Fluid control devices and methods of using the same

Abstract

To acquire samples of bodily fluids with reduced contamination.SOLUTION: A device (100) for procuring bodily fluid samples with reduced contamination includes a housing (110) having a sequestration chamber (130), an inlet (113) and an outlet (114). A flow controller (140) defines a portion of the sequestration chamber (130) and, in response to suction force exerted by a fluid collection device (180) fluidically coupled to the outlet (114), can transition from a first state in which the sequestration chamber has a first volume to a second state in which the sequestration chamber has a second volume greater than the first volume, to draw an initial volume of bodily fluid into the sequestration chamber (130). An actuator (150) is coupled to the housing (110) and is in fluid communication with the inlet (113) and the sequestration chamber (130) in a first configuration, and transitions to a second configuration to sequester the sequestration chamber (130) from the inlet (113), and allow a subsequent volume of bodily fluid to flow from the inlet (113) to the outlet (114).SELECTED DRAWING: Figure 1

Description

Technical Field

[0001] Cross - reference to Related Applications

[0001] This application claims the priority and benefit of U.S. Provisional Patent Application No. 62 / 816,477, entitled "Fluid Control Devices and Methods of Using the Same," filed on March 11, 2019, the disclosure of which is hereby incorporated by reference in its entirety.

Background Art

[0002] Background

[0002] The embodiments described herein generally relate to the procurement of samples of body fluids, and more particularly to fluid diversion, sequestration, and / or isolation devices and methods for obtaining samples of body fluids with reduced contaminants such as skin commensal microorganisms and / or other contaminants external to the body fluid source. / or isolation, which obtain a sample of body fluid with reduced contaminants. / or isolation devices and methods.

[0003]

[0003] Healthcare providers routinely perform various types of microbial and other extensive diagnostic tests on patients using parenterally obtained body fluids. As advanced diagnostic techniques evolve and improve, the speed, accuracy (both sensitivity and specificity), and value of the information available to clinicians continue to increase. By maintaining the integrity of samples of body fluids during and / or after collection, it is ensured that the analytical diagnostic results represent the in vivo situation of the patient. Examples of diagnostic techniques that rely on high - quality, uncontaminated, and / or foreign - matter - free samples of body fluids include, but are not limited to, microbial detection, molecular diagnostics, gene sequencing (e.g., deoxyribonucleic acid (DNA), ribonucleic acid (RNA), next - generation sequencing (NGS), etc.), biomarker identification, and the like.

[0004] ​​

[0004] If a biological substance containing cells and / or other external contaminants outside the intended sample source is inadvertently included in the sample of the body fluid being analyzed, the presence of such a biological substance may result in inaccurate results from such tests. In short, when the purity of the sample of the body fluid is compromised during the sample acquisition process, the resulting analytical test results may be inaccurate, distorted, contaminated, false positive, false negative, and / or not representative of the patient's actual condition. Furthermore, these results may lead to incomplete, inaccurate, confusing, uncertain, unreliable, and / or otherwise undesirable clinical decision-making.

[0005]

[0005] In some examples, devices and / or systems can be used to reduce the possibility of contamination, foreign matter inclusion, etc. of the sample of the body fluid for testing. For example, some known devices can be configured to collect, divert, separate, and / or isolate (e.g., separate) an initial volume of body fluid that is relatively likely to contain contaminants such as skin commensal microorganisms. However, some of these devices may be recognized as difficult to handle, understand, and use for the target patient population, etc., and may be inappropriate or unusable. Furthermore, some of these devices may require training, user observation, intervention by more than one user, and / or may present problems where their effectiveness may be limited in other ways. In some examples, these problems and / or other problems may complicate the collection of consistently high-quality samples that are not contaminated, sterilized, free of foreign matter, etc., which may further affect the validity of the conclusions of the test results.

[0006]

[0006] Some known devices and / or systems can be configured to limit the amount of user intervention by passively diverting an initial volume of body fluid, but Some such devices and / or systems may not be able to adequately divert, isolate, and / or separate a clinically desirable and / or effective initial volume of body fluid (e.g., a pre-sample volume). Further, in some instances, the operation of some known devices and / or systems depends on a positive pressure (e.g., a patient's blood pressure) applied or supplied by a body fluid source. However, in some such instances, the positive pressure may be insufficient to provide the desired flow dynamics and / or flow rates that make the use of such devices practical in various clinical settings, such as in emergency rooms and other intensive care settings. SUMMARY OF THE INVENTION PROBLEMS TO BE SOLVED BY THE INVENTION

[0007] Therefore, there is a need for fluid control and / or diversion devices and methods that obtain a sample of body fluid with reduced contaminants, such as skin commensal microorganisms and / or other contaminants external to the body fluid source, that provide consistent body fluid collection (e.g., from general and / or refractory patient populations). Further, there is a need for devices and methods that include body fluid collection with the aid of, for example, various external energy sources and / or negative pressure. MEANS FOR SOLVING THE PROBLEM

[0008] SUMMARY

[0008] This specification describes a device and method for obtaining a sample of body fluid with reduced contaminants such as skin commensal microorganisms and / or other contaminants outside the body fluid. In some embodiments, the device for obtaining a sample of body fluid with reduced contamination includes a housing, an actuator, and a flow controller. The housing forms at least a part of an isolation chamber and has an inlet configured to be fluidly coupled to a body fluid source and an outlet configured to be fluidly coupled to a fluid collection device. The fluid collection device applies a suction force within at least a part of the housing when fluidly coupled to the outlet. The actuator is coupled to the housing and has a first configuration in which the inlet is in fluid communication with the isolation chamber and a second configuration in which the inlet is in fluid communication with the outlet and is fluidly separated from the isolation chamber. The flow controller is disposed within the housing and defines a portion of the isolation chamber. The flow controller can exhibit a first state in which the portion of the isolation chamber has a first volume and a second state in which the portion of the isolation chamber has a second volume greater than the first volume. When the actuator is in the first configuration, the flow controller is configured to transition from the first state to the second state in response to the suction force to draw an initial volume of body fluid into the portion of the isolation chamber. The actuator is configured to transition to the second configuration after an initial volume of body fluid has been drawn into the isolation chamber to (1) isolate the isolation chamber from the inlet and (2) allow a subsequent volume of body fluid to flow from the inlet to the outlet in response to the suction force.

Brief Description of the Drawings

[0009] Brief Description of the Drawings

Figure 1

[0010] It is a schematic diagram of a fluid control device according to an embodiment.

Figure 2

[0010] It is a front perspective view of a fluid control device according to an embodiment.

Figure 3

[0010] It is a rear perspective view of a fluid control device according to an embodiment.

Figure 4

[0011] It is a side view of the fluid control device of FIG. 2.

Figure 5

[0011] Top view of the fluid control device of FIG. 2

Figure 6

[0012] Exploded perspective view of the fluid control device of FIG. 2

Figure 7

[0013] Cross-sectional view of the fluid control device of FIG. 2 taken along line 7-7 of FIG. 4, shown in the first state

Figure 8

[0013] Cross-sectional view of the fluid control device of FIG. 2 taken along line 8-8 of FIG. 5, shown in the first state

Figure 9

[0014] Cross-sectional view of the fluid control device of FIG. 2 taken along line 7-7 of FIG. 4, shown in the second state

Figure 10

[0014] Cross-sectional view of the fluid control device of FIG. 2 taken along line 8-8 of FIG. 5, shown in the second state

Figure 11

[0015] Partial cross-sectional view of the fluid control device of FIG. 2 taken along line 8-8 of FIG. 5, shown in the second state

Figure 12

[0016] Front perspective view of a fluid control device according to an embodiment

Figure 13

[0016] Rear perspective view of a fluid control device according to an embodiment

Figure 14

[0017] Side view of the fluid control device of FIG. 12

Figure 15

[0017] Top view of the fluid control device of FIG. 12

Figure 16

[0018] Exploded perspective view of the fluid control device of FIG. 12

Figure 17

[0019] Cross-sectional view of the fluid control device of FIG. 12 taken along line 17-17 of FIG. 14, shown in the first state

Figure 18

[0019] Cross-sectional view of the fluid control device of FIG. 12 taken along line 18-18 of FIG. 15, shown in the first state

Figure 19

[0020] A cross-sectional view of the fluid control device of FIG. 12 taken along line 17-17 of FIG. 14, shown in the second state.

Figure 20

[0020] A cross-sectional view of the fluid control device of FIG. 12 taken along line 18-18 of FIG. 15, shown in the second state.

Figure 21

[0021] A partial cross-sectional view of the fluid control device of FIG. 12 taken along line 18-18 of FIG. 15, shown in the second state.

Figure 22

[0022] A front perspective view of a fluid control device according to an embodiment.

Figure 23

[0022] A rear perspective view of a fluid control device according to an embodiment.

Figure 24

[0023] A cross-sectional view of the fluid control device of FIG. 22 taken along line 24-24, shown in the first state.

Figure 25

[0023] A cross-sectional view of the fluid control device of FIG. 22 taken along line 24-24, shown in the first state.

Figure 26

[0024] A cross-sectional view of the fluid control device of FIG. 22 taken along line 24-24, shown in the second state.

Figure 27

[0024] A cross-sectional view of the fluid control device of FIG. 22 taken along line 24-24, shown in the second state.

Figure 28

[0025] A flowchart showing a method of using a fluid control device according to an embodiment.

Mode for Carrying Out the Invention

[0010] Detailed Description

[0026] This specification describes devices and methods for collecting, diverting, isolating, separating, etc. an initial volume of body fluid to reduce contamination in subsequently obtained body fluid samples. Any of the fluid control devices described herein can be configured to receive, acquire, and / or transfer the flow, bolus, volume, etc. of body fluid. A first reservoir, channel, flow path, or portion of the device can receive an initial amount of body fluid flow and then substantially or completely isolate such body fluid flow therein (e.g., contain or hold, divert, separate, segregate, vapor-lock, disconnect, etc.). In some examples, contaminants such as skin commensals may be included and / or mixed in the initial amount of body fluid, and they are similarly isolated within or by the first reservoir or first portion of the device. Once the initial amount is isolated, any subsequent amount of body fluid flow can be diverted, flowed, directed, and / or otherwise caused to flow into and / or through the second portion of the device and / or any further flow path. Based at least in part on the isolated initial amount, the subsequent amount of body fluid can be made substantially free of contaminants that could otherwise result in inaccurate, distorted, contaminated, and / or incorrect results in some diagnostic and / or testing procedures. In some examples, the initial amount of body fluid can also be used in other tests, such as those that are not as affected by the presence of contaminants, discarded as waste, injected back into the patient's body, and / or used in any other suitable clinical application.

[0011]

[0027] In some embodiments, features of the fluid control devices and / or methods described herein are the use of an external negative pressure source (e.g., provided by a fluid collection device or any other suitable means), which can overcome physical patient problems that may limit and / or prevent a pressure differential (e.g., the difference between blood pressure and ambient air pressure) sufficient to fully operate the isolation chamber and / or transfer fluid flow to the fluid collection device, cause the isolation chamber to be appropriately filled with a clinically validated and / or desired volume of body fluid, provide an efficient, timely, and / or user-acceptable consistency with the body fluid collection process, and / or enable isolation and / or separation of an initial amount (e.g., a pre-sample amount) and subsequent collection of samples by providing means to transfer fluid flow (e.g., automatically, or by operating any number of physical components of the system to move, or by changing, switching, actuating, and / or otherwise providing a desired fluid flow regime).

[0012]

[0028] In some embodiments, for example, an apparatus for obtaining a sample of body fluid with reduced contamination includes a housing, an actuator, and a flow controller. The housing forms at least a portion of an isolation chamber and has an inlet configured to be fluidly coupled to a body fluid source and an outlet configured to be fluidly coupled to a fluid collection device. The fluid collection device applies a suction force within at least a portion of the housing when fluidly coupled to the outlet. The actuator is coupled to the housing and has a first configuration in which the inlet is in fluid communication with the isolation chamber and a second configuration in which the inlet is in fluid communication with the outlet and is fluidly separated from the isolation chamber. The flow controller is disposed within the housing and defines a portion of the isolation chamber. The flow controller has a first state in which the portion of the isolation chamber has a first volume and a second state in which the portion of the isolation chamber has a second volume that is greater than the first volume. When the actuator is in the first configuration, the flow controller transitions from the first state to the second state in response to the suction force to draw an initial volume of body fluid into the portion of the isolation chamber. The actuator transitions to the second configuration after an initial volume of body fluid has been drawn into the isolation chamber and is configured to (1) isolate the isolation chamber from the inlet and (2) allow a subsequent volume of body fluid to flow from the inlet to the outlet in response to the suction force.

[0013]

[0029] In some embodiments, an apparatus for obtaining a sample of body fluid with reduced contamination includes a housing, an actuator, and a flow controller. The housing forms at least a portion of an isolation chamber and has an inlet configured to be fluidly coupled to a body fluid source and an outlet configured to be fluidly coupled to a fluid collection device. The fluid collection device applies a suction force within at least a portion of the housing when fluidly coupled to the outlet. The actuator is coupled to the housing and has a first configuration in which the inlet is in fluid communication with the isolation chamber and a second configuration in which the inlet is in fluid communication with the outlet and is fluidly separated from the isolation chamber. The flow controller is disposed within the housing and defines a portion of the isolation chamber. The flow controller has a first state in which a first side of the flow controller contacts at least a portion of a first surface of the isolation chamber and a second state in which a second side of the flow controller contacts at least a portion of a second surface of the isolation chamber that is opposite the first surface. The flow controller transitions from the first state to the second state as a result of a suction force being applied to the second side of the flow controller when the actuator is in the first configuration, drawing an initial volume of body fluid into a portion of the isolation chamber defined between the first surface and the first side of the flow controller. The actuator transitions to the second configuration after an initial volume of body fluid has been drawn into the isolation chamber and is configured to (1) isolate the isolation chamber from the inlet and (2) allow subsequent volumes of body fluid to flow from the inlet to the outlet in response to the suction force.

[0014]

[0030] In some embodiments, the fluid control device includes a housing, an actuator, and a flow controller. The housing has an inlet and an outlet and forms an isolation chamber. The inlet is configured to be placed in fluid communication with a body fluid source. The outlet is configured to be placed in fluid communication with a fluid collection device configured to apply a suction force within at least a portion of the housing. The actuator is coupled to the housing and is configured to isolate fluid communication between the inlet and the isolation chamber when in a first state and to establish fluid communication between the inlet and the outlet when placed in a second state. The flow controller is disposed within the isolation chamber and is configured to transition from the first state to the second state in response to a suction force when the actuator is in its first state, allowing an initial volume of body fluid to flow into a portion of the isolation chamber. The portion of the isolation chamber has a first volume when the flow controller is in the first state and a second volume greater than the first volume when the flow controller is in the second state. The actuator is configured to transition to its second form after an initial volume of body fluid is received within the portion of the isolation chamber to (1) isolate the isolation chamber and (2) allow subsequent volumes of body fluid to flow from the inlet to the outlet in response to the suction force.

[0015]

[0031] In some embodiments, a method of obtaining a sample of body fluid with reduced contamination using a fluid control device having a housing, an actuator, and a flow controller includes establishing fluid communication between a body fluid source and an inlet of the housing. A fluid collection device is coupled to an outlet of the housing and, when coupled to the outlet, applies a suction force within at least a portion of the housing. The flow controller transitions from a first state to a second state in response to the suction force, increasing the volume of an isolation chamber collectively defined by the flow controller and a portion of the housing. In response to the increase in volume, a first portion of the isolation chamber receives a volume of air contained within a flow path defined between the body fluid source and the isolation chamber, and a second portion of the isolation chamber receives an initial volume of body fluid. After the actuator receives the initial volume of body fluid within the second portion of the isolation chamber, the actuator transitions from a first configuration to a second configuration to (1) isolate the isolation chamber and (2) enable subsequent volumes of body fluid to flow from the inlet to the outlet in response to the suction force.

[0016]

[0032] In some embodiments, a method of obtaining a sample of body fluid with reduced contamination using a fluid control device having a housing, a flow controller, and an actuator can include, for example, establishing fluid communication between a body fluid source and an inlet of the housing. A fluid collection device is fluidly coupled to an outlet of the housing. The flow controller transitions from a first state to a second state in response to a suction force applied by the fluid collection device, increasing the volume of a first portion of an isolation chamber and a second portion of the isolation chamber. The first portion of the isolation chamber receives a volume of air contained within a flow path defined between the body fluid source and the isolation chamber in response to the increase in volume of the first portion of the isolation chamber and the second portion of the isolation chamber. The second portion of the isolation chamber receives an initial volume of body fluid in response to the increase in volume of the first portion of the isolation chamber and the second portion of the isolation chamber. After the actuator receives the initial volume of body fluid within the second portion of the isolation chamber, the actuator transitions from a first configuration to a second configuration to (1) isolate the isolation chamber and (2) enable subsequent volumes of body fluid (e.g., a sample of body fluid) to flow from the inlet to the outlet in response to the suction force.

[0017]

[0033] Any of the embodiments and / or methods described herein can be used to obtain a sample of a body fluid, such as a blood sample, that is uncontaminated or substantially free of foreign matter. In some examples, one or more potentially undesirable microorganisms, such as bacteria (e.g., gram-positive and / or gram-negative bacteria), fungi, yeasts (e.g., Candida), etc., may be present in a sample of a body fluid (e.g., a blood sample). Whether or not it is possible to test. During diagnostic tests, various techniques can be employed to help detect the presence of other types of biological materials, predetermined types of cells, biomarkers, proteins, antigens, enzymes, blood components, etc., similar to microorganisms. 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 ("non-culture") specimen analysis (e.g., NGS) and related techniques, morphological kinematic cell analysis, and / or other general or evolving advanced techniques for characterizing patient specimens and / or detecting, identifying, classifying, categorizing, and / or characterizing a given organism, antibiotic susceptibility, etc.

[0018]

[0034] For example, in some instances, microbial testing can include culturing a patient sample in one or more containers that can hold a medium (e.g., a nutrient-rich and / or environmentally controlled medium that promotes growth, and / or other suitable media), common additives, and / or other types of solutions that contribute to the growth of microorganisms. Any microorganisms and / or organisms present in the patient sample will thrive and / or grow over time (e.g., for a variable amount of time ranging from less than 1 hour to over several days, which can be shorter or longer depending on the diagnostic technique employed) in the medium. The presence of the microorganisms and / or organisms can be detected (e.g., by observing carbon dioxide levels and / or other detection methods) using an automated continuous monitoring, and / or analysis platform or technique specific to detection, identification, etc. The presence of microorganisms and / or organisms in the medium suggests the presence of the same microorganisms and / or organisms in the patient sample, which further suggests the presence of the same microorganisms and / or organisms in the body fluid of the patient from whom the sample was obtained. In other instances, a sample of the body fluid can be analyzed directly (i.e., without culturing) for the presence or absence of microorganisms and / or organisms. If it is determined that microorganisms are present in the sample used for testing, one or more antibiotics or other treatments specifically designed to diagnose the patient and treat or otherwise remove the unwanted microorganisms and / or organisms from the patient can be prescribed to the patient.

[0019]

[0035] However, patient samples can be contaminated during acquisition and / or may otherwise be prone to yielding incorrect results. For example, microorganisms from the body surface (e.g., skin commensals) that slough off during the specimen acquisition process (e.g., directly or indirectly via tissue fragments, hair follicles, sweat glands, and other skin appendage structures) may subsequently be transferred along with the patient sample into a medium, test bottle, or other suitable specimen collection or transfer container and / or may be included in the specimen to be analyzed by other means. Another possible source of contamination is from the person obtaining the patient sample. For example, the equipment, supplies, and / or devices used during the patient sample acquisition process often include multiple fluid interfaces (e.g., from the patient to the needle, from the needle to the transfer adapter, from the transfer adapter to the sample container, from the catheter hub to the syringe, from the syringe to the transfer adapter, from the needle / tube to the sample container, and / or any other fluid interface, or any combination thereof), each of which can introduce potential contamination points. In some instances, such contaminants can proliferate in the medium and / or may otherwise be identified, thereby increasing the risk or likelihood of false positive microbiology test results, which may not accurately reflect the presence or absence of such microorganisms in the patient's body (i.e., in vivo).

[0020]

[0036] Such inaccurate results due to contamination and / or adulteration are problematic when attempting to diagnose or treat a wide range of suspected illnesses, diseases, infections, patient conditions, and / or other maladies. For example, incorrect results from a microbiology test can lead to a patient receiving one or more antibacterial therapies unnecessarily and / or can lead to misdiagnosis and / or delay in treatment of the patient's illness, either of which can result in serious side effects or outcomes for the patient, including, for example, death. Thus, due to incorrect results, prolonged patient hospitalization and / or other complications associated with incorrect treatment 、It may cause unnecessary burdens and costs to the medical system. The use of diagnostic imaging devices that reach these incorrect results is also a problem from both the perspective of cost and patient safety, because the unnecessary exposure to intensive radiation associated with various imaging procedures (e.g., CT scans) brings many known adverse effects to the long-term health of patients.

[0021]

[0037] As used in this specification and / or any claims contained herein, the singular forms "a", "an", and "the" include plural referents unless the context clearly dictates otherwise. Thus, for example, the term "(a) member" is intended to mean a single member or a combination of members, and "(a) material" is intended to mean one or more materials, and so on.

[0022]

[0038] As used in this specification, "body fluid" can include any fluid obtained directly or indirectly from a patient's body. For example, "body fluid" includes, but is not limited to, blood, cerebrospinal fluid, urine, bile, lymph fluid, saliva, synovial fluid, serous fluid, pleural fluid, amniotic fluid, mucus, sputum, vitreous humor, air, etc. or any combination thereof.

[0023]

[0039] As used in this specification, the terms "proximal" and "distal" refer to the direction closer to and farther from the user who contacts the device with the patient, respectively. Thus, for example, the end of the device that first contacts the patient's body is the distal end of the device, and the end on the opposite side of the device (e.g., the end of the device being operated by the user) is the proximal end of the device.

