiments, one or more devices that selectively control the flow of fluids and / or gases can be disposed within and / or can cover the openings. For example, in some embodiments, the openings can include mechanical ports, valves, membranes, vents, gates, and / or the like

[0069] The openings and / or semi-permeable members can be configured to "vent the isolation portion 134." In some embodiments, venting of the isolation portion 134 as a result of the initial portion of the body fluid passing into the isolation portion 134 can allow for equalization of pressure in the isolation portion 134 and / or between the isolation portion 134 and, for example, a portion of the fluid source and / or fluid flow path external to the isolation portion 134 or equalization of pressure of the ambient environment into which the isolation portion 134 is vented. In some embodiments, the equalization of pressure can be a factor in determining and / or defining how the body fluid flows through the control device 100 and / or the amount or volume of the body fluid to be passed into the isolation portion 134.

[0070] Further expanding, venting of the isolation portion 134 can allow the flow of air or gas through the opening or semi-permeable member in response to displacement by the flow of bodily fluid. For example, in some embodiments, the isolation portion 134, the fluid flow path 133, and / or at least a portion of the internal volume of the control device 100 can contain a volume of air or gas prior to use. As bodily fluid flows through the inlet 132 of the control device 100 and into the fluid flow path 133, the bodily fluid displaces at least a portion of the air or gas contained therein. Moreover, in some embodiments, at least one outlet 136 of the control device 100 can be sealed prior to the transfer and / or isolation of the initial portion of bodily fluid. Thus, as bodily fluid enters the fluid flow path 133 and displaces the volume of air or gas otherwise disposed therein, the sealed arrangement of the at least one outlet forms an airlock or the like that restricts and / or substantially prevents the flow of fluid toward the at least one outlet 136. Conversely, the opening and / or semi-permeable member of the isolation portion 134 allows for venting of the isolation portion 134 in response to the volume of air or gas displaced by the bodily fluid. Thus, as described above, the venting of the isolation portion 134 and / or wicking arrangement facilitates, urges, encourages, draws, and / or otherwise directs the initial flow of bodily fluid into the isolation portion 134 as described above, as described in further detail herein with respect to particular embodiments.

[0071] As described above, in some embodiments, the opening can be and / or can be included in a port or the like. In some such embodiments, the port can be configured to couple to any suitable device, reservoir, pressure source, or the like. For example, in some embodiments, the port can be configured to couple to an external reservoir, which in turn can allow a larger volume of bodily fluid to be collectively transferred and / or delivered into the isolation portion 134 and the external reservoir. In other embodiments, the port can couple to a negative pressure source, e.g., a vacuum container, a pump, a syringe, and / or the like. In other embodiments, the port can be configured to receive a probe, a sampling tool, a testing device, and / or the like, which 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 disposed or isolated in the isolation portion 134. In yet other embodiments, the port can be coupled to any suitable infusion device configured to infuse the initial volume of bodily fluid isolated in the isolation chamber back into the patient and / or the source of bodily fluid (e.g., in the case of a patient who is critically ill or has a low volume of blood, or the like). In yet other embodiments, the port can couple to the outlet 136 such that the flow of the initial volume can be delivered to a fluid collection device coupled to the outlet 136 (e.g., after collecting one or more desired sample volumes that are substantially free of contaminants in a separate fluid collection device).

[0072] At least one outlet 136 of the control device 100 is in fluid communication with the fluid flow path 133 and / or is configured to be placed in fluid communication with the fluid flow path 133. The outlet 136 can be any suitable outlet, opening, port, stopcock, lock, seal, coupler, valve (e.g., a one-way valve, check valve, duckbill valve, umbrella valve, and / or the like), etc., and is configured to be fluidly coupled to a fluid collection device (not shown in FIG. 1 In some embodiments, the outlet 136 can be integrally formed with the fluid collection device. In other embodiments, the outlet 136 can be at least temporarily coupled to the fluid collection device via adhesive, force fit, mechanical fastener, threaded coupling, a perforation or piercing arrangement, any number of mating recesses, and / or any other suitable coupling or combination thereof. Similarly stated, the outlet 136 can be physically (e.g., mechanically) and / or fluidly coupled to the fluid collection device such that an internal volume defined by the fluid collection device is in fluid communication with the outlet 136. In yet other embodiments, the outlet 136 can be operably coupled to the fluid collection device via an intervening structure (not shown in FIG. 1 such as a flexible sterile tube. As noted above, in some embodiments, the arrangement of the at least one outlet 136 can be such that the outlet 136 is physically and / or fluidly sealed and / or otherwise fluidly isolated from at least a portion of the fluid flow path 133 prior to being coupled to the fluid collection device. In some embodiments, such a sealing arrangement can facilitate, direct, and / or otherwise encourage the flow of bodily fluid initially into the isolated portion 134 rather than the outlet 136.

[0073] The fluid collection device can be any suitable device for receiving and / or at least temporarily containing bodily fluid, such as any of those described above. In some embodiments, the fluid collection device can be one or more single-use disposable collection tubes, one or more vacuum-based collection tubes, and / or the like. For example, in some embodiments, the fluid collection device can be substantially similar or identical to a known sample container, such as the Vacutainer® (manufactured by BD), Vacutainer® Plus SN, or Vacutainer® Zestra® (manufactured by Becton, Dickinson and Company). FA (manufactured by Biomerieux, Inc.) and / or any suitable reservoir, vial, microvial, microliter vial, nanoliter vial, container, microcontainer, nancontainer, and / or the like. In some embodiments, the fluid collection device can include a vacuum seal that maintains a negative pressure condition (vacuum condition) inside the fluid collection device, which in turn can facilitate the extraction of bodily fluid from the patient through the control device 100 into the fluid collection device via a vacuum or suction. In embodiments in which the fluid collection device is a vacuum container or the like, after an initial portion of bodily fluid is transferred into and / or isolated by the isolation portion 134, which in turn can limit and / or substantially prevent the transfer of the initial portion of bodily fluid (potentially containing contaminants) into the fluid collection device, the user can couple the fluid collection device to the outlet 136, as described in further detail herein.

[0074] While the outlet 136 of the control device 100 is described above as being fluidly coupled to and / or otherwise placed in fluid communication with a fluid collection device, in other embodiments, the control device 100 can be used in cooperation with any suitable bodily fluid collection device and / or system. For example, in some embodiments, the control device 100 described herein can be used in any suitable fluid transfer device, such as those described in U.S. Patent Publication No. 2015 / 0342510, entitled "Sterile Bodily-Fluid Collection Device and Methods," filed on June 2, 2015 (referred to herein as the " '510 publication"), the disclosure of which is incorporated by reference herein in its entirety, and attached herewith as Exhibit B. More specifically, the control device 100 can be used in an "integrated" or pre-assembled device (e.g., such as those described in the '510 publication) to receive and isolate an initial volume of bodily fluid in order to reduce and / or eliminate contaminants in subsequent volumes of bodily fluid.

[0075] As described above, in some embodiments, the device 100 can be used to obtain a sample of bodily fluid that has been reduced in contamination from microorganisms, such as microorganisms that reside on the skin and / or the like. For example, in certain instances, a user, such as a doctor, physician, nurse, phlebotomist, technician, and / or the like, can manipulate the device 100 to establish fluid communication between the access device and a source of bodily fluid (e.g., a vein of a patient, cerebrospinal fluid (CSF) from a spinal canal, urine collection, and / or the like). As a particular example, in certain instances, the access device can include a needle or the like that can be manipulated to pierce the skin of a patient and insert at least a portion of the needle into a vein of the patient, thereby placing the access device in fluid communication with the source of bodily fluid (e.g., the vein). In other instances, the device 100 can be used to transfer a sample of bodily fluid that has been reduced in contamination from microorganisms, such as microorganisms that reside on a partially or not fully sterilized transfer device, surface, interface, personnel, and / or the like.

[0076] In some embodiments, once the inlet 132 is placed in fluid communication with a source of bodily fluid (e.g., a portion of a patient or a container), the outlet 136 can be fluidly coupled to a fluid collection device. As described above, in some embodiments, the fluid collection device can be any suitable reservoir, container, and / or device configured to receive a volume of bodily fluid. For example, the fluid collection device can be a vacuum reservoir or container that defines a negative pressure and / or can be a syringe that can be manipulated to create a negative pressure. In some instances, coupling the outlet 136 to the fluid collection device selectively exposes at least a portion of the fluid flow path 133 to a negative pressure, thereby creating a negative pressure differential that is operable to draw bodily fluid from the source of bodily fluid (e.g., a patient) through the inlet 132 into at least a portion of the fluid flow path 133.

[0077] The control device 100 can be coupled to the access device before or after the access device is placed in fluid communication with a source of bodily fluid. In other embodiments, the inlet 132 of the control device 100 comprises, forms, and / or is integrally formed with the access device. Thus, by coupling the inlet 132 to the access device or by forming the inlet 132 with the access device, the fluid communication established between the access device and the source of bodily fluid places the control device 100 in fluid communication with the source of bodily fluid. Thus, bodily fluid can flow from the source of bodily fluid (e.g., a vein of a patient or a collection device or reservoir) through the access device and / or at least through the inlet 132 into the flow fluid path 133 of the control device 100.

[0078] As described above, the fluid flow path 133 of the control device 100 establishes fluid communication between the inlet 132 and the isolation portion 134 and / or the outlet 136. In some embodiments, the arrangement of the control device 100 is such that when a volume of bodily fluid is delivered to and / or through the inlet 132, an initial portion of the volume of bodily fluid (also referred to herein as an "initial volume" or a "first volume") flows from the inlet 132 into the isolation portion 134 through at least a portion of the fluid flow path 133. That is, in some embodiments, the control device 100 can be in a first state or initial state in which the initial portion or initial volume of bodily fluid can flow into or through at least a portion of the fluid flow path 133 into the isolation portion 134. For example, in some embodiments, the initial state of the control device 100 can be a state in which the isolation portion 134 is vented and the outlet 136 is sealed and / or otherwise fluidically isolated from the inlet 132. In this way, bodily fluid entering the fluid flow path 133 displaces a volume of air or gas otherwise disposed therein, which in turn is released, expelled, and / or vented through the isolation portion 134 to a volume (e.g., ambient environment) external to the isolation portion 134. In this way, the initial portion of bodily fluid is pushed, drawn, and / or otherwise transferred into the isolation portion 134 by the venting before the bodily fluid flows to the outlet 136.

[0079] The initial portion and / or amount of bodily fluid can be any suitable volume of bodily fluid as described above. For example, in certain instances, the control device 100 can remain in the first state until a predetermined and / or desired volume (e.g., initial volume) of bodily fluid is delivered to the isolation portion 134. In some embodiments, the initial volume can be associated with and / or based at least in part on the volume of the isolation portion 134 and / or a bladder, bag, container, chamber, volume, etc. disposed therein. In some embodiments including one or more flow controllers, the initial volume can be associated with and / or based at least in part on a volume of bodily fluid sufficient to transition the one or more flow controllers from the first state and / or configuration to the second state and / or configuration.

[0080] For example, in some embodiments, the initial volume can be associated with and / or based at least in part on an amount or volume of such bodily fluid that can be absorbed by the absorbent material, swellable material, hydrophilic material, wicking material, and / or other suitable material disposed in the isolation portion 134 (e.g., material of one or more flow controllers). Further, as an example, the absorbent material, when sufficiently saturated, can affect a pressure differential between the isolation portion 134 and the fluid flow path 133 and / or the source of bodily fluid, thereby placing the isolation portion 134 in a sealed state. Similarly, the initial volume can be associated with and / or based at least in part on an amount or volume of such bodily fluid that is sufficient to completely wet or saturate a semi-permeable member or membrane otherwise configured to vent the isolation portion 134 (e.g., transition the isolation portion 134 from a "vented" state to a "sealed" state or similar state).

[0081] In some embodiments, the control device 100 can be configured to pass a volume (e.g., an initial volume) of bodily fluid into the isolation portion 134 until a pressure differential between the isolation portion 134 and the fluid flow path 133 and / or the source of bodily fluid is placed in substantial equilibrium, substantially equalized, and / or otherwise reduced below a desired threshold. In embodiments including a flow controller (e.g., one or more mechanical actuators (e.g., plungers)), an amount of movement and / or travel of the mechanical actuators can determine a resulting volume and / or pressure (or changes thereof) of or in the isolation portion 134. In such embodiments, the amount of the initial portion of bodily fluid can be sufficient to fill the volume and / or substantially equalize a pressure differential resulting from changes in the configuration of the mechanical actuators (or at least reduce the pressure differential below a threshold level). In other embodiments, the initial volume can be any suitable volume based on any combination of features and / or characteristics of the control device 100.

[0082] After the initial volume of bodily fluid is delivered and / or transferred into the isolation portion 134, the initial volume is isolated, sequestered, held, contained, compartmentalized, etc. in the isolation portion 134. For example, in some embodiments, a wicking and / or absorbent configuration of the isolation portion 134 (and / or a flow controller disposed therein) can be configured to maintain the initial volume of bodily fluid in the isolation portion 134 despite one or more changes occurring in other portions of the control device 100 (e.g., the opening of the outlet 136 and / or the like). In some embodiments, one or more portions of the flow path 133 that allow fluid communication between the inlet 132 and the isolation portion 134 and / or between the inlet 132 and the outlet 136 can include one or more flow controllers, e.g., a one-way valve (e.g., a check valve, duckbill valve, etc.) that allows fluid to flow in one direction (e.g., from the inlet 132 toward the isolation portion 134) but not in the other direction (e.g., from the isolation portion 134 toward the outlet 136 or toward the inlet 132). For example, in some embodiments, the delivery of the initial volume of bodily fluid into the isolation portion 134 is coordinated with the function of a one-way valve that prevents backflow of fluid from the isolation portion 134, which can place the isolation portion 134 in a sealed and / or isolated state. In some such embodiments, access to the fluid collection device (via the outlet 136) and / or a negative pressure within the fluid collection device can be operable to seal one or more valves, thereby placing the isolation portion 134 in a sealed and / or isolated state. As such, the isolation portion 134 can isolate and / or hold an initial portion of bodily fluid in the isolation portion 134. As described in further detail herein, in certain instances, contaminants such as skin-remaining microorganisms or the like that are dislodged during a venipuncture event can be entrained and / or included in the initial volume of bodily fluid, and thereby isolated in the isolation portion 134 when the initial volume is isolated in the isolation portion 134.

[0083] Upon initial volume transfer and / or transfer into the isolation portion 134, the device 100 can transition to a second state, in which one or more subsequent volumes of bodily fluid can flow from the inlet 132 through at least a portion of the fluid flow path 133 to the outlet 136. In some embodiments, once the initial volume of bodily fluid is isolated in the isolation portion 134, the control device 100 can passively and / or automatically (e.g., without user intervention) transition from the first state to the second state. For example, in some embodiments, filling the isolation portion 134 to bring the absorbent or similar material disposed in the isolation portion 134 to capacity and / or complete saturation, wetting and / or impregnation can limit and / or substantially prevent further transfer of bodily fluid into the isolation portion 134. In other embodiments, the control device 100 can be transitioned manually or at least in response to indirect user interaction. For example, in some embodiments, the user can at least partially block the openings and / or vents of the isolation portion 134, which in turn can limit and / or substantially prevent additional flow of bodily fluid into and / or transfer into the isolation portion 134. In other embodiments, the user can actuate the actuator or the like. FIG. 1 (Not shown) to transition control device 100 from a first state to a second state. In some other embodiments, at least a portion of an initial volume of bodily fluid can transition control device 100 from the first state to the second state. For example, control device 100 may include a bodily fluid-activated flow controller, such as a switch, valve, port, and / or the like. In other embodiments, a volume of bodily fluid can cause one or more flow controllers, such as actuators or the like, to move and / or displace, which may, for example, open ports, flow paths, and / or outlets. In some other embodiments, a user can manipulate the flow controller, such as a switch, valve, port, actuator, etc., to transition control device 100 from the first state to the second state.

[0084] Before or after the control device 100 is placed in the second state, the fluid collection device ( FIG. 1The outlet 136 can be at least fluidically coupled to the outlet 136 (not shown). In some embodiments, the arrangement of the outlet 136 can be such that the outlet 136 (or a portion of the fluid flow path 133 leading to the outlet 136) remains sealed until the initial volume of bodily fluid is isolated in the isolation portion 134, regardless of whether the fluid collection device is coupled to the outlet 136. Thus, with the fluid collection device fluidically coupled to the outlet 136 and the control device 100 in the second state (e.g., the initial volume of bodily fluid is / is isolated by the isolation portion 134), one or more any subsequent volumes of bodily fluid can flow from the inlet 132, through the fluid flow path 133 and the outlet 136, into the fluid collection device. Thus, as described above, isolating the initial volume of bodily fluid in the isolation portion 134 prior to collecting or acquiring 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 can be such that the control device 100 cannot transition to the second state until the initial volume is collected and isolated in the isolation portion 134.

[0085] FIG. 2 to FIG. 4 A fluid control device 200 according to an embodiment is shown. As described above with reference to the control device 100, the fluid control device 200 (also referred to herein as a "control device" or "device") is configured to draw and isolate a first portion or amount (e.g., an initial amount) of bodily fluid from a patient or other source of bodily fluid and subsequently draw a second portion or amount (e.g., a subsequent amount) of bodily fluid for use, for example, in a bodily fluid sampling and / or testing. By isolating the first portion or amount of bodily fluid, contaminants or the like (e.g., skin-surface resident microorganisms dislodged during a venipuncture event and / or microorganisms left on a transfer device, surface, and / or interface that is not fully sterilized) are similarly isolated, leaving the second portion or amount of bodily fluid substantially free of contaminants. In some embodiments, portions and / or aspects of the control device 200 are substantially similar in form and / or function to corresponding portions and / or aspects of the control device 100 described above with reference to FIGS. 1-4. Accordingly, such similar portions and / or aspects are not further described in detail here. FIG. 1 Corresponding portions and / or aspects of the control device 100 described are substantially similar. Accordingly, such similar portions and / or aspects are not further described in detail here.

[0086] As described above with reference to the control device 100, the control device 200 is configured to draw and isolate a first portion or amount (e.g., an initial amount) of bodily fluid from a patient or other source of bodily fluid and subsequently draw a second portion or amount (e.g., a subsequent amount) of bodily fluid for use, for example, in a bodily fluid sampling and / or testing. By isolating the first portion or amount of bodily fluid, contaminants or the like (e.g., skin-surface resident microorganisms dislodged during a venipuncture event and / or microorganisms left on a transfer device, surface, and / or interface that is not fully sterilized) are similarly isolated, leaving the second portion or amount of bodily fluid substantially free of contaminants. In some embodiments, portions and / or aspects of the control device 200 are substantially similar in form and / or function to corresponding portions and / or aspects of the control device 100 described above with reference to FIGS. 1-4. Accordingly, such similar portions and / or aspects are not further described in detail here. FIG. 2As shown in FIG. 1, the control device 200 includes an inlet device 210 and a housing 230 that is in fluid communication with and / or configured to be placed in fluid communication with the inlet device 210. Generally, the inlet device 210 can be any suitable device or set of devices configured to establish fluid communication between the housing 230 and a source of bodily fluid, such as the vasculature of a patient or a reservoir of collected bodily fluid. The housing 230 of the control device 200 can be any suitable device or set of devices configured to (1) receive a flow of bodily fluid, (2) store and isolate, sequester, hold, contain, segregate, etc., 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.

[0087] The inlet device 210 can be one or more of any suitable device, such as an IV catheter, a sharp catheter or sharp needle, and / or any other suitable device that includes a lumen. While shown in FIG. 2 to FIG. 4 FIG. 1 as a needle for obtaining fluid directly from a patient (e.g., from the vasculature of a patient), in other embodiments the inlet device 210 can be configured to obtain fluid from a reservoir or container or the like of bodily fluid that is collected from a patient. In some cases, the inlet device can include a suitable port or coupler or the like that can be connected to a corresponding port or coupler or the like of a reservoir containing collected bodily fluid, or to a corresponding port or coupler of a transfer device that in turn can be connected to a source of collected bodily fluid. In some embodiments, an inlet device coupled to a transfer device or reservoir of collected fluid can include associated structure and / or control devices to operate the inlet device to control fluid communication between the inlet device and the source of bodily fluid. For example, in the embodiment shown in FIG. 2 to FIG. 4 FIG. 1, the inlet device 210 is a butterfly needle or other suitable access device having a body 211, a needle 214, and a flexible tube 220. As shown in FIG. 4 FIG. 1, the body 211 defines a lumen 212 extending through the body 211, the needle 214 defines a lumen 215 extending through the needle 214, and the flexible tube 220 defines a lumen 221 extending through the flexible tube 220. The needle 214 is coupled to, for example, a distal end portion of the body 211 such that the lumen 215 of the needle 214 is in fluid communication with the lumen 212 of the body 211. Likewise, the flexible tube 220 is coupled to, for example, a proximal end portion of the body 211 such that the lumen 221 of the flexible tube 220 is in fluid communication with the lumen 212 of the body 211. Thus, the lumen 215 of the needle 214, the lumen 212 of the body 211, and the lumen 221 of the flexible tube 220 collectively define a fluid flow path extending through the inlet device 210.

[0088] In FIG. 2 to FIG. 4In the embodiment shown in FIGS. 1-3, the housing 230 of the control device 200 includes a body 231 having an inlet 232 and an outlet 236, and defines a fluid flow path 233 and an isolation and / or diversion portion 234 (also referred to herein as an "isolation portion"). The body 231 of the housing 230 can be any suitable shape, size, and / or configuration. For example, in some embodiments, the body 231 can be formed of a relatively rigid material, such as plastic or the like, and can be configured to maintain its shape and / or form when exposed to changes in pressure of the fluid and / or flow over the inlet and outlet. As shown in FIGS. 1-3, the inlet 232 of the body 231 is physically and fluidly coupled to an end portion of the flexible tube 220 (e.g., the flexible tube 220 is a flexible inlet tube for the housing 230). A portion of the fluid flow path 233 extends through the inlet 232 of the housing 230 such that the coupling of the inlet 232 to the flexible tube 220 establishes fluid communication between the inlet device 210 and the fluid flow path 233. Thus, as described in further detail herein, the housing 230 can receive a flow of bodily fluid from the inlet device 210. FIG. 2 and FIG. 4 As shown in FIGS. 1-3, the inlet 232 of the body 231 is physically and fluidly coupled to an end portion of the flexible tube 220 (e.g., the flexible tube 220 is a flexible inlet tube for the housing 230). A portion of the fluid flow path 233 extends through the inlet 232 of the housing 230 such that the coupling of the inlet 232 to the flexible tube 220 establishes fluid communication between the inlet device 210 and the fluid flow path 233. Thus, as described in further detail herein, the housing 230 can receive a flow of bodily fluid from the inlet device 210.

[0089] The fluid flow path 233 extends through the inlet 232 and places the inlet 232 in fluid communication with the isolation portion 234 and the outlet 236. In other words, a first portion of the fluid flow path 233 extends and / or is defined between the inlet 232 and the isolation portion 234, and a second portion of the fluid flow path 233 extends and / or is defined between the inlet 232 and the outlet 236. In some embodiments, the fluid flow path 233 can be a single, continuous fluid flow path that includes the first and second portions. In other embodiments, the housing 230 can be configured to selectively direct, divert, and / or control (e.g., via an automatic or user-controlled actuator or flow controller, such as a valve, a membrane, and / or the like) the flow of bodily fluid through the first or second portions of the fluid flow path 233.

[0090] The isolation portion 234 of the housing 230 is at least temporarily placed in fluid communication with the inlet 232 via the fluid flow path 233. As described in further detail herein, the isolation portion 234 is configured to (1) receive a flow and / or volume of bodily fluid from the inlet 232 and (2) isolate (e.g., separate, isolate, contain, hold, partition, etc.) the flow and / or volume of bodily fluid therein. The isolation portion 234 can be any suitable shape, size, and / or configuration. For example, in some embodiments, the isolation portion 234 can be formed of a relatively rigid material, such as plastic or the like, and can be configured to maintain its shape and / or form when exposed to changes in pressure of the fluid and / or flow over the inlet and outlet. FIG. 2 to FIG. 4In the embodiment shown in FIG. 2, the isolation portion 234 is at least partially formed by the body 231 of the housing 230. More specifically, the isolation portion 234 is offset from and / or non-coaxial with the axis defined by the lumen 221 of the flexible tube 220. In other words, the isolation portion 234 is not "in-line" between the inlet 232 and the outlet 236. For example, as shown in FIG. 2, the isolation portion 234 is offset from the axis defined by the lumen 221 of the flexible tube 220 by a distance D. In other embodiments, the isolation portion 234 can be offset from the axis defined by the lumen 221 of the flexible tube 220 by any suitable distance, such as a distance of 0.1 mm or more, 0.5 mm or more, 1 mm or more, 2 mm or more, 3 mm or more, 4 mm or more, 5 mm or more, 6 mm or more, 7 mm or more, 8 mm or more, 9 mm or more, 10 mm or more, 15 mm or more, 20 mm or more, 25 mm or more, 30 mm or more, 35 mm or more, 40 mm or more, 45 mm or more, 50 mm or more, 55 mm or more, 60 mm or more, 65 mm or more, 70 mm or more, 75 mm or more, 80 mm or more, 85 mm or more, 90 mm or more, 95 mm or more, 100 mm or more, 150 mm or more, 200 mm or more, 250 mm or more, 300 mm or more, 350 mm or more, 400 mm or more, 450 mm or more, 500 mm or more, 550 mm or more, 600 mm or more, 650 mm or more, 700 mm or more, 750 mm or more, 800 mm or more, 850 mm or more, 900 mm or more, 950 mm or more, 1000 mm or more, or any distance therebetween. FIG. 4 As shown in FIG. 2, the fluid flow path 233 is split, bifurcated, divided, and / or the like into a first portion configured to place the isolation portion 234 in fluid communication with the inlet 232 and a second portion configured to place the outlet 236 in fluid communication with the inlet 232.