[0024]

[0040] As used herein, the terms "about," "approximately," and "substantially," when used in connection with a stated value and / or a geometric structure or relationship, are intended to mean that the so-defined value or feature is nominally the stated value or the described feature. In some instances, the terms "about," "approximately," and / or "substantially" can generally mean a value or feature within the desired tolerance range (e.g., ±10% of the stated value or feature), and / or can generally be contemplated. For example, a value of about 0.01 can include 0.009 and 0.011, a value of about 0.5 can include 0.45 and 0.55, a value of about 10 can include 9 to 11, and a value of about 1000 can include 900 to 1100. Similarly, if a first surface and a second surface are nominally parallel, the first surface can be stated to be substantially parallel to the second surface. Although a stated value, structure, and / or relationship may be desirable, it should be understood that some variation can occur as a result of, for example, manufacturing tolerances or other practical considerations (e.g., pressure or force applied through a portion of a device, conduit, lumen, etc.). Thus, the terms "about," "approximately," and / or "substantially" can be used herein to account for such tolerances and / or considerations.

[0025]

[0041] As used herein, the terms "presample", "first" and / or "initial" can be used interchangeably to describe an amount, portion or volume of a body fluid that is collected and / or isolated prior to obtaining a "sample" volume. A "presample", "first" and / or "initial" volume can be a predetermined, defined, desired and / or given amount of a body fluid. For example, a predetermined and / or desired presample volume of a body fluid can be the volume of one drop of the body fluid, the volume of several drops of the body fluid, about 0.1 milliliter (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 20.0 mL, about 50.0 mL, and / or any volume therebetween or any proportion of volumes therebetween. In other embodiments, the presample volume can be greater than 50 mL or less than 0.1 mL. In some predetermined embodiments, the predetermined and / or desired presample volume can be from about 0.1 mL to about 5.0 mL. In other embodiments, the presample volume can be, for example, the combined volume of any number of lumens (e.g., lumens forming at least a portion of a flow path from a body fluid source to an initial collection chamber, portion, reservoir, etc.). In other embodiments, the presample volume can be, for example, the combined volume of any number of lumens (e.g., lumens forming at least a portion of a flow path from a body fluid source to an initial collection chamber, portion, reservoir, etc.).

[0026]

[0042] As used herein, the terms "sample", "second" and / or "subsequent" can be used interchangeably to describe, for example, an amount, portion or volume of a body fluid used in one or more samples or diagnostic tests. A "sample" volume can be either a random volume of a body fluid collected after collecting, isolating and / or separating the body fluid of the presample volume or a predetermined or desired volume. In some embodiments, the desired sample volume of a body fluid can be from about 10 mL to about 60 mL. In other embodiments, the desired sample volume of a body fluid can be less than 10 mL or greater than 60 mL. In some embodiments, for example, the sample volume can be at least partially based on one or more tests, assays, analyses and / or processes performed on that sample volume.

[0027]

[0043] The embodiments described herein can be configured to transfer substantially contaminant-free bodily fluid to one or more fluid collection devices. In some embodiments, fluid collection devices can include, but are not limited to, any suitable container, receptacle, reservoir, bottle, adapter, dish, vial, syringe, device, diagnostic and / or testing instrument, and the like. In some embodiments, the fluid collection device can be substantially similar or identical to a known sample container such as a Vacutainer® (manufactured by Becton Dickinson and Company (BD)), BacT / ALERT® SN or BacT / ALERT® FA (manufactured by Biomerieux, Inc.) and / or any suitable reservoir, vial, microvial, microliter vial, nanoliter vial, container, microcontainer, nanocontainer, and the like. In some embodiments, the fluid collection device can be substantially similar or identical to any of the sample reservoirs described in U.S. Patent No. 8,197,420 (the "420 Patent") entitled "Systems and Methods for Parenterally Procuring Bodily-Fluid Samples with Reduced Contamination", filed December 13, 2007, the disclosure of which is hereby incorporated by reference in its entirety.

[0028]

[0044] In some embodiments, the fluid collection device can be made to be empty before receiving a sample volume of body fluid. For example, in some embodiments, the fluid collection device or reservoir can be configured to define and / or generate a vacuum or suction, such as a vacuum-based collection tube (e.g., Vacutainer®), syringe, etc. In other embodiments, the fluid collection device can contain any suitable additive, medium, substance, enzyme, oil, fluid, etc. For example, the fluid collection device can be a sample or culture bottle containing, for example, an aerobic or anaerobic medium. The sample or culture bottle can be configured to receive a sample of body fluid that can be tested (e.g., via in vitro diagnostic (IVD) testing and / or any other suitable test after culturing) to determine whether, for example, Gram-positive bacteria, Gram-negative bacteria, yeast, fungi, and / or any other organisms are present. In some instances, if such a medium test results in a positive outcome, the medium can then be tested using a PCR-based system to identify a given organism. In some embodiments, the sample reservoir can contain any suitable additive, etc., in addition to or in place of the medium. Such additives can include, for example, heparin, citrate, ethylenediaminetetraacetic acid (EDTA), oxalate, sodium polyanetholesulfonate (SPS), etc. In some embodiments, the fluid collection device can contain any suitable additive or medium, and the fluid collection device can be evacuated and / or air can be removed from the fluid collection device in other ways.

[0029]

[0045] The term "medium" reacts with organisms (e.g., microorganisms such as bacteria) in body fluid The term "additive" can be used to describe a substance that is configured to react with a part of a body fluid (e.g., blood constituent cells, serum, synovial fluid, etc.). It should be understood that the sample reservoir can contain any suitable substance, liquid, solid, powder, lyophilized compound, gas, etc. Further, when referring to an "additive" within the sample reservoir, the additive can be a medium such as an aerobic medium and / or an anaerobic medium contained in a culture bottle, an additive, and / or any other suitable substance or combination of substances contained in any other suitable reservoir such as a culture bottle and / or those described above. That is, the embodiments described herein can be used with any suitable fluid reservoir that contains any suitable substance or combination of substances.

[0030]

[0046] The embodiments and / or portions thereof described in this specification can be formed or constituted 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, such as, for example, rigidity, toughness, durometer hardness, bioactivity, etc. Examples of suitable biocompatible materials include metals, glasses, ceramics, or polymers. Examples of suitable metals include pharmaceutical grade stainless steel, gold, titanium, nickel, iron, platinum, tin, chromium, copper, and / or their alloys. The polymeric material can be biodegradable or non - biodegradable. Examples of suitable biodegradable polymers include polylactide, polyglycolide, polylactide - co - glycolide (PLGA), polyanhydrides, polyorthoesters, polyether esters, polycaprolactone, polyesteramides, poly(butyric acid), poly(valeric acid), polyurethanes, and / or their blends and copolymers. Examples of non - biodegradable polymers include nylon, polyester, polycarbonate, polyacrylate, polysiloxane (silicone), ethylene vinyl acetate, and polymers of other acyl - substituted cellulose acetates, non - degradable polyurethanes, polystyrene, polyvinyl chloride, polyvinyl fluoride, poly(vinyl imidazole), chlorosulfonated polyolefin, polyethylene oxide, and / or their blends and copolymers.

[0031]

[0047] The embodiments described in this specification and / or parts thereof can include components formed from one or more parts, features, structures, etc. When referring to such components, it should be understood that the component can be formed by a single part having any number of sections, regions, parts, and / or features, or can be formed by a plurality of parts or features. For example, when referring to a structure such as a wall or a chamber, the structure can be regarded as a single structure having a plurality of parts, or as a plurality of separate sub-structures joined together to form the structure. Thus, an integrally constructed structure can include, for example, a set of sub-structures. Such a set of sub-structures can include a plurality of parts that are either continuous or discontinuous with each other. A set of sub-structures can also be manufactured from a plurality of articles or components that are manufactured separately and later joined together (for example, via welding, adhesives, or any suitable method).

[0032]

[0048] Although some of the embodiments are described herein as being used to obtain body fluid for one or more culture sample tests, it should be understood that the embodiments are not limited to such use. Any of the embodiments and / or methods described herein can be used to transfer the flow of body fluid to any suitable device placed in fluid communication therewith. Thus, although certain examples are described herein, the devices, methods, and / or concepts are not intended to be limited to such certain examples.

[0033]

[0049] Referring now to the drawings, FIG. 1 shows a fluid control device 100 according to one embodiment is a schematic diagram. Generally, a fluid control device 100 (also referred to herein as a "control device" or a "device") is configured to draw body fluid from a patient's body. A first portion or amount of the drawn body fluid (e.g., an initial amount) is isolated from a second portion or amount of the drawn body fluid (e.g., a subsequent amount). In some examples, contaminants and the like can be isolated within the first portion or amount, leaving a second portion or amount substantially free of contaminants. And the second portion or amount of the body fluid can be used as a biological sample in one or more tests (e.g., blood culture tests, etc.) as described in more detail herein. The first portion or amount of the body fluid can be discarded as waste or used in any suitable test that is unlikely to produce false, inaccurate, distorted, inconsistent, or unreliable results as a result of potential contaminants contained therein.

[0034]

[0050] The control device 100 includes a housing 110, a flow controller 140, and an actuator 150. The housing 110 of the device 100 can be of any suitable shape, size, and / or configuration. For example, in some embodiments, the housing 110 can have a size based at least in part on an initial amount or volume of body fluid configured to be transferred into and / or isolated within a portion of the housing 110. In some embodiments, the housing 110 can have a size and / or shape configured to improve the ergonomics and / or ease of use associated with the device 100. Further, in some embodiments, one or more portions of the housing 110 can be formed from a relatively transparent material configured such that a user can visually inspect and / or verify the flow of body fluid through at least a portion of the housing 110.

[0035]

[0051] Housing 110 has and / or forms an inlet 113, an outlet 114, and an isolation chamber 130. The inlet 113 is configured to fluidly couple to a lumen-containing device, which in turn can fluidly communicate the housing 110 with a body fluid source. For example, the housing 110 can be coupled to and / or can include a lumen-containing device (e.g., a butterfly needle, an intravenous (IV) catheter, a peripherally inserted central catheter (PICC), an intermediate lumen-containing device, etc.) that fluidly communicates with the inlet 113 and is configured to be placed percutaneously within a patient's body. Thus, as described in more detail herein, body fluid can be transferred from a patient and / or other body fluid source through the inlet 113 into the housing 110. The outlet 114 can be fluidly communicated with a fluid collection device 180 (e.g., a fluid or sample reservoir, a syringe, an evacuated container, a culture flask, etc.). As described in more detail herein, the control device 100 can be used and / or operated to selectively transfer a volume of body fluid from a body fluid source, through the inlet 113, the housing 110, and the outlet 114, to the fluid collection device 180.

[0036]

[0052] The housing 110 can define at least a portion of any number of flow paths. For example, as shown in FIG. 1, the housing 110 defines one or more flow paths 115 between the inlet 113 and the isolation chamber 130 and / or one or more flow paths 116 between the inlet 113 and the outlet 114. As described in more detail herein, the control device 100 and / or the housing 110 can be configured to transition between any number of states, operating modes, and / or configurations to selectively control the flow of body fluid through at least one of the flow paths 115 and / or 116. Further, the control device 100 and / or the housing 110 can be configured to transition automatically (e.g., based on a pressure differential, based on time, electronically, based on saturation of a membrane, absorbent, and / or barrier material, etc.) or via an intervention (e.g., user intervention, mechanical intervention, etc.).

[0037]

[0053] The isolation chamber 130 is placed in fluid communication with the inlet 113 via the flow path 115 at least temporarily. As described in more detail herein, the isolation ch The isolation chamber 130 is configured to (1) receive the flow and / or volume of body fluid from the inlet 113 and (2) isolate (e.g., separate, disconnect, contain, hold, segregate, etc.) the flow and / or volume of the body fluid therein. The isolation chamber 130 can have any suitable arrangement configuration, such as those described herein with respect to certain embodiments. However, it should be understood that the control device 100 and / or the housing 110 can have an isolation chamber 130 arranged in any suitable manner, and thus the isolation chamber 130 is not intended to be limited to that shown and described herein. For example, in some embodiments, the isolation chamber 130 can be at least partially formed by the housing 110. In other embodiments, the isolation chamber 130 can be a reservoir placed and / or disposed within a portion of the housing 110. In other embodiments, the isolation chamber 130 can be formed and / or defined by a portion of the flow path 115. That is, the housing 110 can define one or more lumens and / or include one or more lumen-defining devices configured to receive the initial flow or volume of body fluid from the inlet 113, thereby forming and / or functioning as the isolation chamber 130.

[0038]

[0054] The isolation chamber 130 can have any suitable volume and / or fluid capacity. For example, in some embodiments, the isolation chamber 130 can have a volume and / or fluid capacity of from about 0.1 mL to about 5.0 mL. In some embodiments, the isolation chamber 130 can have a volume measured with respect to the amount of body fluid configured to be transferred within the isolation chamber 130 (e.g., an initial or first amount of body fluid). For example, in some embodiments, the isolation chamber 130 can have a volume sufficient to receive a body fluid having an initial volume on the order of microliters or less of body fluid (e.g., 20 drops of body fluid, 10 drops of body fluid, 5 drops of body fluid, 1 drop of body fluid, or any suitable volume on the order of volume therebetween). In other embodiments, the isolation chamber 130 can have a volume sufficient to receive a body fluid having an initial volume of up to, for example, 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 isolation chamber 130 can have a volume equal to at least some of the volume of one or more lumens (e.g., a combined volume of the lumens of the needle, inlet 113, and flow path 115) that fluidly connect the isolation chamber 130 to the body fluid source.

[0039]

[0055] The outlet 114 of the housing 110 is in fluid communication with and / or configured to be placed in fluid communication with the flow path 115 and / or 116. The outlet 114 can be any suitable outlet, opening, port, stopper, lock (e.g., luer lock), seal, coupler, valve (e.g., one-way, check valve, duckbill valve, umbrella valve, etc.), etc., and is configured to be physically and / or fluidly coupled to the fluid collection device 180. In some embodiments, the outlet 114 can be integrally formed with the fluid collection device 180. In other embodiments, the outlet 114 can be at least temporarily coupled to the fluid collection device 180 via an adhesive, resistance fit, mechanical fastener, screw connection, piercing or puncture configuration, a plurality of mating recesses, and / or any other suitable connection or combinations thereof. In still other embodiments, the outlet 114 can be operably coupled to the fluid collection device 180 via an intervening structure (not shown in FIG. 1), such as a sterile tube. In some embodiments, the arrangement of the outlet 114 can be such that the outlet 114 is physically and / or fluidly sealed before being coupled to the fluid collection device 180. In some embodiments, the outlet 114 can be transitioned from a sealed configuration to an unsealed configuration in response to being coupled to the fluid connection device 180 and / or in response to a negative pressure difference between the environment within the outlet 114 and / or the housing 110 and the environment within the fluid collection device 180.

[0040]

[0056] Regarding the outlet 114 of the control device 100 and / or the housing 110, it has been described above as being fluidly coupled to and / or placed in fluid communication in some other manner with the fluid collection device 180. However, in other embodiments, the device 100 can be used with any suitable bodily fluid collection device, system, adapter, etc. For example, in some embodiments, the device 100 can be used with or in conjunction with any suitable fluid transfer device and / or adapter, such as those described in U.S. Patent No. 10,123,783, entitled "Apparatus and Methods for Disinfection of a Specimen Container" (referred to herein as the "‘783 patent"), filed on March 3, 2015, and / or U.S. Patent Application Publication No. 2015 / 0342510, entitled "Sterile Bodily-Fluid Collection Device and Methods" (referred to herein as the "‘510 publication"), filed on June 2, 2015. The entire disclosure of each of the above patents and publications is hereby incorporated by reference herein in its entirety.

[0041]

[0057] The fluid collection device 180 can be any suitable device that at least temporarily holds a body fluid, such as, for example, any of those described in detail above (e.g., evacuated blood collection tube, sample reservoir, syringe, culture bottle, etc.). In some embodiments, the fluid collection device 180 can be a sample reservoir that includes a vacuum seal to maintain a negative pressure (vacuum) inside the sample reservoir, thereby facilitating the withdrawal of body fluid from the patient through the control device 100 into the sample reservoir via a vacuum or suction force. In embodiments where the fluid collection device 180 is an evacuated blood collection tube or the like, as described in further detail herein, the user couples the fluid collection device 180 to the outlet 114 to initiate the flow of body fluid from the patient into the device 100, such that the first or initial portion of the body fluid flow is transferred into and isolated by the isolation chamber 130, and the second or subsequent portion of the body fluid flow can be diverted away from the isolation chamber 130 (e.g., via the outlet 114) into the fluid collection device 180, to bypass and / or otherwise shunt.

[0042]

[0058] The flow controller 140 of the device 100 is at least partially disposed within the housing 110 and is configured to control, direct, and / or otherwise facilitate a selective flow of fluid through at least a portion of the housing 110. More particularly, in some embodiments, the flow controller 140 can be disposed within a portion of the isolation chamber 130 that receives an initial flow or volume of body fluid and / or within the interior volume of the isolation chamber 130, and / or can at least partially define such portion and / or interior volume. In some embodiments, the flow controller 140 can be disposed within the housing 110 such that one or more surfaces of the flow controller 140 and one or more inner surfaces of the housing 110 together define the isolation chamber 130. Stated another way, the flow controller 140 can be disposed within the isolation chamber 130 such that the inner surface of the housing 110 that at least partially defines the isolation chamber 130 and one or more surfaces of the flow controller 140 together define a portion of the isolation chamber 130 and / or the volume within the isolation chamber 130. In some embodiments, the flow controller 140 can form a barrier and / or can otherwise fluidly separate at least a portion of the flow path 116 from at least a portion of the flow path 115. For example, the flow controller 140 can be disposed within the housing 110 such that a first side and / or a first surface of the flow controller 140 is selectively in fluid communication with at least a portion of the flow path 115 and / or the inlet 113, and a second side and / or a second surface of the flow controller 140 is selectively in fluid communication with at least a portion of the flow path 116 and / or the outlet 114.

[0043]

[0059] The flow controller 140 can be of any suitable shape, size, and / or configuration. For example, the flow controller 140 can be, for example, a membrane, diaphragm, bladder, plunger, piston, bag, pouch, and / or have a desired stiffness, flexibility, and / or du It may be any other suitable member having a Romer hardness. In some embodiments, the flow controller 140 can be configured to transition from a first state to a second state in response to a negative pressure difference and / or a suction force being applied to at least a portion of the flow controller 140. For example, in some embodiments, as will be described in more detail herein with respect to a given embodiment, the flow controller 140 can be a bladder configured to transition from a first state to a second state or "invert" in response to a negative pressure difference and / or a suction force being applied to the surface of the bladder.

[0044]

[0060] Flow controller 140 can be in a first state (e.g., a storage or unused state) before using device 100, and can transition flow controller 140 to a second state in response to outlet 114 being fluidly coupled to a fluid collection device 180 (e.g., a collection device configured to define or define a negative pressure and / or suction force). In some embodiments, flow controller 140 can define at least a portion of isolation chamber 130 when flow controller 140 is in the second state. In some embodiments, the arrangement of flow controller 140 is such that isolation chamber 130 defines and / or has a first volume when flow controller 140 is in the first state, and defines and / or has a second volume that is larger than the first volume when flow controller 140 is placed in the second state. As described in more detail herein, an increase in the volume of isolation chamber 130 can result in a suction force operable to draw an initial volume of body fluid into isolation chamber 130. Further, in some embodiments, flow controller 140 can have a size, shape, and / or configuration such that isolation chamber 130 can receive a volume of air or gas (e.g., a volume of air disposed in a flow path between a body fluid source and an isolation portion) and an initial amount or volume of body fluid. In such embodiments, flow controller 140 can be configured to define any number of portions, volume portions, channels, etc. that can receive and / or contain at least one of a volume of air or an initial volume of body fluid.

[0045]

[0061] In some embodiments, the size, shape, arrangement configuration, and / or constituent material of the flow controller 140 can be configured and / or otherwise selected such that the flow controller 140 transitions from the first state to the second state in a predetermined manner and / or at a predetermined or desirable rate. In some examples, by controlling the rate at which the flow controller 140 transitions from the first state to the second state, the rate of the body fluid flow into the isolation chamber 130 and / or the magnitude of the suction force generated within the isolation chamber 130 that is operable to draw an initial volume of the body fluid into the isolation chamber 130 can be controlled and / or adjusted. Although not shown in FIG. 1, in some embodiments, the housing 110 can include a valve, a membrane, a porous material, a throttle, an orifice, and / or any other suitable member, device, and / or feature configured to adjust the suction force applied to the surface of the flow controller 140, whereby the rate at which the flow controller 140 transitions from the first state to the second state can be adjusted.

[0046]

[0062] In some examples, by controlling the rate at which the flow controller 140 transitions and / or the magnitude of the pressure difference and / or suction force generated within the isolation chamber 130, the possibility of, for example, hemolysis of a blood sample and / or collapsing a vein can be reduced (for example, this can be particularly important when obtaining a body fluid sample from a frail patient). In some examples, by adjusting the transition of the flow controller 140 and / or the pressure difference generated within the isolation chamber 130, the amount or volume of the body fluid transferred into the isolation chamber 130 can be at least partially controlled (i.e., the volume of the initial amount of the body fluid can be controlled).

[0047]

[0063] The actuator 150 of the device 100 is at least partially disposed within the housing 110 and is configured to control, direct, and / or otherwise facilitate a selective flow of fluid through at least a portion of the housing 110. The actuator 150 can be of any suitable shape, size, and / or configuration. For example, in some embodiments, the actuator 150 can be any suitable member or device configured to transition between a first state and a second state. In some embodiments, for example, the actuator 150 can be a valve, a plunger, a seal, a membrane, a bladder, a flap, a plate, a rod, a switch, etc. In some embodiments, the actuator 150 can include one or more seals configured to selectively establish fluid communication between the fluid flow channel 113 and the fluid flow channel 116 when the actuator 150 transitions from the first state to the second state.