[0091] The isolation portion 234 and / or the portion of the body 231 defining and / or forming the isolation portion 234 also includes and / or defines an opening 235 (e.g., a vent opening or the like) in fluid communication with the isolation portion 234. As described in detail above with reference to the isolation portion 134, the isolation portion 234 can have any suitable volume and / or fluid capacity (e.g., from a drop or drops of bodily fluid to 50 mL or more of bodily fluid). In other embodiments, the volume of the isolation portion 234 can be equal to and / or based at least in part on the combined volume of the lumens 212, 215, and 221 of the inlet device 210 and the volume of the portion of the fluid flow path 233 defined between the inlet 232 of the housing 230 and the isolation portion 234. In this way, the transfer of bodily fluid into the isolation portion 234 flushes the lumens 212, 215, and 221 and the fluid flow path 233, which in turn can remove and / or isolate contaminants previously contained therein.

[0092] The isolation portion 234 can include and / or can contain one or more flow controllers or the like configured to interact with bodily fluid transferred into the isolation portion 234. For example, as shown in FIG. 2, the isolation portion 234 can include one or more flow controllers 237 configured to interact with bodily fluid transferred into the isolation portion 234. The one or more flow controllers 237 can be of any suitable configuration, such as the configurations described above with reference to the flow controller 137. For example, in the embodiment shown in FIG. 2, the one or more flow controllers 237 are configured to interact with bodily fluid transferred into the isolation portion 234 by at least partially occluding the opening 235. FIG. 4 As shown in FIG. 2, the isolation portion 234 can include one or more materials configured to interact with bodily fluid. The one or more materials can be of any suitable configuration, such as the configurations described above with reference to the isolation portion 134. For example, in the embodiment shown in FIG. 2, the isolation portion 234 includes a first material 238 and a second material 239. The first material 238 can be of any suitable configuration, such as the configurations described above with reference to the first material 138. The second material 239 can be of any suitable configuration, such as the configurations described above with reference to the second material 139. FIG. 2 to FIG. 4In the embodiment shown in FIG. 2, the housing 230 includes a hydrophilic material 240 (e.g., a foam, a sintered plastic, a body fluid-absorbing material, and / or the like) and an air release material 242 (e.g., a selectively permeable material) disposed within the isolation portion 234. Thus, when body fluid is delivered into the isolation portion 234, the hydrophilic material 240 can absorb, attract, push, suction, hold, swell, and / or otherwise interact with at least a portion of the body fluid, which in turn can isolate and / or retain at least an initial portion of the body fluid within the isolation portion 234, as described in further detail herein. In other words, the hydrophilic material 240 can be a flow controller or the like configured to enhance and / or facilitate wicking, which in turn can draw body fluid into the isolation portion 234.

[0093] The air release material 242 can be configured to vent the isolation portion 234 via the opening 235 to allow, enhance, facilitate, and / or otherwise urge the flow of body fluid into the isolation portion 234. The air release material 242 can be arranged such that, upon delivery of body fluid into the isolation portion 234, the body fluid wets the air release material 242. In response to wetting, the air release material 242 can swell and / or can otherwise transition from a configuration and / or state in which the air release material 242 vents the isolation portion 234 to a configuration and / or state in which the air release material 242 seals the isolation portion 234. That is, the air release material 242 can be a self-sealing material configured to selectively allow the flow of gas (e.g., air) to vent from the isolation portion 234 through the opening 235.

[0094] In certain instances, the wetting or transition of the air release material 242 is associated with and / or related to an amount or volume of body fluid delivered into the isolation portion 234. For example, in some embodiments, the air release material 242 can be placed in a fully sealed configuration and / or can transition to a fully sealed configuration when a predetermined and / or desired amount of body fluid is delivered into the isolation portion 234 (e.g., an initial portion or volume). In some embodiments, the isolation portion 234 can isolate and / or retain a predetermined and / or desired volume of body fluid in the isolation portion 234 in response to the transition of the air release material 242 to a fully sealed configuration. Moreover, the housing 230 can transition (e.g., passively and / or automatically) from a first state to a second state in which body fluid flows to the outlet 236 through the fluid flow path 233 when the air release material 242 is in a fully sealed state and / or when an initial portion of body fluid is delivered to the isolation portion 234.

[0095] Both the hydrophilic material 240 and the air release material 242 can be any suitable shape, size, and / or configuration. In some embodiments, the hydrophilic material 240 and the air release material 242 can be substantially as described above with reference to the hydrophilic material 240 and the air release material 242, respectively, of the embodiment shown in FIG. 1. FIG. 1The hydrophilic or wicking material and the selectively permeable member or membrane described in isolation portion 134 are analogous. While the hydrophilic material 240 and the vent material 242 are shown and described herein as separate components and / or members, in some embodiments, the isolation portion can include a single piece of hydrophilic material that can form and / or can function as both the hydrophilic material 240 and the vent material 242. In other embodiments, the hydrophilic material 240 and the vent material 242 can be coupled and / or otherwise co-formed or unitarily formed during manufacture. Thus, the hydrophilic material 240 and the vent material 242 can independently or collectively form a flow controller that is configured to selectively control fluid flow into and / or out of the isolation portion 234.

[0096] The outlet 236 formed in and / or included in the body 231 is configured to be placed (directly or indirectly) with any suitable fluid collection device (not shown). For example, in some embodiments, the outlet 236 can be physically and fluidly directly coupled to a fluid collection device. In other embodiments, the outlet 236 can be indirectly coupled to and / or otherwise placed in fluid communication with a fluid collection device via any suitable intervening structure (e.g., a port, a conduit, a rigid or flexible tube, an adapter, etc.). In FIG. 2 to FIG. 4 In the embodiment shown in FIG. 1, for example, the outlet 236 can be physically and fluidly coupled to a flexible outlet tube 247. The outlet 236 can be any suitable outlet, opening, port, lock, seal, coupler, etc., and is in fluid communication with an internal lumen 248 of the flexible outlet tube 247, which in turn places the internal lumen 248 of the flexible outlet tube 247 in fluid communication with the fluid flow path 233. The outlet 236 can be coupled to the flexible outlet tube 247 (also referred to herein as an “outlet tube”) via any suitable connection, fit, adhesive, etc.

[0097] While in the embodiment shown in FIG. 1, the outlet 236 is directly coupled to the flexible outlet tube 247, in other embodiments, the outlet 236 can be indirectly coupled to and / or otherwise placed in fluid communication with the flexible outlet tube 247 via any suitable intervening structure (e.g., a port, a conduit, a rigid or flexible tube, an adapter, etc.). FIG. 2 to FIG. 4The end portion of the outlet tube 247 (e.g., opposite the end portion coupled to the outlet 236) is configured to establish fluid communication between the internal cavity 248 of the outlet tube 247 and a fluid collection device (not shown), although not shown. For example, in some embodiments, the end portion of the outlet tube 247 can include and / or can be coupled to an outlet needle or the like. In other embodiments, the outlet tube 247 can be coupled to a transfer adapter and / or the like, such as the transfer adapter described in U.S. Patent Publication No. 2015 / 0246352, entitled "Apparatus and Methods for Disinfection of a Specimen Container," filed March 3, 2015 (hereinafter the '352 publication), the disclosure of which is incorporated by reference herein in its entirety. Thus, the outlet tube 247 can place the outlet 236 of the housing 230 in fluid communication with a fluid collection device (not shown). As described above with reference to the outlet 136 of the housing 130, the outlet 236 of the housing 230 can be in a sealed or closed configuration when the housing 230 is in the first state, and the outlet 236 of the housing 230 can transition to an open configuration when the housing 230 transitions to the second state. The fluid collection device can be any suitable reservoir and / or container, such as the fluid collection devices described above with reference to the control device 100, and thus are not described in further detail herein.

[0098] As described in detail above with reference to the device 100, the device 200 can be used to transfer, isolate, segregate, hold (e.g., passively transfer), etc. a first or initial volume of bodily fluid such that a subsequently acquired or transferred sample of bodily fluid has reduced contamination from microorganisms, such as microorganisms left over from the skin or microorganisms left on a transfer set and / or the like that is not fully sterilized. For example, in some instances, a user, such as a physician, a medical doctor, a nurse, a phlebotomist, a technician, etc., can manipulate the device 200 by inserting at least a portion of the needle 214 into a vein of a patient (e.g., a venipuncture event) or a container of collected bodily fluid, and / or can establish fluid communication between the needle 214 and a source of bodily fluid. Once in fluid communication with the source of bodily fluid, fluid can flow from the source of bodily fluid (e.g., a vein of a patient or a container of collected bodily fluid) through the inlet device 210 and into the housing 230. In some embodiments, the housing 230 can be in and / or can be placed in a first or initial state in which an initial portion or initial volume of bodily fluid can flow into or through at least a portion of the fluid flow path 233 and into the isolation portion 234.

[0099] The initial portion and / or volume of the body fluid can be any suitable volume of body fluid as described above. For example, in some cases, the housing 230 can be held in a first state until a predetermined and / or desired volume (e.g., the initial volume) of body fluid is transferred to the isolation portion 234. FIG. 2 to FIG. 4 In the illustrated embodiments, the initial volume may be associated with and / or at least partially based on the amount or volume of bodily fluid that can be absorbed by the hydrophilic material 240 (e.g., a flow controller). Furthermore, as described above, the initial volume may be associated with and / or at least partially based on the transition of the venting material 242 to the sealing configuration. In some embodiments, the hydrophilic material 240 becoming saturated (e.g., after absorbing a maximum or substantially maximum amount of bodily fluid) and the venting material 242 (e.g., a flow controller) becoming saturated (e.g., such that the venting material 242 transitions to the sealing configuration) may occur simultaneously in response to the transfer of the same predetermined volume of bodily fluid to the isolation portion 234 (i.e., the initial volume). After the initial volume of bodily fluid is transferred and / or moved to the isolation portion 234, the initial volume is isolated, insulated, held, contained, separated, etc., within the isolation portion 234. As described above, contaminants (e.g., skin microorganisms or similar substances shed during a venipuncture event) may be entrained and / or included in the initial volume of the body fluid, and thus the contaminants may also be isolated in the isolation portion 234 when the initial volume is isolated in the isolation portion 234.

[0100] With the initial volume isolated in the isolation section 234, the device 200 can transition to a second state in which one or more subsequent volumes of body fluid can flow from the inlet 232 through at least a portion of the fluid flow path 233 to the outlet 236. FIG. 2 to FIG. 4 In the illustrated embodiment, the housing 230 is configured to automatically (e.g., without user intervention) transition from a first state to a second state once an initial volume of bodily fluid is isolated in the isolation portion 234. For example, filling the isolation portion 234 to bring the hydrophilic material 240 and / or the venting material 242 to capacity and / or complete saturation, wetting, and / or impregnation can limit and / or substantially prevent any additional volume of bodily fluid from entering the isolation portion 234. Additionally, complete saturation, wetting, and / or impregnation of the hydrophilic material 240 and / or the venting material 242 can limit and / or substantially prevent any fluid from flowing out of the isolation portion 234 into the fluid flow path 233. Thus, as subsequent flow and / or volume of bodily fluid enters the fluid flow path 233, the housing 230 guides and / or diverts the flow through a portion of the fluid flow path 233 to the outlet 236.

[0101] Despite FIG. 2 to FIG. 4The outlet tube 247 can be fluidly coupled to the fluid collection device prior to or after the housing 230 transitions to the second state, although not shown. In some embodiments, the arrangement of the outlet 236 can be such that the outlet 236 remains sealed until the initial volume of bodily fluid is isolated in the isolation portion 234, regardless of whether the fluid collection device is coupled to the outlet 236 and / or the outlet tube 247. Thus, in the event that the fluid collection device is fluidly coupled to the outlet tube 247 and the housing 230 is already in the second state, one or more any subsequent volumes of bodily fluid can flow from the inlet 232 through the fluid flow path 233 and the outlet 236 into the fluid collection device. Thus, as described above, isolating the initial volume of bodily fluid in the isolation portion 234 prior to collecting or acquiring 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 housing 230 can be such that the housing 230 directs and / or diverts flow into the isolation portion 234 prior to directing and / or diverting flow to the outlet 236. In other words, the housing 230 is configured to be forced compliance such that the housing 230 cannot transition to the second state until the initial volume is collected and isolated in the isolation portion 234.

[0102] Although the housing 230 is shown and described above as having the hydrophilic material 240 and the vent material 242 disposed in the isolation portion 234, which can be a flow controller, in other embodiments, a portion of the control device can include an isolation portion having any suitable configuration. For example, as described above with reference to the isolation portion 134, in some embodiments, the isolation portion 234 can include a hydrophilic coating or surface finish and / or any other suitable flow controller(s). In other embodiments, the isolation portion 234 can have a geometry configured to enhance and / or facilitate wicking and / or absorption, configured to act as a flow controller, or the like. Although the vent material 242 is described as an absorbent material and / or a selectively permeable member or membrane, in other embodiments, the isolation portion 234 can include a vent hole that forms or is formed with a one-way valve or the like. In some embodiments, such a valve can be gas permeable and liquid impermeable. In some embodiments, such a valve can be user actuated, fluid actuated, pressure actuated, time-based, or the like. In some embodiments, the isolation portion 234 can include a one-way valve and the vent material 242, which can collectively act to vent the isolation portion 234. In such embodiments, the one-way valve can be disposed in any suitable position relative to the vent material 242 (e.g., upstream or downstream relative to the vent material 242).

[0103] FIG. 5 and FIG. 6A fluid control device 300 according to an embodiment is shown. 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 draw and isolate a first portion or amount (e.g., an initial amount) of bodily fluid from a patient such that any subsequently drawn amounts, portions, and / or volumes of bodily fluid are substantially free of contaminants. In some embodiments, portions and / or aspects of control device 300 are substantially similar in form and / or function, respectively, to corresponding portions and / or aspects of control devices 100 and / or 200 described above with reference to FIG. 1 and FIG. 2 to FIG. 4 control devices 100 and / or 200 described above with reference to

[0104] As shown in FIG. 5 , control device 300 includes an inlet device 310 and a housing 330 that is in fluid communication with and / or configured to be placed in fluid communication with inlet device 310. Inlet device 310 can be one or more of any suitable device, e.g., an IV catheter, a sharp catheter or sharp needle, a coupler, a port, a connector, and / or any other suitable device that includes a lumen. In the embodiment shown in FIG. 5 and FIG. 6 , inlet device 310 is a butterfly needle or other suitable access device having a body 311, a needle 314, and a flexible tube 320. In addition, inlet device 310 is similar and / or substantially the same as inlet device 210 described in detail above with reference to FIG. 2 to FIG. 4 control device 200. Accordingly, inlet device 310 is not further described in detail herein. As described above with reference to inlet device 210 of control device 200, although shown as a needle for obtaining fluid directly from a patient (e.g., from the vasculature of a patient) in FIG. 5 to FIG. 6 , in other embodiments inlet device 310 can be configured to obtain fluid from a reservoir or container or the like of bodily fluid that is collected from a patient. In some cases, the inlet device can include a suitable port or coupler or the like that can be connected to a corresponding port or coupler or the like of a reservoir that contains the collected bodily fluid, or to a corresponding port or coupler of a transfer device that in turn can be connected to a source of the collected bodily fluid. In some embodiments, an inlet device coupled to a transfer device or reservoir of collected fluid can include associated structures and / or control devices to operate the inlet device to control fluid communication between the inlet device and the source of bodily fluid.

[0105] The housing 330 includes a body 331 having an inlet 332 and an outlet 336, and defines a fluid flow path 333 and a transfer and / or isolation portion 334 (also referred to herein as an "isolation portion"). The body 331 of the housing 330 can be of any suitable shape, size, and / or configuration. For example, in some embodiments, the body 331 can be formed of a more rigid material such as plastic or the like, and can be configured to maintain its shape and / or form when exposed to changes in fluid pressure and / or inlet and outlet flow. FIG. 5 and FIG. 6 As shown, body 331 forms and / or includes an inlet 332, which is physically coupled to an end portion of flexible tube 320 and fluidly coupled to an inlet device 310 via a lumen 321 defined by flexible tube 320 (e.g., flexible tube 320 is a flexible inlet tube for housing 330). Similarly, body 331 forms and / or includes an outlet 336, which is physically and fluidly coupled to a flexible outlet tube 347 (and / or any other suitable medical tubing, connector, and / or intermediate catheter), which defines a lumen 348 configured to position the outlet in fluid communication with a fluid collection device (not shown). An isolation portion 334 is offset from and / or non-coaxial with the inlet 332, and therefore, a fluid flow path 333 extends through a portion of body 331 to fluidly couple the inlet 332 to the isolation portion 334 and the outlet 336. Therefore, housing 330 may be at least in form or function similar to the above reference. FIG. 2 to FIG. 4 The housing 230 is similar to the one described in detail, and therefore, parts and / or aspects of the housing 330 will not be described in further detail here.

[0106] However, the housing 330 may differ from the housing 230 of the control device 200 in the arrangement of the isolation portion 334. For example, although the housing 230 includes a hydrophilic material 240 and a venting material 242 disposed in the isolation portion 234, the housing 330 includes an expandable bladder 343 (e.g., a flow controller and / or the like) disposed in the isolation portion 334, for example, as in FIG. 6In some embodiments, the inflatable bladder 343 disposed in the isolation portion 334 can be sealed, closed, and / or otherwise not vented when a volume of the isolation portion 334 external to the inflatable bladder 343 is vented and / or otherwise defines an opening configured to vent a volume of the isolation portion 334 external to and / or around the inflatable bladder 343. In some embodiments, the closed arrangement of the inflatable bladder 343 can be such that the opening need not include a selectively permeable member or membrane to prevent venting or escape of bodily fluid. In other embodiments, the isolation portion 334 can include venting materials, valves, and / or the like as described above with reference to the housing 230. The isolation portion 334, and more particularly the internal volume of the inflatable bladder 343 disposed therein, is at least temporarily placed in fluid communication with the inlet 332 via the fluid flow path 333 and is configured to (1) receive a flow and / or volume of bodily fluid from the inlet 332 and (2) isolate (e.g., separate, sequester, contain, hold, partition, etc.) the flow and / or volume of bodily fluid therein. As described in further detail herein, the isolation portion 334 can be configured to vent a volume of the isolation portion 334 external to and / or around the inflatable bladder 343 when a flow and / or volume of bodily fluid is delivered into the inflatable bladder 343, which in turn can displace air or gas that can otherwise impede and / or limit inflation of the inflatable bladder 343.

[0107] The inflatable bladder 343 can be any suitable shape, size, and / or configuration. For example, in the embodiments shown in FIG. 5 and FIG. 6 The inflatable bladder 343 (e.g., flow controller) is a flexible pouch, sachet, liner, and / or reservoir that includes and / or defines a single opening to allow fluid to flow from the fluid flow path 333 into the inflatable bladder 343, in the embodiments shown in FIG. 5 and FIG. 6While not shown in FIG. 3, in some embodiments, the inflatable bladder 343 can include and / or can contain an inflatable material, such as a foam or sintered plastic, which can absorb, attract, push, suction, hold, inflate at least a portion of the bodily fluid and / or otherwise interact therewith. Moreover, as the material expands in response to being wetted by the bodily fluid, the inflatable bladder 343 likewise expands, thereby allowing the bodily fluid to flow therein.

[0108] As described in detail above with reference to the devices 100 and / or 200, FIG. 5 and FIG. 6 The device 300, as shown in FIGS. 3A-3C, can be used to divert (e.g., passively) a first or initial volume of bodily fluid such that a subsequently acquired bodily fluid sample has reduced contamination from microorganisms, such as microorganisms left over the skin or microorganisms left on a transfer device that is not fully sterilized and / or the like. For example, in some instances, a user, such as a physician, a medical doctor, a nurse, a phlebotomist, a technician, and / or the like, can manipulate the device 300 by inserting at least a portion of the needle 314 into a vein of a patient (e.g., a venipuncture event) or a container of collected bodily fluid and / or can otherwise establish fluid communication between the needle 314 and a source of bodily fluid. Once in fluid communication with the patient, bodily fluid can flow from the source of bodily fluid (e.g., a vein of a patient or a source of collected fluid) through the inlet device 310 and into the housing 330. In some embodiments, the housing 330 can be in and / or can be placed in a first or initial state in which an initial portion or initial volume of bodily fluid can flow into or through at least a portion of the fluid flow path 333 and into the isolation portion 334, and more particularly, into the inflatable bladder 343.

[0109] The initial portion and / or volume of bodily fluid can be any suitable volume of bodily fluid as described above. For example, in certain instances, the housing 330 can be maintained in the first state until a predetermined and / or desired volume (e.g., initial volume) of bodily fluid is transferred to the isolation portion 334. In FIG. 5 and FIG. 6 In the embodiments shown in FIGS. 3A-3C, the initial volume can be associated with and / or based at least in part on an amount or volume of bodily fluid that can be stored, contained, and / or isolated in the inflatable bladder 343.

[0110] After the initial volume of bodily fluid is transferred and / or diverted into the isolation portion 334 or the inflatable bladder 343, the initial volume is isolated, sequestered, held, contained, compartmentalized, etc. in the isolation portion 334. For example, in some embodiments, the transfer of the initial portion or volume of bodily fluid into the inflatable bladder 343 can place the inflatable bladder 343 in a fully inflated state and / or configuration (e.g., the second state and / or the second configuration), and thus, the volume of bodily fluid contained in the inflatable bladder 343 substantially prevents any subsequent volume of bodily fluid from being disposed in the inflatable bladder 343. In some embodiments, once the inflatable bladder 343 is fully inflated, the pressure differential between the inflatable bladder 343 and, for example, the fluid flow path 333 can be reduced and / or substantially equalized such that no subsequent volume of bodily fluid is "sucked" into the inflatable bladder 343. In other embodiments, the opening to the inflatable bladder 343 can include a valve, a selectively permeable membrane, a fluid-actuated (e.g., bodily fluid-actuated) switch or seal, a user-actuated switch or seal, and / or the like, which can transition from a first state or open state to a second state or closed state to limit and / or substantially prevent bodily fluid from flowing into or out of the inflatable bladder 343. As noted above, contaminants (e.g., skin-dwelling microorganisms or the like that are dislodged during a venipuncture event) can be entrained and / or included in the initial volume of bodily fluid, and thus, can also be isolated in the isolation portion 334 (and / or the inflatable bladder 343) when the initial volume is isolated in the isolation portion 334 (and / or the inflatable bladder 343).

[0111] With the initial volume isolated in the isolation portion 334, the device 300 can transition to a second state in which one or more subsequent volumes of bodily fluid can flow from the inlet 332 through at least a portion of the fluid flow path 333 to the outlet 336. In some embodiments, the transition from the first state to the second state can be initiated by a user (e.g., a clinician) and / or automatically (e.g., without user intervention) upon the isolation of the initial volume in the isolation portion 334. FIG. 5 And FIG. 6 In the embodiment shown in FIGS. 1-3, the housing 330 is configured to automatically (e.g., without user intervention) transition from the first state to the second state upon the isolation of the initial volume of bodily fluid in the inflatable bladder 343. Thus, as subsequent flow and / or volumes of bodily fluid enter the fluid flow path 333, the housing 330 directs and / or diverts the flow through a portion of the fluid flow path 333 to the outlet 336. As noted above, the outlet 336 is in fluid communication with one or more fluid collection devices (e.g., via the flexible outlet tube 347) such that one or more subsequent volumes of bodily fluid can flow from the inlet 332, through the fluid flow path 333, the outlet 336, and the flexible outlet tube 347, and into the fluid collection devices (not shown). Thus, as noted above, the isolation of the initial volume of bodily fluid in the isolation portion 334 prior to the collection or acquisition of one or more sample volumes of bodily fluid reduces and / or substantially eliminates the amount of contaminants in the one or more sample volumes.

[0112] Furthermore, in some embodiments, the arrangement and / or like of the expandable pouch 343, the orifice or inlet into the expandable pouch 343, and the valve, switch, or actuator disposed in the orifice or inlet of the expandable pouch 343 can limit and / or substantially prevent the outflow of bodily fluid from the expandable pouch in response to a negative pressure or the like generated by the fluid collection device. In some embodiments, the vent and / or opening of the isolation portion 334 may include a valve or flow controller that, when transitioning from an open or venting state to a closed or sealed state, can generate a negative pressure within the volume of the isolation portion 334 outside the expandable pouch 343, the negative pressure being operable to retain an initial volume of bodily fluid within the expandable pouch 343. That is, despite being at least partially exposed to a negative pressure differential generated by the fluid collection device, the expandable pouch 343 is configured to retain and / or isolate an initial volume of bodily fluid. In other words, the expandable pouch 343 may be a flow controller configured to selectively control the inflow or outflow of fluid from the isolation portion 334.

[0113] Although devices 200 and 300 are described herein as including isolation chambers or isolation portions 234 and 334, respectively, which are offset from and / or not coaxial with inlets 232 and 332, respectively, in other embodiments, the isolation portions and / or at least a portion thereof may be “in a straight line” between the inlet and outlet. For example, FIG. 7 and FIG. 8 A fluid control device 400 according to an embodiment is shown. As described above with reference to devices 100, 200, and / or 300, the fluid control device 400 (also referred to herein as a “control device” or “device”) is configured to draw from and isolate a first portion or amount (e.g., an initial amount) of bodily fluid from a patient such that any subsequent draws of bodily fluid are substantially free of contaminants in terms of quantity, portion, and / or volume. In some embodiments, portions and / or aspects of the device 400 are substantially similar in form and / or function to corresponding portions and / or aspects of the devices 100, 200, and / or 300 described above. Therefore, such similar portions and / or aspects are not described in further detail herein.

[0114] like FIG. 7 As shown, the control device 400 includes an inlet device 410 and a housing 430, the housing 430 being in fluid communication with and / or configured to be positioned in fluid communication with the inlet device 410. The inlet device 410 can be one or more of any suitable devices, such as an IV catheter, a pointed catheter or a pointed needle, a port, a connector, a coupling, and / or any other suitable lumen-containing device. FIG. 7 to FIG. 8In the illustrated embodiment, the inlet device 410 is a butterfly needle or other suitable entry device, having a body 411, a needle 414, and a flexible tube 420. Furthermore, the inlet device 410 is similar to the one described above. FIG. 2 to FIG. 4 The inlet device 210 described in detail is similar to and / or substantially the same. Therefore, the inlet device 410 will not be described in further detail here. As described above with reference to the inlet devices 210 and 310 of control devices 100 and 200, although in FIG. 7 and FIG. 8 The image is illustrated as a needle for directly obtaining fluid from a patient (e.g., from the patient's vascular system), but in other embodiments, the inlet device 410 may be configured to obtain fluid from a reservoir or container or the like, which is bodily fluid collected from a patient. In some cases, the inlet device may include suitable ports or connectors or the like that can be connected to corresponding ports or connectors or the like of a reservoir containing the collected bodily fluid, or to corresponding ports or connectors of a delivery device that can in turn be connected to a source of the collected bodily fluid. In some embodiments, the inlet device coupled to a delivery device or reservoir for the collected fluid may include associated structures and / or control means for operating the inlet device to control fluid communication between the inlet device and the source of the bodily fluid.

[0115] Housing 430 includes a body 431 having an inlet 432 and an outlet 436. Furthermore, housing 430 defines a fluid flow path 433 and an isolation and / or diversion portion 434 (also referred to herein as an "isolation portion"). The body 431 of housing 430 can be of any suitable shape, size, and / or construction. For example, in some embodiments, the body 431 can be formed of a more rigid material such as plastic or the like and can be configured to maintain its shape and / or form when exposed to changes in fluid pressure and / or inlet and outlet flow. FIG. 7 and FIG. 8 As shown, an inlet 432 formed by the body 431 is physically coupled to an end portion of a flexible tube 420 and fluidly coupled to an inlet device 410 via a lumen 421 defined by the flexible tube 420 (e.g., the flexible tube 420 is a flexible inlet tube for the housing 430). Similarly, an outlet 436 formed by the body 431 is physically and fluidly coupled to an outlet tube 447 (e.g., a flexible medical tube and / or any other suitable port or catheter), which defines a lumen 448 configured to place the outlet in fluid communication with a fluid collection device (not shown). A fluid flow path 433 extends through the inlet 432 and places the inlet 432 in fluid communication with at least an isolation portion 434. Thus, the housing 430 can be at least formally or functionally associated with the above-mentioned references. FIG. 2 to FIG. 4 and FIG. 5 to FIG. 6The housing 230 and / or 330 described in detail are similar. Accordingly, portions and / or aspects of the housing 430 are not further described in detail herein.

[0116] However, the housing 430 can differ from the portions 230 and 330 in the arrangement of the isolation portion 434. For example, while the isolation portion 234 and the outlet 236 of the housing 230 are offset from and / or not coaxial with the inlet 432 thereof, in the embodiment shown in FIG. 7 and FIG. 8 the isolation portion 434 is "in-line" or coaxial with the inlet 432 and the outlet 436. In other words, the bodily fluid can flow from the inlet 432 to or through the isolation portion 434 within the fluid flow path 433 of the housing 430, and can again flow from the isolation portion 434 to the outlet 436 within the fluid flow path 433. In some embodiments, this arrangement can force compliance with a transfer protocol or the like in which an initial volume of bodily fluid is passed or drawn into the isolation portion 434 prior to being passed to the outlet 436, as described in further detail herein. While the isolation portion 434 is described as being "in-line" or coaxial with the inlet 432 and the outlet 436, in other embodiments, the fluid flow path 433 can be flexed or curved such that the isolation portion 434 is not coaxial with the inlet 432 and / or the outlet 436 while remaining "in-line" therewith.

[0117] As shown in FIG. 8 the isolation portion 434 includes a flow controller or the like, e.g., a hydrophilic material 440 disposed therein. In some embodiments, the hydrophilic material 440 can be substantially similar and / or identical to the hydrophilic material 240 described above with reference to FIG. 2 to FIG. 4 In other embodiments, the hydrophilic material 440 can be any suitable material and / or flow controller configured to attract, collect, and / or absorb fluid. In the embodiment shown in FIG. 7 to FIG. 8 the hydrophilic material 440 can include and / or can define an internal lumen 441 extending therethrough. For example, as shown in FIG. 8 the internal lumen 441 of the hydrophilic material 440 extends through the entire material 440. While the internal lumen 441 of the hydrophilic material 440 is shown as being substantially straight, linear, and / or extending along a single axis, in other embodiments, the internal lumen 441 of the hydrophilic material 440 can be flexed, curved, tortuous, and / or the like. In some embodiments, this configuration of the internal lumen 441 can restrict and / or substantially prevent the flow of bodily fluid through the internal lumen 441 without contacting the hydrophilic material 440.

[0118] In some embodiments, the arrangement of the hydrophilic material 440 is such that the lumen 441 is substantially closed and / or otherwise has a smaller diameter prior to the fluid contacting the hydrophilic material 440 (e.g., when the hydrophilic material 440 is substantially dry, such as prior to use of the device 400). In some embodiments, the initial diameter of the lumen 441 when in the closed configuration or state can limit and / or can substantially prevent the passage of fluid through the hydrophilic material 440. Upon the fluid being placed in contact with the hydrophilic material 440 disposed in the isolation portion 434, the hydrophilic material 440 is configured to absorb at least a portion of the fluid, and as a result the hydrophilic material 440 expands and / or swells. The expansion or swelling of the hydrophilic material 440 can cause the diameter of the lumen 441 therethrough to similarly and / or correspondingly expand or increase, which in turn can allow the fluid to flow through the lumen 441, as described in further detail herein.

[0119] As described in detail above with reference to the devices 100, 200, and / or 300, FIG. 7 to FIG. 8 The device 400, as shown in FIG. 4, can be used to transfer (e.g., passively) a first or initial volume of bodily fluid such that a subsequently obtained sample of bodily fluid has reduced contamination from microorganisms, such as skin- resident microorganisms and / or the like. For example, in some instances, a user such as a physician, a medical doctor, a nurse, a phlebotomist, a technician, and / or the like can manipulate the device 400 by inserting at least a portion of the needle 414 into a vein of a patient (e.g., a venipuncture event), and / or can otherwise establish fluid communication between the needle 414 and a source of bodily fluid. Once in fluid communication with the patient, bodily fluid can flow from the source of bodily fluid (e.g., the vein of the patient) through the inlet device 410 and into the housing 430.

[0120] In some embodiments, the housing 430 can be in a first or initial state prior to use, in which state the hydrophilic material 440 is in an initial or first state or configuration (e.g., as described above, the hydrophilic material 440 is substantially dry). As such, bodily fluid can flow from the inlet 432 through a portion of the fluid flow path 433 into the isolation portion 434, where the bodily fluid contacts the hydrophilic material 440. A first or initial amount of bodily fluid can be absorbed by the hydrophilic material 440, which causes the material 440 to expand or swell. In some embodiments, the first or initial amount of bodily fluid is a volume sufficient to wet or saturate the hydrophilic material 440 to a degree at which the lumen 441 defined by the material 440 transitions to an open configuration or state. That is, the expansion or swelling of the hydrophilic material 440 increases the diameter of the lumen 441 therethrough. Accordingly, any flow, amount, or volume of bodily fluid that flows through the fluid flow path 433 after the initial amount or volume can flow through the lumen 441 having the increased diameter.

[0121] In some embodiments, the arrangement of the hydrophilic material 440 and / or the isolation portion 434 can be such that bodily fluid is drawn into the isolation portion in response to a pressure differential between, for example, a source of bodily fluid (e.g., a patient's bloodstream) and the isolation portion 434. In such embodiments, the pressure differential can be sufficient to draw or push bodily fluid flow toward or into the hydrophilic material 440. Additionally or alternatively, in some embodiments, the fluid collection device can be fluidically coupled to the outlet tube 447 prior to drawing an initial volume of bodily fluid. In such cases, the fluid collection device can define a negative pressure (e.g., the fluid collection device can be a vacuum container or the like) that can be operable to draw or extract bodily fluid from a patient. In such embodiments, because the isolation portion 434 is upstream of the fluid collection device, bodily fluid flowing through the fluid flow path 433 can enter the isolation portion 434 and can engage the hydrophilic material 440, which in turn absorbs, attracts, retains, and / or isolates the initial volume of bodily fluid as it flows into the isolation portion 434. In other words, such an arrangement can increase the pressure differential between a source of bodily fluid (e.g., a patient's blood pressure or a container of collected bodily fluid or the like) and the isolation portion 434, which can otherwise be insufficient to transfer a desired amount of bodily fluid into the isolation portion 434 (e.g., as with the vasculature of a critically ill, young, or elderly patient or a small amount of collection of bodily fluid from which a greater pressure is not applied).

[0122] The arrangement of the isolation portion 434 and the hydrophilic material 440 is such that the hydrophilic material 440 absorbs, retains, and / or isolates an initial volume or amount of the bodily fluid. As described in detail above, contaminants (e.g., skin-dwelling microorganisms or the like that are dislodged during a venipuncture event (and / or other undesirable microorganisms)) can be entrained and / or included in the initial volume of bodily fluid, and thus can also be isolated in or by the hydrophilic material 440 in the isolation portion 434. In some embodiments, saturation of the hydrophilic material 440 (e.g., absorption and / or isolation of the initial amount or volume) can place the device 400 in a second state or configuration in which any subsequent volumes of bodily fluid flow through the lumen 441 of the hydrophilic material 440 (e.g., due to its increased diameter) and to the outlet 436 of the housing 430. As described in detail above, the outlet 436 is in fluid communication with one or more fluid collection devices (e.g., via the outlet tube 447) such that one or more subsequent volumes of bodily fluid can flow from the inlet 432, through the fluid flow path 433, the lumen 441 of the hydrophilic material 440, the outlet 436, and the outlet tube 447, and into the fluid collection devices (not shown). Thus, as described above, isolating the initial amount or volume of bodily fluid in the isolation portion 434 (or in or by the hydrophilic material 440 or other flow controller disposed therein) prior to collecting or obtaining one or more sample volumes of bodily fluid reduces and / or substantially eliminates the amount of contaminants in the one or more sample volumes.

[0123] While the devices 200, 300, and 400 are described herein as including flexible tubes 220, 320, and 420, respectively, that are configured to place the inlet devices 210, 310, and 410 in fluid communication with the isolation portions 230, 330, and 430, respectively, in other embodiments, the control devices can include inlet devices and diverters and / or housings that are physically and / or fluidically coupled in any suitable manner. For example, FIG. 9 to FIG. 12 A fluid control device 500 according to an embodiment is shown. As described above with reference to the devices 100, 200, 300, and / or 400, the fluid control device 500 (also referred to herein as a "control device" or "device") is configured to draw and isolate a first portion or amount (e.g., an initial amount) of bodily fluid from a patient such that any subsequently drawn amounts, portions, and / or volumes of bodily fluid are substantially free of contaminants. In some embodiments, portions and / or aspects of the device 500 are substantially similar in form and / or function to corresponding portions and / or aspects of the devices 100, 200, 300, and / or 400 described above. Accordingly, such similar portions and / or aspects are not described in further detail here.

[0124] As FIG. 9 andFIG. 10 As shown, the control device 500 includes an inlet device 510 and a housing 530, the housing 530 being at least partially disposed within the body 511 of the inlet device 510. The body 511 of the inlet device 510 may be a substantially hollow tube or body configured to receive at least a portion of the housing 530. Although the inlet device described above has included needles or the like, in FIG. 9 to FIG. 12 In the illustrated embodiment, the needle 514 is included in and / or coupled to a portion of the housing 530. Thus, the housing 530 can be inserted into and / or arranged within the inlet device 510 such that the needle 514 extends through a distal opening defined by the body 511 of the inlet device 510. In some embodiments, the arrangement of the inlet device 510 and the housing 530 can facilitate use by maintaining a generally common or known shape of the body of the inlet device 510 (e.g., similar to a butterfly needle or the like). In other embodiments, the body 511 of the inlet device 510 can be of any suitable shape and / or size, and does not require a similarly known device or the like. As previously described with reference to inlet devices 210, 310, 410, although the inlet device 510 is in FIG. 9 to FIG. 12 While illustrated as being configured to obtain fluid directly from a patient (e.g., from the patient's vascular system), in other embodiments, the inlet device 510 may be configured to obtain fluid from a reservoir or container or the like, which is bodily fluid collected from a patient. In some cases, the inlet device may include suitable ports or connectors or the like that can be connected to corresponding ports or connectors or the like of a reservoir containing the collected bodily fluid, or to corresponding ports or connectors of a delivery device that can in turn be connected to a source of the collected bodily fluid. In some embodiments, the inlet device coupled to a delivery device or reservoir for the collected fluid may include associated structures and / or control means to operate the inlet device to control fluid communication between the inlet device and the source of the bodily fluid.

[0125] The housing 530 includes a body 531 that includes and / or forms an inlet 532 and an outlet 536. Furthermore, the housing 530 defines a fluid flow path 533 and an isolation and / or transfer portion 534 (also referred to herein as an “isolation portion”). The body 531 of the housing 530 can be of any suitable shape, size, and / or configuration. For example, in some embodiments, the body 531 can be formed of a more rigid material such as plastic or the like and can be configured to retain its shape and / or form when exposed to variations in fluid pressure and / or inlet and outlet flow. The inlet 532 is physically and fluidly coupled to an end portion of a needle 514. More specifically, a proximal end portion of the needle 514 extends through the inlet 532 to position an interior 515 defined by the needle 514 in fluid communication with a fluid flow channel 533 defined by the housing 530. Outlet 536 is physically and fluidly connected to flexible outlet pipe 547 (also referred to herein as “outlet pipe”), which is configured to place the outlet in fluid communication with a fluid collection device (not shown).

[0126] For example, such as FIG. 12 As shown, outlet 536 is at least partially disposed within a slot 513 defined by the body 511 of inlet device 510. Therefore, outlet 536 can be coupled to outlet tube 547 without increasing the size of the body 511 of inlet device 510. In some embodiments, the arrangement of outlet 536 and / or outlet tube 547 extending through a portion of slot 513 can allow housing 530 to move within the body 511 of inlet device 510. In some such embodiments, device 500 can be configured such that housing 530 can move relative to inlet device 511 to selectively position needle 514 relative to inlet device 510. For example, in some embodiments, housing 530 may be in a proximal position or similar position before use, such that needle 514 is disposed within inlet device 510. Similarly, after collecting one or more bodily fluid samples using device 500, housing 530 can move to a proximal position (e.g., pre-use position) and / or toward said proximal position to retract the used needle 514 into inlet device 510. Therefore, this arrangement can reduce unwanted needle pricks or similar incidents.

[0127] like FIG. 10 and FIG. 12As shown in FIG. 5, a portion of the body 531 of the housing 530 includes and / or defines an isolation portion 534. More specifically, the body 531 of the housing 530 can include the isolation portion 534 at or in a portion of the housing 530 proximal to the needle 514 and the outlet 536 and / or can define the isolation portion 534, as described in further detail herein. As described above with reference to the isolation portion 234 of the housing 230, the housing 530 and / or the isolation portion 534 includes and / or defines an opening 535 (e.g., a vent opening) in fluid communication with the isolation portion 534 and / or otherwise has a substantially open proximal end.

[0128] The isolation portion 534 includes and / or houses one or more flow controllers configured to interact with bodily fluid transferred into the isolation portion 534. For example, as shown in the embodiment of FIG. 5, the isolation portion 534 includes a hydrophilic material 540 and a vent material 542 (e.g., one or more flow controllers), which can be similar to and / or substantially the same as the hydrophilic material 240 and the vent material 242, respectively, of the housing 230. Thus, when bodily fluid is transferred into the isolation portion 534, the hydrophilic material 540 can absorb, attract, retain, swell, and / or otherwise interact with at least a portion of the bodily fluid, which in turn can at least isolate and / or retain an initial portion of the bodily fluid within the isolation portion 534, as described in further detail herein. FIG. 9 to FIG. 12

[0129] The vent material 542 can be configured to vent the isolation portion 534 to allow, enhance, promote, and / or otherwise urge the flow of bodily fluid into the isolation portion 534. The vent material 542 can be arranged such that the bodily fluid wets the vent material 542 when the bodily fluid is transferred into the isolation portion 534, and the vent material 542 can transition from a configuration and / or state in which the vent material 542 vents the isolation portion 534 to a configuration and / or state in which the vent material 542 seals the isolation portion 534 once sufficiently wetted and / or saturated, as described above with reference to the vent material 242. Although the isolation portion 534 is described above as including the vent material 542 in other embodiments, the isolation portion 534 can include a vent hole or opening that includes a selectively permeable valve, membrane, and / or the like, as described above with reference to the isolation portion 234.

[0130] As described in detail above with reference to the devices 100, 200, 300, and / or 400, FIG. 9 to FIG. 12 ​The device 500 shown in FIG. 6 can be used to transfer (e.g., passively) a first or initial volume of bodily fluid such that a subsequently acquired bodily fluid sample has reduced contamination from microorganisms, such as microorganisms left over from the skin or microorganisms left over on a transfer set that was not fully sterilized and / or the like. For example, in some instances, a user such as a physician, a medical doctor, a nurse, a phlebotomist, a technician, or the like can manipulate the device 500 by inserting at least a portion of the needle 514 into a vein of a patient (e.g., a venipuncture event) or a source of bodily fluid and / or can establish fluid communication between the needle 514 and the source of bodily fluid. Once in fluid communication with the source of bodily fluid, fluid can flow from the source of bodily fluid (e.g., a vein of a patient) through the lumen 515 of the needle 514 into the inlet 532 of the housing 530.

[0131] In some embodiments, the housing 530 can be in a first or initial state prior to use in which the hydrophilic material 540 is in an initial or first state or configuration (e.g., the hydrophilic material 540 is substantially dry, as described above). As such, bodily fluid can flow from the lumen 515 of the needle 514 through a portion of the fluid flow path 533 (e.g., a portion of the fluid flow path 533 proximal of the outlet 536, for example, see FIG. 12 ) into the isolation portion 534. As described in detail above with reference to the housing 230, a first or initial amount of bodily fluid can be absorbed by the hydrophilic material 540, which causes the material 540 to expand or swell. In some embodiments, the first or initial amount of bodily fluid is a volume sufficient to wet or saturate the hydrophilic material 540 to, for example, a maximum level or extent. Further, in some instances, the vent material 542 can be wetted or saturated substantially simultaneously with the hydrophilic material 540. In other embodiments, the vent material 542 can be wetted and / or saturated substantially after the hydrophilic material 540 is saturated. In some embodiments, the first or initial amount of bodily fluid can be a volume of bodily fluid sufficient to fully wet and / or saturate each of the hydrophilic material 540 and the vent material 542. In other words, the first or initial amount of bodily fluid can be a volume of bodily fluid sufficient to transition one or more flow controllers from a first state to a second state.

[0132] After the initial volume of bodily fluid is transferred and / or moved into the isolation portion 534, the initial volume is isolated, insulated, retained, contained, separated, etc., within the isolation portion 534. For example, in some cases, the initial volume of bodily fluid is transferred into the isolation portion to completely saturate the hydrophilic material 540 (and / or the venting material 542), thereby limiting and / or substantially preventing further absorption and / or retention of the bodily fluid. Thus, the hydrophilic material 540 isolates the initial volume within the isolation portion 534 and rejects any subsequent volume of bodily fluid. As described above, contaminants (e.g., transdermal microorganisms or similar substances shed during a venipuncture event) may be entrained and / or included in the initial volume of bodily fluid, and thus, when the initial volume is isolated within the isolation portion 534, the contaminants may also be isolated within the isolation portion 534.

[0133] In some embodiments, the transfer and / or isolation of an initial volume of bodily fluid can automatically transition the device 500 from a first state to a second state, in which one or more subsequent volumes of bodily fluid can flow to an outlet 536 through at least a portion of a fluid flow path 533. For example, bodily fluid can flow through the lumen 515 of the needle 514 into the fluid flow path 533 of the body 531. Because the initial volume of bodily fluid is isolated in an isolation portion 534, bodily fluid can flow into the outlet 536, for example, in a distal direction toward the outlet 536 (see, for example). FIG. 12 In other words, with the housing 530 in its second state or configuration, subsequent flow and / or volume of bodily fluid can enter the fluid flow path 533, and the housing 530 can guide and / or transfer the flow through a portion of the fluid flow path 533 into the outlet 536. As described above, the outlet 536 is in fluid communication with one or more fluid collection devices (e.g., via an outlet pipe 547), allowing one or more subsequent volumes of bodily fluid to flow from the outlet 536 and the outlet pipe 547 into the fluid collection device (not shown). Therefore, as described above, isolating the initial amount or volume of bodily fluid in the isolation portion 534 (or in or by the hydrophilic material 540 disposed therein) before collecting or obtaining one or more sample volumes of bodily fluid reduces and / or substantially eliminates the amount of contaminants in one or more sample volumes.

[0134] Although the device 500 is described above as including an isolation portion 534, which is static and / or in a fixed position near the outlet 536, in other embodiments, the steering gear and / or housing may include an expandable and / or movable isolation portion (or a portion thereof). For example, FIG. 13 to FIG. 16BA fluid control device 600 according to an embodiment is shown. As described above with reference to control devices 100, 200, 300, 400 and / or 500, the fluid control device 600 (also referred to herein as a “control device” or “device”) is configured to aspirate and isolate a first portion or amount (e.g., an initial amount) of bodily fluid from a patient such that any subsequent aspirated bodily fluid is substantially free of contaminants in terms of volume, portion and / or volume. In some embodiments, portions and / or aspects of the device 600 are substantially similar in form and / or function to corresponding portions and / or aspects of the devices 100, 200, 300, 400 and / or 500 described above. Therefore, such similar portions and / or aspects are not described in further detail herein.

[0135] like FIG. 13 and FIG. 14 As shown, device 600 includes an inlet device 610 and a housing 630, the housing 630 being at least partially disposed within the body 611 of the inlet device 610. The body 611 of the inlet device 610 may be a substantially hollow tube or body configured to receive at least a portion of the body of the housing 630. FIG. 13 to FIG. 16B In the embodiment shown, the inlet device 610 is similar in form and / or function to the above-referenced FIG. 9 to FIG. 12 The inlet device 510 is substantially similar and therefore will not be described in further detail here. However, it should be noted that the inlet device 610 is presented by way of example and not as a limitation. The inlet device 610 can be any suitable inlet device, such as those described herein, and can be configured to obtain fluid from any suitable source of bodily fluid. For example, in some cases, the inlet device may include a suitable port or connector or the like that can be connected to a corresponding port or connector or the like of a reservoir containing the collected bodily fluid, or it may be connected to a corresponding port or connector of a transfer device that can in turn be connected to the source of the collected bodily fluid.

[0136] The housing 630 has a body 631 that includes and / or forms an inlet 632 and an outlet 636. Furthermore, the housing 630 defines a fluid flow path 633 and an isolation and / or transfer portion 634 (also referred to herein as an “isolation portion”). The body 631 of the housing 630 can be of any suitable shape, size, and / or configuration. For example, in some embodiments, the body 631 can be formed of a more rigid material such as plastic or the like and can be configured to retain its shape and / or form when exposed to variations in fluid pressure and / or inlet and outlet flow. The inlet 632 is physically and fluidly coupled to an end portion of the needle 614. More specifically, a proximal end portion of the needle 614 extends through the inlet 632 to position an interior 635 defined by the needle 614 in fluid communication with the fluid flow path 633 defined by the housing 630. Outlet 636 is physically and fluidly connected to a flexible outlet conduit 647 (also referred to herein as the "outlet conduit"), which is configured to place the outlet in fluid communication with a fluid collection device (not shown). For example, as FIG. 16A and FIG. 16B As shown, the outlet 636 is at least partially disposed within a slot 613 defined by the body 611 of the inlet device 610. In some embodiments, this arrangement may allow for movement of the housing 630 relative to the inlet device 610, as described in detail above with reference device 500.