[0048]

[0064] Actuator 150 can be operated and / or transitioned between a first state and a second state in any suitable manner. For example, in some embodiments, the transition of actuator 150 can include starting, pressing, moving, translating, rotating, switching, sliding, releasing, closing, and / or reconfiguring actuator 150 in other ways. In some examples, actuator 150 can transition between a first state and a second state in response to manual actuation by a user (e.g., manually applying force to a button, slider, plunger, switch, valve, rotating member, conduit, etc.). In other embodiments, actuator 150 can be configured to automatically transition between a first state and a second state in response to a pressure difference (or lack of pressure), a change in position or kinetic energy, a change in composition or configuration (e.g., a portion of the actuator can at least partially dissolve or transform), etc. In yet other embodiments, actuator 150 can be mechanically and / or electrically actuated or transitioned (e.g., via a motor, etc.) based on a predetermined time, the volume of body fluid received, the volumetric flow rate of the body fluid flow, the flow velocity of the body fluid flow, etc. Although examples of actuators and / or ways in which an actuator can transition are provided, it should be understood that they are presented by way of example only and not by way of limitation.

[0049]

[0065] In some embodiments, the actuator 150 can be configured to separate, isolate, disconnect, and / or otherwise prevent fluid communication between at least a portion of the flow path 115 and at least a portion of the flow path 116 when in the first state, and to place the flow path 115 (or at least a portion thereof) in fluid communication with the flow path 116 (or at least a portion thereof) when in the second state. Further, the actuator 150 can be configured to isolate, disconnect, separate, and / or otherwise prevent fluid communication between the isolation chamber 130 and at least a portion of the inlet 113, the outlet 114, and / or the flow paths 115 and 116. Thus, when the actuator 150 is placed in its second position, the isolation chamber 130 can be isolated and / or fluidly separated from other flow paths or portions of the housing 110, and the inlet 113 can be placed in fluid communication with the outlet 114. Thus, as described in further detail herein, the actuator 150 can cause a subsequent volume of body fluid (e.g., a volume of body fluid after an initial volume of body fluid) to be transferred to the fluid collection device 180 fluidly coupled to the outlet 114.

[0050]

[0066] As described above, the device 100 can be used to obtain a sample of body fluid with reduced contamination from microorganisms such as skin commensal microorganisms. For example, in some instances, a user such as a physician, internist, nurse, phlebotomist, technician, etc. can operate the device 100 to establish fluid communication between the inlet 113 and a body fluid source (e.g., a patient's vein, cerebrospinal fluid (CSF) from the spinal canal, urine collection, etc.). As a specific example, in some instances, the inlet 113 can pierce the patient's skin, insert at least a portion of a needle into the patient's vein, and operate to place the inlet 113 in fluid communication with a body fluid source (e.g., a vein, an IV catheter, a PICC, etc.), be coupled to a needle or the like, and / or include such a needle or the like.

[0051]

[0067] In some embodiments, when the inlet 113 is placed in fluid communication with a body fluid source (e.g., a part of a patient), the outlet 114 can be fluidly coupled to a fluid collection device 180. As described above, in some embodiments, the fluid collection device 180 can be any suitable reservoir, container, and / or device configured to receive a body fluid of a certain body fluid. For example, the fluid collection device 180 can be a vacuum reservoir or container that defines a negative pressure, and / or can be a syringe that can be operated to generate a negative pressure. In some examples, by coupling the outlet 114 to the fluid collection device 180, at least a portion of the flow path 116 is selectively exposed to the negative pressure and / or suction force within the fluid collection device 180. As described above, a portion and / or surface of the flow rate controller 140 can be in fluid communication with the flow path 116, and thus, a negative pressure and / or suction force can be applied to a portion and / or surface of the flow rate controller 140. The negative pressure and / or suction force can be operable to cause the flow rate controller 140 to transition from its first state in which the isolation chamber 130 has a first volume to its second state in which the isolation chamber 130 has a second volume that is larger than the first volume. Accordingly, an initial volume of body fluid can be drawn into the isolation chamber 130 in response to the transition of the flow rate controller 140 (e.g., an increase in the volume of the isolation chamber 130 as a result of the flow rate controller 140 transitioning from the first state to the second state).

[0052]

[0068] In some embodiments, for example, the flow controller 140 can be a bladder or the like configured to shift or “invert” in response to negative pressure. The flow controller 140 can be configured to shift in a predetermined manner and / or at a predetermined rate, thereby controlling, adjusting, and / or otherwise determining one or more characteristics associated with the flow of an initial volume of body fluid into the isolation chamber 130. In some embodiments, the flow controller 140 and one or more inner surfaces of, for example, the housing 110 can together define a plurality of different portions of the isolation chamber 130. In such embodiments, at least one of the portions of the isolation chamber 130 can be configured to receive a volume of air drawn into the isolation chamber 130 immediately prior to the initial volume of body fluid, as described in detail above. Thus, by shifting the flow controller 140 from a first state to a second state, an initial portion (also referred to herein as the “initial volume” or “first volume”) of the volume of body fluid can be caused to flow into the isolation chamber 130 through at least a portion of the flow path 115 from the inlet 113. In some embodiments, by shifting the flow controller 140 from a first state to a second state, the control device 100 can shift from a first or initial state or configuration to a second state or configuration in which an initial portion or volume of body fluid can flow into the isolation chamber 130 within and / or through at least a portion of the flow path 115.

[0053]

[0069] The initial volume of the body fluid can be any suitable volume of the body fluid, as described above. For example, in some instances, the control device 100 can remain in the second state or configuration until a predetermined and / or desired volume (e.g., the initial volume) of the body fluid is transferred to the isolation chamber 130. In some embodiments, the initial volume can be related to and / or at least partially based on the volume of the isolation chamber 130 or a portion thereof (e.g., a volume sufficient to fill the isolation chamber 130 or a desired portion of the isolation chamber 130). In other embodiments, the initial volume of the body fluid can be related to and / or at least partially based on an amount or volume of the body fluid that is the same as or greater than the volume defined by the flow path between the body fluid source and the isolation chamber 130. In yet other embodiments, the control device 100 is such that the pressure difference between the isolation chamber 130 and the flow path 115 and / or the volume source is substantially brought to an equilibrium state and / or reduced below a desired threshold value in another manner, and the flow of the body fluid (e.g., the initial volume) can be configured to be transferred into the isolation chamber 130.

[0054]

[0070] After an initial volume of body fluid has been transferred and / or diverted into the isolation chamber 130, the control device 100 can be transitioned from a second state or configuration to a third state or configuration. For example, in some embodiments, when an initial volume of body fluid is transferred into the isolation chamber 130, the actuator 150 can be transitioned from its first state to its second state, whereby the control device 100 assumes its third state. More particularly, in some embodiments, the arrangement of the control device 100 and / or the isolation chamber 130 can be such that the flow of body fluid into the isolation chamber 130 substantially stops or slows in response to receiving the initial volume. In some embodiments, for example, the isolation chamber 130 can receive the flow of body fluid (e.g., the initial volume of body fluid) until the pressure differential is equal within the isolation chamber 130 and / or between the isolation chamber 130 and the flow path 115 and / or the volume source. In some instances, the user can visually inspect a portion of the device 100 and / or the housing 110 to determine that an initial volume of body fluid is disposed within the isolation chamber 130 and / or that the flow of body fluid into the isolation chamber 130 has slowed or substantially stopped. In some embodiments, the user can apply a force to the actuator 150 and / or otherwise activate the actuator 150 to transition the actuator 150 from its first state to its second state. In other embodiments, the actuator 150 can be automatically transitioned (e.g., without user intervention).

[0055]

[0071] When the actuator 150 transitions from its first state to its second state (e.g., placing the control device 100 in its third state or configuration), the initial volume of body fluid can be isolated, separated, disconnected, and / or retained within the isolation chamber 130. As described in more detail herein, in some examples, contaminants such as skin commensal microorganisms shed during a venipuncture event, other external sources of contamination, and colonization of catheters and PICC lines used to collect samples may be mixed in and / or contained within the initial volume of body fluid. Thus, such contaminants are isolated within the isolation chamber 130 when the initial volume is isolated within the isolation chamber 130.

[0056]

[0072] In addition to isolating an initial volume of body fluid within the isolation chamber 130, by placing the actuator 150 in its second state, fluid communication can be established between at least a portion of the flow path 115 and at least a portion of the flow path 116 such that a subsequent volume of body fluid can flow from the inlet 113 through at least a portion of the flow path 115 and / or 116 to the outlet 114. For example, in some embodiments, by transitioning the actuator 150 from its first state to its second state, for example, opening or closing a port or valve, moving one or more seals, moving or removing one or more obstacles, defining one or more portions of the flow path, etc. can be done. With the fluid collection device 180 being fluidly coupled to the outlet 114 and the control device 100 being in a third state or configuration, the negative pressure differential and / or suction force that would otherwise be applied to the flow rate controller 140 can be applied to at least a portion of or through the flow paths 115 and 116. Thus, any subsequent volume of body fluid can flow from the inlet 113, through at least a portion of the flow paths 115 and 116, through the outlet 114, and into the fluid collection device 180. As described above, by isolating an initial volume of body fluid within the isolation chamber 130 prior to collecting or obtaining one or more sample volumes of body fluid (e.g., within the fluid collection device 180), the amount of contaminants in the one or more sample volumes is reduced and / or substantially eliminated. Further, in some embodiments, the arrangement of the control device 100 can be such that the control device 100 cannot transition to the third state until after collecting and isolating the initial volume within the isolation chamber 130.

[0057]

[0073] Figures 2-11 show a fluid control device 200 according to another embodiment. The fluid control device 200 (also referred to herein as the "control device" or "device") may be similar to the device 100 described above with reference to FIG. 1 at least in form and / or function. For example, as described above with respect to device 100, device 200 is configured to (1) draw body fluid into device 200 from a body fluid source, (2) divert and isolate a first portion or amount (e.g., an initial volume) of the body fluid in a portion of device 200, and (3) allow a second portion or amount (e.g., a subsequent volume) of the body fluid to flow through device 200 (bypassing the isolated initial volume) into a fluid collection device fluidly coupled to device 200, in response to being placed in fluid communication with a negative pressure source (e.g., a suction or vacuum source). Thus, contaminants, etc., can be isolated within or with the initial volume of body fluid, leaving a subsequent volume of body fluid substantially free of contaminants.

[0058]

[0074] The fluid control device 200 (also referred to herein as the "control device" or "device") includes a housing 210, a flow controller 240, and an actuator 250. In some embodiments, the control device 200 or at least a portion of the control device 200 can be arranged in a modular configuration, where one or more portions of the housing 210 and / or the actuator 250 can be physically and fluidly coupled (e.g., by the end user) to together form the control device 200. Similarly, in some embodiments, the control device 200 can be packaged, transported, and / or stored separately from a fluid collection device (e.g., a sample reservoir, syringe, etc.) and / or an inlet device (e.g., a needle, catheter, peripheral intravenous line (PIV), peripherally inserted central catheter (PICC), etc.) that a user can couple to the control device 200 before or during use. In other embodiments, the control device 200 need not be modular. For example, in some embodiments, the control device 200 can be assembled during manufacture and delivered to a supplier and / or end user as an assembled device. In some embodiments, the control device 200 can include a fluid collection device such as any of those described above, and / or can be pre-coupled to such a fluid control device (e.g., during manufacture and / or before delivery to the end user). Similarly, in some embodiments, the control device 200 can include an inlet device such as any of those described herein, and / or can be pre-coupled to such an inlet device.

[0059]

[0075] The housing 210 of the control device 200 can be of any suitable shape, size, and / or configuration. The housing 210 includes an actuator portion 212 and an isolation portion 220. The actuator portion 212 of the housing 210 receives at least a portion of the actuator 250. The isolation portion 220 of the housing 210 is coupled to the cover 235 and includes, receives, houses, and / or at least partially defines an isolation chamber 230. As described in further detail herein, the housing 210 can include and / or define a first port 217 and a second port 218, each of which establishes fluid communication between the actuator portion 212 and the isolation portion 220 of the housing 210 to selectively control and / or enable the flow of fluid through one or more portions of the housing 210.

[0060]

[0076] As shown in FIGS. 2-6, the actuator portion 212 of the housing 210 includes an inlet 213 and an outlet 214. The inlet 213 is configured to be placed in fluid connection with a body fluid source and receive a flow of body fluid therefrom, as described in detail above. For example, the inlet 213 can be directly or indirectly coupled to a lumen-containing device such as a needle, an IV catheter, a PICC line, etc., which is further in fluid communication with a body fluid source (e.g., inserted into a patient's body). The outlet 214 is configured to be fluidly coupled to a fluid collection device such as any of those described above. For example, the fluid collection device can be a sample reservoir, a syringe, an intermediate body fluid transfer device, an adapter, or a container (e.g., a transfer adapter similar to that described in the '783 patent). Further, the fluid collection device can be operated to define and / or regulate a vacuum within the fluid collection device and, by coupling the fluid collection device to the outlet 214, create a negative pressure differential between one or more portions of the housing 210. of the above, etc.

[0061]

[0077] For example, as shown in FIGS. 7-11, the actuator portion 212 defines a flow path 215 in fluid communication with an inlet 213 and a flow path 216 in fluid communication with an outlet 214. More specifically, the flow path 215 (e.g., the first flow path) is configured to selectively place the inlet 213 in fluid connection with the first port 217, and the flow path 216 (e.g., the second flow path) is configured to selectively place the outlet 214 in fluid connection with the second port 218. Further, as described in more detail herein, after an initial volume of body fluid has been transferred into the isolation chamber 230, fluid communication can be established between the flow paths 215 and 216, whereby a subsequent volume of body fluid can flow from the inlet 213 through at least a portion of the flow paths 215 and 216 to the outlet 214 (and / or to a fluid collection device coupled to the outlet 214).

[0062]

[0078] The isolation portion 220 of the housing 210 can be of any suitable shape, size, and / or configuration. For example, as shown in FIGS. 6-8, the isolation portion 220 includes and / or forms an inner surface, and a portion of the inner surface is arranged and / or configured to form a first contoured surface 221. As described in more detail herein, at least a portion of the first contoured surface 221 can form and / or define a portion of the isolation chamber 230. Further, as described in more detail herein, the first port 217 and the second port 218 are configured to form a portion of and / or extend through a portion of the first contoured surface 221 to selectively place the isolation chamber 230 in fluid connection with the flow paths 215 and 216.

[0063]

[0079] The isolation portion 220 includes an outer member 225 and a flow controller 240, and is configured to form and / or house. More specifically, as shown in FIGS. 6-8, the isolation portion 220 receives and / or is coupled to the outer member 225 such that the flow controller 240 is disposed between the isolation portion 220 and the outer member 225. In some embodiments, the outer member 225 can be fixedly coupled to the isolation portion 220 via an adhesive, ultrasonic welding, and / or any other suitable coupling method. In some embodiments, the outer member 225, the isolation portion 220, and the flow controller 240 together can form a substantially fluid-tight and / or hermetic seal that separates the isolation portion 220 from the volume outside the isolation portion 220.

[0064]

[0080] As shown, a cover 235 is disposed around the outer member 225, and the cover 235 and the isolation portion 220 of the housing 210 are configured to surround and / or house the outer member 225 and the flow controller 240. In some embodiments, the cover 235 can be coupled to the outer member 225 and / or the isolation portion 220 via an adhesive, ultrasonic welding, one or more mechanical fasteners, friction fitting, snap fit, screw coupling, and / or any other suitable mode of coupling. In some embodiments, the cover 235 can define openings, windows, slots, etc. configured to enable visualization of at least a portion of the isolation chamber 230. Although the outer member 225 and the cover 235 have been described as separate parts and / or components, in other embodiments, the outer member 225 can be integrated with and / or formed integrally with the cover 235.

[0065]

[0081] The outer housing member 225 includes and / or forms the second uneven surface 226. The arrangement configuration of the outer housing member 225 and the isolation portion 220 of the housing 210 can be such that at least a part of the first uneven surface 221 is aligned with and / or opposed to the corresponding part of the second uneven surface 226 of the outer housing member 225 (see, for example, FIG. 8). Therefore, a space, volume portion, opening, gap, chamber, etc. defined between the first uneven surface 221 and the second uneven surface 226 forms and / or defines the isolation chamber 230. Further, as described in more detail herein, the flow controller 240 is disposed between the first uneven surface 221 and the second uneven surface 226, and is configured to transition between a first state and a second state in response to a negative pressure difference and / or a suction force being applied to at least a part of the isolation chamber 230.

[0066]

[0082] The ports 217 and 218 of the housing 210 can be of any suitable shape, size, and / or configuration. As described above, the first port 217 is in fluid communication with the isolation chamber 230 and can selectively establish fluid communication between the isolation chamber 230 and the flow path 215 and / or the inlet 213. More specifically, the first port 217 is in fluid communication with a first portion of the isolation chamber 230 defined between the second uneven surface 226 and the first side portion of the flow controller 240. As described in more detail herein, the first port 217 can be configured to provide and / or transfer the flow of body fluid from the inlet 213 and the flow path 215 into the first portion of the isolation chamber 230 defined between the second uneven surface 226 and the first side portion of the flow controller 240 in response to the flow controller 240 transitioning from the first state to the second state.

[0067]

[0083] The second port 218 is in fluid communication with the isolation chamber 230 and can selectively establish fluid communication between the isolation chamber 230 and the flow path 216 and / or the outlet 214. More specifically, the second port 218 is in fluid communication with a second portion of the isolation chamber 230 defined between the first uneven surface 221 and the second side (e.g., the side opposite the first side) of the flow rate controller 240. As described in more detail herein, the second port 218 exposes a second portion of the isolation chamber 230 defined between the first uneven surface 221 and the second side of the flow rate controller 240 to a negative pressure difference and / or suction force resulting from the fluid collection device (e.g., a vacuum blood collection tube, a culture bottle, a syringe, etc.) being fluidly coupled to the outlet 214. Further, the negative pressure difference and / or suction force can be operable to shift the flow rate controller 240 from its first state to its second state. In some examples, it may be desirable to adjust and / or control the magnitude of the negative pressure difference. Accordingly, the second port 218 can include a throttle 219 and / or be coupled to the throttle 219. As described in more detail herein, the throttle 219 can restrict and / or limit the flow of fluid (e.g., air or gas) between the second portion of the isolation chamber 230 and the flow path 216, thereby configuring to adjust and / or control the magnitude of the pressure difference and / or suction force applied to or received by the flow rate controller 240.

[0068]

[0084] The flow controller 240 is disposed (e.g., within the isolation chamber 230) between the isolation portion 220 and the outer housing member 225 within the housing 210. The flow controller 240 can be of any suitable shape, size, and / or configuration. Similarly, the flow controller 240 can be formed of any suitable material (e.g., any suitable biocompatible material such as those described herein, and / or any other suitable material). For example, the flow controller 240 can be a fluid-impermeable bladder, membrane, diaphragm, etc. configured to transition from a first state and / or form to a second state and / or form. In some embodiments, the flow controller 240 (e.g., the bladder) can include any number of relatively thin and flexible portions configured to deform in response to a pressure differential across the flow controller 240. For example, in some embodiments, the flow controller 240 can be formed of or from any of the above-described biocompatible materials and / or any suitable medical grade elastomer. In some embodiments, the flow controller 240 can have a durometer hardness of from about 5 Shore A to about 70 Shore A, from about 10 Shore A to about 60 Shore A, from about 20 Shore A to about 50 Shore A, from about 30 Shore A to about 40 Shore A, and / or any other suitable durometer hardness. In some embodiments, the flow controller 240 can be formed of or from silicone having a durometer hardness of from about 20 Shore A to about 50 Shore A. More particularly, in some such embodiments, the flow controller 240 can be formed of or from silicone having a durometer hardness of about 30 Shore A. In some embodiments, the flow controller 240 can include a relatively thin and flexible portion having a thickness of from about 0.001 inches to about 0.1 inches. In other embodiments, the relatively thin and flexible portion can have a thickness of less than 0.001 inches or greater than 0.1 inches.

[0069]

[0085] In some embodiments, the flow controller 240 can have a size and / or shape configured to facilitate, promote, and / or otherwise provide a fluid flow having a desired set of flow characteristics. Similarly, the flow controller 240 can be formed of or from a material having one or more material properties and / or one or more surface finishes configured to facilitate, promote, and / or otherwise provide a fluid flow having a desired set of flow characteristics. As described in further detail herein, the set of flow characteristics can be a relatively uniform or smooth fluid flow, a substantially laminar fluid flow and / or a relatively low-turbulence fluid flow, a fluid flow having a substantially uniform front face, a fluid flow that does not readily mix with other fluids (e.g., an air flow or a body fluid flow that does not mix with a volume of air), and / or the like, and / or can include such.

[0070]

[0086] In the embodiments shown in FIGS. 2-11, the flow controller 240 is a bladder (or diaphragm) formed of or from silicone having a durometer hardness of about 30 Shore A. The flow controller 240 (e.g., the bladder) includes a first deformable portion 241, a second deformable portion 242, and a third deformable portion 243. Further, the flow controller 240 defines an opening 244. For example, as shown in FIG. 8, the flow controller 240 can be positioned within the isolation portion 220 of the housing 210 such that the first port 217 extends through the opening 244. In some embodiments, the arrangement of the flow controller 240 is such that the surface of the flow controller 240 defining the opening 244 forms a substantially fluid-tight seal with a portion of the inner surface of the isolation portion 220 of the housing 210 (e.g., the portion defining and / or forming the first port 217). Further, as described in further detail herein, the flow controller 240 can include one or more portions configured to form one or more seals between the flow controller 240 and each of the concave and convex surfaces 221 and 226, and / or between the flow controller 240 and each of the concave and convex surfaces 221 and 226.

[0071]

[0087] The deformable portions 241, 242, and 243 of the flow controller 240 can be relatively thin and flexible portions configured to deform in response to a pressure difference between a first side portion and a second side portion of the flow controller 240. More specifically, the deformable portions 241, 242, and 243 can each have a thickness of about 0.005 inches. As shown, for example, in FIGS. 8 and 10, the deformable portions 241, 242, and 243 of the flow controller 240 correspond to and / or substantially have the same overall shape as at least a portion of the concave-convex surfaces 221 and / or 226. Thus, as described in more detail herein, the deformable portions 241, 242, and 243 and the corresponding portions of the concave-convex surfaces 221 and / or 226 can together form and / or define one or more channels or the like, which can further receive an initial volume of body fluid. It can be done.