[0137] The insulating portion 634 includes and / or contains one or more materials configured to interact with bodily fluids delivered to the insulating portion 634. For example, in FIG. 13 to FIG. 16B In the illustrated embodiment, housing 630 includes a hydrophilic material 640 and an venting material 642, each of which can act as a flow controller. The hydrophilic material 640 and venting material 642 may be similar to and / or substantially the same as the hydrophilic material 540 and venting material 542 of housing 530, respectively. Therefore, when bodily fluids are transferred to the isolation portion 634, the hydrophilic material 640 can absorb, attract, push, retain, swell at least a portion of the bodily fluids, and / or otherwise interact with them, which in turn can isolate and / or retain at least an initial portion of the bodily fluids within the isolation portion 634, as further described herein. Additionally, as bodily fluids are transferred to the isolation portion 634, the venting material 642 becomes wetted and / or saturated, which can transition the venting material 642 from a configuration and / or state in which the venting material 642 vents the isolation portion 634 to a configuration and / or state in which the venting material 642 seals the isolation portion 634, as described above with reference to the venting material 542. Therefore, at least a portion of the housing 630 may be formally and / or functionally similar to the above-referenced FIG. 9 to FIG. 12 The described housing 530 is basically similar.

[0138] However, the housing 630 can differ from the housing 530 by including a movable seal 644 configured to form a boundary and / or surface of the isolation portion 634. For example, in the embodiment shown in FIG. 13 to FIG. 16B the movable seal 644 includes and / or forms a sleeve 645 and an extension 646 extending from the sleeve 645. The seal 644 is movably disposed in the interior volume of the body 631 and in contact with an interior surface of the body 631 that defines at least a portion of the isolation portion 634. More specifically, as shown in FIG. 16A and FIG. 16B the sleeve 645 can be disposed about a portion of the hydrophilic material 640 such that the sleeve 645 is disposed between the portion of the hydrophilic material 640 and the interior surface of the body 631. In some embodiments, the hydrophilic material 640 and the seal 660 are integrally and / or unitarily formed. In other embodiments, the hydrophilic material 640 can be at least partially disposed within a portion of the seal 660 and retained therein via a press fit, a friction fit, and / or the like. In some embodiments, the seal 644, the hydrophilic material 640, and the vent material 640 can collectively form a flow controller or the like that can selectively control the flow of fluid through the isolation portion 634, as described in further detail herein.

[0139] The contact between the sleeve 645 of the seal 644 and the interior surface forms and / or defines a fluid seal. In some embodiments, the seal 644 can be formed of a material that is liquid-impermeable but still remains gas-permeable. In such embodiments, the seal 644 can prevent the flow of bodily fluids into a location within the body 631 of the housing 630 that is proximal to the seal 644 while simultaneously allowing the flow of gas (e.g., air) through the seal 644. Thus, as described above, the vent material 642 can function to vent the isolation portion 634 through the opening 635. In other embodiments, the seal 644 can be fluid-impermeable (e.g., liquid- and gas-impermeable). In such embodiments, the vent material 642 can be configured to vent a portion of the interior volume of the body 631 that is proximal to the seal 644. For example, in certain instances, the vent material 642 can expel air from the portion of the interior volume of the body 631 in response to movement of the fluid-impermeable seal 644 in a proximal direction.

[0140] As shown in FIG. 16A and FIG. 16BAs shown in FIG. 6, the extension 646 of the seal 644 is configured to selectively obstruct the outlet 636 of the housing 630. For example, in some embodiments, the extension 646 can contact a portion of the inner surface of the body 631 to form and / or define a fluid seal therebetween. Thus, when the movable seal 644 is in a distal position (e.g., a first or initial position, state, and / or configuration), the extension 646 obstructs the outlet 636 and isolates or sequesters the outlet 636 from the fluid flow path 633. Conversely, when the seal 644 is moved into and / or placed in a proximal position (e.g., a second or subsequent position, state, and / or configuration), the extension 646 is proximal to the outlet 636 such that the outlet 636 is in fluid communication with the fluid flow path 633, as described in further detail herein.

[0141] As described in detail above with reference to the device 500 (or any of the other devices described herein), FIG. 13 to FIG. 16B The device 600, as shown in FIG. 6, can be used to transfer (e.g., passively) a first or initial volume of bodily fluid such that a subsequently acquired sample of bodily fluid has reduced contamination from microorganisms, such as skin- resident microorganisms and / or the like. For example, in some instances, a user such as a physician, surgeon, nurse, phlebotomist, technician, and / or the like can manipulate the device 600 by inserting at least a portion of the needle 614 into a vein of a patient (e.g., a venipuncture event) and / or can otherwise establish fluid communication between the needle 614 and the patient. Once in fluid communication with the patient, bodily fluid can flow from the source of bodily fluid (e.g., the vein of the patient) through the lumen 635 of the needle 614 and into the inlet 632 of the housing 630.

[0142] In some embodiments, the housing 630 can be in a first or initial state prior to use in which the seal 644 is in a distal position, as shown in FIG. 6. FIG. 16A Further, with the housing 630 in the first or initial state, the hydrophilic material 640 can be substantially dry, unsaturated, and / or otherwise unexpanded. In this manner, bodily fluid can flow from the lumen 635 of the needle 614 through a portion of the fluid flow path 633 and into the sequestration portion 634 where the hydrophilic material 640 interacts with, attracts, aspirates, and / or absorbs the bodily fluid. As described in detail above with reference to the housing 230, a first or initial amount of bodily fluid can be absorbed by the hydrophilic material 640 (and / or any other suitable expandable or absorbent material), which causes the material 640 to expand or swell. In some embodiments, the first or initial amount of bodily fluid is a volume sufficient to wet or saturate the hydrophilic material 640 to, for example, a maximum level or extent.

[0143] In some embodiments, expansion or swelling of the material 640 can cause the seal 644 to move in a distal direction, as indicated by arrow AA in FIG. 16B In other words, as the hydrophilic material 640 absorbs the first or initial volume of bodily fluid that flows into the fluid flow path 633, the material 640 can push or otherwise move the seal 644 in the distal direction. In some embodiments, the movement of the seal 644 can create a negative pressure within the isolation portion 634 and / or the fluid flow path 633 (e.g., due to the increase in volume), which is operable to draw bodily fluid into the isolation portion 634. In this way, the hydrophilic material 640 and the negative pressure can draw the first or initial volume or amount of bodily fluid into the isolation portion 634. Moreover, as noted above, the vent material 642 can be configured to vent the housing 630 and the isolation portion 634 as the seal 644 moves in the AA direction.

[0144] After the initial volume of bodily fluid is delivered and / or transferred into the isolation portion 634, the initial volume is isolated, sequestered, held, contained, partitioned, etc. in the isolation portion 634. For example, in some cases, the delivery of the initial volume of bodily fluid into the isolation portion causes the hydrophilic material 640 to become fully saturated, such that further absorption and / or holding of bodily fluid is limited and / or substantially prevented. Thus, the hydrophilic material 640 isolates the initial volume in the isolation portion 634 and rejects any subsequent volumes of bodily fluid. As noted above, contaminants (e.g., skin-dwelling microorganisms or the like that are dislodged during a venipuncture event) can be entrained and / or included in the initial volume of bodily fluid, and thus can also be isolated in the isolation portion 634 when the initial volume is isolated in the isolation portion 634.

[0145] As noted above, movement of the seal 644 in the AA direction (e.g., the proximal direction) causes the extension 646 of the seal 644 to move relative to the outlet 636. In particular, as shown in FIG. 16B the movement of the seal 644 in response to the first or initial volume being transferred into the isolation portion 634 and / or being absorbed by the hydrophilic material 640 places the extension 646 in a proximal position relative to the outlet 636. Thus, a fluid communication path is established between the outlet 636 and the fluid flow path 633, which in turn is operable to transition the device 600 from the first state to a second state in which one or more subsequent volumes of bodily fluid can flow through at least a portion of the fluid flow path 633 and through the outlet 636.

[0146] With the initial volume of body fluid isolated within the isolation portion 634, one or more subsequent volumes of body fluid can flow through the lumen 635 of the needle 614, through a portion of the fluid flow path 633, and into the outlet 636. In other words, with the housing 630 in its second state or configuration, subsequent flows and / or volumes of body fluid can enter the fluid flow path 633, and the housing 630 can guide and / or divert the flow flowing through a portion of the fluid flow path 633 into the outlet 636. As described in detail above, the outlet 636 is in fluid communication with one or more fluid collection devices (e.g., via the lumen 648 defined by the outlet pipe 647), allowing one or more subsequent volumes of body fluid to flow from the outlet 636 and the outlet pipe 647 into a fluid collection device (not shown). Therefore, as described above, isolating the initial amount or volume of body fluid in the isolation portion 634 (or in the hydrophilic material 640 disposed therein or isolated by said hydrophilic material 640) before collecting or acquiring one or more sample volumes of body fluid reduces and / or substantially eliminates the amount of contaminants in one or more sample volumes.

[0147] Although the insulating portion 634 is described above as receiving an initial volume of body fluid, this in turn causes the hydrophilic material 640 to expand and causes the seal 644 to move in the AA direction (see, for example, see...). FIG. 17 to FIG. 20 However, in other embodiments, the flow of bodily fluids can generate and / or be associated with a force operable to transition the housing 630 from a first state to a second state. For example, in some embodiments, the force associated with the flow of bodily fluids into the isolation portion 634 can be sufficient to move the seal, regardless of whether the hydrophilic material 640 expands in response to contact and / or absorption of the initial volume of bodily fluids. In other words, the flow of bodily fluids can be and / or can be operable to transition the housing 630 and / or the control device 600 from a first state to a second state. In some embodiments, this can be based on the force associated with the flow of bodily fluids. In other embodiments, bodily fluids can transition a component or membrane from a first state to a second state. For example, in some embodiments, the extension 646 of the seal 644 can include or be formed of a soluble material or the like. In this way, bodily fluids can come into contact with soluble materials, which can dissolve or otherwise transition from a first state in which the material blocks the outlet 636 to a second state in which the material does not block the outlet 636 (e.g., the material is at least partially dissolved) after a desired or predetermined time.

[0148] FIG. 17A fluid control device 700 according to another embodiment is shown. As described above with reference to devices 100, 200, 300, 400, 500, and / or 600, fluid control device 700 (also referred to herein as a "control device" or "device") is configured to draw and isolate a first portion or amount (e.g., an initial amount) of bodily fluid from a patient such that any subsequently drawn bodily fluid is substantially free of contaminants. In some embodiments, portions and / or aspects of device 700 are substantially similar in form and / or function to corresponding portions and / or aspects of any of the above-described devices. Accordingly, such similar portions and / or aspects are not described in further detail herein.

[0149] As shown in FIG. 17 , control device 700 includes an inlet device 710 and a housing 730 that is in fluid communication with and / or configured to be placed in fluid communication with inlet device 710. Inlet device 710 can be one or more of any suitable device, e.g., an IV catheter, a sharp catheter or sharp needle, and / or any other suitable device that includes a lumen. For example, in the embodiment shown in FIG. 20 and FIG. 2 to FIG. 4 , inlet device 710 is a butterfly needle or other suitable access device having a body 711, a needle 714, and a flexible tube 720. In addition, inlet device 710 is similar to and / or substantially the same as inlet device 210 described in detail above with reference to FIG. 19 . Accordingly, inlet device 710 is not described in further detail herein. As previously described with reference to inlet devices 210, 310, 410, 510, and 610, although illustrated as being configured for direct access of fluid from a patient (e.g., from the vasculature of a patient), in other embodiments, inlet device 710 can be configured to access bodily fluid from any suitable source, reservoir, and / or container, as described above. FIG. 20

[0150] Housing 730 includes a body 731 having and / or forming an inlet 732, a first outlet 736, and a second outlet 737. In addition, housing 730 defines a fluid flow path 733 that is configured to selectively place inlet 732 in fluid communication with first outlet 736 or second outlet 737 (see, e.g., FIG. 17 ). Body 731 of housing 730 can be any suitable shape, size, and / or configuration. For example, in the embodiment shown in FIG. 20 and FIG. 19 ​In the embodiment shown in FIG. 7, the body 731 forms a T-shaped connector or a Y-shaped connector. In some embodiments, the body 731 can be formed of a relatively rigid material, such as plastic or the like, and can be configured to maintain its shape and / or form when exposed to changes in pressure of the fluid and / or flow across the inlet and outlet.

[0151] As such, the inlet 732 is coupled to a flexible tube 720 (e.g., the flexible tube 720 is a flexible inlet tube for the housing 730) that defines a lumen configured to place the inlet 732 in fluid communication with the inlet device 710. The first outlet 736 is coupled to a first flexible outlet tube 738 (also referred to herein as a "first outlet tube") that defines a lumen 739 configured to receive a first or initial volume of bodily fluid that flows through the housing 730. The first outlet tube 738 is also coupled to a vent 735 having a vent material 742 that can selectively vent the lumen 739 of the first outlet tube 738. As such, at least a portion of the lumen 739 can form, for example, an isolation and / or transfer portion and / or the like, as described in further detail herein. The second outlet is in fluid communication with a second flexible outlet tube 747 (also referred to herein as a "second outlet tube") that defines a lumen 748 configured to place the second outlet 747 in fluid communication with one or more fluid collection devices (not shown).

[0152] The fluid flow path 733 defined by the housing 730 establishes selective fluid communication with the first outlet 736 and the second outlet 737. As such, the fluid flow path 733 can be configured to selectively allow fluid to flow from the inlet 732 to the first outlet 736 and / or the second outlet 737, as described in further detail herein. FIG. 20 and FIG. 17 to FIG. 20 As shown in FIGS. 7 and 8, the housing 730 is arranged such that the fluid flow path 733 is restricted and / or reduced at or near the first outlet 736 and the second outlet 737. In some embodiments, for example, a portion of the fluid flow path 733 associated with and / or defined by the first outlet 736 can be offset and / or misaligned from a portion of the fluid flow path 733 associated with and / or defined by the inlet 732, which in turn forms and / or defines a reduced diameter and / or other suitable restriction therebetween. Likewise, a portion of the fluid flow path 733 associated with and / or defined by the second outlet 737 can be offset and / or misaligned from a portion of the fluid flow path 733 associated with and / or defined by the inlet 732, which in turn forms and / or defines a reduced diameter and / or other suitable restriction therebetween. In some embodiments, the restriction or like parameter can allow for selective fluid flow from the inlet 732 to the first outlet 736 or the second outlet 737 based on, for example, a differential pressure and / or the like, as described in further detail herein.

[0153] While the fluid flow path 733 is described above as forming a restriction or the like within the fluid flow path 733 to both the first outlet 736 and the second outlet 737, in other embodiments, the housing 730 can define and / or include a restricted flow path for the first outlet 736 or the second outlet 737. For example, in some embodiments, the housing 730 can form a flow restriction and / or the like within the fluid flow path 733 to the second outlet 737. In some embodiments, the flow restriction can restrict the flow of fluid from the inlet 732 toward the second outlet 737, while there is no such flow restriction in the flow of fluid from the inlet 732 toward the first outlet 736. In some cases, such an arrangement can facilitate a desired and / or predetermined flow of bodily fluid through the first outlet 736 into the first outlet tube 738 (e.g., isolation portion) before the bodily fluid flows through the second outlet 737 to the first outlet tube 747.

[0154] As described in detail above with reference to the devices 100, 200, 300, 400, 500, and / or 600, FIG. 20 The device 700, as shown in FIG. 7, can be used to transfer (e.g., passively) a first or initial volume of bodily fluid such that a subsequently acquired bodily fluid sample has reduced contamination from microorganisms, such as skin- resident microorganisms and / or the like. For example, in some cases, a user such as a physician, a surgeon, a nurse, a phlebotomist, a technician, and / or the like can manipulate the device 700 by inserting at least a portion of the needle 714 into a vein of a patient (e.g., a venipuncture event) and / or can otherwise establish fluid communication between the needle 714 and the patient. Once in fluid communication with the patient, bodily fluid can flow from the source of bodily fluid (e.g., the vein of the patient) through the inlet device 710 and into the housing 730.

[0155] In some embodiments, the housing 730 can be in a first or initial state prior to use and / or prior to establishing fluid communication between the second outlet tube 747 and one or more fluid collection devices (not shown). Although not shown, in such embodiments, the second outlet tube 747 can include a port or the like that can be in a closed configuration prior to coupling to a fluid collection device such that the second outlet tube 747 is substantially sealed. In contrast, as noted above, the first outlet tube 738 is coupled to the vent 735, which can be configured to vent the internal cavity 739 (e.g., isolation portion, reservoir, and / or chamber) of the first outlet tube 738 when the housing 730 is in the first or initial state. As such, the pressure differential (e.g., negative pressure differential) between the internal cavity 739 of the first outlet tube 738 and the internal cavity 721 of the flexible tube 720 can be greater than the pressure differential between the internal cavity 748 of the second outlet tube 747 and the internal cavity 721 of the flexible tube 720. Accordingly, as the bodily fluid flows into the fluid flow path 733, the bodily fluid will flow into the first outlet 736 in response to the greater pressure differential (e.g., based at least in part on the venting of the first outlet tube 738). That is, when the housing 730 is in the first or initial state, the housing 730 diverts and / or directs the flow of bodily fluid from the inlet 732 to the first outlet 736. Moreover, in some embodiments, the housing 730 can define and / or include one or more flow restrictions or the like between the fluid flow path 733 and the second outlet 737, which can encourage a desired and / or predetermined flow of bodily fluid from the fluid flow path 733 through the first outlet 736.

[0156] As such, the bodily fluid can flow from the inlet 732 through a portion of the fluid flow path 733 and the first outlet 736 into the internal cavity 739 of the first outlet tube 738, as indicated by arrow BB in FIG. 20 The first or initial amount of bodily fluid can be diverted into the internal cavity 739 of the first outlet tube 738. In some cases, the first outlet tube 738 can be curved, bent, and / or positioned such that the flow of bodily fluid into the internal cavity 739 of the first outlet tube 738 is aided and / or enhanced by gravity. For example, in some cases, an end portion of the first flexible outlet tube 738 (e.g., an end portion coupled to and / or including the vent 735) can be placed in a position (e.g., at a lower elevation) below the body 731 of the housing 730, thereby facilitating the flow of bodily fluid toward the vent 735.

[0157] In some cases, the first or initial amount of bodily fluid is a volume sufficient to wet or saturate the vent material 742. As described above with reference to the vent material 242 included in the housing 230, the vent material 742 (e.g., flow controller) 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). As such, the delivery of the first or initial volume of bodily fluid into the inner cavity 739 (e.g., isolation portion, flow path, inner cavity, chamber, etc.) of the first outlet tube 738 seals the vent material 742, which in turn allows the pressure within the inner cavity 739 to equalize and / or substantially equal the pressure in, for example, the fluid flow path 733 and / or the inner cavity 721 of the flexible tube 720. In some embodiments, the first or initial volume of bodily fluid can be a volume sufficient to completely fill the inner cavity 739 of the first outlet tube 738 without the vent material 742 becoming fully saturated or without becoming saturated at all. In such embodiments, the first outlet tube 738 can include, for example, a valve or a selectively permeable membrane configured to limit and / or substantially prevent the flow of bodily fluid out of the first outlet tube 738. In some embodiments, such a valve or membrane can be activated automatically, by a user, and / or a combination thereof.

[0158] The arrangement of the first outlet tube 738 (e.g., isolation chamber) is such that the inner cavity retains and / or isolates the initial volume or amount of bodily fluid therein. As described in detail above, contaminants (e.g., skin-dwelling microorganisms or the like that are dislodged during a venipuncture event) can be entrained and / or included in the initial volume of bodily fluid and, as such, can also be isolated in the first outlet tube 738. In some embodiments, completely filling the inner cavity 739 of the first outlet tube 738 and / or saturating the vent material 742 can place the housing 730 and / or the device 700 in a second state or configuration in which any subsequent volumes of bodily fluid flow through the fluid flow path 733 into the second outlet 737, as indicated by arrow CC in FIG. 21

[0159] As described in detail above, the second outlet 737 is in fluid communication with one or more fluid collection devices (e.g., via the second outlet tube 747) such that one or more subsequent volumes of bodily fluid can flow from the inlet 732 through the fluid flow path 733, the second outlet 736, and the second outlet tube 747 into the fluid collection device (not shown). Thus, as described above, isolating the initial amount or volume of bodily fluid in the first outlet tube 738 (e.g., isolation chamber) prior to collecting or acquiring one or more sample volumes of bodily fluid reduces and / or substantially eliminates the amount of contaminants in the one or more sample volumes.

[0160] FIG. 22 and FIG. 1 ​A fluid control device 800 according to yet another embodiment is shown. As described above with reference to control devices 100, 200, 300, 400, 500, 600, and 700, fluid control device 800 can be configured to draw and isolate or sequester or hold a first portion or amount (e.g., an initial amount) of bodily fluid from a patient or reservoir of collected bodily fluid and subsequently draw a second portion or amount (e.g., a subsequent amount) of bodily fluid for use in, for example, bodily fluid sampling and / or testing. When a bodily fluid sample is delivered, contaminants or the like (e.g., skin-borne microorganisms expelled during a venipuncture or microorganisms left in a delivery device that is not fully sterilized) are similarly isolated by isolating the first portion or amount of bodily fluid, leaving the second portion or amount of bodily fluid substantially free of contaminants. In some embodiments, portions and / or aspects of control device 800 are substantially similar in form and / or function to corresponding portions and / or aspects of control devices 100 described above with reference to FIGS. 1-7. Accordingly, such similar portions and / or aspects are not further described in detail herein. FIG. 21 to FIG. 22 Corresponding portions and / or aspects of control device 100 described above with reference to FIGS. 1-7 are substantially similar in form and / or function. Accordingly, such similar portions and / or aspects are not further described in detail herein.

[0161] Control device 800 can be any suitable device or set of devices configured to (1) receive a flow of bodily fluid, (2) store and isolate a first volume or initial volume of bodily fluid, and (3) direct, divert, and / or otherwise facilitate a subsequent flow of bodily fluid to a fluid collection device (not shown). In the embodiment shown in FIG. 8, control device 800 includes an inlet 832 (or inlet portion) and an outlet 836 (or outlet portion) and defines an isolation and / or diversion portion 834 (also referred to herein as an "isolation portion"). Additionally, control device 800 defines one or more fluid flow paths 813 between inlet 832 and isolation portion 834 and / or between inlet 832 and one or more outlets 816, as described in further detail herein. FIG. 21 Inlet 832 of control device 800 is configured to be fluidically coupled to an inlet device (not shown in FIGS. 1-7) to place control device 800 in fluid communication with a source of bodily fluid (e.g., a patient's vasculature or any other suitable source of bodily fluid). The inlet device can be any suitable device or set of devices. For example, in some embodiments, the inlet device can be an intravenous (IV) catheter, a needle, and / or any other suitable device including a lumen. In other embodiments, the inlet device can be a port, a valve, and / or the like, such as a Luer

[0162] FIG. 22 FIG. 22 ​​​or any other suitable coupler. In such embodiments, the inlet device (e.g., port or coupler) can be configured to couple to an access device that is in fluid communication with a patient (e.g., an indwelling or placed IV catheter or needle) and / or in fluid communication with any other suitable source of bodily fluid. In some embodiments, the inlet 832 can be physically and fluidically coupled to the inlet device via a lock, coupler, port, or the like. In other embodiments, the inlet 832 can be in fluid communication with the inlet device via an intermediate, lumen-containing device (e.g., a sterile tube or the like). In yet other embodiments, the inlet 832 of the control device 800 can form and / or can be integrally or monolithically formed with the inlet device. Thus, the inlet 832 and / or inlet device can be any suitable device, component, and / or feature configured to obtain bodily fluid from any suitable source of bodily fluid, such as those described above.

[0163] The control device 800 can be any suitable shape, size, and / or configuration. For example, in some embodiments, the control device 800 can be sized based at least in part on a volume of bodily fluid that is at least temporarily stored in, for example, the isolation portion 834. As shown in the cross-sectional view of FIG. 8B, the control device 800 can have a size that is at least partially based on the volume of bodily fluid that is at least temporarily stored in the isolation portion 834. FIG. 21 to FIG. 22 As shown in the cross-sectional view of FIG. 8B, the control device 800 can include and / or can form a bifurcation (e.g., a Y-shaped or T-shaped bifurcation or the like), thereby forming one or more portions of the fluid flow path 833. In some embodiments, the control device 800 can be formed of a relatively rigid material, such as a rigid plastic or the like, and can be configured to maintain its shape and / or form when exposed to changes in pressure of the fluid and / or changes in flow at the inlet and outlet. In some embodiments, some portions of the control device 800 (e.g., the isolation portion 834) can be formed of a relatively rigid material, while at the same time some other portions of the control device 800 (e.g., a tube or the like that defines at least a portion of the one or more flow paths 833) can be formed of a relatively flexible material, such as a flexible plastic, rubber, or the like.

[0164] In some embodiments, the control device 800 can be configured such that a first portion of the fluid flow path 833 (also referred to herein as a "flow path") places the inlet 832 in selective fluid communication with the isolation portion 834, and a second portion of the flow path 833 places the inlet 832 in selective fluid communication with the outlet 836. In some embodiments, the different portions of the flow path 833 can be formed by integrally or unitarily configured portions of the control device 800. In other embodiments, the portions of the flow path 833 can be formed by assembly of one or more components of the control device 800. For example, in some embodiments, the inlet 832 (or inlet portion) can comprise and / or can define the first portion of the flow path 833, the isolation portion 834 (or a portion of the isolation portion 834) can comprise and / or can form the second portion of the flow path 833, and the outlet 836 (or outlet portion) can comprise and / or can define the third portion of the flow path 833. In some embodiments, the inlet 832 (or inlet portion), the isolation portion 834 (or a portion thereof), and the outlet 836 (or outlet portion) can comprise and / or can be formed with one or more tubes or other lumen-containing devices coupled to one another by one or more suitable couplers or ports (e.g., T- connectors, Y-connectors, and / or one or more any other suitable couplers), or attached to one another by any suitable mechanism to form portions of a continuous fluid flow path 833. More particularly, in some embodiments, the control device 800 can comprise a junction 817 or the like collectively formed at or near the connection of the inlet 832 (or inlet portion), the isolation portion 834 (or a portion thereof), and the outlet 836 (or outlet portion). As described in further detail herein, in some embodiments, the control device 800 can be configured to transition at or near the junction 817 to control the flow of bodily fluid therethrough.

[0165] The control device 800 (and / or the inlet 832, the isolation portion 834, the outlet 836, and / or the junction 817) can be arranged such that any suitable portion of the flow path 833 has any suitable and / or desired length, width, shape, and / or configuration. Similarly, any suitable portion(s) of the flow path 833 can have any suitable form and / or can include any suitable interior surface (e.g., a textured interior surface, a fluted interior surface, a smooth interior surface, etc.). For example, in some embodiments, a portion of the flow path 833 formed by and / or between the inlet 832 and the isolation portion 834 (and portions thereof) can be configured to, for example, facilitate fluid flow toward the isolation portion 834 (e.g., relative to the outlet 836). For example, in some embodiments, this portion of the flow path 833 can be relatively wide compared to a portion of the flow path 833 defined between, for example, the junction 817 and the outlet 836. In other embodiments, the portion of the control device 800 defining the portion of the flow path 833 between the inlet 832 and the junction 817 and / or between the junction 817 and the isolation portion 834 can have a textured interior surface (e.g., a recessed interior surface) configured to aid in the absorption, attraction, and / or wicking of bodily fluid. In some embodiments, the fluid flow path 833 can be a continuous fluid flow path including one or more portions. In other embodiments, the control device 800 can be configured to selectively direct, divert, and / or control the flow of bodily fluid through the portion of the fluid flow path 833 via an automatic actuator (e.g., without user intervention) or a user-controlled actuator or flow controller (e.g., a valve, a membrane, and / or the like). For example, in some embodiments, the junction 817 can include any suitable actuator (e.g., a passive actuator or an active actuator).

[0166] The isolation portion 834 of the control device 800 is placed in fluid communication with the inlet 832 via a fluid flow path 833 (e.g., defined at least in part by the inlet 832, the junction 817, and the isolation portion 834) at least temporarily. As described in further detail herein, the isolation portion 834 is configured to (1) receive a flow and / or volume of bodily fluid from the inlet 832 and (2) isolate (e.g., separate, sequester, contain, hold, partition) the flow and / or volume of bodily fluid therein. The isolation portion 834 of the control device 800 can be integrally formed as part of the control device 800. Alternatively, the isolation portion 834 can be separately formed and configured to be attached or assembled to the control device 800 by suitable attachment or connection mechanisms or members (e.g., the junction 817). For example, the isolation portion 834 can be made with an open end portion (not shown) configured to be engagingly connected with an open end portion of the control device 800, which can be, for example, an open end portion of the junction 817 integrally formed with the control device 800 or separately formed and assembled to the control device 800. The engaging connection can be made by any suitable connection mechanisms, members, or couplings (e.g., pressure fittings, friction fittings, barbed fittings, one or more locking couplings, etc.).

[0167] The isolation portion 834 can be any suitable shape, size, and / or configuration. In some embodiments, the control device 800 can include an isolation portion 834 having a particular shape, size, and / or configuration. For example, in the embodiment shown in FIG. 21 , the isolation portion 834 is at least partially formed by the control device 800 and is configured to have a relatively flat, cylindrical shape, as shown in the front view in FIG. 22 and the cross-sectional view in FIG. 22 .

[0168] The isolation portion 834 and / or the control device 800 defining and / or forming a portion of the isolation portion 834 also includes and / or defines an opening 835 (e.g., vent, port, aperture, orifice, or the like) in fluid communication with the isolation portion 834. As described in detail above with reference to the isolation portion 134, the isolation portion 834 can have any suitable volume and / or fluid capacity (e.g., from a drop or drops of bodily fluid to 50 milliliters or more of bodily fluid). In some embodiments, the volume or fluid capacity can be defined by one or more portions of the control device 800 in addition to the isolation portion 834, such as a portion of the flow path 833 and / or the junction 817. In this way, the transfer of bodily fluid into the isolation portion 834 flushes at least a portion of the fluid flow path 833, which in turn can remove, entrain, and / or isolate contaminants previously contained therein.

[0169] AsFIG. 21 As shown, the isolation portion 834 may include and / or may accommodate one or more flow controllers configured to interact with bodily fluids delivered to the isolation portion 834. For example, in some embodiments, the isolation portion 834 may include one or more flow controllers comprising one or more materials configured to interact with bodily fluids. In such embodiments, the one or more materials may be any suitable configuration, such as the configuration described above with reference to the isolation portion 134. For example, in FIG. 22 and FIG. 21 In the illustrated embodiment, the isolation portion 834 of the control device 800 includes a hydrophilic material 840 (e.g., foam, sintered plastic, fluid-absorbing material, and / or the like) disposed within the isolation portion 834. The isolation portion 834 also includes an venting material 842 (e.g., a semi-permeable membrane or material, etc.) disposed within the opening 835. Thus, when fluid is transferred into the isolation portion 834, the hydrophilic material 840 can absorb, attract, push, aspirate, retain at least a portion of the fluid, and / or otherwise interact with it, which in turn can cause at least an initial portion of the fluid to swell or expand and isolate and / or retain it within the isolation portion 834, as described further in detail herein. In other words, the hydrophilic material 840 can enhance and / or facilitate wicking, which in turn can draw fluid into the isolation portion 834 (e.g., the hydrophilic material 840 can at least partially control the inflow or outflow of fluid into the isolation portion 834). When disposed within the isolation portion 834, the hydrophilic material 840 can take any shape or size. For example, in some embodiments, the hydrophilic material 840 may be a relatively flat and / or thin cylindrical shape disposed within the cylindrical insulating portion 834, such as FIG. 22 and FIG. 22 As shown in the image.

[0170] In some embodiments, the hydrophilic material 840 disposed in the insulating portion 834 may be configured to occupy a first portion of the volume of the insulating portion 834 and leave a second portion of the insulating portion 834 unoccupied. That is, the hydrophilic material 840 may be configured to have a pre-specified size and / or shape before use, such that when disposed within the insulating portion 834, a volume, space, or gap remains within the insulating portion 834 unoccupied by the hydrophilic material 840. For example, such as... FIG. 1 As shown, a hydrophilic material 840 is disposed in the insulating portion 834 such that a space 845 (e.g., a gap, volume, and / or other unoccupied portion) is defined between the surface of the hydrophilic material 840 and the inner surface of the insulating portion 834. Furthermore, the space 845 is in fluid communication with a portion of the flow path 833 extending between, for example, the joint 817 and the insulating portion 834.

[0171] In some embodiments, the space 845 can include, for example, a volume of air or other gaseous contents that can be expelled through the opening 835 prior to the aspiration of the bodily fluid to be isolated. In some embodiments, the space 845 can be configured to accommodate at least any swelling of the hydrophilic material 840 upon the absorption of an initial volume of bodily fluid. In some embodiments, the space 845 can be configured to facilitate and / or otherwise allow the hydrophilic material 840 to swell, which in turn can create a pressure differential that draws or helps draw the flow of bodily fluid toward and / or into the isolation portion 834. For example, a negative pressure differential can be created between the isolation portion 834 and the junction 817, a portion of the flow path 833, and / or the inlet 832 that is sufficient to push or draw an initial volume of bodily fluid from the inlet 832 through the junction 817 and toward and / or into the isolation portion 834. In other embodiments, the space 845 can be smaller to reduce the amount of otherwise gaseous air or other contents disposed therein to be expelled, while still allowing the hydrophilic material 840 to swell.

[0172] The vent material 842 can be configured to vent the isolation portion 834 via the opening 835 to allow, enhance, facilitate, and / or otherwise draw the flow of bodily fluid into the isolation portion 834. The vent material 842 can also function to retain the initial volume of bodily fluid transferred into the isolation portion 834 disposed or isolated therein. The arrangement of the vent material 842 can be such that the vent material 842 is wetted by the bodily fluid as the bodily fluid is transferred into the isolation portion 834. In response to the wetting, the vent material 842 can swell and / or can otherwise transition from a configuration and / or state in which the vent material 842 vents the isolation portion 834 to a configuration and / or state in which the vent material 842 seals the isolation portion 834. That is, the vent material 842 can be a self-sealing material configured to selectively allow the flow of gas (e.g., air) to be expelled from the isolation portion 834 through the opening 835 until the vent material 842 is saturated with liquid (e.g., bodily fluid), thereby sealing the opening 835.

[0173] In some cases, the wetting or transition of the vent material 842 is associated with and / or related to an amount or volume of bodily fluid that is delivered to the isolation portion 834. For example, in some embodiments, the vent material 842 can be placed in a sealed configuration and / or can transition to a sealed configuration when a predetermined and / or desired volume of bodily fluid is delivered into the isolation portion 834 (e.g., an initial portion or volume). In some embodiments, the isolation portion 834 can isolate and / or retain the predetermined and / or desired volume of bodily fluid in the isolation portion 834 in response to the vent material 842 transitioning to the sealed configuration. Further, when the vent material 842 is in the sealed state and / or when the initial portion of bodily fluid is delivered to the isolation portion 834, the control device 800 can (e.g., passively and / or automatically, without user intervention) transition from the first state to a second state in which bodily fluid can flow, for example, from the inlet 832 through the junction 817 to, toward, or through the outlet 836.

[0174] The hydrophilic material 840 and the vent material 842 can each be any suitable shape, size, and / or configuration. In some embodiments, the hydrophilic material 840 and the vent material 842 can be substantially similar to the hydrophilic or wicking material and the selectively permeable member or membrane described above with reference to the isolation portion 134, respectively. FIG. 21 to FIG. 22 Although the hydrophilic material 840 and the vent material 842 are shown and described herein as separate components and / or members, in some embodiments, the control device and / or the isolation chamber can include a single piece of hydrophilic material that can form and / or can function as both the hydrophilic material 840 and the vent material 842. In other embodiments, the hydrophilic material 840 and the vent material 842 can be coupled and / or otherwise co-formed or unitarily formed during manufacturing. Thus, the hydrophilic material 840 and the vent material 842 can each be, or collectively be, a flow controller configured to selectively control the flow of fluid (e.g., gas and / or liquid) into and out of the isolation portion 834.

[0175] An outlet 836, formed by and / or included in the control device 800, is at least fluidly coupled to a junction 817 and / or otherwise coupled to the control device 800, such that the outlet 836 is in fluid communication with a flow path 833. For example, in some embodiments, the outlet 836 may be physically and fluidly coupled to the junction 817 and / or otherwise may be an integrally formed part of the control device 800. In some other embodiments, the control device 800, the junction 817, and / or the outlet 836 (or the outlet portion) may include a sterile flexible tube or the like configured to position the outlet 836 in fluid communication with the junction 817, and thereby in fluid communication with and / or define at least a portion of the flow path 833. Although described as a single tube, the outlet 836 may be in fluid communication with and / or coupled to, for example, the junction 817 via one or more parts of the tube, which may be joined together to form a continuous lumen.

[0176] Despite FIG. 21 Not specifically shown, outlet 836 can be any suitable outlet, opening, port, lock, seal, connector, etc., and is in fluid communication with at least a portion of the fluid flow path 833. For example, outlet 836 can be a port, connector, transfer adapter, and / or device connected to control device 800 via any suitable connection, fit, adhesive, etc. (e.g., via a flexible outlet tube or the like). In some embodiments, outlet 836 may include and / or be connected to an outlet needle or the like. In other embodiments, outlet 836 may be connected to a transfer adapter and / or the like, such as the transfer adapter described in '352 publication. Thus, outlet 836 can position control device 800 in fluid communication with a fluid collection device connected to a transfer adapter and / or the like. As described above with reference to outlet 136 of control device 100, outlet 836 of control device 800 can be in a sealed or closed configuration when control device 800 is in a first state, and control device 800 can transition to an open configuration when control device 800 is transferred to the first state. The fluid collection device can be any suitable device, syringe, reservoir, and / or container, such as those described above with reference to control device 100, and therefore will not be described in further detail here. In other embodiments, outlet 836 can be physically and / or fluidly connected to any suitable device, such as a syringe or other suitable fluid collection device.

[0177] As described in detail above with reference to devices 100, 200, 300, 400, 500, 600, and / or 700, device 800 can be used to divert (e.g., passively divert) and / or otherwise facilitate the flow of a first volume or initial volume of bodily fluid such that a subsequently acquired bodily fluid sample has reduced contamination from microorganisms, e.g., skin-surface resident microorganisms and / or the like. For example, in certain instances, a user such as a physician, a medical doctor, a nurse, a phlebotomist, a technician, and / or the like can manipulate device 800 by inserting at least a portion of an inlet device (e.g., a needle) into a vein of a patient (e.g., a venipuncture event) and / or can otherwise establish fluid communication between the needle and the patient. Once in fluid communication with the patient, bodily fluid can flow from the source of bodily fluid (e.g., the vein of the patient) into control device 800 through inlet 832. In some embodiments, control device 800 can be in and / or can be placed in a first state or initial state in which an initial portion or initial volume of bodily fluid can flow into or through at least a portion of fluid flow path 833 into isolation portion 834.

[0178] The initial portion and / or volume of bodily fluid can be any suitable volume of bodily fluid as described above. In some instances, control device 800 can remain in the first state until a predetermined and / or desired volume (e.g., initial volume) of bodily fluid is transferred onto isolation portion 834. In some embodiments, the initial volume can be associated with and / or based at least in part on an amount or volume of bodily fluid that can be absorbed by hydrophilic material 840 (e.g., a flow controller). In some embodiments, the initial volume can be associated with and / or based at least in part on the amount of bodily fluid that can be absorbed by hydrophilic material 840 and / or the amount of bodily fluid that can be absorbed by hydrophilic material 840 before the initial volume of bodily fluid is transferred into isolation portion 834. FIG. 22 In some embodiments, the initial volume can be associated with and / or based at least in part on the amount of bodily fluid that can be absorbed by hydrophilic material 840 and / or the amount of bodily fluid that can be absorbed by hydrophilic material 840 before the initial volume of bodily fluid is transferred into isolation portion 834. In some embodiments, the initial volume can be associated with and / or based at least in part on the amount of bodily fluid that can be absorbed by hydrophilic material 840 and / or the amount of bodily fluid that can be absorbed by hydrophilic material 840 before the initial volume of bodily fluid is transferred into isolation portion 834. FIG. 21 In the embodiments shown in Figs. 8A-8C, the initial volume can be associated with and / or based at least in part on an amount or volume of bodily fluid that can be absorbed by hydrophilic material 840 (e.g., a flow controller). In addition, as described above, the initial volume can be associated with and / or based at least in part on the vent material 842 transitioning to a sealed configuration. In some embodiments, hydrophilic material 840 becoming saturated (e.g., after absorbing a maximum amount or substantially a maximum amount) and vent material 842 becoming saturated (e.g., such that vent material 842 transitions to a sealed configuration) can occur simultaneously in response to the same predetermined volume of bodily fluid being transferred into isolation portion 834 (i.e., the initial volume). After the initial volume of bodily fluid is transferred and / or diverted into isolation portion 834, the initial volume is isolated, sequestered, held, contained, compartmentalized, and / or the like in isolation portion 834. As described above, contaminants (e.g., skin-surface resident microorganisms or the like that are shed during a venipuncture event) can be entrained and / or included in the initial volume of bodily fluid and, as such, can also be isolated in isolation portion 834 when the initial volume is isolated in isolation portion 834.

[0179] In the event that the initial volume is isolated in the isolation portion 834, the device 800 can transition to a second state in which one or more subsequent volumes of bodily fluid can flow from the inlet 832, through at least a portion of the fluid flow path 833, through the junction 817, and to the outlet 836. In the event that the initial volume is not isolated in the isolation portion 834, the device 800 can remain in the first state and / or can transition to a third state in which one or more subsequent volumes of bodily fluid can flow from the inlet 832, through at least a portion of the fluid flow path 833, and to the outlet 836. FIG. 22 and FIG. 21 In the embodiment shown in and

[0180] In the embodiment shown in FIG. 22 and FIG. 23The outlet 836 is not shown, but can be fluidically coupled to the fluid collection device prior to or after the control device 800 transitions to the second state. In some embodiments, the outlet 836 can be arranged such that the outlet 836 remains sealed until the initial volume of bodily fluid is isolated in the isolation portion 834. Thus, in the event that the fluid collection device is fluidically coupled to the outlet 836 and the control device 800 is already in the second state, one or more any subsequent volumes of bodily fluid can flow from the inlet 832 through the fluid flow path 833 (e.g., defined at least in part by the inlet 832, a portion of the junction 817, and the outlet 836) into the fluid collection device. Thus, as described above, isolating the initial volume of bodily fluid in the isolation portion 834 prior to collecting or acquiring 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 control device 800 can be arranged such that the control device 800 directs, diverts, and / or otherwise facilitates a flow stream into the isolation portion 834 prior to directing, diverting, and / or otherwise facilitating the flow stream to the outlet 836. In other words, the control device 800 is configured to be compliance- enforced such that the control device 800 cannot transition to the second state until the initial volume is collected and isolated in the isolation portion 834.

[0181] Although the control device 800 is shown and described above as having a hydrophilic material 840 and an air vent material 842 disposed in the isolation portion 834, in other embodiments, the control device can include an isolation and / or diversion portion (e.g., a cavity, reservoir, lumen, channel, etc.) having any suitable configuration. For example, as described above with reference to the isolation portion 134, in some embodiments, the isolation portion 834 can include a hydrophilic coating or surface finish. Although the air vent material 842 is described as being an absorbent material and / or a selectively permeable member or membrane, in other embodiments, the isolation portion 834 can include an air vent hole that forms or is formed with a one-way valve or the like. In some embodiments, such a valve can be gas permeable and liquid impermeable. In some embodiments, such a valve can be user actuated, fluid actuated, pressure actuated, time-based, etc. In some embodiments, the isolation portion 834 can include a combination of the air vent material 842 and a valve or other flow control device. In some embodiments, the isolation portion 834 can include a one-way valve and an air vent material 842 that can collectively function to vent the isolation portion 834. In such embodiments, the one-way valve can be disposed in any suitable position relative to the air vent material 842 (e.g., upstream or downstream relative to the air vent material 842).

[0182] As described above, the isolation portion can have any suitable geometry or shape configured to enhance and / or facilitate wicking and / or absorption. For example, FIG. 24 and FIG. 23 to FIG. 24 A fluid control device 900 according to yet another embodiment is shown. As previously described with reference to control devices 100, 200, 300, 400, 500, 600, 700, and / or 800, fluid control device 900 (also referred to herein as a "control device" or "device") is configured to draw and isolate a first portion or amount (e.g., an initial amount) of bodily fluid from a patient such that any subsequently drawn bodily fluid is substantially free of contaminants. In some embodiments, portions and / or aspects of control device 900 are substantially similar in form and / or function to corresponding portions and / or aspects of control devices 100, 200, 300, 400, 500, 600, 700, and / or 800 described above. Accordingly, such similar portions and / or aspects are not described in further detail herein.

[0183] Control device 900 can be any suitable device or set of devices configured to (1) receive a flow of bodily fluid, (2) store and isolate a first volume or initial volume of bodily fluid, and (3) direct, divert, and / or otherwise facilitate subsequent bodily fluid flow to a fluid collection device (not shown). In FIG. 23 the embodiment shown in FIG. 9, control device 900 includes an inlet 932 (or inlet portion) and an outlet 936 (or outlet portion) and defines a diversion and / or isolation portion 934 (also referred to herein as an "isolation portion").

[0184] Inlet 932 formed by and / or included in control device 900 is configured to be fluidically coupled to an inlet device (not shown in FIG. 24 and FIG. 23 to FIG. 24 ) to place control device 900 in fluid communication with a source of bodily fluid (e.g., a patient's vasculature). Although not specifically shown in FIG. 23 to FIG. 24 , inlet 932 can be any suitable inlet, opening, port, lock, seal, coupler, etc., as described above with reference to inlet 832. Similarly, the inlet device (which is configured to be coupled to or otherwise in fluid communication with inlet 932) can be any suitable device or set of devices. For example, in some embodiments, the inlet device can be a device containing a lumen (e.g., a needle, a catheter, etc.), a port, a valve, and / or any other suitable coupler, as described in detail above. Accordingly, inlet 932 and the inlet device are not described in further detail herein.

[0185] Outlet 936 formed by and / or included in control device 900 is configured to be fluidically coupled to a fluid collection device. Although not specifically shown inFIG. 21 The outlet 936 is not specifically shown, but can be any suitable outlet, opening, port, lock, seal, coupling, etc., as described in detail above. In some embodiments, the outlet 936 can include and / or can be coupled to an outlet needle, a transfer adapter (e.g., the transfer adapter described in the '352 publication), a sample container, a syringe, and / or any other suitable device or collection member. Thus, the outlet 936 is configured to place the control device 900 in fluid communication with a sample reservoir (or other suitable device). As such, the outlet 936 can be similar to or substantially identical to the outlets 136, 236, 336, 436, 536, 636, 736, and / or 836. Likewise, a fluid collection device configured to be coupled to the outlet 936 can be similar to or substantially identical to any of the fluid collection devices described above. Accordingly, the outlet 936 and the fluid collection devices coupled to the outlet 936 are not described in further detail herein.

[0186] The control device 900 can be any suitable shape, size, and / or configuration. For example, in some embodiments, the control device 900 can be formed of a relatively rigid material, such as plastic or the like, and can be configured to maintain its shape and / or form when exposed to changes in pressure of the fluid and / or flow across the inlet and outlet. In some embodiments, some portions of the control device 900 can be formed of a relatively rigid material, while some other portions of the control device 900 can be formed of a relatively flexible material, such as flexible plastic, rubber, or the like.

[0187] As described above with reference to control device 800, control device 900 defines one or more fluid flow paths 933 between inlet 932 and isolation portion 934 and / or between inlet 932 and one or more outlets 936. In some embodiments, control device 900 can be configured such that a first portion of fluid flow path 933 (also referred to herein as a "flow path") places inlet 932 in selective fluid communication with isolation portion 934, and a second portion of flow path 933 places inlet 932 in selective fluid communication with outlet 936. In some embodiments, inlet 932 (or an inlet portion), isolation portion 934 (or a portion thereof), and outlet 936 (or an outlet portion) can comprise and / or can be formed with one or more tubes or other lumen-containing devices coupled to one another by one or more suitable couplers or ports (e.g., T- connectors, Y-connectors, and / or one or more any other suitable couplers) or attached to one another by any suitable mechanism to form portions of a continuous fluid flow path (e.g., flow path 933). More specifically, in some embodiments, control device 900 can comprise a junction 917 or the like collectively formed at or near the connection of inlet 932 (or an inlet portion), isolation portion 934 (or a portion thereof), and outlet 936 (or an outlet portion). As described in further detail herein, in some embodiments, control device 900 can be configured to transition at or near junction 917 to control the flow of bodily fluid therethrough, as described above with reference to control device 800. Accordingly, control device 900 can be at least formally or functionally similar to control device 800 described above with reference to FIG. 22 and FIG. 23 the detailed description, except for the differences described below, and accordingly, such similar portions and / or aspects of control device 900 are not further described in detail herein.

[0188] Control device 900 can differ from control device 800, for example, in the arrangement and / or shape of isolation portion 934. For example, where isolation portion 834 of control device 800 has a relatively shallow cylindrical shape, isolation portion 934 in control device 900 can have and / or can exhibit a scalloped shape, as illustrated by the schematic side view in FIG. 24 and the schematic top view in FIG. 23The isolation portion 934 can include a hydrophilic material 940 disposed therein (e.g., a flow controller), and the hydrophilic material 940 can conform to any suitable shape (e.g., the shape of the isolation portion 934), as described below. The hydrophilic material 940 can be a suitable material to wick, pump, and / or otherwise facilitate the flow of bodily fluid, draw more bodily fluid from the bodily fluid source via the inlet 932. The isolation portion 934 and / or the hydrophilic material 940 disposed therein is at least temporarily placed in fluid communication with the inlet 932 via the fluid flow path 933 and is configured to (1) receive the flow and / or volume of bodily fluid from the inlet 932 and (2) isolate (e.g., separate, isolate, contain, hold, partition, etc.) the flow and / or volume of bodily fluid therein. In some embodiments, the hydrophilic material 940 can be substantially similar to the hydrophilic material 840 disposed in the isolation portion 834.

[0189] The hydrophilic material 940 can have any suitable geometry, size, and / or configuration. For example, as shown in the embodiment shown in FIG. 24 and FIG. 23 The hydrophilic material 940 takes on a shape that matches the shape and geometry of the isolation portion 934. That is, in this embodiment, the hydrophilic material 940 takes on a two-layered fan shape, defining a space or gap 945 between the two layers of the hydrophilic material 940 to allow fluid to flow from the fluid flow path 933 into the isolation portion 934. The fan-shaped form of the hydrophilic material 940 can be configured to facilitate the substantially free flow of bodily fluid drawn into the isolation portion 934 without occlusion, and the gap or space 945 can allow for expansion of the hydrophilic material 940, which in turn can help to establish a negative pressure differential between the isolation portion 934 and at least a portion of the fluid flow path 933, thereby enhancing the wicking, wicking, or pumping action of the hydrophilic material 940 disposed in the isolation portion 934.