[0072]

[0088] As described above, the flow controller 240 is configured to transition between a first state and a second state. For example, as shown in FIG. 8, when the flow controller 240 is in its first state, the deformable portions 241, 242, and 243 are disposed adjacent to and / or in substantial contact with the second concave-convex surface 226. More specifically, the first deformable portion 241 can be disposed adjacent to and / or in substantial contact with a first recess 227 formed by the second concave-convex surface 226, the second deformable portion 242 can be disposed adjacent to and / or in substantial contact with a second recess 228 formed by the second concave-convex surface 226, and the third deformable portion 243 can be disposed adjacent to and / or in substantial contact with a third recess 229 formed by the second concave-convex surface 226.

[0073]

[0089] Therefore, the first portion of the isolation chamber 230 (e.g., the portion defined between the second uneven surface 226 and the first surface of the flow controller 240) can have a relatively small and / or relatively very small volume. In contrast, when the flow controller 240 transitions from its first state to its second state (e.g., in response to a negative pressure applied and / or transmitted through the second port 218), at least the deformable portions 241, 242, and 243 are disposed adjacent to and / or in substantial contact with the first uneven surface 221. More specifically, the first deformable portion 241 can be disposed adjacent to and / or in substantial contact with the first recess 222 formed by the first uneven surface 221, the second deformable portion 242 can be disposed adjacent to and / or in substantial contact with the second recess 223 formed by the first uneven surface 221, and the third deformable portion 243 can be disposed adjacent to and / or in substantial contact with, for example, the non-recessed portion of the first uneven surface 221.

[0074]

[0090] Therefore, the volume of the first portion of the isolation chamber 230 is larger when the flow controller is in its second state than when it is in its first state. In other words, the deformable portions 241, 242, and 243 and the second uneven surface 226 can define one or more channels (e.g., the isolation chamber 230) configured to receive an initial volume of body fluid. In some examples, as described in more detail herein, an increase in the volume of the first portion of the isolation chamber 230 can result in a negative pressure or vacuum that can be operable to draw an initial volume of body fluid into the isolation chamber 230. Further, in some embodiments, the arrangement of the deformable portions 241, 242, and / or 243 can be such that a volume of air drawn into the isolation chamber 230 immediately prior to the flow of body fluid can flow into and / or be disposed within the portion of the isolation chamber 230 corresponding to the first deformable portion 241 and / or the second deformable portion 242.

[0075]

[0091] Although the flow controller 240 has been described in detail above with reference to FIGS. 6-11, in other embodiments, the flow controller 240 and / or the isolation chamber 230 can have any suitable configuration and / or arrangement. For example, in some embodiments, the concave and convex surfaces 221 and / or 226 can include more or fewer recesses (e.g., recesses 222 and 223 and recesses 227, 228, and 229, respectively). In other embodiments, the depth of one or more of the recesses can be changed. Similarly, the flow controller 240 can be modified in any suitable manner to substantially correspond to the shape and / or configuration of the concave and convex surfaces 221 and / or 226. In some embodiments, such modifications can change one or more characteristics related to the flow of gas (e.g., air) and / or fluid (e.g., body fluid), one or more characteristics related to the manner and speed at which the flow controller 240 transitions, etc., as described in more detail herein.

[0076]

[0092] The flow controller 240 has been described as being, for example, a bladder that includes a plurality of deformable portions. However, in other embodiments, the flow controller can be arranged and / or configured as, for example, a bellows, a flexible pouch, an inflatable bag, an inflatable chamber, a plunger (similar to a syringe), and / or any other suitable reconfigurable container, etc. Further, the isolation chamber 230, at least partially formed by the flow controller 240, can have any suitable shape, size, and / or configuration.

[0077]

[0093] The actuator 250 of the control device 200 can be of any suitable shape, size, and / or configuration. At least a portion of the actuator 250 is disposed within the actuator portion 212 of the housing 210 and is configured to transition between a first state, form, and / or position and a second state, form, and / or position. In the embodiments shown in FIGS. 2 - 11, the actuator 250 is configured as an actuator rod or plunger that is configured to move relative to the actuator portion 212 of the housing 210. The actuator 250 is disposed external to the housing 210 and includes an end 251 that is configured to be actuated by a user to transition the actuator 250 between its first state and its second state. As shown in FIGS. 6 - 11, a portion of the actuator 250 includes and / or is coupled to a set of seals 255. The seals 255 can be, for example, O-rings, elastomeric overmolds, raised or bulged flanges, or fixtures. The arrangement of the actuator 250 and the actuator portion 212 of the housing 210 can be such that the inner portion of the seal 255 forms a fluid-tight seal with the surface of the actuator 250 and the outer portion of the seal 255 forms a fluid-tight seal with the inner surface of the actuator portion 212 of the body 210. In other words, the seal 255 forms one or more fluid-tight seals between the actuator 250 and the inner surface of the actuator portion 212. As shown in FIGS. 7 - 11, the actuator 250 includes and / or is coupled to four seals 255, and the four seals 255 can be dispersed along the actuator 250 to selectively form and / or define one or more flow paths between the actuator 250 and themselves. Further, as described in more detail herein, the actuator 250 defines a flow channel 252 defined between a pair of seals 255 that can assist and / or facilitate fluid communication between the flow paths 215 and 216 when the actuator 250 transitions to its second state.Although the actuator 250 has been described above as including four seals 255, in other embodiments, the actuator 250 can include fewer than four seals 255 or more than four seals 255.

[0078]

[0094] In some embodiments, the actuator portion 212 of the housing 210 and the actuator 250 together include a lock and / or together form a lock. For example, as shown in FIGS. 6 and 8, the actuator portion 212 of the housing 210 can define an opening 238, and the actuator 250 can include a locking member, latch, protrusion, tab, etc. (referred to herein as "lock 253") configured to be at least partially disposed within the opening 238. In some embodiments, the lock 253 can be aligned and / or disposed within the opening 238 to restrict and / or substantially prevent the actuator 250 from being removed from the housing 210. In some embodiments, the lock 253 can transition between a locked state in which the lock 253 restricts and / or substantially prevents the actuator 250 from moving relative to the housing 210 and an unlocked state in which the actuator 250 can be moved, for example, between its first state and / or position and its second state and / or position. In some examples, such an arrangement can restrict and / or substantially prevent the actuator 250 from operating, for example, before transferring an initial volume of body fluid within the isolation chamber 230. In other embodiments, the lock 253 can transition from an unlocked state to a locked state, for example, after transferring an initial volume of body fluid into the isolation chamber 230. can.

[0079]

[0095] As shown in FIGS. 7 and 8, when the actuator 250 is placed in a first state and / or position (e.g., before using the device 100), the flow path 215 can establish fluid communication between the inlet 213 and the first port 217. More specifically, the actuator 250 can be positioned relative to the housing 210 such that each of the seals 255 is located on the side of the inlet 213 opposite to the side associated with the first port 217 of the inlet 213. In other words, the actuator 250 and / or the seals 255 do not obstruct and / or block the flow path 215 when the actuator 250 is in the first state and / or position, as shown in FIGS. 7 and 8. Thus, as described in more detail herein, when the actuator 250 is in the first state and / or position, a certain volume (e.g., an initial volume) of body fluid can flow from the inlet 213, through the flow path 215 and the first port 217, and into the isolation chamber 230.

[0080]

[0096] As shown in FIGS. 9-11, a force can be applied to the end 251 of the actuator 250 to place the actuator 250 in its second state and / or position. When in the second state and / or position, the inlet 213 and the outlet 214 are placed in a fluidly connected state via at least a portion of the flow paths 215 and 216 and / or the flow channel 252. As shown in FIGS. 9 and 11, the inlet 213 and the outlet 214 are each disposed between the same pair of seals 255, whereby the actuator 250 can be positioned to allow the flow of body fluid therethrough. Further, the flow channel 252 defined by the actuator 250 assists and / or facilitates the flow of body fluid (see, e.g., FIG. 11). For example, in some embodiments, the flow channel 252 can establish fluid communication between a portion of the flow path 215 defined by the inlet 213 and a portion of the flow path 216 defined by the outlet 214. Further, the arrangement of the seals 255 is such that the first port 217 and the second port 218 are each isolated and / or separated from each of the inlet 213 and the outlet 214. Thus, by placing the actuator 250 in the second state and / or position, (1) the isolation chamber 230 and any volume of body fluid disposed therein are isolated and / or separated, and (2) fluid communication is established between the inlet 213 and the outlet 214, whereby a volume of body fluid can flow through the device 200 and into a fluid collection device (not shown) fluidly coupled to the outlet 214.

[0081]

[0097] In some embodiments, the set of seals 255 can be configured to isolate, separate, and / or seal one or more portions of the device 200 before establishing fluid communication between other portions of the device 200. For example, in some embodiments, as described above, the actuator 250 can be in a first position relative to the actuator portion 212 of the housing 210 when in the first state. In such an example, actuating the actuator 250 (e.g., applying a force to the end 251 of the actuator 250) can include moving the actuator 250 from a first position relative to the actuator portion 212 to a second position relative to the actuator portion 212, at which second position: (1) the first seal 255 is disposed between the first port 217 and the inlet 213 and / or its lumen, (2) the inlet 213 and / or its lumen is disposed between the first seal 255 and the second seal 255, (3) the outlet 214 and / or its lumen is disposed between the second seal 255 and the third seal 255, and (4) the second port 218 is disposed between the third seal 255 and the fourth seal 255. Thus, the inlet 213 is isolated from the first port 217, the outlet 214 is isolated from the second port 218, and fluid communication has not yet been established between the inlet 213 and the outlet 214 (e.g., the inlet 213 is isolated from the outlet 214).

[0082]

[0098] In some examples, the operation of the actuator 250 can further include moving the actuator 250 from a second position relative to the actuator portion 212 to a third position relative to the actuator portion 212 where the actuator 250 is in the second state. Accordingly, the second seal 255 is disposed between the first port 217 and the inlet 213 and / or its lumen, each of the inlet 213 and the outlet 214 (and / or their lumens) is disposed between the second seal 255 and the third seal 255, and the second port 218 is disposed between the third seal 255 and the fourth seal 255. Accordingly, each of the first port 217 and the second port 218 is isolated from the inlet 213 and the outlet 214 (and / or their lumens), and fluid communication is established between the inlet 213 and the outlet (and / or between their lumens) (e.g., via the flow channel 252).

[0083]

[0099] In this example, the actuator 250 is described as moving between a first position, a second position, and a third position relative to the actuator portion 212. However, it should be understood that transitioning the actuator 250 from the first state to the second state can include moving the actuator 250 in a substantially continuous manner from the first position relative to the actuator portion 212, through the second position relative to the actuator portion 212, to the third position relative to the actuator portion 212. In other embodiments, the actuator 250 can be actuated, moved, and / or transitioned in any number of discontinuous steps. For example, in some instances, the actuator 250 can be transitioned by a first predetermined amount to move the actuator 250 from the first position relative to the actuator portion 212 to the second position relative to the actuator portion 212, and then the actuator 250 can be transitioned by a second predetermined amount (e.g., in a second and / or discontinuous step) to move the actuator 250 from the second position relative to the actuator portion 212 to the third position relative to the actuator portion 212. Although the actuator 250 has been described above as including four seals 255, in other embodiments, the actuator can be functionally similar to the actuator 250 and can include fewer than four seals (e.g., one seal, two seals, or three seals) or more than four seals (e.g., five seals, six seals, seven seals, or more seals).

[0084]

[0100] As described above, using the device 200, a sample of body fluid with reduced contamination (e.g., contamination from microorganisms such as skin commensal microorganisms, microorganisms external to the body fluid source, etc.) can be obtained. For example, before use, the device 200 can be in its first, initial, and / or storage state or operating mode, in which each of the flow controller 240 and the actuator 250 is in its respective first or initial state. When the device 200 is in the first state, a user such as a physician, internist, nurse, phlebotomist, technician, etc. can operate the device 200 to establish fluid communication between the inlet 213 and a body fluid source (e.g., a patient's vein). When the inlet 213 is placed in a state of being fluidly connected to the body fluid source, the outlet 214 can be fluidly coupled to a fluid collection device (not shown in FIGS. 2 - 11). In the embodiments shown in FIGS. 2 - 11, for example, the fluid collection device can be a vacuum blood collection tube, a culture bottle, a sample reservoir, a syringe, and / or any other suitable container or device configured to define or generate negative pressure, suction, vacuum, and / or energy potential.

[0085]

[0101] When the actuator 250 is in the first position and / or configuration, the inlet 213 of the housing 210 is in fluid communication with, for example, the flow path 215, and the flow path 215 is further in fluid communication with the first port 217. The outlet 214 of the housing 210 is in fluid communication with the flow path 216, and the flow path 216 is further in fluid communication with the second port 218. More specifically, as shown in FIGS. 7 and 8, one or more of the seals 255 of the actuator 250 (1) enable and / or establish fluid communication between the inlet 213, the flow path 215, and the first port 217, and (2) isolate the inlet 213, the flow path 215, and the first port 217 from the outlet 214, the flow path 216, and It may be located relative to the actuator portion 212 of the housing 210 and be fluidly separated from the second port 218. Thus, when the control device 200 is in the first state or operating mode (for example, when the actuator 250 and the flow controller 240 are each in their first states), by fluidly coupling the fluid collection device to the outlet 214, a negative pressure difference and / or suction force is generated and / or otherwise brought about within at least a portion of the flow path 216 and further within a portion of the isolation chamber 230 defined between the surface (for example, the first surface) of the flow controller 240 and the first concavo-convex surface 221 of the housing 210.

[0086]

[0102] The flow controller 240 is in the first state and / or configuration before the fluid collection device is coupled to the outlet 214. In the embodiments shown in FIGS. 2 - 11, the flow controller 240 can be a fluid-impermeable bladder, diaphragm, membrane, etc. that has an inverted, reversed, collapsed, and / or empty configuration (for example, the first state and / or configuration) before the fluid collection device is coupled to the outlet 214. For example, as shown in FIG. 8, when the flow controller 240 is in its first state and / or configuration, the flow controller 240 can be disposed adjacent to and / or in contact with the second concavo-convex surface 226. In other words, the first side (opposite the second side) of the flow controller 240 can be disposed adjacent to and / or brought into contact with the second concavo-convex surface 226.

[0087]

[0103] As described above, the flow controller 240 is configured to transition from its first state and / or form to its second state and / or form in response to a negative pressure difference and / or suction force being generated within a portion of the isolation chamber 230 defined between the flow controller 240 and the first uneven surface 221. For example, as shown in FIG. 10, the flow controller 240 can be configured to transition, move, "invert" and / or reconfigure to its second state and / or form in which the flow controller 240 and / or a second side (opposite the first side) of the flow controller 240 is disposed adjacent to and / or in contact with the first uneven surface 221. In other words, the negative pressure difference and / or suction force pulls, draws, and / or otherwise moves at least a portion of the flow controller 240 towards the first uneven surface 221 and away from the second uneven surface 226. Further, when the actuator 250 is in its first state and the flow controller 240 is in its second state, the control device 200 is placed in its second state and / or form.

[0088]

[0104] Upon the transition of the flow controller 240, the internal volume of a portion of the isolation chamber 230 defined between the surface of the flow controller 240 (e.g., the first side of the flow controller 240) and the second uneven surface 226 will increase. And due to the increase in the internal volume, a negative pressure difference can be provided that is operable to draw at least a portion of the initial flow, amount or volume of body fluid from the inlet 213 through the flow path 215 and the first port 217 into the above portion of the isolation chamber 230. In some examples, for example, the initial volume and / or flow of body fluid can be transferred into the isolation chamber 230 until the flow controller 240 is fully inflated, inverted and / or transitioned, until the negative pressure difference decreases and / or equalizes, and / or until a desired volume of body fluid is disposed within the above portion of the isolation chamber 230.

[0089]

[0105] In some examples, it may be desirable to adjust and / or control how the flow controller 240 moves and / or the magnitude of the negative pressure difference and / or suction force generated within the isolation chamber 230 on one or both sides of the flow controller 240. In the embodiments shown in FIGS. 2-11, for example, the second port 218 defines, includes, receives, and / or is otherwise coupled to a throttle 219 that establishes fluid communication between the flow path 216 and a portion of the isolation chamber 230 defined between the flow controller 240 and the first uneven surface 221. The throttle 219 defines, includes, receives, and / or is otherwise coupled to a throttle 219 that establishes fluid communication between the flow path 216 and a portion of the isolation chamber 230 defined between the flow controller 240 and the first uneven surface 221.

[0090]

[0106] In some embodiments, the aperture 219 can define a lumen or flow path having a relatively small diameter (e.g., relative to the diameter of at least a portion of the flow path 216). For example, in some embodiments, the aperture 219 can have a diameter of about 0.0005 inches, about 0.001 inches, about 0.003 inches, about 0.005 inches, about 0.01 inches, about 0.1 inches, about 0.5 inches or greater. In other embodiments, the aperture 219 can have a diameter less than 0.0005 inches or greater than 0.5 inches. In some embodiments, the aperture 219 can have a predetermined and / or desired length of about 0.01 inches, about 0.05 inches, about 0.1 inches, about 0.15 inches, about 0.2 inches, about 0.5 inches or greater. In other embodiments, the aperture 219 can have a predetermined and / or desired length that is less than 0.01 inches or greater than about 0.5 inches. Further, in some embodiments, the aperture 219 can have any suitable combination of diameter and length that enables and / or provides desired fluid (e.g., air) flow characteristics through at least a portion of the control device 200. Although the aperture 219 has been described above as defining a relatively small lumen and / or flow path, in other embodiments, the aperture can have any suitable shape, size and / or configuration. For example, in some embodiments, the aperture can be a porous material, a semi-permeable member or membrane, a mechanical valve, a restrictor and / or float, and / or any other suitable member or device configured to regulate a pressure differential across at least a portion of itself.

[0091]

[0107] In the embodiments shown in FIGS. 2-11, due to the relatively small diameter of the aperture 219, a lower magnitude of negative pressure is applied through and / or within the portion of the isolation chamber 230 than would otherwise be applied by an aperture having a larger diameter, or than if the second port 218 did not include or receive the aperture 219. For example, in some embodiments, a fluid collection device and / or other suitable negative pressure source can define and / or generate a negative pressure differential having a magnitude (e.g., a negative magnitude) of about 0.5 pounds per square inch (PSI), about 1.0 PSI, about 2.0 PSI, about 3.0 PSI, about 4.0 PSI, about 5.0 PSI, about 10.0 PSI, about 12.5 PSI, or about 14.7 PSI (e.g., at or substantially at atmospheric pressure at approximately sea level). In some embodiments, a fluid collection device such as a vacuum blood collection tube can have a predetermined negative pressure of about 12.0 PSI. Thus, by controlling the diameter and / or length of the aperture 219, the amount of negative pressure to which the portion of the isolation chamber 230 is exposed, and / or the rate at which the negative pressure is applied, can be controlled, reduced, and / or otherwise adjusted. In some examples, the use of the aperture 219 can cause the negative pressure applied over or within the portion of the isolation chamber 230 to be delayed or increased.

[0092]

[0108] Regarding the pressure adjustment, although it has been described above as being based on the diameter of the throttle 219 (i.e., a single restricted flow path), it should be understood that this is presented merely as an example and not a limitation. Other means for adjusting the magnitude of the negative pressure to which the above portion of the isolation chamber 230 is exposed include, for example, porous materials, valves, membranes, diaphragms, predetermined restrictions, vents, deformable members or flow paths, and / or any other suitable means. In other embodiments, the control device can include any suitable number of restricted flow paths, each of which can have substantially the same diameter or different diameters. For example, in some embodiments, the control device can include up to 100 or more restricted flow paths. In such embodiments, each of the restricted flow paths can have a diameter of from about 0.0005 inches to about 0.1 inches, from about 0.0005 inches to about 0.05 inches, or from about 0.0005 inches to about 0.01 inches. In some embodiments, the plurality of restricted flow paths can be configured to selectively provide a flow path that exposes the above portion of the isolation chamber 230 to a negative pressure differential between the outlet 214 and the above portion of the isolation chamber 230.

[0093]

[0109] In some embodiments, by adjusting and / or controlling the magnitude of the pressure to which the above portion of the isolation chamber 230 is exposed, the rate at which one or more volumes of the isolation chamber 230 increase can be adjusted. In some examples, by adjusting the rate of volume increase (and thus the suction force), the magnitude of the pressure applied to the body fluid and / or into the patient's vein can be adjusted and / or limited. In some examples, such pressure adjustment can reduce, for example, the possibility of hemolysis of a blood sample and / or collapsing the vein. In some examples, by being able to adjust and / or control the amount or magnitude of the negative pressure or suction, the negative pressure is necessary, for example, to facilitate the collection of body fluids such as blood (i.e., the pressure difference between the atmospheric pressure and the patient's vascular pressure is not sufficient to facilitate a consistent and strong enough flow), but the rapid force is not so great as to reduce, collapse, indent, and / or otherwise impede the viability and ability to collect blood. The control device 200 can be used over a wide range of patients having such physiological challenges.

[0094]

[0110] In some embodiments, by the shape, size and / or arrangement configuration of the isolation chamber 230 and / or the flow controller 240, the magnitude of the negative pressure difference or suction force, and / or the manner in which the negative pressure difference or suction force is applied, the rate and / or manner in which the flow controller 240 transitions from the first state to the second state can be indicated and / or controlled. In some examples, by controlling the rate, sequence and / or manner in which the flow controller 240 transitions, one or more desired flow characteristics associated with the flow of air, gas and / or body fluid into and / or through at least a portion of the isolation chamber 230 can be provided.