[0190] In some embodiments, for example, in response to the absorption of bodily fluid, the expansion of the two-layered fan-shaped form of the hydrophilic material 940 increases the volume of the hydrophilic material 940, which in turn draws in bodily fluid (e.g., via capillary action, wicking, absorption, etc.). In some embodiments, the particular shape of the isolation portion 934 and the hydrophilic material 940 can be configured to facilitate the desired and / or predetermined flow of bodily fluid into the isolation portion 934. For example, in FIG. 24 and FIG. 23 to FIG. 24In the embodiment shown in FIG. 9, the fan-shaped form of the isolation portion 934 and the hydrophilic material 940 includes an increased volume of the isolation portion 934 and the hydrophilic material 940 (and / or other absorbent material) due to the increased width of the isolation portion 934 and the hydrophilic material 940. In some cases, this configuration can result in greater absorption along the radius of the fan-shaped form of the hydrophilic material 940 and / or the isolation portion 934. Further, in some cases, the increased volume of the isolation chamber or portion 934 can create a pressure differential and / or gradient that can help draw bodily fluid into the isolation chamber or portion 934. The space 945 defined by the hydrophilic material 940 can form a channel to allow fluid to flow into the isolation portion 934 without obstruction, coagulation, or other sources of disruption to the wicking, capillary action, and / or pumping action associated with the swelling of the hydrophilic material 940.

[0191] The isolation portion 934 can also define an opening 935 and can include an air release material 942 (e.g., a flow controller) disposed within the opening 935. Similar to the description above with respect to the air release material 842 disposed in the opening 835 of the control device 800, the air release material 942 can be configured to vent the isolation portion 934 through the opening 935. The opening 935 and / or the air release material 942 can be configured to transition from an open or vented configuration and / or state prior to the isolation portion 934 receiving a first or initial volume of bodily fluid to a sealed, closed, and / or otherwise non-vented configuration after the first or initial volume of bodily fluid has flowed into the isolation portion 934. In some embodiments, the isolation portion 934 can be vented to a volume external to the isolation portion 934 (e.g., the ambient environment). For example, in some embodiments, the opening 935 or the like can receive a volume or flow of air or gas displaced as the hydrophilic material 940 swells. In some embodiments, the air release material 942 can be similar or substantially identical to the air release material 842 included in the control device 800. In some embodiments, the arrangement of the hydrophilic material 940 can be such that the opening 935 need not include an air release material 942 and / or any other selectively permeable member or membrane to prevent venting or escape of bodily fluid (e.g., a portion of the hydrophilic material 940 is disposed within or around the opening 935 and functions similarly to the air release material 942). As such, the hydrophilic material 940 and the air release material 942 can each be a flow controller or can collectively be a flow controller configured to selectively control the flow of fluid (e.g., gas and / or liquid) into and out of the isolation portion 934.

[0192] As described in detail above with reference to previous embodiments, FIG. 23The device 900 shown in FIG. 9 can be used to divert (e.g., passively) a first volume or initial volume of bodily fluid such that a subsequently acquired sample of bodily fluid has reduced contamination from microorganisms, such as microorganisms left behind by the skin and / or the like. In some embodiments, the control device 900 can be in and / or can be placed in a first state or initial state in which an initial portion or initial volume of bodily fluid can flow into or through at least a portion of the fluid flow path 933, through at least a portion of the junction 917, and into the isolation portion 934.

[0193] The initial portion and / or volume of bodily fluid can be any suitable volume of bodily fluid as described above. For example, the initial volume can be associated with and / or based at least in part on an amount or volume of bodily fluid that can be stored, contained, and / or isolated in and / or by the isolation portion 934 and / or the hydrophilic material 940. After the initial volume of bodily fluid is transferred and / or diverted into the isolation portion 934, the initial volume is isolated, sequestered, held, contained, partitioned, etc. in the isolation portion 934. For example, in some embodiments, the transfer of the initial portion or initial volume of bodily fluid into the isolation portion 934 can place the hydrophilic material 940 (and / or any other suitable flow controller) in an expanded state and / or configuration, and as such, the hydrophilic material 940 can substantially prevent any subsequent volume of bodily fluid from being disposed in the isolation portion 934. Further, in some embodiments, when the hydrophilic material 940 is in the expanded state, a central space or gap 945 defined by the hydrophilic material 940, which can be operable to allow fluid to flow into the isolation portion 934 without clogging or otherwise disrupting the wicking or pumping action of the hydrophilic material 940, can be reduced, constricted, narrowed, and / or closed. In some cases, the closing of the space 945 can prevent a subsequent volume of bodily fluid from flowing into and / or out of the isolation portion 934.

[0194] In some embodiments, once the hydrophilic material 940 is swollen, a pressure differential associated with and / or caused by the swelling of the hydrophilic material 940 can decrease and / or substantially equalize such that subsequent volumes of bodily fluid are not "sucked" into the isolation portion 934 and / or the hydrophilic material 940. That is, once the hydrophilic material 940 is placed in a swollen configuration, the negative pressure otherwise associated with the hydrophilic material 940 that absorbs bodily fluid is substantially equalized. In some embodiments, the vent material 942 can absorb bodily fluid and swell or saturate in a similar manner as the hydrophilic material 940, thereby placing the vent material 942 in a sealed, closed, or impermeable state. In some embodiments, the saturation of the hydrophilic material 940 and / or the saturation of the vent material 942 can occur simultaneously and can collectively limit and / or substantially prevent the subsequent flow of fluid into and / or out of the isolation portion 934. In other embodiments, at least a portion of the junction 917 leading to the isolation portion 934 can include a valve, a selectively permeable membrane, a fluid-activated (e.g., bodily fluid-activated) switch or seal, a user-activated switch or seal, and / or the like, which can limit and / or substantially prevent the flow of bodily fluid into and / or out of the isolation portion 934. As noted above, contaminants (e.g., skin-dwelling microorganisms or the like that are dislodged during a venipuncture event) can be entrained and / or included in the initial volume of bodily fluid and, thus, can also be isolated in the isolation portion 934 when the initial volume is isolated in the isolation portion 934.

[0195] With the initial volume isolated in the isolation portion 934, the device 900 can transition to a second state in which one or more subsequent volumes of bodily fluid can flow from the inlet 932, through at least a portion of the fluid flow path 933, through the junction 917, and to the outlet 936. In some embodiments, the device 900 can transition to the second state when the initial volume of bodily fluid is isolated in the isolation portion 934 and / or when the saturation of the hydrophilic material 940 and / or the vent material 942 is complete. FIG. 24 and FIG. 25In the embodiment shown in FIG. 9, the control device 900 is configured to automatically (e.g., without user intervention) transition from the first state to the second state once the initial volume of bodily fluid is isolated in the isolation portion 934. Thus, as subsequent volumes of bodily fluid enter the fluid flow path 933, the control device 900 directs and / or diverts the fluid to flow through a portion of the fluid flow path 933 (e.g., through the junction 917) to the outlet 936. As described in detail above, the outlet 936 is configured to be placed in fluid communication with one or more fluid collection devices such that one or more subsequent volumes of bodily fluid can flow from the inlet 932, through the fluid flow path 933, the junction 917, and the outlet 936, and into a fluid collection device (not shown). Accordingly, as described above, isolating the initial volume of bodily fluid in the isolation portion 934 prior to collecting or acquiring one or more sample volumes of bodily fluid reduces and / or substantially eliminates the amount of contaminants in the one or more sample volumes.

[0196] In some embodiments, the arrangement of the junction 917, the isolation portion 934, and / or the hydrophilic material 940 disposed in the isolation portion 934 can cause the initial volume of bodily fluid to remain in the isolation portion 934 despite being at least partially exposed to the negative pressure differential generated by the fluid collection device. In some embodiments, the isolation portion 934 and / or the junction 917 can include an orifice or an inlet into the isolation portion 934 that includes a valve, a switch, or an actuator. The valve, switch, or actuator (or any other suitable flow controller) can limit and / or substantially prevent bodily fluid from flowing out of the isolation portion 934 in response to the negative pressure generated by the fluid collection device or the like. That is, the isolation portion 934 is configured to retain and / or isolate the initial volume of bodily fluid despite being at least partially exposed to the negative pressure differential generated by the fluid collection device.

[0197] While some devices are described herein as including an isolation and / or diversion portion having one or more flow controllers arranged as absorbent, hydrophilic, and / or selectively permeable members, in other embodiments, the control device can include an isolation and / or diversion portion that can include any suitable flow controller configured to draw bodily fluid into the isolation chamber. For example, FIG. 25A fluid control device 1000 according to an embodiment is shown. As described above with reference to devices 100, 200, 300, 400, 500, 600, 700, 800 and / or 900, the fluid control device 1000 (also referred to herein as a “control device” or “device”) is configured to aspirate and isolate a first portion or amount (e.g., an initial amount) of bodily fluid from a patient such that any subsequent aspiration of the bodily fluid in any amount, portion and / or volume is substantially free of contaminants. In some embodiments, portions, features and / or aspects of the device 1000 are substantially similar in form and / or function to corresponding portions, features and / or aspects of the devices 100, 200, 300, 400, 500, 600, 700, 800 and / or 900 described above. Therefore, such similar portions, features and / or aspects are not described in further detail herein.

[0198] The control device 1000 can be any suitable device or set of devices configured to (1) receive the flow of bodily fluids, (2) store and isolate a first volume or initial volume of bodily fluids, and (3) guide, transfer, and / or otherwise facilitate subsequent flow of bodily fluids to a fluid collection device (not shown). FIG. 25 In the illustrated embodiment, control device 1000 includes an inlet 1032 (or inlet portion) and an outlet 1036 (or outlet portion), and defines an isolation and / or transfer portion 1034 (also referred to herein as an “isolation portion”). Control device 1000 includes and / or forms a junction 1017 or the like, which is formed at or near the junction of inlet 1032 (or inlet portion), isolation portion 1034 (or a portion thereof), and outlet 1036 (or outlet portion). Furthermore, control device 1000 defines a fluid flow path 1033 (also referred to herein as a “flow path”) that positions inlet 1032 (or inlet portion) in selective fluid communication with isolation portion 1034 and / or outlet 1036 (or outlet portion). As described further in detail herein, in some embodiments, control device 1000 may be configured to transition at or near junction 1017 to control the flow of bodily fluid through flow path 1033, as described above with reference to control devices 800 and / or 900.

[0199] An inlet 1032 formed and / or included in control device 1000 is configured to position control device 1000 in fluid communication with a source of bodily fluid (e.g., via an inlet or outlet device), as described in detail above. An outlet 936 formed and / or included in control device 900 is configured to be fluidly coupled to a fluid collection device (e.g., syringe, vacuum container, tray, sampling device, or machine, etc.). Although in FIG. 25The outlet 1036 can be any suitable outlet, opening, port, lock, seal, coupler, etc., as described above with reference to the outlets 136, 236, 336, 436, 536, 636, 736, 836, and / or 936, unless specifically illustrated otherwise. Thus, the outlet 1036 is configured to place the control device 1000 in fluid communication with a fluid collection device (or other suitable device), as described in detail above. Accordingly, the inlet 1032 (e.g., couplable to an inlet device) and the outlet 1036 (e.g., couplable to a fluid collection device) are not described in further detail herein and should be considered to be similar to any of the inlets and / or outlets described above with reference to the previous embodiments, unless explicitly stated otherwise.

[0200] However, the control device 1000 can differ from the control devices 100, 200, 300, 400, 500, 600, 700, 800, and 900 in the arrangement of the isolation portion 1034. For example, FIG. 25 The isolation portion 1034 illustrated in FIG. 10 is configured to include one or more flow controllers shaped, geometrically, and / or structured to draw or assist in drawing bodily fluid into the isolation portion 1034. In other words, bodily fluid can flow from the inlet 1032 through the junction 1017 within the fluid flow path 1033 of the control device 1000 and into or through the isolation portion 1034 and into or through the flow controllers (and / or one or more other suitable structures) defined or formed within the isolation portion 1034 that function to draw or wick the fluid into the isolation portion 1034.

[0201] For example, as FIG. 25As shown in FIG. 10, the isolation portion 1034 can include a series of capillaries 1050 (e.g., one or more flow controllers), each of which has a relatively high surface area to volume ratio that is operable to draw a fluid through one or more of the capillaries 1050. Each of the capillaries 1050 can have a desired diameter and can extend a desired length across or within the isolation portion 1034. As shown, the capillaries 1050 can occupy a desired portion in a desired location of the isolation portion 1034, such that bodily fluid can flow from the inlet 1032 into the isolation portion 1034 (e.g., the capillaries 1050 need not occupy all of the isolation portion 1034). The number and shape of the capillaries 1050 can be designed, at least in part, to determine the volume of bodily fluid drawn into the isolation portion 1034. Although the isolation portion 1034 is described as including one or more capillaries 1050 that are operable to draw bodily fluid into the isolation portion 1034 (e.g., via capillary action, wicking, etc.), in other embodiments, the isolation chamber can include any suitable material, structure, pattern, feature, etc., that is configured to draw bodily fluid into the isolation chamber via capillary action, wicking, and / or any other suitable mode.

[0202] In some embodiments, the isolation portion 1034 can be vented and / or can include an opening or vent hole that is configured to selectively vent the isolation portion 1034 to a volume (e.g., ambient environment) outside of the isolation portion 1034. For example, in some embodiments, the isolation portion 1034 can define an opening 1035 or the like that can receive a volume or flow of air or gas displaced as the capillaries 1050 fill with bodily fluid and / or otherwise draw in bodily fluid. In some embodiments, as previously described, the isolation portion 1034 can include a vent material 1042 or the like disposed in and / or around the opening 1035. The vent material 1042 can be similar or substantially identical to the vent materials 842 and / or 942 included in the control devices 800 and / or 900, respectively. Accordingly, the vent material 1042 will not be described in further detail herein. In other embodiments, the arrangement of the capillaries 1050 can be such that the isolation portion 1034 need not include a vent material or the like disposed in and / or around the opening.

[0203] As described in detail above with reference to the devices 100, 200, 300, 400, 500, 600, 700, 800, and / or 900, FIG. 25The device 1000 shown in the middle can be used to direct or divert (e.g., passively) a first volume or initial volume of bodily fluid such that a subsequently acquired bodily fluid sample has reduced contamination from microorganisms, such as skin- resident microorganisms and / or the like. For example, in some cases, a user such as a physician, medical practitioner, nurse, phlebotomist, technician, or the like can manipulate the device 1000 to establish fluid communication between, for example, an access device and a patient and / or other source of bodily fluid. Moreover, the arrangement of the control device 1000 can be such that the inlet 1032 is coupled to and / or otherwise includes the access device, and, as such, the control device 1000 is likewise placed in fluid communication with the patient and / or other source of bodily fluid. In some embodiments, the control device 1000 can be in and / or can be placed in a first state or initial state in which an initial portion or initial volume of bodily fluid can flow into or through at least a portion of the fluid flow path 1033, through the junction 1017, and into the isolation portion 1034.

[0204] As described in detail above, the initial portion and / or volume of bodily fluid can be any suitable volume of bodily fluid. For example, in some cases, the control device 1000 can remain in the first state until a predetermined and / or desired volume (e.g., initial volume) of bodily fluid is transferred into the isolation portion 1034. In some embodiments, the initial volume can be associated with and / or based at least in part on an amount or volume of such bodily fluid that can be drawn, stored, contained, and / or isolated within the series of capillaries 1050. After the initial volume of bodily fluid is transferred / or diverted into the isolation portion 1034, the initial volume is isolated, sequestered, held, contained, partitioned, and / or the like in the isolation portion 1034.

[0205] For example, in some embodiments, the transfer of the initial portion or volume of bodily fluid into the portion of the isolation portion 1034 that includes the capillary 1050 can fill the capillary 1050 such that no further volume of bodily fluid is drawn therein (e.g., via capillary action, wicking, etc.). Moreover, in some embodiments, the filling of the capillary 1050 and / or otherwise filling or substantially filling of the isolation portion 1034 can cause and / or can be in response to a reduction in the pressure differential between the junction 1017 and at least a portion of the isolation portion 1034. For example, in some embodiments, the filling or substantial filling of the isolation portion 1034 can transition the vent material 1042 (e.g., flow controller) from a first state in which the vent material 1042 allows venting of the isolation portion 1034 through the opening 1035 to a second state in which the vent material 1042 is saturated, sealed, and / or otherwise prevented from venting through the opening 1035, which in turn can facilitate and / or can allow pressure equalization.

[0206] In some embodiments, the filling of the capillary 1050 and the saturation of the vent material 1042 can occur simultaneously, and can limit and / or at least partially prevent subsequent fluid flow into or out of the isolation portion 1034. In other words, the capillary 1050 and the vent material 1042 can each be, or collectively can be, a flow controller configured to at least partially control the flow of fluid into and / or out of the isolation portion 1034. In some embodiments, the device 1000 and / or the junction 1017 can include a valve, a selectively permeable membrane, a fluid-activated (e.g., bodily fluid-activated) switch or seal, a user-activated switch or seal, and / or the like, which can limit and / or substantially prevent bodily fluid flow into or out of the isolation portion 1034. Moreover, as previously described, in some embodiments, the arrangement of the device 1000, the junction 1017, and / or the isolation portion 1034 can be such that, despite the introduction of a negative pressure differential associated with establishing fluid communication between the outlet and a fluid collection device, the initial volume of bodily fluid is maintained and / or isolated in the isolation portion 1034.

[0207] With the initial volume isolated in the isolation portion 1034, the device 1000 can transition to a second state in which one or more subsequent volumes of bodily fluid can flow from the inlet 1032, through at least a portion of the fluid flow path 1033, through the junction 1017, and into the fluid collection device fluidically coupled to the outlet 1036. In some embodiments, the device 1000 can transition to the second state in response to a user-activated switch or seal, a fluid-activated (e.g., bodily fluid-activated) switch or seal, and / or the like. FIG. 26In the embodiment shown in FIG. 10, the control device 1000 is configured to automatically (e.g., without user intervention) transition from the first state to the second state once the initial volume of bodily fluid is isolated in the isolation portion 1034. For example, in some embodiments, the delivery of the initial volume of bodily fluid into the isolation portion 1034 can cause, can allow, and / or otherwise can be operable to cause the junction 1017 to transition from the first state in which bodily fluid can flow from the inlet 1032 to the isolation portion 1034 to the second state in which bodily fluid can flow from the inlet 1032 to the outlet 1036. Thus, as subsequent flow and / or volume of bodily fluid enters the fluid flow path 1033, the control device 1000 and / or the junction 1017 directs and / or diverts the flow through a portion of the fluid flow path 1033, a portion of the junction 1017, and the outlet 1036 into one or more fluid collection devices (e.g., one or more sample reservoirs, one or more syringes, a delivery adapter, etc.) fluidically coupled thereto.

[0208] FIG. 26 A fluid control device 1100 according to yet another embodiment is shown. The fluid control device 1100 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, divert, and / or otherwise facilitate subsequent bodily fluid flow to a fluid collection device (not shown). In FIG. 25 In the embodiment shown in FIG. 11, the control device 1100 includes an inlet 1132 (or inlet portion), an outlet 1136 (or outlet portion), and a junction 1117, and includes and / or defines one or more fluid flow paths 1133 and a diversion and / or isolation portion 1134 (also referred to herein as an “isolation portion”). The inlet 1132 is configured to be placed in fluid communication (directly or indirectly) with a source of bodily fluid, as described in detail above. The outlet 1136 is configured to be coupled to a fluid collection device (not shown), as described in detail above. Accordingly, the inlet 1132 and the outlet 1136 are not described in further detail herein.

[0209] As described with respect to previous devices (e.g., devices 100, 200, 300, 400, 500, 600, 700, 800, 900, and / or 1000), the control device 1100 can have any suitable size and / or shape. For example, FIG. 26The control device 1100 shown in FIG. 11 forms a bifurcation (e.g., a Y-bifurcation, a T-bifurcation, and / or the like). More specifically, the inlet 1132 or inlet portion, the outlet 1136 or outlet portion, and the isolation portion 1134 or a portion thereof join, interface, and / or otherwise meet at the junction 1117. The junction 1117, in turn, is configured to selectively establish fluid communication between the inlet 1132 or inlet portion and the isolation portion 1134 or portion thereof, and between the inlet 1132 or inlet portion and the outlet 1136 or outlet portion, as described in further detail herein. While the control device 1100 is shown in FIG. 11 as forming a Y-bifurcation, in other embodiments, the control device 1100 can form any suitable shape and / or can have any suitable configuration or arrangement. FIG. 26 While the control device 1100 is shown in FIG. 11 as forming a Y-bifurcation, in other embodiments, the control device 1100 can form any suitable shape and / or can have any suitable configuration or arrangement.

[0210] The isolation portion 1134 can have any shape and / or size to draw in a sufficient volume (e.g., a desired initial volume) of bodily fluid. In some embodiments, the isolation portion 1134 can include a flow controller and / or the like that is configured to transition between a first state and a second state to draw or assist in drawing bodily fluid into the isolation portion 1134. For example, in the embodiment shown in FIG. 11, the isolation portion 1134 can include an actuator 1151 (e.g., a flow controller) that is configured to be actuated and / or moved within the isolation portion 1134 in response to contact with at least a portion of the initial volume of bodily fluid. More specifically, the actuator 1151 can be and / or can include a plunger or piston that is disposed within the isolation portion 1134 and is movable along an axis of the isolation portion 1134. In some embodiments, the actuator 1151 can be configured to separate, divide, isolate, and / or otherwise partition a first volume of the isolation portion 1134 that is configured to be in fluid communication with the inlet 1132 of the control device 1100 from a second volume of the isolation portion 1134 that is not in fluid communication with or otherwise partitioned from the inlet 1132, as shown in FIG. 11. FIG. 26 FIG. 27

[0211] ​​Actuator 1151 is disposed within isolation portion 1134 such that movement of actuator 1151 can define and / or cause a change in the relative dimensions of a first volume and a second volume of isolation portion 1134. For example, actuator 1151 may be in an initial state or position before use and may be held and / or retained in the initial state or position via one or more active or passive mechanisms and / or devices. In some embodiments, when in the initial state, actuator 1151 or a portion thereof may have a higher potential energy and / or may be disposed in a configuration associated with a higher potential energy. In such embodiments, actuator 1151 may be configured such that activation of actuator 1151 converts potential energy into other suitable forms, such as kinetic energy. In other embodiments, actuator 1151 may be held in the initial state in a resting state, and activation may involve actively moving actuator 1151 away from the initial resting state (e.g., as referenced below). FIG. 26 (As described in the embodiments shown).

[0212] like FIG. 26 As shown, the isolation portion 1134 includes a spring 1154 that connects the plunger 1151 to a wall or surface of the isolation portion 1134. In some embodiments, the initial state of the actuator 1151 may be such that the spring 1154 is loaded with a predetermined and / or desired tension before use (e.g., during the manufacture and / or assembly of the device 1100), such that the spring 1154 is under tension when the actuator 1151 is in the initial position. In other words, when the actuator 1151 is in the initial state or position, the spring 1154 may be in a state or configuration with higher potential energy. In such embodiments, the actuator 1151 may be held in place in the initial state and / or position by using one or more components acting through a mechanism (such as adhesives, glue, physical stops, or the like), which may allow the tension in the spring 1154 to be released when removed, released, dissolved, or deactivated, thereby moving the actuator 1151 (or its piston or plunger) away from the initial state and / or position. In other words, when one or more components are removed, released, dissolved, transitioned and / or deactivated, actuator 1151 and spring 1154 can transition from an initial state or position with higher potential energy (e.g., from potential energy to kinetic energy) to a subsequent state or position with lower potential energy.

[0213] As an example, FIG. 26The device 1100 may include a soluble adhesive 1155 (e.g., glue, adhesive, fastener, epoxy, foam, and / or the like) that at least temporarily bonds the actuator 1151 to one or more surfaces of the isolation portion 1134 until the soluble adhesive is dissolved, for example, by contact with a flow of bodily fluid into the isolation portion 1134. In some embodiments, the amount of the soluble adhesive 1155 may depend at least in part on the amount of adhesive, bonding, and / or frictional forces sufficient to hold the actuator 1151 in its initial state (e.g., sufficient to apply a reaction force in response to the force generated by the weight of the actuator 1151, the characteristics of the spring 1154 (e.g., spring stiffness, material properties, the amount of tension in the spring 1154, etc.) and / or the like). In some embodiments, the amount of the soluble adhesive 1155 may depend at least in part on a desired amount of bodily fluid sufficient to substantially dissolve the soluble adhesive 1155 to release the actuator 1151 away from its initial state.