[0095]

[0111] For example, the arrangement configuration included in the present embodiment may be such that the transition and / or inversion of the third deformable portion 243 of the flow rate controller 240 is completed before the completion of the transition and / or inversion of the first deformable portion 241 and the second deformable portion 242. In some examples, this arrangement configuration is such that a portion of the isolation chamber 230 (for example, the first volume portion of the isolation chamber 230) collectively defined by the first deformable portion 241 and the first recess 227 of the second concavo-convex surface 226 receives at least a portion of a certain volume of air that was in the flow path between the body fluid source and the isolation chamber 230 before the flow path received and / or was filled with body fluid. Similarly, a portion of the isolation chamber 230 (for example, the second volume portion of the isolation chamber 230) collectively defined by the second deformable portion 242 and the second recess 228 of the second concavo-convex surface 226 can receive at least a portion of the above-mentioned volume of air that was in the flow path. In other words, by the transition of the flow rate controller 240, air or gas can be exhausted, discharged, and / or purged from the flow path between the body fluid source and the isolation chamber 230, and then such air or gas can be collected, stored, and / or accommodated within the first volume portion and the second volume portion of the isolation chamber 230. On the other hand, a portion of the isolation chamber 230 (for example, the third volume portion of the isolation chamber 230) collectively defined by the third deformable portion 243 and the third recess 229 of the second concavo-convex surface 226 can receive an initial volume of body fluid flowing through the flow path between the body fluid source and the isolation chamber 230 after air or gas has been collected within the first volume portion and / or the second volume portion of the isolation chamber 230.

[0096]

[0112] In some examples, the arrangement configuration and / or the order of transition of the deformable portions 241, 242, and / or 243 can result in, for example, a uniform flow of an initial volume of body fluid into the third volume portion of the isolation chamber 230. More specifically, the third deformable portion 243 is configured to complete or substantially complete its transition and / or inversion from its first state and / or position before the completed or substantially completed transition and / or inversion of each of the first deformable portion 241 and / or the second deformable portion 242, whereby the body fluid It can flow within and / or through at least a portion of the third deformable portion 243 with a substantially uniform front surface. Thus, the third deformable portion 243 can be in a second state, form, and / or position before the flow of body fluid enters the isolation chamber 230. Accordingly, the third volume portion of the isolation chamber 230 can have and / or define a relatively consistent and / or uniform cross-sectional shape and / or cross-sectional area when the flow of body fluid enters the isolation chamber 230, thereby limiting the suction of a portion of the body fluid flow, the inconsistent local flow velocity of the body fluid flow, and / or the non-uniform filling in other aspects of the third volume portion of the isolation chamber 230.

[0097]

[0113] As shown in FIGS. 8 and 10, the first uneven surface 221 includes recesses 222 and 223, each of which is deeper than a portion of the first uneven surface 221 that is aligned with and / or otherwise associated with the deformable portion 243 of the flow rate controller 240. In other words, the distances between the first recess 222 and the second recess 223 of the first uneven surface 221 and the first recess 227 and the second recess 228 of the second uneven surface 226, respectively, are greater than the distance between the above-mentioned portion of the first uneven surface 221 and the third recess 229 of the second uneven surface 226. Accordingly, the distance that the first deformable portion 241 and the second deformable portion 242 move when they transition and / or reverse is greater than the distance that the third deformable portion 243 moves when it transitions and / or reverses. Further, the widths of the first deformable portion 241 and the second deformable portion 242 can be the same as or smaller than the width of the third deformable portion 243. In some examples, with such an arrangement, the third deformable portion 243 can complete and / or substantially complete its transition and / or reversal before each of the first deformable portion 241 and the second deformable portion 242 completes and / or substantially completes its transition and / or reversal. In other embodiments, the moving distance and / or width of one or more of the deformable portions 241, 242, and / or 243 are changed (increased or decreased) to change and / or vary the speed, order, and / or sequence associated with the deformable portions 241, 242, and / or 243 that transition and / or reverse from the first state to the second state.

[0098]

[0114] In some embodiments, by including fewer deformable portions or more deformable portions, for example, the relative stiffness of each deformable portion or associated therewith can be changed, and / or the speed and / or manner in which each of the deformable portions transitions or reverses can be otherwise controlled, thereby changing the speed and / or manner in which fluid (e.g., air and / or volume) flows into the isolation chamber 230. For example, in some embodiments, by increasing the number of deformable portions, the surface area to which negative pressure is applied can be reduced, thereby increasing the pressure differential sufficient to transition and / or reverse the deformable portions. In FIGS. 8 and 10, the deformable portions 241, 242, and 243 are shown as having substantially the same thickness, but in other embodiments, at least one deformable portion can have a thickness different from the thickness of the other deformable portions (e.g., the deformable portion 241 can have a thickness different from the thickness of the deformable portion 242 and / or the deformable portion 243 (or vice versa, or in other combinations)). In some examples, by increasing the thickness of a deformable portion relative to the thickness of other deformable portions, the stiffness of that deformable portion can be increased relative to the stiffness of the other deformable portions. In some such examples, due to the increase in stiffness of the thicker deformable portion, other deformable portions (e.g., thinner deformable portions) can transition and / or reverse before the thicker / higher-stiffness deformable portion transitions and / or reverses. In some embodiments, a deformable portion can have a different thickness along at least a portion of that deformable portion.

[0099]

[0115] In some embodiments, the flow rate controller 240 and / or the size, shape, material properties, surface finish, etc. of the deformable portions 241, 242, and / or 243 can also facilitate, promote, and / or otherwise result in a fluid flow having a substantially uniform front surface This is possible. For example, the third volume portion of the isolation chamber 230 (collectively defined by the third deformable portion 243 and the third recess 229 of the second concavo-convex surface 226) can have a size, shape, diameter, perimeter length, and / or cross-sectional area that at least in part restricts and / or substantially prevents air from mixing with the body fluid flow (e.g., the front of the flow) due to the surface tension between the body fluid flow and each of the third deformable portion 243 and the third recess 229 of the second concavo-convex surface 226. In some embodiments, for example, the third volume portion of the isolation chamber 230 is from about 0.0001 square inches (in 2 ) to about 0.16 in 2 , from about 0.001 in 2 to about 0.08 in 2 , from about 0.006 in 2 to about 0.06 in 2 , or from about 0.025 in 2 to about 0.04 in 2 can have a cross-sectional area. In other embodiments, the third volume portion of the isolation chamber 230 can have a cross-sectional area that is less than 0.0001 in 2 or greater than 0.16 in 2 .

[0100]

[0116] In some embodiments, the flow controller 240 and / or the uneven member 225 (or at least its second uneven surface 226) can be formed of or from a material having one or more material properties and / or one or more surface finishes configured to facilitate, promote, and / or otherwise result in a fluid flow having a desired set of flow characteristics. In other embodiments, the flow controller 240 and / or the second uneven surface 226 can have a coating configured to provide a desired set of flow characteristics. For example, in some embodiments, the flow controller 240 and / or the second uneven surface 226 can be formed from a coating of a hydrophobic or hydrophilic material and / or can include such a coating in other ways. Further, at least a portion of the flow controller 240 and the uneven member 225 (or at least its second uneven surface 226) can be formed of or from the same material and / or can include the same coating, or can be formed of or from different materials and / or can include different coatings. Similarly, the flow controller 240 and / or the second uneven surface 226 can include any suitable surface finish that can be substantially the same or different. In some examples, a non-exhaustive list of desired sets of flow characteristics can include one or more of a relatively uniform or smooth fluid flow, a substantially laminar fluid flow and / or a relatively low-turbulence fluid flow, a fluid flow having a substantially uniform front face, a fluid flow that does not readily mix with other fluids (e.g., an air flow or a body fluid flow that does not mix with a volume of air), a flow with a relatively uniform velocity, etc., and / or can include one or more of them.

[0101]

[0117] Regarding some aspects and / or features of the embodiments shown in FIGS. 2 to 11, while the methods of changing and / or "adjusting" such aspects and / or features have been described above, the flow controller and / or the isolation chamber (or any structure forming the isolation chamber) can have any suitable arrangement configuration that provides the desired speed, manner, and / or sequence for transporting an initial volume of body fluid within one or more portions or volumes of the isolation chamber 230. It should be understood that in some embodiments, the flow controller and / or the isolation chamber can include and / or incorporate any suitable combination of the aspects and / or features described above. Any number of the above-described aspects and / or features can be included in the device, and such aspects and / or features can act together or cooperate to provide the desired fluid flow and / or desired fluid flow characteristics through at least a portion of the isolation chamber. Further, it should be understood that the above-described aspects and / or features are provided by way of example only and not by way of limitation.

[0102]

[0118] When an initial volume of body fluid is transferred to the isolation chamber 230, as described above, a force can be applied to the end 251 of the actuator 250 to move and / or place the actuator 250 in its second position, state, mode of operation, and / or configuration. In some examples, the actuator 250 can be transitioned from a locked configuration or state to an unlocked configuration or state before a force is applied to the end 251 of the actuator 250. In the embodiments shown in FIGS. 2 to 11 the transition of the actuator 250 can be achieved by the interaction and / or operation of the actuator 250 by the user and / or can be brought about in other ways. However, in other embodiments, the transition of the actuator 250 can occur automatically in response to the negative pressure and / or associated flow dynamics within the device 200 and / or can be carried out by or in response to an external energy source that generates one or more dynamics or states that bring about the transition of the actuator 250.

[0103]

[0119] As shown in FIGS. 9 to 11, when each of the flow controller 240 and the actuator 250 is in its second state, the control device 200 is placed in its third state. When the actuator 250 transitions from its second state, position and / or configuration, the inlet 213 and the outlet 214 are placed in a fluidly connected state (e.g., via the flow paths 215 and 216 and / or a part of the flow channel 252), while the first port 217 and the second port 218 are isolated, separated, and / or otherwise not in fluid communication with the inlet 213 and / or the outlet 214. Thus, an initial volume of body fluid is isolated within a part of the isolation chamber 230 (e.g., the third volume portion of the isolation chamber 230 as described above). Further, in some examples, contaminants such as, for example, skin commensal microorganisms and / or any other contaminants may be mixed in and / or contained within the initial volume of body fluid, and thus, when the initial volume is isolated within the isolation chamber 230, it is isolated within the isolation chamber 230. Thus, the negative pressure that was previously applied over or through the flow path 216 and through the second port 218 is now applied to and / or through the outlet 214 and the inlet 213, for example, via at least a part of the flow paths 215 and 216 and / or the flow channel 252 of the actuator 250 (FIG. 11). Accordingly, the body fluid can flow from the inlet 213, through the actuator portion 212 of the housing 210, through the outlet 214, and into a fluid collection device coupled to the outlet 214. Thus, the device 200 can function in a manner substantially similar to the device 100 described in detail above with reference to FIG. 1.

[0104]

[0120] Figures 12-21 illustrate a fluid control device 300 according to another embodiment. The fluid control device 300 (also referred to herein as the "control device" or the "device") may be similar to the devices 100 and / or 200 described above at least in form and / or function. For example, as described above with respect to devices 100 and 200, when the device 300 is placed in fluid connection with a negative pressure source (e.g., a suction or vacuum source), (1) body fluid is drawn into the device 300 from a body fluid source, (2) a first portion or volume (e.g., an initial volume) of the body fluid is diverted and isolated in a portion of the device 300, and (3) a second portion or volume (e.g., a subsequent volume) of the body fluid is configured to flow through the device 300 (bypassing the isolated initial volume) into a fluid collection device fluidly coupled to the device 300. Thus, contaminants, etc., can be isolated in and / or with the initial volume of body fluid, leaving a subsequent volume of body fluid substantially free of contaminants. In some embodiments, portions and / or aspects of the control device 300 may be the same and / or substantially identical to portions and / or aspects of the control device 200 described above with reference to FIGS. 2-11. Thus, such similar portions and / or aspects may not be described in further detail herein.

[0105]

[0121] The fluid control device 300 (also referred to herein as the "control device" or the "device") includes a housing 310, a flow controller 340, and an actuator 350. In some embodiments, the control device 300 or at least a portion of the control device can be arranged in a modular configuration, where one or more portions of the housing 310 and / or the actuator 350 can be physically and fluidly (e.g., by the end user) coupled together to form the control device 300 as a whole. Similarly, several In one embodiment, the control device 300 can be packaged, transported, and / or stored separately from a fluid collection device (e.g., a sample reservoir, syringe, etc.) and / or an inlet device (e.g., a needle, catheter, PIV, PICC, etc.) that a user can couple to the control device 300 before or during use. In other embodiments, the control device 300 need not be modular. For example, in some embodiments, the control device 300 can be assembled during manufacturing and delivered to a supplier and / or end user as an assembled device. In some embodiments, the control device 300 can include a fluid collection device such as any of those described above, and / or can be pre-coupled to such a fluid control device (e.g., during manufacturing and / or before delivery to the end user). Similarly, in some embodiments, the control device 300 can include an inlet device such as any of those described herein, and / or can be pre-coupled to such an inlet device.

[0106]

[0122] The housing 310 of the control device 300 can be of any suitable shape, size, and / or configuration. The housing 310 includes an actuator portion 312 and an isolation portion 320. The actuator portion 312 receives at least a portion of the actuator 350. The isolation portion 320 is coupled to the cover 335 and includes an isolation chamber 330 that receives, houses, and / or at least partially defines. As described in further detail herein, the housing 310 can include and / or define a first port 317 and a second port 318, each of which establishes fluid communication between the actuator portion 312 and the isolation portion 320 of the housing 310 to selectively control and / or enable the flow of fluid through one or more portions of the housing 310.

[0107]

[0123] As shown in FIGS. 12 to 16, the actuator portion 312 of the housing 310 includes an inlet 313 and an outlet 314, and defines a flow path 315 (for example, a first flow path) configured to selectively place the inlet 313 in a fluid communication state with the first port 317, and a flow path 316 (for example, a second flow path) configured to selectively place the outlet 314 in a fluid communication state with the second port 318. The inlet 313 of the housing 310 is placed in a fluid connection state with a body fluid source (for example, in fluid communication with a patient via a needle, an IV catheter, a PICC line, etc.) and is configured to receive a flow of body fluid therefrom as described in detail above. The outlet 314 is configured to be fluidly coupled to a fluid collection device such as any of those described above (for example, a sample reservoir, a syringe, a culture flask, an intermediate body fluid transfer device or an adapter, etc.). The fluid collection device can define a vacuum or negative pressure that creates a negative pressure difference between desired portions of the housing 310 when the fluid collection device is coupled to the outlet 314 and / or can be operated to define such. Further, after an initial volume of body fluid has been transferred into the isolation chamber 330, fluid communication can be established between the flow paths 315 and 316 to allow a subsequent volume (for example, a sample of body fluid) to flow through the device 300 and into the fluid collection device. Accordingly, the actuator portion 312 of the housing 310 can be made substantially similar to the actuator portion 212 of the housing 210 at least in form and / or function, and thus will not be described in further detail herein.

[0108]

[0124] The isolation portion 320 of the housing 310 can have any suitable shape, size, and / or configuration. For example, as shown in FIGS. 16-18, the isolation portion 320 includes and / or forms an inner surface, and a part of the inner surface is arranged and / or configured to form a first uneven surface 321. As described in more detail herein, at least a part of the first uneven surface 321 can form and / or define a part of the isolation chamber 330. Further, as described in more detail herein, the first port 317 and the second port 318 form a part of the first uneven surface 321 and / or extend through a part of the first uneven surface 321 so as to selectively place the isolation chamber 330 in fluid communication with the flow paths 315 and 316. configured as such.

[0109]

[0125] The isolation portion 320 includes, forms, and / or houses an outer member 325 and a flow controller 340. More specifically, as shown in FIGS. 16-18, the isolation portion 320 receives and / or is coupled to the outer member 325 such that the flow controller 340 is disposed between the isolation portion 320 and the outer member 325. In some embodiments, the outer member 325 can be fixedly coupled to the isolation portion 320 via an adhesive, ultrasonic welding, and / or any other suitable coupling method. In some embodiments, the outer member 325, the isolation portion 320, and the flow controller 340 together can form a substantially fluid-tight and / or sealed seal that separates the isolation portion 320 from the volume outside the isolation portion 320.

[0110]

[0126] As shown, a cover 335 is disposed around an outer member 325 such that the cover 335 and the isolation portion 320 of the housing 310 are configured to surround and / or contain the outer member 325 and the flow controller 340. In some embodiments, the cover 335 can be coupled to the outer member 325 and / or the isolation portion 320 via an adhesive, ultrasonic welding, one or more mechanical fasteners, friction fitting, snap fit, screw connection, and / or any other suitable coupling method. In some embodiments, the cover 335 can define an opening, window, slot, etc. configured to enable visualization of at least a portion of the isolation chamber 330. Although the outer member 325 and the cover 335 have been described as separate parts and / or components, in other embodiments, the outer member 325 can be integrated with and / or formed integrally with the cover 335.

[0111]

[0127] The outer member 325 includes and / or forms a second uneven surface 326. The arrangement of the outer member 325 and the isolation portion 320 of the housing 310 can be such that at least a portion of the first uneven surface 321 is aligned with and / or opposed to a corresponding portion of the second uneven surface 326 of the outer member 325 (see, for example, FIG. 18). Accordingly, a space, volume, opening, gap, chamber, etc. defined between the first uneven surface 321 and the second uneven surface 326 forms and / or defines the isolation chamber 330. Further, as described in more detail herein, the flow controller 340 is disposed between the first uneven surface 321 and the second uneven surface 326 and can be configured to transition between a first state and a second state in response to a negative pressure difference and / or a suction force being applied to at least a portion of the isolation chamber 330.

[0112]

[0128] Ports 317 and 318 of the housing 310 can be of any suitable shape, size, and / or configuration. As detailed above with respect to the first port 217, the first port 317 is in fluid communication with a first portion of the isolation chamber 330 defined between the second uneven surface 326 and the first side of the flow controller 340, and is configured to provide and / or transfer the flow of body fluid from the inlet 313 and / or the flow path 315 to the first portion of the isolation chamber 330 in response to the flow controller 340 transitioning from the first state to the second state. As described above with respect to the second port 218, the second port 318 is in fluid communication with a second portion of the isolation chamber 330 defined between the first uneven surface 321 and the second side (e.g., opposite the first side) of the flow controller 340. Thus, as detailed above with respect to the device 200, the second port 318 can be configured to expose the second portion of the isolation chamber 330 to a negative pressure difference and / or suction force provided by a fluid collection device that is operable to move the flow controller 340 from its first state to its second state. Further, the second port 318 can include and / or be coupled to a throttle 319, and the throttle 319 is configured to restrict and / or limit the flow of fluid (e.g., air or gas) between the second portion of the isolation chamber 330 and the flow path 316, as detailed above with respect to the throttle 219 of the device 200, thereby adjusting and / or controlling the pressure difference and / or suction force applied to or received by the flow controller 340.

[0113]

[0129] The flow controller 340 disposed within the isolation portion 320 of the housing 310 can be of any suitable shape, size, and / or configuration. Similarly, the flow controller 340 can be formed of any suitable material (e.g., any suitable biocompatible material such as those described herein, and / or any other suitable material). For example, the flow controller 340 can be a fluid-impermeable bladder configured to transition from a first state and / or form to a second state and / or form. In some embodiments, the flow controller 340 (e.g., the bladder) can include any number of relatively thin and flexible portions configured to deform in response to a pressure differential across the flow controller 340. In some embodiments, the flow controller 340 can be substantially similar in at least form and / or function to the flow controller 240 described in detail above with reference to FIGS. 2-11. For example, in some embodiments, the flow controller 340 can be formed of or from any suitable material, such as the materials and / or durometer hardness described above with respect to the flow controller 240, and / or can have any suitable durometer hardness. Similarly, the flow controller 340 can have a size, shape, surface finish, and / or material properties configured to facilitate, promote, and / or otherwise provide a fluid flow having a desired set of flow characteristics, as described above with respect to the flow controller 240. Accordingly, the portions of the flow controller 340 may not be described in further detail herein.

[0114]

[0130] In the embodiments shown in FIGS. 12 - 21, the flow controller 340 is a bladder made of or formed from silicone having a durometer hardness of about 30 Shore A. The flow controller 340 (e.g., the bladder) includes a first deformable portion 341 and a second deformable portion 342. Further, the flow controller 340 defines an opening 344 configured to receive at least a portion of the first port 317, as described above with respect to the flow controller 240. In some embodiments, as described in more detail herein, the flow controller 340 can include one or more portions configured to form one or more seals between the flow controller 340 and each of the concave and convex surfaces 321 and 326, and / or between the flow controller 340 and each of the concave and convex surfaces 321 and 326.

[0115]

[0131] The deformable portions 341 and 342 of the flow controller 340 can be relatively thin and flexible portions configured to deform in response to a pressure differential between a first side and a second side of the flow controller 340. More specifically, the deformable portions 341 and 342 can each have a thickness of about 0.005 inches. For example, as shown in FIGS. 18 and 20, the deformable portions 341 and 342 of the flow controller 340 correspond to and / or substantially have the same overall shape as at least a portion of the concave and convex surfaces 321 and / or 326. Thus, as described in more detail herein, the deformable portions 341 and 342 and the corresponding portions of the concave and convex surfaces 321 and / or 326 can together form and / or define one or more channels, volumes, etc., which can further receive an initial volume of body fluid.

[0116]

[0132] As described above with respect to the flow controller 240, the flow controller 340 is configured to transition between a first state and a second state. For example, when the flow controller 340 is in its first state, the first deformable portion 341 can be disposed adjacent to and / or in substantial contact with the first recess 327 formed by the second uneven surface 326, and the second deformable portion 342 can be disposed adjacent to and / or in substantial contact with the second recess 328 formed by the second uneven surface 326. Thus, the first portion of the isolation chamber 330 (for example, the portion defined between the second uneven surface 326 and the first surface of the flow controller 340) can have a relatively small and / or relatively very small volume. In contrast, when the flow controller 340 transitions from its first state to its second state (for example, in response to a negative pressure applied and / or transmitted through the second port 318), the first deformable portion 341 can be disposed adjacent to and / or in substantial contact with the first recess 322 formed by the first uneven surface 321, and the second deformable portion 342 can be disposed adjacent to and / or in substantial contact with the second recess 323 formed by the first uneven surface 321. Thus, the volume of the first portion of the isolation chamber 330 is larger when the flow controller 340 is in its second state than when it is in its first state. As described in detail above with respect to the isolation chamber 230 and the flow controller 240, an increase in the volume of the first portion of the isolation chamber 330 can result in a negative pressure or vacuum that can operate to draw an initial volume of body fluid into the isolation chamber 330 along with a certain volume of air or gas therein.

[0117]

[0133] Although the flow controller 340 has been specifically shown and described, in other embodiments, the flow controller 340 and / or the isolation chamber 330 can have any suitable configuration and / or arrangement. For example, in some embodiments, the concave and convex surfaces 321 and / or 326 can include more or fewer recesses (e.g., recesses 322 and 323 and recesses 327 and 328). In other embodiments, the depth of one or more of the recesses can be changed. Similarly, the flow controller 340 can be modified in any suitable manner to substantially correspond to the shape and / or configuration of the concave and convex surfaces 321 and / or 326. Although the flow controller 340 has been described as being, for example, a bladder including a plurality of deformable portions, in other embodiments, the flow controller can be arranged and / or configured as, for example, a bellows, a flexible pouch, an inflatable bag, an inflatable chamber, a plunger (similar to a syringe, for example), and / or any other suitable reconfigurable container, etc. Further, the isolation chamber 330, at least partially formed by the flow controller 340, can have any suitable shape, size, and / or configuration.

[0118]

[0134] The actuator 350 of the control device 300 can be of any suitable shape, size, and / or configuration. At least a portion of the actuator 350 is disposed within the actuator portion 312 of the housing 310 and is configured to transition between a first state, form, and / or position and a second state, form, and / or position. In the embodiments shown in FIGS. 12-21, the actuator 350 is configured as an actuator rod or plunger that is configured to move relative to the actuator portion 312 of the housing 310. The actuator 350 further includes a set of seals 355 that define a flow channel 352. The actuator 350 includes an end 351 disposed outside the housing 310, and the end 351 is configured to be actuated by a user to transition the actuator 350 between its first state in which the flow path 315 can establish fluid communication between the inlet 313 and the first port 317 and its second state, in which (1) the first port 317 (and thus the isolation chamber 330) is isolated and / or fluidly separated, and (2) the inlet 313 and the outlet 314 are placed in a state of being fluidly connected via at least a portion of the flow paths 315 and 316 and / or the flow channel 352 of the actuator 350. Thus, the actuator 350 is similar in form and / or function to the actuator 250 described above with reference to FIGS. 2-11. Thus, the actuator 350 will not be described in further detail herein.

[0119]

[0135] Using the device 300, a sample of body fluid with reduced contamination (e.g., contamination from microorganisms such as skin commensal microorganisms, microorganisms external to the body fluid source) can be obtained in a manner substantially similar to that described above with respect to the device 200. For example, during use Previously, the device 300 can be in its first, initial and / or storage state or operating mode where each of the flow controller 340 and the actuator 350 is in its respective first or initial state. When the device 300 is in the first state, a user such as a physician, internist, nurse, phlebotomist, technician, etc. can operate the device 300 to establish fluid communication between the inlet 313 and a body fluid source (e.g., a patient's vein). When the inlet 313 is placed in fluid connection with the body fluid source, the outlet 314 can be fluidly coupled to a fluid collection device (not shown in FIGS. 12 - 21). In the embodiments shown in FIGS. 12 - 21, for example, the fluid collection device can be a vacuum blood collection tube, a culture bottle, a sample reservoir, a syringe, and / or any other suitable container or device configured to define or generate negative pressure, suction, vacuum and / or energy potential.

[0120]

[0136] When the actuator 350 is in the first position and / or configuration, the inlet 313 of the housing 310 is in fluid communication with, for example, the flow path 315, and the flow path 315 is further in fluid communication with the first port 317 (see, for example, FIGS. 17 and 18). The outlet 314 of the housing 310 is in fluid communication with the flow path 316, and the flow path 316 is further in fluid communication with the second port 318 (see, for example, FIGS. 17 and 18). As described in detail above, when the control device 300 is in the first state or operating mode (e.g., when the actuator 350 and the flow controller 340 are each in their first states), by fluidly coupling the fluid collection device to the outlet 314, a negative pressure differential and / or suction force is generated and / or otherwise brought about within at least a portion of the flow path 316 and further within a portion of the isolation chamber 330 defined between the surface (e.g., the first surface) of the flow controller 340 and the first uneven surface 321 of the housing 310.

[0121]

[0137] Flow controller 340 is in a first state and / or configuration before the fluid collection device is coupled to outlet 314. In the embodiments shown in FIGS. 12-21, flow controller 340 can be a fluid-impermeable bladder or the like that has an inverted, reversed, collapsed, and / or empty configuration (e.g., a first state and / or configuration) before coupling the fluid collection device to outlet 314. For example, as shown in FIG. 18, when flow controller 340 is in its first state and / or configuration, flow controller 340 can be disposed adjacent to and / or in contact with second relief surface 326.

[0122]

[0138] As described above, flow controller 340 is configured to transition from its first state and / or configuration to its second state and / or configuration in response to a negative pressure differential and / or suction force being generated within a portion of isolation chamber 330 defined between flow controller 340 and first relief surface 321. For example, flow controller 340 can be disposed adjacent to and / or in contact with second relief surface 326 when flow controller 340 is in its first state (FIG. 18), and can be transitioned, moved, “reversed”, placed, and / or otherwise reconfigured to its second state (FIG. 20) in which flow controller 340 is disposed adjacent to and / or in contact with first relief surface 321. Further, when actuator 350 is in its first state and flow controller 340 is in its second state, control device 300 is placed in its second state and / or configuration.

[0123]

[0139] With the shift of the flow controller 340, the internal volume of the portion of the isolation chamber 330 defined between the surface of the flow controller 340 (e.g., the second surface opposite the first surface) and the second uneven surface 326 will increase. As described in detail above with respect to the device 200, the increase in the internal volume can create a negative pressure differential that is operable to draw at least a portion of the initial flow, amount, or volume of body fluid from the inlet 313 through the flow path 315 and the first port 317 into the above-described portion of the isolation chamber 330. In some examples, for instance, until the flow controller 340 is fully inflated, inverted and / or shifted, until the negative pressure differential decreases and / or equalizes, and / or until a desired volume of body fluid is disposed within the above-described portion of the isolation chamber 330, the initial volume and / or flow of body fluid can be transferred into the isolation chamber 330. Further, as described above with respect to the device 200, the throttle 319 can be configured to limit, restrict, control, and / or adjust the magnitude of the negative pressure differential and / or suction force generated within the isolation chamber 330 and / or with respect to the surface of the flow controller 340, thereby adjusting the suction force within one or more flow paths and / or within a body fluid source (e.g., a patient's vein). In other embodiments, the second port 318 and / or any suitable portion of the device 300 can be configured to adjust the suction force within one or more portions of the isolation chamber 330 in any suitable manner, such as, for example, in the manner described above with respect to the device 200.

[0124]

[0140] In some embodiments, the shape, size, and / or arrangement configuration of the isolation chamber 330 and / or the flow controller 340, the magnitude of the negative pressure difference or suction force, and / or the manner in which the negative pressure difference or suction force is applied can indicate and / or control the speed and / or manner in which the flow controller 340 transitions from the first state to the second state. For example, although the flow controller 240 has been described above as including the first deformable portion 241, the second deformable portion 242, and the third deformable portion 243, the flow controller 340 included in the embodiments shown in FIGS. 12 to 21 includes only the first deformable portion 341 and the second deformable portion 342. Further, as shown in FIGS. 18 and 20, the recesses 322 and 323 of the first uneven surface 321 have substantially the same depth. In some embodiments, such an arrangement configuration can limit and / or reduce the amount of negative pressure and / or suction force sufficient to transition and / or invert the first deformable portion 341 and the second deformable portion 342 of the flow controller 340, for example, with respect to the amount of negative pressure and / or suction force sufficient to transition and / or invert the first deformable portion 341.

[0125]

[0141] As described above, in some embodiments, the first deformable portion 341 has a thickness and / or rigidity greater than that of the second deformable portion 342, such that the second deformable portion 342 completes or substantially completes its transition and / or inversion before the first deformable portion 341 completes or substantially completes its transition and / or inversion. In other embodiments, the flow rate controller 340 can include any suitable features, structures, material properties, surface finishes, etc., and / or any other portion of the device 300 can include any suitable features, structures, etc. configured to control the order and / or manner in which the flow rate controller 340 transitions from the first state to the second state, such as any of those described above with respect to the flow rate controller 240. In some embodiments, due to the arrangement configuration of the flow rate controller 340, the device 300 can be made compatible with a fluid collection device having a relatively low amount of negative pressure. In some embodiments, such an arrangement configuration can also facilitate and / or simplify one or more manufacturing processes, etc. In some examples, by controlling the speed, order, and / or manner, one or more desired flow characteristics related to the flow of air, gas, and / or body fluid into and / or through at least a portion of the isolation chamber 230 can be achieved.

[0126]

[0142] As described above with respect to the deformable portions 241 and 242, the first deformable portion 341 and the first recess 327 of the second uneven surface 326 (e.g., the first volume portion of the isolation chamber 330) can be configured to receive a certain volume of air in the flow path between the body fluid source and the isolation chamber 330 before the flow path receives and / or is filled with body fluid. In other words, by the transition of the flow rate controller 340, air or gas can be exhausted or purged from the flow path between the body fluid source and the isolation chamber 330, and then such air or gas can be stored and / or contained within the first and second volume portions of the isolation chamber 330. On the other hand, the portion of the isolation chamber 330 (e.g., the The second volume portion) can be configured to receive an initial volume of body fluid that flows through the flow path between the body fluid source and the isolation chamber 330 after air or gas has been exhausted and / or purged. Thus, as described above with respect to device 200, the initial volume can be transferred into the isolation chamber 330.

[0127]

[0143] In some examples, the isolation chamber 330 and / or the flow controller 340 arrangement can provide, for example, a uniform flow of the initial volume of body fluid into the second volume of the isolation chamber 330. For example, as described in detail above with respect to device 200, the isolation chamber 330 and / or the flow controller 340 can be configured and / or arranged such that the body fluid flows into and / or through at least a portion (e.g., the second volume portion of the isolation chamber 330) of the isolation chamber 330 without substantially mixing with the volume of air that is within the isolation chamber 330 and in front of the uniform flow. In other embodiments, the flow controller can have any other suitable arrangement to provide, for example, any of those described above with respect to device 200, the desired rate, manner, and / or order of transporting the initial volume of body fluid into one or more portions or volume portions of the isolation chamber 330.

[0128]

[0144] When the initial volume of body fluid is transferred into the isolation chamber 330, as described above, a force can be applied to the end 351 of the actuator 350 to shift and / or place the actuator 350 into its second position, state, mode of operation, and / or configuration. In some examples, prior to applying a force to the end 351 of the actuator 350, the actuator 350 can be shifted from a locked configuration or state to an unlocked configuration or state. In the embodiments shown in FIGS. 12-21, the shift of the actuator 350 can be achieved by the interaction and / or operation of the actuator 350 by the user and / or otherwise may occur as a result. However, in other embodiments, the shift of the actuator 350 can occur automatically in response to a negative pressure and / or associated flow dynamics within the device 300 and / or can be implemented by or in response to an external energy source that generates one or more dynamics or states that result in the shift of the actuator 350.

[0129]

[0145] As shown in FIGS. 19 to 21, when each of the flow controller 340 and the actuator 350 is in its second state, the control device 300 is placed in its third state. When the actuator 350 transitions from its second state, position and / or configuration, the inlet 313 and the outlet 314 are placed in a fluidly connected state (e.g., via the flow path 316 and / or the flow channel 352), while the flow path 315 and / or the first port 317 are isolated, separated, and / or otherwise not in fluid communication with the inlet 313 and / or the outlet 314. Thus, an initial volume of body fluid is isolated within a portion of the isolation chamber 330 (e.g., the third volume portion of the isolation chamber 330 as described above). Further, in some examples, contaminants such as, for example, skin commensal microorganisms and / or any other contaminants may be mixed in and / or contained within the initial volume of body fluid, and thus are isolated within the isolation chamber 330 when the initial volume is isolated therein. Thus, the negative pressure that was otherwise applied over or through the flow path 316 and through the second port 318 is now applied to and / or through the outlet 314 and the inlet 313, for example, via at least a portion of the flow paths 315 and 316 and / or the flow channel 352 of the actuator 350 (FIG. 21). Accordingly, the body fluid can flow from the inlet 313, through the actuator portion 312 of the housing 310, through the outlet 314, and into a fluid collection device coupled to the outlet 314. Thus, the device 300 can function in a manner substantially similar to the devices 100 and / or 200 described in detail above.

[0130]

[0146] Figures 22 to 27 show a fluid control device 400 according to another embodiment. The fluid control device 400 (also referred to herein as the "control device" or "device") may be similar to the devices 100, 200, and / or 300 described above at least in form and / or function. For example, as described above with respect to devices 100, 200, and / or 300, when the device 400 is placed in fluid connection with a negative pressure source (e.g., a suction or vacuum source), (1) body fluid is drawn into the device 400 from a body fluid source, (2) a first portion or volume (e.g., an initial volume) of the body fluid is diverted and isolated in a part of the device 400, and (3) a second portion or volume (e.g., a subsequent volume) of the body fluid is configured to flow through the device 400 (bypassing the isolated initial volume) into a fluid collection device fluidly coupled to the device 400. Thus, contaminants and the like can be isolated in or with the initial volume of body fluid, leaving a subsequent volume of body fluid substantially free of contaminants. In some embodiments, portions and / or aspects of the control device 400 may be similar and / or substantially identical to portions and / or aspects of the control device 200 described above with reference to at least FIGS. 2 to 11. Accordingly, such similar portions and / or aspects may not be described in further detail herein.

[0131]

[0147] The fluid control device 400 includes a housing 410, a flow controller 440, and an actuator 450. In some embodiments, as described above with respect to device 200, the control device 400 or at least a part of the control device 400 can be arranged in a modular configuration (e.g., including one or more independent or separate components to be assembled later), or in an integrated or at least partially integrated configuration (e.g., including one or more components to be pre-assembled or pre-coupled). For example, in some embodiments, the control device 400 can include and / or be coupled to a fluid collection device and / or an inlet device, such as any of those described above.

[0132]

[0148] The housing 410 of the control device 400 can be of any suitable shape, size, and / or configuration. Generally, the housing 410 can be substantially similar to the housing 210 at least in form and / or function. Therefore, although some components, features, aspects, and / or functions of the housing 410 will be identified and described hereinafter in the drawings, such similarities will not be described in further detail herein, and such similarities should be considered in the same manner as the corresponding components, features, aspects, and / or functions described above with respect to the device 200, unless there is an explicit description to the contrary.

[0133]

[0149] The housing 410 includes an actuator portion 412 and an isolation portion 420. The actuator portion 412 receives at least a portion of the actuator 450. The isolation portion 420 is coupled to the cover 435 and includes, receives, houses, and / or at least partially defines the isolation chamber 430. As will be described in further detail herein, the housing 410 can include and / or define a first port 417 and a second port 418, each of which establishes fluid communication between the actuator portion 412 and the isolation portion 420 of the housing 410 to selectively control and / or enable the flow of fluid through one or more portions of the housing 410.

[0134]

[0150] The actuator portion 412 of the housing 410 includes an inlet 413 and an outlet 414, and defines a flow path 415 (e.g., a first flow path) configured to selectively place the inlet 413 in fluid communication with the first port 417 and a flow path 416 (e.g., a second flow path) configured to selectively place the outlet 414 in fluid communication with the second port 418. The actuator portion 412 of the housing 410 can be substantially similar to the actuator portion 212 of the housing 210 at least in form and / or function and thus will not be described in further detail herein.

[0135]

[0151] The isolation portion 420 of the housing 410 can be of any suitable shape, size, and / or configuration. The isolation portion 420 includes an outer contour member 425 and a flow controller 440 and is configured to form and / or house them. More specifically, a cover 435 is disposed around the outer contour member 425 such that the cover 435 and the isolation portion 420 of the housing 410 surround and / or house the outer contour member 425 and the flow controller 440. The isolation portion 420 of the housing 410 and / or components of or coupled to the isolation portion 420 can be made substantially similar in at least form and / or function to the isolation portion 220 of the housing 210 (and / or components of or coupled to the isolation portion 220), and thus will not be described in further detail herein.

[0136]

[0152] For example, as shown in FIGS. 24-27, the isolation portion 420 includes and / or forms an inner surface, and a part of the inner surface is arranged and / or configured to form a first uneven surface 421. As will be described in more detail herein, at least a part of the first uneven surface 421 can form and / or define a part of the isolation chamber 430. Further, as described above with respect to the device 200, the first port 417 and the second port 418 are configured to form a part of and / or extend through a part of the first uneven surface 421 so as to selectively place the isolation chamber 430 in fluid communication with the flow paths 415 and 416.

[0137]

[0153] The first uneven surface 421 can have any suitable shape, curvature, and / or texture, and can be substantially similar to, for example, the first uneven surface 221 of the housing 220. For example, the first uneven surface 421 includes and / or forms at least a first recess 422 and a second recess 423. However, as shown in FIGS. 24 to 27, the first contoured surface 421 can be different from the first uneven surface 221 by including any number of ventilation ridges 424. The distribution of the ventilation ridges 424 on the first contoured surface 421 can include a plurality of arrangements. For example, as shown in FIGS. 25 and 27, the first contoured surface 421 has one ventilation ridge 424, a plurality of ventilation ridges 424, a plurality of concentric ventilation ridges 424, etc., arranged within and / or formed by the first recess 422, and / or one ventilation ridge 424, a plurality of ventilation ridges 424, a plurality of concentric ventilation ridges 424, etc., arranged within and / or formed by the second recess 423 of the first contoured surface 421. In some embodiments, the ventilation ridge 424 is configured to reduce and / or control the ability or possibility of the flow controller 440 or a part thereof to form a seal in response to a negative pressure (e.g., the negative pressure in the volume between the first uneven surface 421 and the flow controller 440) being applied and / or transmitted through the second port 418. In other words, the ventilation ridge 424 can form a discontinuity along one or more portions of the first uneven surface 421, as described in more detail herein, and this discontinuity allows air to flow freely between the flow controller 440 and one or more portions of the first contoured surface 421, thereby preventing air from being trapped in the local region between the flow controller 440 and one or more portions of the first contoured surface 421.

[0138]

[0154] As shown in FIGS. 24 to 27, the isolation portion 420 receives and / or is coupled to the outer member 425 such that the flow controller 440 is disposed between the isolation portion 420 and the outer member 425. In some embodiments, the outer member 425 may be substantially similar to the outer member 225 described above with respect to the device 200, at least in form and / or function. For example, the uneven member 425 includes and / or forms a second uneven surface 426. The second contour surface 426 can be of any suitable shape, curvature, and / or texture, and can be substantially similar to the second uneven surface 226 of the housing 220, for example. For example, the second uneven surface 426 includes and / or forms a first recess 427, a second recess 428, and a third recess 429. However, the second contour surface 426 can be different from the second uneven surface 226 by including any number of ventilation channels 431, as shown in FIGS. 24 to 27. The distribution of the ventilation channels 431 on the second contour surface 426 can include a plurality of arrangements. For example, as shown in FIGS. 25 and 27, the second contour surface 426 has one ventilation channel 431, a plurality of ventilation channels 431, or a plurality of concentric ventilation channels 431 disposed within and / or formed by the first recess 427, and / or one ventilation channel 431, a plurality of ventilation channels 431, or a plurality of concentric ventilation channels 431 disposed within and / or formed by the second recess 428 of the second contour surface 426. The ventilation channels 431 are configured to reduce and / or control the ability or possibility of the flow controller 440 or a part thereof to form a seal when placed in contact with the second contour surface 426 in response to a negative pressure (e.g., within the volume between the first uneven surface 421 and the flow controller 440), as described above with respect to the ventilation ridges 424. It can be a texture, for example, and can be substantially similar to the second uneven surface 226 of the housing 220. For example, the second uneven surface 426 includes and / or forms a first recess 427, a second recess 428, and a third recess 429. However, the second contour surface 426 can be different from the second uneven surface 226 by including any number of ventilation channels 431, as shown in FIGS. 24 to 27. The distribution of the ventilation channels 431 on the second contour surface 426 can include a plurality of arrangements. For example, as shown in FIGS. 25 and 27, the second contour surface 426 has one ventilation channel 431, a plurality of ventilation channels 431, or a plurality of concentric ventilation channels 431 disposed within and / or formed by the first recess 427, and / or one ventilation channel 431, a plurality of ventilation channels 431, or a plurality of concentric ventilation channels 431 disposed within and / or formed by the second recess 428 of the second contour surface 426. The ventilation channels 431 are configured to reduce and / or control the ability or possibility of the flow controller 440 or a part thereof to form a seal when placed in contact with the second contour surface 426 in response to a negative pressure (e.g., within the volume between the first uneven surface 421 and the flow controller 440), as described above with respect to the ventilation ridges 424.

[0139]

[0155] Regarding the first contour surface 421, it has been described above as including the ventilation ridge 424, and the second contour surface 426 has been described above as including the ventilation channel 431. However, it should be understood that the ventilation ridge 424 and the ventilation channel 431 are presented merely as examples, not as limitations. Various alternative forms and / or combinations are contemplated. For example, in some embodiments, the first contour surface 421 can include a ventilation channel, and the second contour surface 426 can include a ventilation ridge. In other embodiments, the first contour surface 421 and / or the second contour surface 426 can include a combination of a ventilation channel and a ventilation ridge. Thus, the contour surfaces 421 and 426 can have any suitable shape, size, and / or configuration that enables and / or ensures that air can flow between the flow controller 440 and the contour surfaces 421 and 426, and can include one or more discontinuities. Further, each of the contour surfaces 421 and 426 is shown as including a ventilation feature or a discontinuity. However, in other embodiments, the first contour surface 421 can include a ventilation feature or a discontinuity while the second contour surface 426 does not, and vice versa.

[0140]

[0156] The flow controller 440 disposed within the isolation portion 420 of the housing 410 can be of any suitable shape, size, and / or configuration. Similarly, the flow controller 440 can be formed of any suitable material (e.g., any suitable biocompatible material such as those described herein, and / or any other suitable material). For example, the flow controller 440 can be a fluid-impermeable bladder configured to transition from a first state and / or form to a second state and / or form. In some embodiments, the flow controller 440 (e.g., the bladder) can include any number of relatively thin and flexible portions configured to deform in response to a pressure differential across the flow controller 440. In some embodiments, the flow controller 440 can be substantially similar in at least form and / or function to the flow controller 240 described in detail above with reference to FIGS. 2-11. For example, in some embodiments, the flow controller 440 can be formed of or from any suitable material, such as the materials and / or durometer hardness described above with respect to the flow controller 240, and / or can have any suitable durometer hardness. Similarly, the flow controller 440 can have a size, shape, surface finish, and / or material properties configured to facilitate, promote, and / or otherwise result in a fluid flow having a desired set of flow characteristics, as described above with respect to the flow controller 240. Accordingly, the portions of the flow controller 440 may not be described in further detail herein.