[0214] In some embodiments, the actuator 1151 may be suitably configured in terms of form, shape, size, surface, etc., to facilitate temporary adhesion of the actuator 1151 to one or more surfaces or walls of the insulating portion 1134 using an adhesive material 1155. For example, the actuator 1151 may include and / or may have a surface area and / or surface finish that increases and / or promotes adhesion. In some embodiments, at least a portion of the actuator 1151 may be formed of a porous and / or absorbent material configured to increase and / or promote adhesion to and / or to the adhesive material 1155. FIG. 26 In the illustrated embodiment, actuator 1151 may include a protrusion (e.g., a finger-like protrusion or the like) extending toward inlet 1132 or junction 1117, which is at least temporarily in contact with the soluble adhesive material 1155. In such embodiments, the protrusion may be configured to increase the amount of surface area of ​​actuator 1151 in contact with the soluble adhesive material 1155. In other embodiments, actuator 1151 and / or a portion thereof may have any suitable shape, size, or surface finish, and / or may be formed of any suitable material that helps to temporarily bond actuator 1151 to the wall of isolation portion 1134.

[0215] In some embodiments, the isolation portion 1134 may include one or more openings or vents configured to allow the flow of gas and / or fluid to be discharged from the isolation portion 1134. For example, as FIG. 26As shown in FIG. 11, the isolation portion 1134 can include an opening 1159 disposed in or in fluid communication with the second portion of the isolation portion 1134. The opening 1159 can be used to vent contents disposed within the isolation portion 1134, such as any volume of air or gaseous contents disposed within the second volume of the isolation portion 1134 that is not fluidically connected to the junction 1117 prior to use. As such, the opening 1159 can allow for venting of the second volume of the isolation portion 1134 as the actuator 1151 transitions from the first state to the second state.

[0216] In some embodiments, venting through the opening 1159 can be similar to venting described above with reference to the devices 100, 200, 300, 400, 500, 600, 700, 800, 900, and / or 1000. However, in the example shown in FIG. 11, the isolation portion 1134 does not include venting material or the like disposed within the opening 1159 (as described above with reference to other devices) because the arrangement of the actuator 1151 fluidically isolates the second volume of the isolation portion 1134 from the first volume of the isolation portion 1134. As such, the second volume of the isolation portion 1134 does not receive a volume of bodily fluid such that venting material would otherwise be prevented from exiting the opening 1159. Although not shown, in other embodiments, the isolation portion 1134 can include venting material, a selectively permeable membrane, a flow controller, a one-way valve, or the like disposed within and / or about the opening 1159, for example, to limit and / or substantially prevent contaminants within the ambient environment from entering the second volume of the isolation portion 1134. FIG. 26

[0217] Although not shown in FIG. 11, in some embodiments, the isolation portion 1134 can also define an opening or vent in fluid communication with, for example, the first volume of the isolation portion 1134. In some such embodiments, the venting material can be substantially similar to the venting material described herein and can be configured to vent the first volume of the isolation portion 1134. As described above with reference to previous embodiments, venting of the first volume of the isolation portion 1134 can create a pressure differential between the first volume of the isolation portion 1134 and, for example, the junction 1117, which can facilitate the desired and / or predetermined flow of bodily fluid into the first volume of the isolation portion 1134. For example, in certain instances, venting can allow for displacement of a volume of air or gas that would otherwise impede the flow of bodily fluid. Thus, by venting the first volume of the isolation portion 1134 and sealing and / or otherwise not venting a portion of the fluid flow path 1133 leading to the outlet 1136, an initial flow from the inlet 1132 can flow through the junction 1117 into the first volume of the isolation portion 1134. FIG. 26 ​​

[0218] As described with reference to previous embodiments, the venting material can transition from a first or selectively permeable state to a second or substantially impermeable state saturated and / or wetted in response to an initial inflow of bodily fluid into the first volume of the isolation portion 1134. In some embodiments, the control device 100 may be configured such that the volume of bodily fluid sufficient to transition the venting material to the substantially impermeable state is also sufficient to dissolve the adhesive material 1155. In some embodiments, vent holes or the like may be formed in the walls or surfaces of the isolation portion 1134. In other embodiments, vent holes or the like may be formed, for example, in a portion of the actuator 1151, such that air or gas in the first volume of the isolation portion 1134 is displaced or vented into a second volume of the isolation portion 1134, which vents to the surrounding environment via an opening 1159.

[0219] As described in detail above, in FIG. 26 The device 1100 shown can be used to guide or transfer a first volume or initial volume of bodily fluid, such that subsequent bodily fluid samples have been reduced from contamination by microorganisms, such as skin-borne microorganisms and / or similar substances. For example, once a user such as a doctor, physician, nurse, phlebotomist, technician, etc., can establish fluid communication between the device 1100 and the source of bodily fluid (e.g., as described in detail above with reference to previous embodiments), bodily fluid can flow from the source (e.g., a patient's vein or other suitable source of bodily fluid) into the control device 1100. In some embodiments, the control device 1100 may be in a first state or initial state and / or may be placed in a first state or initial state in which an initial portion or initial volume of bodily fluid can flow through inlet 1132, a portion of fluid flow path 1133, and junction 1117 into isolation portion 1134.

[0220] In certain circumstances, the control device 1100 may remain in a first state with the actuator 1151 in its initial state until a predetermined and / or desired flow or volume of bodily fluid is delivered to a first volume of the isolation portion 1134, which is in fluid communication with a junction 1117 that, in turn, positions at least a portion of the bodily fluid in contact with the soluble adhesive material 1155. Furthermore, the predetermined and / or desired flow or volume of bodily fluid may be associated with and / or at least partially based on an amount or volume sufficient to dissolve the soluble adhesive material 1155 that holds the actuator 1151 in its initial state. Thus, the soluble adhesive material 1155 may dissolve in response to contact with at least a portion of the bodily fluid delivered to the first volume of the isolation portion 1134, thereby removing or releasing the adhesion between the actuator 1151 and one or more surfaces and / or walls of the isolation portion 1134. Therefore, upon removal and / or release of the adhesive and / or force, the force associated with the spring 1154 in tension can move the actuator 1151 from an initial state or position toward a subsequent state or position. In other words, once the soluble adhesive 1155 no longer resists the tension in the spring 1154 and holds the actuator 1151 in the initial state, the spring 1154 retracts, compresses, and / or otherwise releases the tension (e.g., by converting potential energy into kinetic energy) to be placed in a resting state, which in turn will transition and / or move the actuator 1151 connected to the spring 1154 to a second state and / or position.

[0221] The actuator 1151 alters and / or redistributes the first and second volumes of the isolation portion 1134 through movement within the isolation portion 1134. That is, for example, as... FIG. 27 As shown, the movement of actuator 1151 increases the first volume of isolation portion 1134 and decreases the second volume of isolation portion 1134. Furthermore, the increase in the first volume is accompanied by and / or otherwise causes a decrease in pressure (e.g., suction) within the first volume of isolation portion 1134. Therefore, when control device 1100 is in a configuration or state in which isolation portion 1134 is in fluid communication with inlet 1132 (e.g., via junction 1117 and at least a portion of flow path 1133), the decrease in pressure can draw and / or help draw or push an initial volume of bodily fluid into the first volume of isolation portion 1134.

[0222] In some embodiments, the amount and / or rate of bodily fluid aspirated into the isolation portion 1134 can be determined, at least in part, by the dimensions of the first and second volumes of the isolation portion 1134, one or more properties associated with the actuator 1151 (e.g., weight, motility, inertial forces resisting its motion, frictional forces, gravitational forces, etc.), the dissolution rate of the dissolvable adhesive material 1155, one or more properties of the spring 1154 (e.g., dimensions, material, length, elasticity, allowable tension, spring rate, etc.), and / or the like. Concurrently, the motion of the actuator 1151 and the reduction of the second volume of the isolation portion 1134 can cause the venting of the contents of the second volume of the isolation portion 1134 (e.g., air or gas) by expelling or releasing the contents of the second volume of the isolation portion 1134 through the opening 1159.

[0223] In some embodiments, the size and / or configuration of the opening 1159 can be varied, for example, to control and / or modify one or more characteristics associated with the venting of the second volume of the isolation portion 1134. For example, in some embodiments, the opening 1159 can have a smaller diameter configured to limit flow through the opening 1159 and / or be provided with a material configured to limit flow in the opening 1159. In such embodiments, the limitation and / or restriction of flow (e.g., flow of air or gas) through the opening 1159 can reduce the rate of venting of the second volume of the isolation portion 1134, which in turn can slow and / or modulate the rate of motion of the actuator 1151 with the isolation portion 1134. In such embodiments, controlling the rate of motion of the actuator 1151 within the isolation chamber or isolation portion 1134 can, for example, modulate and / or control the amount of negative pressure within the first volume of the isolation portion 1134. In some embodiments, the opening 1159 can be sealed by the actuator 1151 after the transition and / or motion of the actuator 1151 and the venting of the second volume of the isolation portion 1134, thereby preventing any leakage or flow of bodily fluid through the opening 1159.

[0224] After the initial volume of bodily fluid is delivered and / or transferred into the isolation portion 1134 and / or any other suitable portion of the device 1100, the initial volume is isolated, sequestered, held, contained, compartmentalized, etc. in the isolation portion 1134. For example, in some embodiments, the delivery of the initial portion or initial volume of bodily fluid into the resulting first volume of the isolation portion 1134 can place the isolation portion 1134 in a filled configuration, and as such, the volume of bodily fluid contained in the first portion of the isolation portion 1134 substantially prevents any subsequent volume of bodily fluid from being disposed therein. Further, in some embodiments, the filling or substantially filling of the first volume of the isolation portion 1134 can reduce and / or can substantially equalize a pressure differential created between the isolation portion 1134 and a portion of the flow path 1133, e.g., and / or in fluid communication with the inlet 1132, between the junction 1117. The reduction and / or substantial equalization of the pressure differential can cause the flow of any subsequent volume of fluid flowing into the isolation portion 1134 to be restricted and / or stopped or substantially stopped. In other embodiments, the junction 1117 and / or a portion of the isolation portion 1134 can include a valve, a selectively permeable membrane, a fluid-activated (e.g., bodily fluid-activated) switch or seal, a user-activated switch or seal, and / or the like, which can restrict and / or substantially prevent bodily fluid from flowing into or out of the isolation portion 1134. As noted above, contaminants (e.g., skin-dwelling microorganisms or the like that are dislodged during a venipuncture event) can be entrained and / or included in the initial volume of bodily fluid, and as such, can also be isolated in the isolation portion 1134 when the initial volume is isolated in the isolation portion 1134.

[0225] After the initial volume is isolated in the isolation portion 1134, the device 1100 can transition to and / or can otherwise be in a second state in which one or more subsequent volumes of bodily fluid can flow from the inlet 1132, through at least a portion of the fluid flow path 1133, through the junction 1117, and to the outlet 1136. As noted above, the outlet 1136 can be coupled to and / or placed in fluid communication with any suitable fluid collection device, such as a sample reservoir, a syringe, and / or the like. In FIG. 27In the embodiment shown in FIG. 11, the control device 1100 is configured to automatically (e.g., without user intervention) transition from the first state to the second state once the initial volume of the bodily fluid is isolated in the final volume of the first portion of the isolation portion 1134. Thus, as subsequent flows and / or volumes of bodily fluid enter the fluid flow path 1133, the control device 1100 directs and / or diverts the fluid to flow through the inlet 1132, a portion of the fluid flow path 1133, the junction 1117, and the outlet 1136. As described in detail above, the outlet 1136 is in fluid communication with one or more fluid collection devices such that one or more subsequent volumes of bodily fluid can flow through the control device 1100 and into the fluid collection device(s) (not shown). Accordingly, as described above, isolating the initial volume of bodily fluid in the isolation portion 1134 prior to collecting or acquiring one or more sample volumes of bodily fluid reduces and / or substantially eliminates the amount of contaminants in the one or more sample volumes.

[0226] While the isolation portion 1134 is described as including a spring 1154 configured to transition and / or move the actuator 1151, in other embodiments, the isolation portion 1134 can include any suitable energy storage member and / or any other device or mechanism configured to move the actuator 1151. For example, in some embodiments, the second volume of the isolation portion 1134 can be evacuated and the negative pressure therein can move the actuator 1151 when one or more components are removed, released, dissolved, transferred, and / or deactivated. In other embodiments, the isolation portion 1134 can include a spring or other energy storage member that is compressed and configured to move the actuator 1151. In some such embodiments, the spring and / or energy storage member can be disposed, for example, in the first volume of the isolation portion 1134 and / or the second volume of the isolation portion 1134.

[0227] By way of example, FIG. 27 A fluid control device 1200 according to yet another embodiment is shown. The fluid control device 1200 (also referred to herein as a "control device" or "device") 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, divert, and / or otherwise facilitate subsequent bodily fluid flow to a fluid collection device (not shown). As described with respect to previous devices (e.g., devices 100, 200, 300, 400, 500, 600, 700, 800, 900, 1000, and / or 1100), the control device 1200 can have any suitable size and / or shape. For example, in some embodiments, the control device 1200 can have a size and / or shape that is substantially similar to the control device 1100. FIG. 27In the embodiment shown in FIG. 12, the control device 1200 includes an inlet 1232 (or inlet portion), an outlet 1236 (or outlet portion), and a junction 1217, and includes and / or defines one or more fluid flow paths 1233 and an isolation and / or transfer portion 1234 (also referred to herein as an "isolation portion"). The inlet 1232 is configured to be placed in fluid communication (directly or indirectly) with a source of bodily fluid, as described in detail above. The outlet 1236 is configured to be coupled to a fluid collection device (not shown), as described in detail above. Accordingly, the inlet 1232 and the outlet 1236 are not described in further detail herein.

[0228] FIG. 27 The device 1200 shown in FIG. 12 includes a first channel 1218 and a second channel 1258 that form one or more junctions with or along a portion of the device 1200. For example, the first channel 1218 is in fluid communication with a first volume of the isolation portion 1234 and is configured to place the isolation portion 1234 in selective fluid communication with the junction 1217. The second channel 1258 is in fluid communication with a second volume of the isolation portion 1234 and is configured to selectively place the second volume of the isolation portion 1234 in fluid communication with a portion of the flow path 1233. In some embodiments, the device 1200 and / or one or more portions thereof can include one or more valves or seals to selectively control the flow of fluid in one or more directions. For example, in the embodiment shown in FIG. 12, the device 1200 includes a valve 1257 disposed between and / or otherwise configured to control the flow of fluid between a portion of the junction 1217 and the first channel 1218. In some embodiments, the valve 1257 is configured to allow fluid to flow from the junction 1217 and limit and / or substantially prevent fluid from flowing out of the first channel 1218. The valve 1257 can be any suitable valve, such as a duckbill valve, a butterfly valve, a one-way check valve, etc., and can be made of any suitable material having any size, shape, and / or other properties, and configured to have any suitable performance. For example, the valve 1257 can be designed to have a particular burst pressure or the like (i.e., an amount of force or pressure needed to open the valve). In other embodiments, the device 1200 can include any other suitable flow control mechanism (e.g., other than a valve) disposed between the junction 1217 and the first channel 1218. FIG. 27

[0229] ​In some embodiments, the isolation portion 1234 can be configured to include one or more flow controllers configured to selectively control the flow of fluid into and / or out of the isolation portion 1234. For example, in some embodiments, the one or more flow controllers can include, for example, actuators, plungers, pistons, seals, vent holes, selectively permeable materials, and / or the like disposed in the isolation portion 1234 and configured to transition between one or more states, configurations, positions, and / or the like. For example, FIG. 27 The isolation portion 1234 illustrated in FIG. 12 includes two actuators or plungers 1251 and 1253 (e.g., flow controllers) connected to one another by a connecting component 1252. The actuators 1251 and 1253 (or plungers) are in contact with the interior surface of the isolation portion 1234 such that a substantially fluid-tight seal is formed between the actuators 1251 and 1253 and a portion of the interior surface. As illustrated in FIG. 26 FIG. 12, the arrangement of the actuators 1251 and 1253 within the isolation portion 1234 separates and / or otherwise defines three volumes of the isolation portion 1234. A first volume of the isolation portion 1234 is in fluid communication with the first channel 1218 and a portion of the isolation portion 1234 defined between the valve 1257 and the first actuator 1251. A second volume of the isolation portion 1234 is defined between the first actuator 1251 and the second actuator 1253 and is in fluid communication with the second channel 1258. A third volume of the isolation portion 1234 is defined on a side of the second actuator 1253 opposite the second volume of the isolation portion 1234. The isolation portion 1234 also includes one (or more) seals 1260 disposed about the connecting component 1252. The seals 1260 are in contact with the connecting component 1252 and the interior surface and / or walls of the isolation portion 1234 and are configured to form a substantially fluid-tight seal therebetween.

[0230] The isolation portion 1234 also includes and / or defines one or more openings or vent holes configured to release or selectively allow release of contents disposed within the isolation portion 1234. For example, as illustrated in FIG. 27 FIG. 12, the isolation portion 1234 defines an opening 1259 defined by and / or in fluid communication with the third volume of the isolation portion 1234. The opening 1259 can be configured to allow for the expulsion of any air or gas disposed in the third volume of the isolation portion 1234, as described above with reference to the opening 1159 defined by the isolation portion 1134 (see, e.g., FIG. 11). FIG. 27 The isolation portion 1234 can also include and / or define an opening 1235 defined by and / or in fluid communication with the first volume of the isolation portion 1234. As illustrated in FIG. 27As shown, the exhaust material 1242 may be disposed within and / or around the opening 1235 and may be configured to selectively allow the release of air or other gaseous contents within the first volume of the isolation portion 1234, while not allowing the release of liquids (e.g., bodily fluids) from the first volume of the isolation portion 1234, as described above with reference to exhaust materials 242, 542, 742, 842, 942 and / or 1042.

[0231] In some embodiments, the isolation portion 1234 may include one or more components, substances, compounds, chemicals, etc., which may alter their properties and / or otherwise react with a volume of fluid (e.g., bodily fluids) upon contact to produce, for example, an actuating agent or the like. FIG. 27 As shown, the first volume of the isolation portion 1234 may include one or more chemical substances 1256 configured to chemically react upon contact with a fluid (e.g., bodily fluids), the chemical reaction producing and / or generating gaseous products. Chemical substance 1256 may be one or more of any suitable substances. In some embodiments, chemical substance 1256 may be a dry or lyophilized chemical substance that can be reconstructed in response to wetting. Furthermore, chemical substance 1256 may cause the generation of one or more gaseous products upon wetting, which can expand within the first volume of the isolation portion 1234 and can apply a force to the first actuator 1251 having an order of magnitude sufficient to move the first actuator 1251 within the isolation portion 1234. Chemical substance 1256 may be selected at least in part based on the size and configuration of the first volume of the isolation portion 1234 and / or the size and configuration of the first actuator 1251, such that the expansion of the gaseous reconstructed chemical substance applies a desired amount of force (e.g., an activating force or actuating force) to the first actuator 1251. Furthermore, the arrangement of chemical substances 1256, actuators 1251 and 1253 and / or exhaust material 1242 can be selected and / or configured to generate a desired amount of negative pressure within at least a first volume of the isolation portion 1234, said negative pressure being operable to draw bodily fluids into the isolation portion 1234, as further described herein.

[0232] As described in detail above, FIG. 27The device 1200 shown in FIG. 12 can be used to pass and / or transfer a first volume or initial volume of bodily fluid such that a subsequently acquired bodily fluid sample has reduced contamination from microorganisms, such as microorganisms left over from the skin and / or the like. For example, once a user, such as a doctor, physician, nurse, phlebotomist, technician, or the like, establishes fluid communication between the control device 1200 and a source of bodily fluid (directly or via an access device, such as those described above), bodily fluid can flow from the source of bodily fluid (e.g., a vein of a patient or any other suitable source of bodily fluid) and into the control device 1200. In some embodiments, the control device 1200 can be in and / or can be placed in a first state or initial state in which an initial portion or initial volume of bodily fluid can flow through the inlet 1232, at least a portion of the fluid flow path 1233, at least a portion of the junction 1217, and the valve 1257 into the isolation state portion 1234 (and / or the first volume of the isolation portion 1234).

[0233] For example, in some cases, the control device 1200 can remain in the first state with the actuators 1251 and 1253 in the initial state until a predetermined and / or first portion of bodily fluid is passed through the valve 1257 into the first volume of the isolation portion 1234. The first portion of bodily fluid can be associated with and / or based at least in part on an amount or volume of bodily fluid that can pass through the valve 1257 that is sufficient to create a break force or pressure sufficient to open the valve 1257. In some embodiments, the first portion of bodily fluid can be an amount of bodily fluid that is passed through the valve 1257 in response to a positive pressure differential between the source of bodily fluid and, for example, the first volume of the isolation portion 1234. In some cases, the first portion of bodily fluid can be a relatively small volume. In some cases, venting of the first volume of the isolation portion 1234 (e.g., through the vent material 1242 and the opening 1235) can cause the first portion of bodily fluid to desirably and / or predictably flow into the first volume of the isolation portion 1234 rather than toward the outlet 1236. That is, venting of the first volume of the isolation portion 1234 can draw the first portion of bodily fluid flow through the valve 1257 into the isolation portion 1234.

[0234] After the first portion of the bodily fluid is transferred and / or transferred to the first volume of the isolation section 1234 via valve 1257, the dried chemical substance 1256, upon wetting, can recombine to induce a chemical reaction that produces one or more gaseous products, which in turn expand within the first volume of the isolation section 1234. The expansion of the gas within the first volume of the isolation section 1234 can increase the pressure therein, sufficient to close valve 1257 (e.g., a one-way valve) and apply force to the first actuator 1251, causing the first actuator 1251 to move within the isolation section 1234. Furthermore, the first portion of the mixture of bodily fluid and / or chemical substance 1256 and / or the first portion of the bodily fluid can contact, wet, and / or saturate the exhaust material 1242, causing the exhaust material 1242 to transition from its first or selectively permeable state to its second or substantially impermeable state. In this way, the first volume of the isolation portion 1234 can be substantially sealed as the chemical substance 1256 expands, which in turn increases the pressure within the first volume of the isolation portion 1234, the pressure being operable to move the first actuator 1251 from its first state and / or position toward its second state and / or position.

[0235] When the first actuator 1251 is connected to the second actuator 1253 via a connecting member 1252 (e.g., a substantially rigid member), movement of the first actuator 1251 causes a similar movement of the second actuator 1253. In some embodiments, an opening 1259 in fluid communication with a third volume of the isolation portion 1234 may allow the third volume of the isolation portion 1234 to vent as the second actuator 1253 moves within the isolation portion 1234, thereby preventing pressure buildup within the third volume of the isolation portion 1234 that could otherwise resist the movement of the actuators 1251 and 1253 (e.g., as described above with reference to control device 1100).

[0236] The arrangement of the seal 1260 is such that the seal 1260 does not move during at least the initial amount of movement of the actuators 1251 and 1253. For example, as FIG. 27As shown in FIG. 12, the seal 1260 can be disposed on a first side of the second channel 1258 and can be spaced apart from the first actuator 1251 when the device 1200 (or actuators 1251 and 1253) is in an initial state. As the gas expands, the actuators 1251 and 1253 can move a predetermined amount before the first actuator 1251 is placed in contact with the seal 1260. Thus, at least a portion of the movement of the actuators 1251 and 1253 is relative to the seal 1260 (e.g., the seal 1260 does not move). However, once the first actuator 1251 contacts the seal 1260, the actuators 1251 and 1253 and the seal 1260 can move together in response to the force exerted by the expanding gas in the first volume of the isolation portion 1234. Although not shown in FIG. 12, in some embodiments, the isolation portion 1234 can include a vent in fluid communication with the volume of the isolation portion 1234 defined between the first actuator 1251 and the seal 1260. In this way, as the first actuator 1251 moves relative to the seal 1260, air or gas disposed therein can be vented, which can otherwise resist and / or substantially prevent the relative movement. FIG. 27 Although not shown in FIG. 12, in some embodiments, the isolation portion 1234 can include a vent in fluid communication with the volume of the isolation portion 1234 defined between the first actuator 1251 and the seal 1260. In this way, as the first actuator 1251 moves relative to the seal 1260, air or gas disposed therein can be vented, which can otherwise resist and / or substantially prevent the relative movement.

[0237] As described above, the second volume of the isolation portion 1234 (e.g., which is defined between the seal 1260 and the second actuator 1253) is in fluid communication with the second channel 1258, which in turn is in fluid communication with the flow path 1233 (see FIG. 11). In this way, movement of the second actuator 1253 relative to the seal 1260 increases the volume of the second volume of the isolation portion 1234, which in turn creates a negative pressure therein. FIG. 28 In this way, movement of the second actuator 1253 relative to the seal 1260 increases the volume of the second volume of the isolation portion 1234, which in turn creates a negative pressure therein. The negative pressure can cause a negative pressure differential that is operable to draw bodily fluid through the inlet 1232, through a portion of the junction 1217, through a portion of the flow path 1233, through the second channel 1258, and into the second volume of the isolation portion 1234. Thus, as the actuators 1251 and 1253 (with or without the seal 1260) move, an initial volume of bodily fluid can be drawn into the second volume of the isolation portion 1234. Furthermore, once the first actuator 1251 is placed in contact with the seal 1260, the seal 1260 can move to a second side of the second channel 1258 opposite the first side (as described above). In this way, when the actuators 1251 and 1253 and the seal 1260 have completed movement within the isolation portion 1234, the initial volume of bodily fluid can be drawn into the second volume of the isolation portion 1234 and isolated between the second actuator 1253 and the seal 1260. In other words, the seal 1260 can isolate the initial volume of bodily fluid from, for example, the second channel 1258, which in turn isolates the initial volume of bodily fluid from the flow path 1233.