[0141]

[0157] In the embodiments shown in FIGS. 22-27, the flow controller 440 is about 30 SHO A bladder made of or formed from silicone having the durometer hardness of A. The flow controller 440 (e.g., the bladder) includes a first deformable portion 441, a second deformable portion 442, and a third deformable portion 443. Further, the flow controller 440 defines an opening 444 configured to receive at least a portion of the first port 417, as described above with respect to the flow controller 240. In some embodiments, the flow controller 440 can include one or more portions configured to form one or more seals between the flow controller 440 and each of the concave and convex surfaces 421 and 426, and / or between the flow controller 440 and each of the concave and convex surfaces 421 and 426. For example, as shown in FIGS. 24-27, the deformable portions 441, 442, and 443 of the flow controller 440 correspond to at least a portion of the concave and convex surfaces 421 and / or 426 and / or have substantially the same overall shape as that portion. Thus, as described in more detail herein, the deformable portions 441, 442, and 443 and the corresponding portions of the concave and convex surfaces 421 and / or 426 can together form and / or define one or more volume portions, etc., which can further receive an initial volume of body fluid.

[0142]

[0158] As described above with respect to the flow controller 240, the flow controller 440 is configured to transition between a first state and a second state. For example, when the flow controller 440 is in its first state, the first deformable portion 441 can be disposed adjacent to and / or in substantial contact with the first recess 427 formed by the second uneven surface 426, the second deformable portion 442 can be disposed adjacent to and / or in substantial contact with the second recess 428, and the third deformable portion 443 can be disposed adjacent to and / or in substantial contact with the second recess 429 formed by the second uneven surface 426. Accordingly, the first portion of the isolation chamber 430 (e.g., the portion defined between the second uneven surface 426 and the first surface of the flow controller 440) can have a relatively small and / or relatively very small volume. In contrast, when the flow controller 440 transitions from its first state to its second state (e.g., in response to a negative pressure applied and / or transmitted through the second port 418), at least the deformable portions 441, 442, and 443 are disposed adjacent to and / or in substantial contact with the first uneven surface 421. More specifically, as described above with respect to the flow controller 240, the first deformable portion 421 can be disposed adjacent to and / or in substantial contact with the first recess 422 formed by the first uneven surface 421, the second deformable portion 442 can be disposed adjacent to and / or in substantial contact with the second recess 423 formed by the first uneven surface 421, and the third deformable portion 243 can be disposed adjacent to and / or in substantial contact with, for example, a non-recessed portion of the first uneven surface 421.

[0143]

[0159] The actuator 450 of the control device 400 can have any suitable shape, size, and / or configuration. At least a portion of the actuator 450 is disposed within the actuator portion 412 of the housing 410 and is configured to transition between a first state, form, and / or position and a second state, form, and / or position. In the embodiments shown in FIGS. 22-27, the actuator 450 is configured as an actuator rod or plunger configured to move relative to the actuator portion 412 of the housing 410. The actuator 450 includes a set of seals 455 and defines a flow channel 452. The actuator 450 further includes an end 451 disposed outside the housing 410, and the end 451 is configured to be actuated by a user to transition the actuator 450 between its first state in which the flow path 415 can establish fluid communication between the inlet 413 and the first port 417 and its second state, in which (1) the first port 417 (and thus the isolation chamber 430) is isolated and / or fluidly separated, and (2) the inlet 413 and the outlet 414 are in a state of being fluidly connected via at least a portion of the flow paths 415 and 416 and / or the flow channel 452 of the actuator 450 is placed in. Accordingly, the actuator 450 is similar in form and / or function to the actuator 250 described above with reference to FIGS. 2-11. Accordingly, the actuator 450 will not be described in further detail herein.

[0144]

[0160] Using device 400, a sample of body fluid with reduced contamination (e.g., contamination from microorganisms such as skin commensal microorganisms, microorganisms outside the body fluid source) can be obtained in a manner substantially similar to the manner described above with respect to device 200. For example, before use, device 400 can be in its first, initial and / or storage state or operating mode in which each of flow controller 440 and actuator 450 is in its respective first or initial state. With device 400 in the first state, a user such as a physician, internist, nurse, phlebotomist, technician, etc. can operate device 400 to establish fluid communication between inlet 413 and a body fluid source (e.g., a patient's vein). When inlet 413 is placed in fluid connection with the body fluid source, outlet 414 can be fluidly coupled to a fluid collection device (not shown in FIGS. 22-27). In the embodiments shown in FIGS. 22-27, for example, the fluid collection device can be a vacuum blood collection tube, a culture bottle, a sample reservoir, a syringe, and / or any other suitable container or device configured to define or generate negative pressure, suction, vacuum, and / or energy potential.

[0145]

[0161] When actuator 450 is in the first position and / or configuration, inlet 413 of housing 410 is in fluid communication with, for example, flow path 415, which is further in fluid communication with first port 417. Outlet 414 of housing 410 is in fluid communication with flow path 416, which is further in fluid communication with second port 418 (see, for example, FIG. 24). As described in detail above, when control device 400 is in the first state or operating mode (e.g., when actuator 450 and flow controller 440 are each in their first states), by fluidly coupling a fluid collection device to outlet 414, a negative pressure differential and / or suction force is generated and / or otherwise brought about within at least a portion of flow path 416 and further within a portion of isolation chamber 430 defined between the surface (e.g., the first surface) of flow controller 440 and the first uneven surface 421 of housing 410.

[0146]

[0162] Flow controller 440 is in a first state and / or configuration before the fluid collection device is coupled to outlet 414. In the embodiments shown in FIGS. 22-27, flow controller 440 can be a fluid-impermeable bladder or the like that has an inverted, reversed, collapsed, and / or empty configuration (e.g., a first state and / or configuration) before coupling the fluid collection device to outlet 414. For example, as shown in FIGS. 24 and 25, when flow controller 440 is in its first state and / or configuration, flow controller 440 can be disposed adjacent to and / or in contact with second contoured surface 426.

[0147]

[0163] As described above, controller 440 is configured to transition from its first state and / or configuration to its second state and / or configuration in response to a negative pressure differential and / or suction force being generated within a portion of isolation chamber 430 defined between flow controller 440 and first contoured surface 421. For example, flow controller 440 can be disposed adjacent to and / or in contact with second contoured surface 426 when flow controller 440 is in its first state (FIGS. 24 and 25), and can be transitioned, moved, “reversed”, placed, and / or otherwise reconfigured to its second state in which flow controller is disposed adjacent to and / or in contact with first contoured surface 421. Further, ventilation channel 431 formed by second contoured surface 426 allows air to flow between second contoured surface 426 and flow controller 440, thereby reducing the likelihood that an air pocket will be trapped between second contoured surface 426 and flow controller 440 in some instances when a positive pressure (e.g., a positive pressure that drives and / or biases flow controller 440 toward second contoured surface 426 during manufacturing, inspection, and / or use, etc.) is applied within the volume between flow controller 440 and first contoured surface 421 via port 418. 2 contoured surface 426 and flow controller 440.

[0148]

[0164] When the actuator 450 is in its first state and the flow controller 440 is in its second state, the control device 400 is placed in its second state and / or configuration. With the transition of the flow controller 440, the internal volume of a portion of the isolation chamber 430 defined between the surface of the flow controller 440 (e.g., the second surface opposite the first surface) and the second uneven surface 426 will increase. As described in detail above with respect to the device 200, the increase in the internal volume can result in a negative pressure differential that is operable to draw at least a portion of the initial flow, amount, or volume of body fluid from the inlet 413 through the flow path 415 and the first port 417 into the above-mentioned portion of the isolation chamber 430. In some examples, for example, until the flow controller 440 is fully inflated, inverted, and / or transitioned, until the negative pressure differential decreases and / or equalizes, and / or until a desired volume of body fluid is disposed within the above-mentioned portion of the isolation chamber 430, the initial volume and / or flow of body fluid can be transferred into the isolation chamber 430. Further, as described above with respect to the device 200, the throttle 419 can be configured to limit, restrict, control, and / or adjust the magnitude of the negative pressure differential and / or suction force generated within the isolation chamber 430 and / or against the surface of the flow controller 440, thereby adjusting the suction force within one or more flow paths and / or within a body fluid source (e.g., a patient's vein). In other embodiments, the second port 418 and / or any suitable portion of the device 400 can be configured to adjust the suction force within one or more portions of the isolation chamber 30 in any suitable manner, such as, for example, in the manner described above with respect to the device 200.

[0149]

[0165] In some embodiments, the rate, order, and / or manner in which the flow controller 440 transitions from the first state to the second state can be defined and / or controlled by the shape, size, and / or arrangement configuration of the isolation chamber 430 and / or the flow controller 440, the ventilation channel 431 and / or the ventilation ridge 424, the magnitude of the negative pressure differential or suction force, and / or the manner in which the negative pressure differential or suction force is applied. In some examples, by controlling the rate, order, and / or manner in which the flow controller 440 transitions, one or more desired flow characteristics associated with the flow of air, gas, and / or body fluid into and / or through at least a portion of the isolation chamber can be provided. For example, the arrangement configuration included in this embodiment can be such that the transition and / or inversion of the third deformable portion 443 of the flow controller 440 is completed before the completion of the transition and / or inversion of the first deformable portion 441 and the second deformable portion 442. Further, the arrangement of the ventilation ridge 424 along the first uneven surface 421 prevents possible flow restrictors and / or seals (which could inherently prevent the negative pressure differential or suction force from causing the transition and / or inversion of the portion of the flow controller 440 disposed on the opposite side of the restrictor or seal), thereby increasing the likelihood that the flow controller 440 will transition and / or invert in the desired manner or order, and / or ensuring such.

[0150]

[0166] This arrangement can be such that the portion of the isolation chamber 430 (e.g., the first volume portion of the isolation chamber 430) collectively defined by the first deformable portion 441 and the first recess 427 of the second concave-convex surface 426 receives at least a portion of a certain volume of air that was in the flow path between the body fluid source and the isolation chamber 430 before the flow path received and / or was filled in volume with body fluid. Similarly, the portion of the isolation chamber 430 (e.g., the second volume portion of the isolation chamber 430) collectively defined by the second deformable portion 442 and the second recess 428 of the second concave-convex surface 426 can receive at least a portion of the above-mentioned volume of air that was in the flow path. Alternative arrangements of the isolation chamber 430 and / or the flow rate controller 440 can be similar in form and function to those described above with respect to the isolation chamber 230 and / or the flow rate controller 240, and thus will not be described in further detail herein. They can be similar in form and function, and thus will not be described in further detail herein.

[0151]

[0167] When an initial volume of body fluid is transferred into the isolation chamber 430, as described above, a force can be applied to the end 451 of the actuator 450 to shift and / or place the actuator 450 in its second position, state, mode of operation, and / or form. In some examples, the actuator 450 can be shifted from a locked form or state to an unlocked form or state before a force is applied to the end 451 of the actuator 450. In the embodiments shown in FIGS. 22-27, the shift of the actuator 450 can be achieved by the user's interaction with and / or operation of the actuator 450 and / or otherwise as a result. However, in other embodiments, the shift of the actuator 450 can occur automatically in response to the negative pressure and / or associated flow dynamics within the device 400 and / or can be implemented by or in response to an external energy source that generates one or more dynamics or states that result in the shift of the actuator 450.

[0152]

[0168] As shown in FIGS. 26 and 27, when each of the flow controller 440 and the actuator 450 is in its second state, the control device 400 is placed in its third state. When the actuator 450 transitions from its second state, position, and / or configuration, the inlet 413 and the outlet 414 are placed in a fluidly connected state (e.g., via the flow path 416 and / or the flow channel 452), while the flow path 415 and / or the first port 417 are isolated, separated, and / or otherwise not in fluid communication with the inlet 413 and / or the outlet 414. Thus, an initial volume of body fluid is isolated within a portion of the isolation chamber 430. Further, in some examples, contaminants such as, for example, skin commensal microorganisms and / or any other contaminants may be mixed in and / or contained within the initial volume of body fluid, and thus are isolated within the isolation chamber 430 when the initial volume is isolated therein. Thus, the negative pressure that was otherwise applied over or through the flow path 416 and through the second port 418 is now applied to or through the outlet 414 and the inlet 413, for example, via at least a portion of the flow paths 415 and 416 and / or the flow channel 452 of the actuator 450. Accordingly, the body fluid can flow from the inlet 413, through the actuator portion 412 of the housing 410, through the outlet 414, and into a fluid collection device coupled to the outlet 414. Thus, the device 400 can function in a manner substantially similar to the devices 100 and / or 200 described in detail above.

[0153]

[0169] Referring now to FIG. 28, there is presented a flowchart showing a method 10 of using a fluid control device to obtain a sample of body fluid with reduced contamination, according to one embodiment. The fluid control device can be similar to and / or substantially identical to any of the fluid control devices 100, 200, 300, and / or 400 described in detail above. Thus, the fluid control device (also referred to herein as the "control device" or "device") can include a housing, a flow controller, and an actuator. Method 10 includes, at 11, establishing fluid communication between a body fluid source and an inlet of the housing. For example, in some embodiments, the user can operate the fluid control device to physically and / or fluidly couple the inlet to a lumen-containing device (e.g., a needle, an IV, a PICC line, etc.), which is in further fluid communication with a patient. In other embodiments, the body fluid source can be a source of body fluid other than a patient (e.g., a reservoir, a container, etc.).

[0154]

[0170] At 12, a fluid collection device is coupled to the outlet of the housing. The coupling to the outlet of the fluid collection device is as described in detail above with respect to devices 100, 200, 300, and / or 400. As described in detail above, it is configured to create and / or otherwise generate a negative pressure differential within at least a portion of the fluid control device. In some embodiments, for example, the fluid collection device can be a vacuum blood collection tube, a sample or culture bottle that defines a negative pressure, a syringe, or the like. The flow controller of the control device, at 13, in response to the suction applied to the fluid collection device, transitions from a first state to a second state, increasing the volume of an isolation chamber defined collectively by the flow controller and a portion of the housing. For example, in some embodiments, the flow controller can be a fluid-impermeable bladder or the like, similar to the flow controllers 240, 340, and / or 440 described in detail above, disposed within the isolation chamber.

[0155]

[0171] A flow controller (e.g., a bladder) can define any number of deformable portions configured to shift, deform, invert, and / or otherwise reconfigure in response to an attractive force. In some embodiments, a first portion of the isolation chamber can be associated with and / or at least partially defined by a first deformable portion of the flow controller, and a second portion of the isolation chamber can be associated with and / or at least partially defined by a second deformable portion of the flow controller. In some embodiments, the arrangement of the flow controller within the isolation chamber can be such that the first and second portions of the isolation chamber are on a first side of the flow controller (e.g., a fluid-impermeable bladder), and a third portion of the isolation chamber is on a second side of the flow controller opposite the first side. As described above, at least with respect to devices 200, 300, and / or 400, the arrangement of the housing, flow controller, and actuator can be such that when the actuator is in a first state and / or configuration, the inlet is in fluid communication with the first and / or second portions of the isolation chamber (e.g., via ports similar to the first ports 217, 317, and / or 417 described above), and the outlet is in fluid communication with the third portion of the isolation chamber (e.g., via ports similar to the second ports 217, 317, and / or 417 described above). Thus, the third portion of the isolation chamber can be exposed to at least a portion of the attractive force generated by the fluid collection device, which attractive force is operable to move the fluid controller from its first state to its second state.

[0156]

[0172] At 14, the first portion of the isolation chamber receives a volume of air contained in a flow path defined between the body fluid source and the isolation chamber in response to an increase in the volume of the isolation chamber. For example, in some embodiments, the inlet of the housing can be fluidly coupled to a needle or a lumen-containing device, and the needle or lumen-containing device is further inserted into a part of the patient. Thus, the flow path can be defined collectively by, for example, the lumen of the needle or lumen-containing device, the lumen of the inlet of the housing, and the lumens of one or more flow paths, channels, openings, ports, etc. defined by the housing. In other words, the control device can be configured to purge air from the flow path before transferring body fluid to the isolation chamber.

[0157]

[0173] In some embodiments, the first portion of the isolation chamber can be, for example, the center or central portion of the isolation chamber. In some embodiments, the first portion of the isolation chamber can be formed collectively by any number of regions, volumes, and / or compartments (similar to, for example, the isolation chambers 230 and / or 430 described above). In other embodiments, the first portion of the isolation chamber can be a single and / or continuous portion (similar to, for example, the isolation chamber 330 described above). In still other embodiments, the first portion of the isolation chamber and the second portion of the isolation chamber can be "in-line" such that the entire isolation chamber or substantially the entire isolation chamber is a single and / or continuous volume. For example, in some embodiments, the isolation chamber has the same shape and / or arrangement configuration as that described in detail in U.S. Patent Application Publication No. 2019 / 0 076074 (referred to herein as the "‘074 publication"), the disclosure of which is hereby incorporated by reference in its entirety. and can have a similar shape and / or arrangement configuration, the disclosure of which is hereby incorporated by reference in its entirety.

[0158]

[0174] At 15, the second portion of the isolation chamber receives an initial volume of body fluid in response to an increase in the volume of the isolation chamber. More specifically, after the first portion of the isolation chamber has received the volume of air, the second portion of the isolation chamber can receive an initial volume of body fluid. In some embodiments, the initial volume of body fluid can be a volume sufficient to substantially fill the second portion of the isolation chamber. In other embodiments, the initial volume of body fluid can be the volume or amount of body fluid that flows into the second portion of the isolation chamber while a negative pressure differential (e.g., resulting from the increase in volume) is less than a threshold magnitude or amount. In other embodiments, body fluid can flow into the second portion of the isolation chamber until the pressures within the isolation chamber and / or within the flow path between the body fluid source and the isolation chamber equalize. In yet other embodiments, the initial volume can be any suitable amount or volume of body fluid, such as any of the amounts or volumes described in detail herein. In some examples, the filling or substantial filling of the second portion of the isolation chamber can be operable to isolate, retain, and / or fluidly lock the volume of air within the first portion of the isolation chamber.

[0159]

[0175] After receiving an initial volume of body fluid, at 16, the actuator of the device transitions from a first configuration to a second configuration to (1) isolate the isolation chamber and (2) allow a subsequent volume of body fluid to flow from the inlet to the outlet in response to a suction force. In some embodiments, the actuator can transition from a first state to a second state to automatically isolate an initial volume of body fluid within the isolation portion. In other embodiments, the actuator can transition from a first state to a second state in response to a force applied by a user, as described above with respect to actuators 250, 350, and / or 450. For example, in some embodiments, the actuator can be a rod or plunger that includes one or more seals that can (1) fluidly separate at least a portion of the flow path between the inlet and the isolation chamber, (2) fluidly separate at least a portion of the flow path between the outlet and the isolation chamber, and (3) establish fluid communication between the inlet and the outlet to allow a subsequent volume of body fluid to flow therebetween.

[0160]

[0176] With a fluid collection device fluidly coupled to the outlet of the housing, a subsequent volume of body fluid (e.g., one or more sample volumes) can be conveyed into the fluid collection device and used in any suitable assay, such as those described herein. As described in detail above, in some examples, by isolating an initial volume of body fluid within the isolation portion of the device, any contaminants contained within that initial volume can be isolated. Thus, contaminants within the subsequent volume of body fluid that would otherwise potentially result in incorrect or inaccurate results in an assay can be reduced or substantially eliminated.

[0161]

[0177] Although various embodiments have been described above, it should be understood that they are presented by way of example and not limitation. If the schematic diagrams and / or embodiments described above show several components arranged in several orientations or positions, the arrangement of those components can be changed. Although embodiments have been particularly illustrated and described, it will be understood that various changes in form and detail can be made. Although various embodiments have been described as having specific features, concepts, and / or combinations of components, other embodiments having any combination or sub - combination of any features, concepts, and / or components from any of the embodiments described herein are possible.

[0162]

[0178] In some embodiments, the specific configuration of various components can also be changed. For example, the size and specific shape of various components can differ from the illustrated embodiments while still providing the functions as described herein. In some embodiments, by changing the size and / or shape of such components, The overall size of the device can be reduced and / or the ergonomics of the device can be improved without changing the function of the device. In some embodiments, the size and / or shape of the various components can be specifically selected for a desired or intended use. For example, in some embodiments, a device such as those described herein can be configured to be used on or for a seemingly healthy adult patient. In such embodiments, the device can include an isolation chamber having a first volume (e.g., from about 0.5 ml to about 5.0 ml). In other embodiments, a device such as those described herein can be configured to be used on or for, for example, critically ill patients and / or pediatric patients. In such embodiments, the device can include an isolation chamber having a second volume that is less than the first volume (e.g., less than about 0.5 ml). Thus, it should be understood that the size, shape, and / or arrangement configuration of the embodiments and / or their components can be adapted for a given use, unless otherwise explicitly specified in the context.

[0163]

[0179] Any of the embodiments described herein can be used with any suitable fluid transfer, fluid collection, and / or fluid storage device, such as, for example, the fluid reservoir described in the '420 patent. In some cases, any of the embodiments described herein can be used with, for example, the devices described in the '783 patent, the '510 publication, the '074 publication, and / or U.S. Patent No. 8,535,241, titled "Fluid Diversion Mechanism for Bodily-Fluid Sampling," filed on October 22, 2012, U.S. Patent No. 9,060,724, titled "Fluid Diversion Mechanism for Bodily-Fluid Sampling," filed on May 29, 2013, and U.S. Patent No. 9,060,724, titled "Fluid Diversion Mechanism for Bodily-Fluid Sampling," filed on December 2, 2013 Desired, "Syringe-Based Fluid Diversion Mechanism for Bodily-Fluid Sampling" U.S. Patent No. 9,155,495, filed June 23, 2016, entitled "Devices and Methods for Syringe Based Fluid Transfer for Bodily-Fluid Sampling", U.S. Patent Application Publication No. 2016 / 0361006, filed November 20, 2017, entitled "Systems and Methods for Sample Collection with Reduced Hemolysis", and / or U.S. Patent No. 9,950,084, filed September 6, 2016, entitled "Apparatus and Methods for Maintaining Sterility of a Specimen Container", and any of the devices described therein such as, etc., can be used with any suitable fluid transfer adapter, fluid transfer device, fluid collection and / or fluid storage device, and the disclosures of the above patents and applications are hereby incorporated by reference in their entirety into this specification.

[0164]

[0180] The control devices 100, 200, 300, and / or 400 have been described as transferring bodily fluid into the device as a result of negative pressure within the fluid collection device. However, in other embodiments, the devices described herein can be used with any suitable device configured to establish a negative pressure differential, suction force, etc., such as a syringe or a pump. In other embodiments, the control device can include a pre-loaded isolation chamber, an evacuated isolation chamber, a manually actuated device configured to generate negative pressure, an energy source (e.g., a chemical energy source, a kinetic energy source, etc.), and / or any other suitable means for defining and / or forming a pressure differential within a portion of the control device. Further, the control device can be coupled to such collection devices by a user (e.g., a physician, a nurse, a technician, a medical doctor, etc.) or can be coupled or assembled during manufacture. In some embodiments, by pre-assembling the control device and the collection device (e.g., a sample container or a syringe), compliance with a sample acquisition protocol that requires isolation of an initial volume of bodily fluid, for example, prior to collecting a sample volume of bodily fluid, can be enforced.

[0165]

[0181] Some of the above-described embodiments have fluid having a particular configuration and / or arrangement includes a metering controller and / or an actuator, although in other embodiments, the fluid control device can include any suitable flow rate controller and / or actuator configured to selectively control the flow of body fluid through one or more portions of the fluid control device. For example, some embodiments include an actuator having one or more seals disposed as an O-ring or an elastomeric overmold that moves with the actuator and relative to a portion of the device (such as the inner surface of the housing), although in other embodiments, the fluid control device can include one or more seals having any suitable configuration. For example, in some embodiments, the fluid control device can include one or more seals disposed as an elastomeric sheet fixedly coupled to a portion of the control device. In such embodiments, a portion of the actuator, such as a pin or rod, can extend through an opening defined in the one or more elastomeric sheets, and the one or more elastomeric sheets form a substantially fluid-tight seal with the outer surface of the pin or rod. Thus, at least a portion of the actuator can move relative to the one or more elastomeric sheets, and the one or more elastomeric sheets remain in a substantially fixed position relative to the portion of the control device. In some embodiments, by removing the portion of the actuator from the opening defined by the one or more elastomeric sheets, it is possible to allow the flow of fluid through the opening that was originally blocked by that portion of the actuator. Thus, the one or more elastomeric sheets can function in a manner similar to any of the seals described herein. Further, in some embodiments, such an arrangement can reduce the amount of friction associated with forming a desired fluid-tight seal, thereby further avoiding the use of lubricants that are originally used to facilitate movement of the seals within the control device.

[0166]

[0182] In some embodiments, the device and / or flow controller can include one or more vents, membranes, members, semi-permeable barriers, etc., configured to at least partially control the flow of fluid through the device, flow controller, and / or actuator. For example, a portion of the isolation chamber 230 has been described above as receiving and holding a volume of air that is discharged, evacuated, and / or purged from the flow path between the body fluid source and the isolation chamber 230. However, in other embodiments, the isolation chamber 230 can include a vent or a selectively permeable membrane configured to allow air to exit the isolation chamber 230. For example, in some embodiments, the bladder or diaphragm (or a portion thereof) can be formed of or from a semi-permeable material through which air can flow but through which body fluid cannot flow. In other embodiments, a semi-permeable material can be disposed within or along the flow path between the isolation chamber and at least one of the outlet or inlet to allow air and / or body fluid to selectively flow therebetween. In some embodiments, the fluid control device can include a semi-permeable member and / or membrane (e.g., a flow controller) that can be similar in form and / or function to the semi-permeable member and / or membrane described in the '074 publication incorporated by reference above.

[0167]

[0183] Regarding the flow controllers 240, 340, and 440, it is described as a bladder configured to transition, move, invert, and / or reconfigure in other ways in response to a negative pressure in an amount exceeding a threshold amount of negative pressure applied to the surface of the bladder. However, in other embodiments, the fluid control device transitions, moves, inverts, and / or reconfigures in any suitable manner in response to being exposed to a desired and / or predetermined amount of negative pressure, and may include any suitable flow controller, actuator, semi-permeable (e.g., air-permeable and liquid-impermeable) member, etc. configured to do so. In other embodiments, the control device is configured to invert from a first state to a second state (e.g., transition relatively rapidly and / or substantially uniformly) in response to being exposed to a negative pressure differential. Or it can include a bladder (or flow controller) configured to transition gradually (e.g., expand (from a wound state), expand (from a folded state), expand (from a stacked state), and / or reconfigure in other ways). In some examples, by controlling the speed at which the bladder (or flow controller) transitions, it is possible to adjust and / or control the negative pressure differential generated within the isolation chamber and further the magnitude of the suction force applied within the patient's vein and / or other suitable body fluid source.

[0168]

[0184] Some of the above-described embodiments include a flow controller and / or an actuator that physically and / or mechanically isolate one or more portions of the fluid control device. However, in other embodiments, the fluid control device need not physically and / or mechanically isolate one or more portions of the fluid control device. For example, in some embodiments, an actuator, such as actuator 250, can be transitioned from a first state in which an initial volume of body fluid can flow from the inlet to the isolation chamber or portion, to a second state in which (1) the isolation chamber or portion is physically and / or mechanically isolated and (2) the inlet is in fluid communication with the outlet of the fluid control device. However, in other embodiments, the actuator and / or any other suitable portion of the fluid control device can be transitioned from a first state in which an initial volume of body fluid can flow from the inlet to the isolation chamber or portion, to a second state in which the inlet is placed in a state of being fluidly connected to the outlet without physically and / or mechanically isolating (or separating) the isolation chamber or portion. When such a control device is in the second state, due to one or more characteristics and / or geometric shapes of the control device, a preferential flow of body fluid can flow from the inlet to the outlet, and the initial volume of body fluid can be held within the isolation chamber or portion without being physically and / or mechanically isolated or separated.

[0169]

[0185] Regarding the aperture 219, it has been described above as adjusting and / or controlling the magnitude of the negative pressure applied on or through at least a portion of the device 200 (e.g., within the isolation chamber 230 and / or on the flow controller 240 in another manner). However, in other embodiments, the control device can include any suitable features, mechanisms, and / or devices configured to adjust, effect, and / or otherwise control one or more pressure differences passing through at least a portion of the control device. For example, in some embodiments, the user can change (e.g., reduce or increase) the size of one or more portions of a flow path or a fluid flow interface within a portion of the control device so as to manually adjust and / or otherwise control the amount and magnitude of the negative pressure within one or more portions of the control device, and thereby move and / or shift an actuator.

[0170]

[0186] Although not shown, any of the devices described herein can include an opening, port, coupler, septum, Luer-Lok, gasket, valve, screw connector, standard fluid interface, etc. (collectively referred to as "ports" for simplicity) that are in fluid communication with the isolation chamber. In some such embodiments, the ports can be configured to couple to any suitable device, reservoir, pressure source, etc. For example, in some embodiments, the ports can be configured to couple to a reservoir, thereby allowing a larger volume of body fluid to be diverted and / or transferred into the isolation chamber. In other embodiments, the ports can be coupled to a negative pressure source such as a vacuum blood collection tube, pump, syringe, etc. to collect a portion or the entire volume of body fluid within the isolation chamber, channel, reservoir, etc., and the ports can be used for further clinical and / or in vitro diagnostic testing purposes with that volume of body fluid (e.g., a pre-sample volume). In other embodiments, the ports can be configured to receive a probe, sampling device, test device, etc. that can be used to perform one or more tests (e.g., tests that are less susceptible to potential contamination) on the initial volume while the initial volume is disposed or isolated within the isolation chamber. In yet other embodiments, the ports can be coupled to any suitable pressure source or injection device configured to inject an initial volume of body fluid isolated within the isolation chamber back into the patient's body and / or a body fluid source (e.g., in the case of pediatric patients, critically ill patients, patients with low blood volume, etc.). In other embodiments, the isolation channel, chamber, and / or reservoir can be configured with additional diagnostic test components (e.g., test strip tests) integrated within the chamber such that the initial body fluid is used for that test. In the case of pediatric patients, critically ill patients, patients with low blood volume, etc., it can be coupled to any suitable pressure source or injection device configured to inject an initial volume of body fluid isolated within the isolation chamber back into the patient's body and / or a body fluid source.

[0171]

[0187] In yet other embodiments, the isolation chamber, channels, and / or reservoirs can be removable and designed, sized, and configured to be compatible with and / or particularly accessible to inspection equipment for other types of body fluid tests commonly performed on patients suspected of having a medical condition. By way of example, patients suspected of having sepsis generally have blood samples collected for lactate tests, procalcitonin tests, and blood culture tests. All of the fluid control devices described herein can be configured such that the isolation chamber, channels, reservoirs, etc. can be removed (e.g., after receiving an initial volume of body fluid), and the body fluid contained therein can be used for these additional test purposes either before or after subsequent samples are collected for microbiological testing.

[0172]

[0188] Although not shown, in some embodiments, the fluid control device can include one or more lumens, channels, flow paths, etc. configured to selectively allow a “bypass” flow of body fluid, where an initial amount or volume of body fluid can flow from the inlet through the lumen, channel, flow path, etc. so as to bypass the isolation chamber and into the collection device. In some embodiments, the fluid control device can include an actuator having, for example, at least three states: a first state in which body fluid can flow from the inlet to the isolation chamber; a second state in which body fluid can flow from the inlet to the outlet after an initial volume has been isolated within the isolation chamber; and a third state in which body fluid can flow from the inlet through a bypass flow path to the outlet. In other embodiments, the control device can include a first actuator configured to transition the device between the first state and the second state, and a second actuator configured to transition the device into a bypass configuration or the like, as detailed above with respect to specific embodiments. In yet other embodiments, the control device can include any suitable device, feature, component, mechanism, actuator, controller, etc. configured to selectively place the fluid control device in a bypass configuration or state.

[0173]

[0189] In some embodiments, a method of using a fluid control device, such as those described herein, can include establishing fluid communication in an ordered manner between a body fluid source (e.g., a patient's vein, etc.) and an inlet of the fluid control device. Then, the outlet of the fluid control device is placed in fluid connection with a negative pressure source and / or engaged with the negative pressure source in another way. Such negative pressure sources can be a sample reservoir, a syringe, a vacuum blood collection tube, an intermediate transfer device, etc. When the outlet of the fluid control device is coupled to the negative pressure source, the fluid control device can be in a first state or operating mode, and thus a negative pressure differential is applied through the fluid control device to draw an initial volume of body fluid into the isolation chamber of the fluid control device. For example, the negative pressure in the sample reservoir can be operable to draw an initial volume of body fluid from the patient into the isolation chamber. When the initial volume of body fluid is disposed in the isolation chamber, the fluid control device automatically or via user intervention transitions from the first state or operating mode to a second state or operating mode to (1) isolate the initial volume in the isolation chamber and (2) establish fluid communication between the inlet and the outlet. The isolation of the initial volume can be such that contaminants mixed in the flow of the initial volume are similarly isolated in the isolation chamber. With the initial volume of body fluid isolated in the isolation chamber and fluid communication established between the inlet and the outlet, a substantially uncontaminated subsequent volume of body fluid can be collected into one or more sample reservoirs.

[0174]

[0190] Although it is explicitly described as including the enumerated and ordered things regarding the method of using the fluid control device, in other embodiments, the order of some events and / or procedures in any of the methods or processes described herein can be changed, and such changes are by variations of the present invention. Further, some events and / or procedures can be performed simultaneously in parallel processes, if possible, and can be performed sequentially as described above. Some steps can be partially completed or omitted before proceeding to subsequent steps. For example, the device is described herein as transitioning from a first state to a second state by a discontinuous operation or the like, but the device described herein can be configured to transition automatically and / or passively from the first state to the second state, and such a transition can occur over a period of time. In other words, the transition from the first state to the second state can be relatively gradual in some examples, such that when at least a portion of the initial volume of body fluid is being transferred into the isolation chamber, the housing begins to transition from the first state to the second state. In some examples, the rate of change when transitioning from the first state to the second state can be selectively controlled to achieve one or more desired characteristics associated with the transition. Further, in some such examples, the inflow of the last portion of the initial volume can limit and / or substantially prevent the body fluid already disposed within the isolation chamber from leaking out therefrom. Thus, although the transition from the first state to the second state can occur over a given amount of time, the isolation chamber can nevertheless isolate the volume of body fluid disposed therein.

Claims

1. 1. A device for collecting a sample of a body fluid with minimal contamination, comprising: a housing forming at least a portion of a sequestration chamber, the housing having an inlet configured to be fluidly connected to a source of bodily fluid and an outlet configured to be fluidly connected to a fluid collection device, the fluid collection device applying a suction force within at least a portion of the housing when fluidly connected to the outlet; an actuator coupled to the housing, the actuator having a first configuration in which the inlet is in fluid communication with the sequestration chamber and a second configuration in which the inlet is in fluid communication with the outlet and is fluidly isolated from the sequestration chamber; a flow controller disposed within the housing and defining a portion of the segregation chamber, the flow controller having a first state in which the portion of the segregation chamber has a first volume and a second state in which the portion of the segregation chamber has a second volume greater than the first volume; Equipped with the flow controller transitions from the first state to the second state in response to the suction force when the actuator is in the first configuration to draw an initial volume of the bodily fluid into the portion of the isolation chamber; the actuator is configured to transition to the second configuration after the initial volume of bodily fluid is drawn into the isolation chamber to (1) isolate the isolation chamber from the inlet and (2) allow a subsequent volume of the bodily fluid to flow from the inlet to the outlet in response to the suction force.

2. the housing includes a first port and a second port; 2. The device of claim 1, wherein when the actuator is in the first configuration, the first port places the inlet in fluid communication with a first portion of the isolation chamber and the second port places the outlet in fluid communication with a second portion of the isolation chamber.

3. 2. The apparatus of claim 1, wherein the flow controller comprises a plurality of deformable portions, each deformable portion of the plurality of deformable portions configured to deform in response to the suction force to transition the flow controller from the first state to the second state.

4. 2. The device of claim 1, wherein a cross-sectional area of ​​the portion of the isolation chamber when in the second state limits mixing of the initial volume of the bodily fluid with a volume of air drawn into the portion of the isolation chamber.

5. 2. The device of claim 1, wherein the portion of the isolation chamber is a first portion of the isolation chamber defined at least in part by a first deformable portion of the flow controller, and a second portion of the isolation chamber defined at least in part by a second deformable portion of the flow controller configured to receive a volume of air before the first portion of the isolation chamber receives the initial volume of the bodily fluid.

6. 6. The device of claim 5, wherein the first and second deformable portions are configured to deform in response to the suction force, the first deformable portion deforms before the bodily fluid flows into the first portion of the isolation chamber, and at least a portion of the second deformable portion deforms after the first deformable portion deforms.

7. When the flow controller is in the first state, a first side of the flow controller contacts at least a portion of a first surface of the isolation chamber, and the flow controller 2. The device of claim 1, wherein when in state two, a second side of the flow controller contacts at least a portion of a second surface of the isolation chamber, the second surface being opposite the first surface.

8. 8. The apparatus of claim 7, wherein when the flow controller is in the first state, the first surface of the isolation chamber forms at least one channel configured to allow air flow to pass between the first surface of the isolation chamber and the first side of the flow controller.

9. 8. The apparatus of claim 7, wherein when the flow controller is in a second state, the second surface of the isolation chamber forms at least one ridge configured to allow air flow to pass between the second surface of the isolation chamber and the second side of the flow controller.

10. 8. The apparatus of claim 7, wherein the flow controller is a fluid impermeable bladder, and the portion of the isolation chamber is a first portion of the isolation chamber defined between the first surface of the isolation chamber and the first side of the fluid impermeable bladder and a second portion of the isolation chamber defined between the second surface of the isolation chamber and the second side of the fluid impermeable bladder.

11. 11. The device of claim 10, wherein a volume of the second portion of the isolation chamber is approximately equal to the second volume when the fluid impermeable bladder is in the first state and is approximately equal to the first volume when the fluid impermeable bladder is in the second state.

12. 1. A device for collecting a sample of a body fluid with minimal contamination, comprising: a housing forming at least a portion of a sequestration chamber, the housing having an inlet configured to be fluidly connected to a source of bodily fluid and an outlet configured to be fluidly connected to a fluid collection device, the fluid collection device applying a suction force within at least a portion of the housing when fluidly connected to the outlet; an actuator coupled to the housing, the actuator having a first configuration in which the inlet is in fluid communication with the sequestration chamber and a second configuration in which the inlet is in fluid communication with the outlet and is fluidly isolated from the sequestration chamber; a flow controller disposed within the housing and defining a portion of the isolation chamber, the flow controller having a first state in which a first side of the flow controller contacts at least a portion of a first surface of the isolation chamber and a second state in which a second side of the flow controller contacts at least a portion of a second surface of the isolation chamber, the second surface being opposite the first surface; Equipped with the flow controller transitions from the first state to the second state as a result of the suction force being applied to the second side of the flow controller when the actuator is in the first configuration, drawing an initial volume of the bodily fluid into a portion of the isolation chamber defined between the first surface and the first side of the flow controller; the actuator is configured to transition to the second configuration after the initial volume of the bodily fluid is drawn into the portion of the isolation chamber to (1) isolate the isolation chamber from the inlet and (2) allow a subsequent volume of bodily fluid to flow from the inlet to the outlet in response to the suction force.

13. The device of claim 12 , wherein the flow controller is a fluid impermeable bladder.

14. The apparatus of claim 12 , wherein the flow controller is a fluid impermeable diaphragm.

15. 13. The device of claim 12, wherein the portion of the isolation chamber is a first portion of the isolation chamber defined at least in part by a first deformable portion of the flow controller, and a second portion of the isolation chamber defined at least in part by a second deformable portion of the flow controller, configured to receive a volume of air before the first portion of the isolation chamber receives the initial volume of bodily fluid.

16. the first surface of the isolation chamber defines at least one discontinuity configured to permit airflow between the first surface of the isolation chamber and the first side of the flow controller when the flow controller is in a first state; 13. The apparatus of claim 12, wherein the second surface of the isolation chamber forms at least one discontinuity configured to allow air flow between the second surface of the isolation chamber and the second side of the flow controller when the flow controller is in a second state.

17. 13. The device of claim 12, wherein the housing defines a first flow path that places the isolation chamber in fluid communication with the inlet when the actuator is in the first configuration, and the housing defines a second flow path that places the outlet in fluid communication with the inlet when the actuator is in the second configuration.

18. 20. The apparatus of claim 17, wherein the actuator fluidly connects the second flow path with a portion of the isolation chamber defined between the second surface and the second side of the flow controller.

19. 20. The apparatus of claim 18, further comprising a flow restriction disposed within a portion of the second flow path, the flow restriction configured to reduce a magnitude of the suction force applied to the second side of the flow controller.

20. 1. A method for obtaining a sample of a body fluid with reduced contamination using a fluid control device having a housing, an actuator, and a flow controller, comprising: fluidly connecting a source of bodily fluid to an inlet of the housing; connecting a fluid collection device to an outlet of the housing, the fluid collection device applying a suction force within at least a portion of the housing when coupled to the outlet; transitioning the flow controller from a first state to a second state in response to the suction force to increase a volume of an isolation chamber defined by the flow controller and the portion of the housing; receiving, in response to the increase in volume, within a first portion of the isolation chamber, a volume of air contained within a flow path defined between the source of bodily fluid and the isolation chamber; receiving an initial volume of the bodily fluid within a second portion of the isolation chamber in response to the increase in volume; transitioning the actuator from a first configuration to a second configuration after receiving the initial volume of the bodily fluid within the second portion of the isolation chamber to (1) isolate the isolation chamber and (2) allow a subsequent volume of the bodily fluid to flow from the inlet to the outlet in response to the suction force; A method comprising:

21. 21. The method of claim 20, wherein the flow controller is a bladder including a plurality of deformable portions, each deformable portion of the plurality of deformable portions configured to deform in response to the suction force to transition the bladder from the first state to the second state.

22. 22. The method of claim 21 , wherein the first portion of the isolation chamber is at least partially defined by a first deformable portion of the plurality of deformable portions and the second portion of the isolation chamber is at least partially defined by a second deformable portion of the plurality of deformable portions.

23. 23. The method of claim 22, wherein the second of the plurality of deformable portions is fully deformed before the first of the plurality of deformable portions is fully deformed.

24. 21. The method of claim 20, wherein the first and second portions of the isolation chamber are on a first side of the flow controller, and the isolation chamber has a third portion disposed on a second side of the flow controller opposite the first side.

25. 25. The method of claim 24, wherein the actuator in the first configuration fluidly connects between (1) the inlet and the first and second portions of the sequestration chamber, and (2) the outlet and the third portion of the sequestration chamber.

26. 21. The method of claim 20, wherein the first and second portions of the isolation chamber are defined between a first surface of the isolation chamber and a first side of the flow controller, and the isolation chamber has a third portion defined between a second surface of the isolation chamber and a second side of the flow controller, the second surface being opposite the first surface and the second side being opposite the first side.

27. The fluid control device includes a flow restrictor disposed in a flow path defined between the third portion of the isolation chamber and the outlet when the actuator is in the first configuration, and the method further comprises:

27. The method of claim 26, further comprising adjusting the suction force applied to the second side of the flow controller when the actuator is in the first configuration.

28. 27. The method of claim 26, wherein the first surface of the isolation chamber forms at least one discontinuity configured to allow air flow to pass between the first surface of the isolation chamber and the first side of the flow controller when the flow controller is in the first state.

29. 27. The method of claim 26, wherein the second surface of the isolation chamber forms at least one discontinuity configured to allow air flow to pass between the second surface of the isolation chamber and the second side of the flow controller when the flow controller is in the second state.

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