[0238] After the initial volume of bodily fluid is isolated in the second volume of the isolation portion 1234, the device 1200 can transition to and / or can otherwise be in a second state in which one or more subsequent volumes of bodily fluid can flow from the inlet 1232, through the junction 1217, the fluid path 1233, and the outlet 1236, into a fluid collection device (not shown) coupled to the outlet 1236. In FIG. 26 In the embodiment shown in FIG. 12, the control device 1200 is configured to automatically (e.g., without user intervention) transition from the first state to the second state once the initial volume of bodily fluid is isolated in the second volume of the isolation portion 1234. Thus, as subsequent flows and / or volumes of bodily fluid enter the fluid flow path 1233, the control device 1200 directs and / or diverts the fluid flow toward the outlet 1236. As described in detail above, the one or more subsequent volumes of bodily fluid can in turn flow through the control device 1200 into the fluid collection device (not shown). In some embodiments, the flow path 1233 can include one or more additional valves or flow controllers that can be configured to selectively control the flow of bodily fluid from the inlet 1232 to the outlet 1236. Moreover, the negative pressure generated by the fluid collection device that is operable to draw bodily fluid into the fluid collection device can also be operable to ensure that the valve 1257 remains in a closed or sealed state. Accordingly, as described above, isolating the initial volume of bodily fluid in the isolation portion 1234 prior to collecting or acquiring one or more sample volumes of bodily fluid reduces and / or substantially eliminates the amount of contaminants in the one or more sample volumes.

[0239] Although the devices 1100 and 1200 are each described as including a junction at least partially configured to direct the flow of bodily fluid toward the diaphragm portion and / or the outlet, in other embodiments, a device can be configured to direct fluid flow through the device without including a junction or the like. In such embodiments, the inlet can be selectively placed in fluid communication with the isolation portion and / or the outlet via one or more flow controllers, actuators, selected or configurable flow paths, and / or the like. For example, FIG. 27 A fluid control device 1300 according to yet another embodiment is shown. The fluid control device 1300 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, divert, and / or otherwise facilitate subsequent bodily fluid flow to a fluid collection device (not shown). In some embodiments, the fluid control device 1300 (also referred to as a "control device" or "device") can be at least formally and / or functionally similar to the devices 1100 and 1200 described above with reference to FIGS. 11 and 12, respectively. In some embodiments, the fluid control device 1300 can be at least formally and / or functionally similar to the devices 1100 and 1200 described above with reference to FIGS. 11 and 12, respectively. FIG. 28 and FIG. 28The control devices 1100 and / or 1200 described are similar. Thus, portions and / or aspects of the control device 1300 are discussed below for context recognition and / or briefly, but are not described in further detail.

[0240] As FIG. 27 The control device 1300 includes an inlet 1332 (or inlet portion), an outlet 1336 (or outlet portion), and includes and / or defines one or more fluid flow paths 1333, as well as an isolation and / or transfer portion 1334 (also referred to herein as an "isolation portion"), as shown in FIG. 13. The inlet 1332 is configured to be placed in fluid communication with a source of bodily fluid (directly or indirectly), as described in detail above. The outlet 1336 is configured to be coupled to a fluid collection device (not shown), as described in detail above. Accordingly, the inlet 1332 and the outlet 1336 are not described in further detail herein.

[0241] The isolation portion 1334 can have any suitable shape and / or size to draw in a sufficient and / or desired volume (e.g., a desired initial volume) of bodily fluid. As described above, in some embodiments, the isolation portion 1334 can include one or more flow controllers, e.g., actuators, plungers, pistons, seals, vent holes, selectively permeable materials, vent holes, and / or the like, disposed in the isolation portion 1334 and configured to transition between one or more states, configurations, positions, and / or the like. For example, as shown in FIG. 13, the isolation portion 1334 includes two actuators and / or plungers 1351 and 1353 (e.g., flow controllers) connected to one another by a connecting member 1352. In addition, the isolation portion 1334 can include one (or more) seals 1360 disposed about the connecting member 1352. In some embodiments, the actuators and / or plungers 1351 and 1353 and the one or more seals 1360 can be substantially similar in form and / or function to the actuators and / or plungers 1251 and 1253 and the seal 1260 described above with reference to FIG. 12, respectively, and thus are not described in further detail herein. FIG. 28 As shown in FIG. 13, the isolation portion 1334 includes two actuators and / or plungers 1351 and 1353 (e.g., flow controllers) connected to one another by a connecting member 1352. In addition, the isolation portion 1334 can include one (or more) seals 1360 disposed about the connecting member 1352. In some embodiments, the actuators and / or plungers 1351 and 1353 and the one or more seals 1360 can be substantially similar in form and / or function to the actuators and / or plungers 1251 and 1253 and the seal 1260 described above with reference to FIG. 12, respectively, and thus are not described in further detail herein. FIG. 27 As shown in FIG. 13, the isolation portion 1334 includes two actuators and / or plungers 1351 and 1353 (e.g., flow controllers) connected to one another by a connecting member 1352. In addition, the isolation portion 1334 can include one (or more) seals 1360 disposed about the connecting member 1352. In some embodiments, the actuators and / or plungers 1351 and 1353 and the one or more seals 1360 can be substantially similar in form and / or function to the actuators and / or plungers 1251 and 1253 and the seal 1260 described above with reference to FIG. 12, respectively, and thus are not described in further detail herein.

[0242] The isolation portion 1334 also includes and / or defines one or more openings or vent holes configured to release or selectively allow release of contents disposed within the isolation portion 1334. For example, as shown in FIG. 13, the isolation portion 1334 defines an opening 1359 in fluid communication with, e.g., a first volume of the isolation portion 1334, and can be configured to allow expulsion and / or evacuation of any air or gas disposed in the first volume of the isolation portion 1334 (e.g., in response to the actuators 1351 and / or 1353), as described above with reference to the opening 1259 defined by the isolation portion 1234 (see, e.g., FIG. 12). FIG. 29 As shown in FIG. 13, the isolation portion 1334 defines an opening 1359 in fluid communication with, e.g., a first volume of the isolation portion 1334, and can be configured to allow expulsion and / or evacuation of any air or gas disposed in the first volume of the isolation portion 1334 (e.g., in response to the actuators 1351 and / or 1353), as described above with reference to the opening 1259 defined by the isolation portion 1234 (see, e.g., FIG. 12). FIG. 28The isolation portion 1334 may also include and / or define an opening 1335 that is fluidly in communication with and defined by a second volume of the isolation portion 1334. FIG. 26 As shown, the exhaust material 1342 may be disposed within and / or around the opening 1335 and may be configured to selectively allow the release of air or other gaseous contents within the first volume of the isolation portion 1334, while not allowing the release of liquids (e.g., bodily fluids) from the first volume of the isolation portion 1334, as described above with reference to exhaust materials 242, 542, 742, 842, 942 and / or 1042.

[0243] exist FIG. 28 In the illustrated embodiment, the isolation portion 1334 may also include an energy storage member or the like, configured to transition, for example, from a first state associated with a higher potential energy to a second state associated with a lower potential energy. For example, the isolation portion 1334 may include a spring 1354 for attaching an actuator (or plunger) 1351 to a wall or surface of the isolation portion 1334. Furthermore, the isolation portion 1334 may include a soluble adhesive 1355 (e.g., glue, adhesive, fastener, epoxy, foam, and / or the like) that at least temporarily bonds the first actuator 1351 to one or more surfaces of the isolation portion 1334 until the soluble adhesive 1355 dissolves, for example, through contact with a flow of bodily fluid into the isolation portion 1334, which in turn allows the spring 1354 to be activated and / or released. Thus, the arrangement and / or function of the first actuator 1351, spring 1354, and soluble adhesive 1355 within the isolation portion 1334 may be consistent with the above-referenced... FIG. 28 The arrangement of the actuator 1151, spring 1154 and adhesive 1155 described are basically similar.

[0244] Although the spring 1154 is described above as having an initial or first state in which the spring 1154 is under tension, FIG. 26 The spring 1354 shown may have an initial state or a first state in which the spring 1354 is compressed before use. That is, before use, the soluble adhesive material 1355 can hold the first actuator 1351 in the initial position or the first position, and can also hold the spring 1354 in the first state or the compressed state. Activation of the spring 1354 can cause the spring 1354 to release a certain amount of stored energy to move it from the initial state or the compressed state to a subsequent or uncompressed state (e.g., with lower potential energy). Therefore, the spring 1354 may be operable to move the first actuator 1351 in response to bodily fluid contact with the soluble adhesive material 1355, regardless of whether the spring 1354 has an initial state in which the spring 1354 is compressed.FIG. 28 ) or an initial state in which the spring 1154 is in tension ( FIG. 28 ).

[0245] As described in detail above with reference to the devices 1100 and 1200, FIG. 28 The device 1300, as shown in FIG. 13, can be used to direct or divert a first or initial volume of bodily fluid such that a subsequently acquired sample of bodily fluid has reduced contamination from microorganisms, such as microorganisms left behind by the skin and / or the like. For example, once a user, such as a doctor, physician, nurse, phlebotomist, technician, or the like, can establish fluid communication between the device 1300 and a source of bodily fluid (e.g., as described in detail above with reference to previous embodiments), bodily fluid can flow from the source of bodily fluid (e.g., a vein of a patient or other suitable source of bodily fluid) into the control device 1300. In some embodiments, the control device 1300 can be in or can be placed in a first or initial state in which an initial portion or initial volume of bodily fluid can flow through the inlet 1332, through a portion of the fluid flow path 1333, and into the isolation portion 1334. Further, the arrangement of the control device 1300 can be such that when the device 1300 is in the initial state, the fluid flow path 1333 places the inlet 1332 in fluid communication with the second volume of, for example, the isolation portion 1334, without the device 1300 including an engagement portion or the like (e.g., the engagement portions 1117 or 1217).

[0246] In certain instances, the control device 1300 can remain in the first state with the first actuator 1351 in the initial state until a predetermined and / or desired flow or volume of bodily fluid is transferred into the second volume of the isolation portion 1334 that is in fluid communication with the fluid flow path 1333. For example, as described above with reference to the device 1100, the desired volume of bodily fluid can be a volume sufficient to dissolve the dissolvable binding material. Further, as the desired volume of bodily fluid is transferred into the second volume of the isolation portion 1334, the second volume of the isolation portion 1334 can be vented by the venting material 1342, as described in detail above. Thus, the bodily fluid can flow into the second volume of the isolation portion 1334 and contact the dissolvable binding material 1355, which in turn is at least partially dissolved to such an extent that the force associated with the spring 1354 in the initial state (e.g., in compression) overcomes the frictional or adhesive force associated with the dissolvable binding material 1355. Accordingly, the spring 1354 can release an amount of stored energy and / or potential energy to transition to the second state in which the spring 1354 is not compressed. Further, the transition of the spring 1354 from the first state to the second state causes the first actuator 1351 to move from its initial state or position toward a subsequent state or position. In other words, once the frictional and / or adhesive force associated with the dissolvable binding material 1355 is overcome, the spring 1354 expands to rest in a rest (e.g., uncompressed) state, which in turn causes the first actuator 1351 connected to the spring 1354 to transition and / or move to the second state and / or position.

[0247] As described above with reference to the device 1200, in instances in which the first actuator 1351 is connected to the second actuator 1353 via a connecting component 1352 (e.g., a substantially rigid component), the movement of the first actuator 1351 causes similar movement of the second actuator 1353, as in FIG. 29indicated by arrow DD. In some embodiments, the opening 1359 in fluid communication with the first volume of the isolation portion 1334 can allow the first volume of the isolation portion 1334 to vent as the second actuator 1353 moves within the isolation portion 1334, thereby preventing pressure from building up within the first volume of the isolation portion 1334 that might otherwise resist movement of the actuators 1351 and 1353 (e.g., as described above with reference to the control device 1100). In some embodiments, the seal 1360 is arranged such that it does not move during at least an initial amount of movement of the actuators 1351 and 1353. Thus, as described above with reference to the device 1200, movement of the second actuator 1353 relative to the seal 1360 increases the volume of the isolation portion 1334 defined therebetween, which in turn creates a negative pressure that is operable to draw bodily fluid into the volume of the isolation portion 1334.

[0248] After the actuators 1351 and 1353 have moved a desired distance relative to the seal 1360, the seal 1360 can begin to move with the actuators 1351 and 1353 (e.g., in response to a force applied by the first actuator 1351 or the like). In this way, the actuators 1351 and 1353 and the seal 1360 can collectively move within the isolation portion 1334 until the seal 1360 moves to an opposite side of the inlet 1332. In this way, when the actuators 1351 and 1353 and the seal 1360 have completed movement within the isolation portion 1334, an initial volume of bodily fluid can be drawn into the volume of the isolation portion defined between the second actuator 1353 and the seal 1360 and can be isolated and / or sequestered from the inlet 1332 (e.g., via the seal 1360).

[0249] After isolating the initial volume of bodily fluid, the device 1300 can transition into and / or can otherwise be in a second state in which the inlet 1332 is in fluid communication with the outlet 1336. As described above, the outlet 1336 can be fluidly coupled to a fluid collection device (not shown) such that, when the device is in the second state, subsequent volumes of bodily fluid can be passed through the inlet 1332, through the outlet 1336, and into the fluid collection device. In FIG. 28 In the embodiment shown in FIG. 13, the control device 1300 can be configured to automatically (e.g., without user intervention) transition from the first state to the second state once the initial volume of bodily fluid is isolated from the inlet 1332. Thus, as described above, isolating the initial volume of bodily fluid in the isolation portion 1334 prior to collecting or acquiring one or more sample volumes of bodily fluid reduces and / or substantially eliminates the amount of contaminants in the one or more sample volumes.

[0250] Although the isolation portion 1334 is described above as including an energy storage member, such as a spring 1354, which is configured to move actuators 1351 and 1353 and one or more seals 1360 within the isolation portion 1334, in other embodiments, movement of one or more flow controllers, actuators, plungers, seals, etc., within the isolation portion can be actuated, activated, and / or initiated in any suitable manner. For example, FIG. 29 A fluid control device 1400 according to yet another embodiment is shown. The fluid control device 1400 can be any suitable device or set of devices configured to (1) receive the flow of bodily fluids, (2) store and isolate a first volume or initial volume of bodily fluids, and (3) guide, transfer, and / or otherwise facilitate subsequent flow of bodily fluids to a fluid collection device (not shown). In some embodiments, the fluid control device 1400 (also referred to as a “control device” or “device”) may be at least in form and / or function similar to the above-referenced device. FIG. 29 The control device 1300 described is similar. Therefore, parts and / or aspects of the control device 1400 are discussed below for context recognition and / or in a brief manner, but without further detailed description.

[0251] like FIG. 28 As shown, the control device 1400 includes an inlet 1432 (or inlet portion), an outlet 1436 (or outlet portion), and includes and / or defines one or more fluid flow paths 1433 and a transfer and / or isolation portion 1434 (also referred to herein as an "isolation portion"). The inlet 1432 is configured to be in fluid communication (directly or indirectly) with a source of bodily fluids, as described in detail above. The outlet 1436 is configured to be coupled to a fluid collection device (not shown), as described in detail above. Therefore, the inlet 1432 and outlet 1436 are not described in further detail here.

[0252] The isolation portion 1434 can have any suitable shape and / or size to draw in sufficient and / or desired volume (e.g., desired initial volume) of bodily fluid. As described above, in some embodiments, the isolation portion 1434 may include one or more flow controllers, such as actuators, plungers, pistons, seals, vents, selectively permeable materials, and / or the like, disposed within the isolation portion 1434 and configured to transition between one or more states, configurations, positions, and / or the like. For example, as FIG. 29As shown, the isolation portion 1434 includes two actuators and / or plungers 1451 and 1453 (e.g., a flow controller) connected to each other via a connecting member 1452. Furthermore, the isolation portion 1434 may include one (or more) seals 1460 disposed around the connecting member 1452. In some embodiments, the actuators and / or plungers 1451 and 1453 and one or more seals 1460 may be respectively related in form and / or function to those referenced above. FIG. 29 The actuators and / or plungers 1351 and 1353 and the seal 1360 are substantially similar and therefore will not be described in further detail here.

[0253] The isolation portion 1434 also includes and / or defines one or more openings or vents configured to discharge or selectively allow the release of contents disposed within the isolation portion 1434. For example, as FIG. 28 As shown, the isolation portion 1434 defines an opening 1459 in fluid communication with, for example, a first volumetric fluid communication portion 1434 and an opening 1435 in fluid communication with, for example, a second volumetric fluid communication portion 1434. FIG. 29 As shown, the exhaust material 1442 may be disposed within and / or around the opening 1435. In some embodiments, the construction, arrangement, and / or function of the openings 1459 and 1435 and the exhaust material 1442 may be substantially the same as those described above. FIG. 29 The openings 1359 and 1335 and the exhaust material 1342 are similar in construction, arrangement and / or function, and therefore will not be described in further detail here.

[0254] Although the isolation portion 1334 of the control device 1300 includes a spring 1354 configured to move actuators 1351 and 1352 and one or more seals 1360, FIG. 29 The isolation portion 1434 shown can be configured to move actuators 1451 and 1453 and one or more seals 1460 in response to forces associated with, for example, a chemical reaction, as described in detail above with reference to control device 1200. For example, as FIG. 29As shown in FIG. 14, the second volume of the isolation portion 1434 can include one or more chemical substances 1456 configured to undergo a chemical reaction upon contact with a fluid (e.g., a bodily fluid), which can produce and / or generate a gaseous product. Additionally, the isolation chamber or isolation portion 1434 can include a valve 1457 configured to control and / or selectively allow fluid to flow into or out of the second volume of the isolation portion 1434, as described in detail above with reference to the device 1200. The chemical substances 1456 can be any suitable substance or substances. In some embodiments, the chemical substances 1456 can be dry or lyophilized chemical substances that can reconstitute in response to being wetted. Further, the chemical substances 1456 can be such that, upon wetting, one or more gaseous products are produced that can expand within the second volume of the isolation portion 1434 and can exert a force on the first actuator 1451 of a magnitude sufficient to cause the first actuator 1451 to move within the isolation portion 1434, as described in detail above with reference to the control device 1200.

[0255] As described in detail above, FIG. 30 The device 1400 shown in FIG. 14 can be used to direct or divert a first or initial volume of bodily fluid such that a sub...

Claims

1. An apparatus comprising: an inlet configured to be placed in fluid communication with a source of bodily fluid; an outlet configured to be placed in fluid communication with a fluid collection device; an isolation portion configured to be in fluid communication with the inlet, the isolation portion comprising a vent configured to allow gas to flow out of the isolation portion, the vent operable to allow a first volume of bodily fluid to flow from the source of bodily fluid into the isolation portion; and a flow controller disposed in the isolation portion, the flow controller comprising an expandable material configured to expand in response to contact with a portion of the first volume of bodily fluid, thereby transitioning the flow controller from a first state to a second state, the flow controller configured to allow a negative pressure differential to be created between the isolation portion and the inlet when the flow controller transitions from the first state to the second state, and to cause the first volume of bodily fluid to flow from the inlet into the isolation portion, the flow controller in the second state configured to (i) allow the negative pressure differential to equalize, (ii) isolate the first volume of bodily fluid in the isolation portion, and (iii) transfer a second volume of bodily fluid from the inlet to the outlet.

2. The apparatus of claim 1, wherein, the flow controller configured to automatically transition from the first state to the second state.

3. The apparatus of claim 1, wherein, the vent comprising a selectively permeable material.

4. The apparatus of claim 3, wherein, the flow controller configured to be placed in the second state in response to the portion of the first volume of bodily fluid saturating the vent.

5. The apparatus of claim 3, wherein, the vent configured to allow gas to flow through the vent and out of the isolation portion when the flow controller is in the first state and to prevent bodily fluid from flowing through the vent and out of the isolation portion.

6. The apparatus of claim 5, wherein, the expandable material configured to prevent gas from flowing through the vent when the flow controller is in the second state.

7. The apparatus of claim 1, wherein, the flow controller configured to be placed in the second state in response to the portion of the first volume of bodily fluid saturating the expandable material.

8. The apparatus of claim 7, wherein, the flow controller in the first state causing a flow path to place the vent in fluid communication with the inlet, the flow controller in the second state causing the expandable material to at least partially obstruct the flow path between the inlet and the vent.

9. The apparatus of claim 8, wherein, the expandable material defining a portion of the flow path between the vent and the inlet.

10. The apparatus of claim 1, wherein, the expandable material is an expandable hydrophilic material.

11. The apparatus of claim 1, wherein, the vent configured to at least temporarily vent the isolation portion such that a pressure within the isolation portion is less than a pressure within a fluid flow path defined between the inlet and the outlet.

12. The apparatus of claim 1, wherein, the fluid collection device is at least one of a syringe and a sample reservoir.

13. The apparatus of claim 12, wherein, the negative pressure differential is a first negative pressure differential, the fluid collection device placed in fluid communication with the outlet operable to create a second negative pressure differential between the outlet and the inlet when the flow controller is in the second state.

14. The apparatus of claim 1, wherein, The flow controller includes a seal configured to move within the isolation portion in response to the first volume of bodily fluid flowing into the isolation portion, the movement of the seal within the isolation portion creating at least a portion of the negative pressure differential.

15. An apparatus comprising: an inlet configured to be placed in fluid communication with a source of bodily fluid; an outlet configured to be placed in fluid communication with a fluid collection device; an isolation portion configured to be in fluid communication with the inlet and configured to receive a first volume of bodily fluid from the inlet, the isolation portion including a selectively permeable vent configured to allow gas to flow out of the isolation portion in response to the first volume of bodily fluid flowing into the isolation portion from the source of bodily fluid; and a flow controller disposed in the isolation portion and including an expandable material configured to expand in response to being placed in contact with bodily fluid, the flow controller configured to transition from a first state to a second state in response to the expandable material being placed in contact with a portion of the first volume of bodily fluid, the flow controller configured to allow a negative pressure differential to be created between the isolation portion and the inlet when the flow controller transitions from the first state to the second state such that the first volume of bodily fluid flows into the isolation portion from the inlet, the flow controller in the second state configured to (i) allow the negative pressure differential to equalize, (ii) isolate the first volume of bodily fluid and potential contaminants therein in the isolation portion, and (iii) pass a second volume of bodily fluid from the inlet to the outlet.

16. The apparatus of claim 15, wherein, the selectively permeable vent configured to transition from a first state in which the selectively permeable vent is configured to allow gas to flow through the selectively permeable vent and prevent bodily fluid from flowing through the selectively permeable vent to a second state in which the selectively permeable vent is configured to prevent gas and bodily fluid from flowing through the selectively permeable vent.

17. The apparatus of claim 16, wherein, the selectively permeable vent configured to be placed in the second state in response to the portion of the first volume of bodily fluid saturating the selectively permeable vent.

18. The apparatus of claim 15, wherein, the selectively permeable vent configured to allow gas to flow through the flow controller such that a pressure within the isolation portion is less than a pressure within a fluid flow path defined between the inlet and the outlet.

19. The apparatus of claim 15, wherein, the selectively permeable vent configured to at least temporarily vent the isolation portion such that a pressure within the isolation portion is less than a pressure within a fluid flow path defined between the inlet and the outlet.

20. The apparatus of claim 15, wherein, the flow controller configured to automatically transition from the first state to the second state in response to contact with the portion of the first volume of bodily fluid.

21. The apparatus of claim 15, wherein, The flow controller includes a seal configured to move within the isolation portion between a first position and a second position in response to the first volume of bodily fluid flowing into the isolation portion, the movement of the seal within the isolation portion creating at least a portion of the negative pressure differential.

22. The apparatus of claim 15, wherein, The fluid collection device is at least one of a syringe and a sample reservoir.

23. The apparatus of claim 22, wherein, The negative pressure differential is a first negative pressure differential, the fluid collection device placed in fluid communication with the outlet is operable to create a second negative pressure differential between the outlet and the inlet when the flow controller is in the second state.

24. The apparatus of claim 15, wherein, The swellable material is a swellable hydrophilic material.

25. The apparatus of claim 15, wherein, The swellable material is configured to prevent gas flow through the vent when the flow controller is in the second state.

26. The apparatus of claim 15, wherein, The flow controller is configured to be placed in the second state in response to a portion of the first volume of bodily fluid saturating the swellable material.

27. The apparatus of claim 15, wherein, The flow controller, in the first state, places a flow path that places the vent in fluid communication with the inlet, the flow controller, in the second state, at least partially obstructs the flow path between the inlet and the vent with the swellable material.

28. The apparatus of claim 27, wherein, The swellable material defines a portion of the flow path between the vent and the inlet. The flow controller includes a seal configured to move within the isolation portion between a first position and a second position in response to the first volume of bodily fluid flowing into the isolation portion, the movement of the seal within the isolation portion creating at least a portion of the negative pressure differential. The fluid collection device is at least one of a syringe and a sample reservoir. The negative pressure differential is a first negative pressure differential, the fluid collection device placed in fluid communication with the outlet is operable to create a second negative pressure differential between the outlet and the inlet when the flow controller is in the second state. The swellable material is a swellable hydrophilic material. The swellable material is configured to prevent gas flow through the vent when the flow controller is in the second state. The flow controller is configured to be placed in the second state in response to a portion of the first volume of bodily fluid saturating the swellable material. The flow controller, in the first state, places a flow path that places the vent in fluid communication with the inlet, the flow controller, in the second state, at least partially obstructs the flow path between the inlet and the vent with the swellable material. The swellable material defines a portion of the flow path between the vent and the inlet.

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