Fluid control device and method of use thereof

Abstract

Obtain samples of bodily fluids with reduced contamination. [Solution] The apparatus (100) for obtaining a sample of decontaminated bodily fluids includes a housing (110) having an isolation chamber (130), an inlet (113), and an outlet (114). A flow controller (140) defines a portion of the isolation chamber (130) and, depending on the suction force applied by a fluid collection device (180) fluidically connected to the outlet (114), can transition the isolation chamber from a first state having a first volume to a second state having a second volume greater than the first volume, thereby drawing an initial volume of bodily fluid into the isolation chamber (130). An actuator (150) is coupled to the housing (110) and, in the first embodiment, is fluidically connected to the inlet (113) and the isolation chamber (130), and, in the second embodiment, isolates the isolation chamber (130) from the inlet (113), allowing a subsequent volume of bodily fluid to flow from the inlet (113) to the outlet (114).

Description

[Technical Field]

[0001] Cross-reference of related applications

[0001] This application takes precedence over U.S. Provisional Patent Application No. 62 / 816,477, entitled "FluidControl Devices and Methods of Using the Same," filed on March 11, 2019. Claims of rights and interests, the disclosure of the application is incorporated herein by reference in its entirety. [Background technology]

[0002] background

[0002] The embodiments described herein generally relate to the procurement of body fluid samples, and more specifically to the procurement of skin commensal microorganisms and / or other contaminants outside the body fluid source. Obtain samples of bodily fluids with reduced levels of contaminants, fluid separation, sequestration, and / or relating to isolation devices and methods.

[0003]

[0003] Healthcare professionals routinely perform a variety of microbiological and other extensive diagnostic tests on patients using parenterally acquired bodily fluids. As advanced diagnostic techniques evolve and improve, the speed, accuracy (both sensitivity and specificity), and value of the information that can be provided to clinicians continue to increase. Maintaining the integrity of bodily fluid samples during and / or after collection ensures that analytical diagnostic results reflect the patient's in vivo condition. This ensures certainty. Examples of diagnostic techniques that rely on high-quality, uncontaminated, and / or foreign-free bodily fluid samples include, but are not limited to, microbial detection, molecular diagnostics, gene sequencing (e.g., deoxyribonucleic acid (DNA), ribonucleic acid (RNA), next-generation sequencing (NGS), etc.), and biomarker identification.

[0004]

[0004] If biomaterials, including cells and / or other external contaminants from outside the intended sample source, are accidentally included in the body fluid sample being analyzed, the presence of such biomaterials may lead to inaccurate results from such tests. In short, when the purity of a body fluid sample is compromised during the sample acquisition process, the resulting analytical test results may be inaccurate, distorted, contaminated, false positive, false negative, and / or do not represent the patient's actual condition. Furthermore, these results may lead to incomplete, inaccurate, confused, uncertain, unreliable, and / or otherwise undesirable clinical decisions.

[0005]

[0005] In some cases, devices and / or systems can be used to reduce the possibility of contamination, foreign matter, etc., of bodily fluid samples for testing. For example, some known devices can be configured to collect, divert, separate, and / or isolate (e.g., isolate) an initial volume of bodily fluid that is relatively likely to contain contaminants such as skin commensal microorganisms. However, some of these devices may be perceived as unsuitable or unusable by the target patient population, etc., because they are difficult to handle, confusing, and difficult to use. Furthermore, some of these devices may require training, user observation, intervention by two or more users, and / or otherwise present challenges that may limit their effectiveness. In some cases, these challenges and / or other challenges may complicate the collection of consistently high-quality samples that are uncontaminated, sterile, and free of foreign matter, which may further affect the validity of conclusions drawn from 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 bodily fluids, Some of these devices and / or systems may not be able to adequately divert, isolate, and / or separate a clinically desired and / or effective initial volume of body fluid (e.g., pre-sample volume). Furthermore, in some cases, the operation of some known devices and / or systems depends on positive pressure applied or supplied by the body fluid source (e.g., patient blood pressure). However, in some of these cases, the positive pressure may be insufficient to produce the desired flow dynamics and / or flow rate that would make the use of these devices practical in various clinical settings, such as emergency rooms and other intensive care settings. [Overview of the Initiative] [Problems that the invention aims to solve]

[0007]

[0007] Therefore, there is a need for fluid control and / or flow diversion devices and methods to obtain a sample of body fluid with reduced contaminants, such as skin commensal microorganisms and / or other contaminants outside the body fluid source, resulting in consistent body fluid collection (for example, from a general patient population and / or a refractory patient population). Furthermore, there is a need for devices and methods that include body fluid collection with the assistance of various external energy sources and / or negative pressure, for example. [Means for solving the problem]

[0008] overview

[0008] This specification describes devices and methods for obtaining samples of body fluids from which contaminants such as commensal skin microorganisms and / or other contaminants outside the body fluids have been reduced. In some embodiments, the apparatus for obtaining samples of decontaminated body fluids includes a housing, an actuator, and a flow controller. The housing has an inlet configured to form at least a portion of an isolation chamber and 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, when fluidly coupled to the outlet, exerts an attractive force within at least a portion of the housing. The actuator has a first embodiment in which it is coupled to the housing and its inlet is in fluid communication with the isolation chamber, and a second embodiment in which its inlet is in fluid communication with the outlet and is fluidly separated from the isolation chamber. The flow controller is located 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 state, the flow controller is configured to transition from the first state to the second state in response to the suction force, drawing an initial volume of bodily fluid into the aforementioned portion of the isolation chamber. After the initial volume of bodily fluid has been drawn into the isolation chamber, the actuator transitions to the second state, configured 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. [Brief explanation of the drawing]

[0009] Brief explanation of the drawing [Figure 1]

[0009] This is a schematic diagram of a fluid control device according to one embodiment. [Figure 2]

[0010] This is a front perspective view of a fluid control device according to one embodiment. [Figure 3]

[0010] This is a rear perspective view of a fluid control device according to one embodiment. [Figure 4]

[0011] Figure 2 is a side view of the fluid control device. [Figure 5]

[0011] It is a top view of the fluid control device of Figure 2. [Figure 6]

[0012] It is an exploded perspective view of the fluid control device of Figure 2. [Figure 7]

[0013] It is a cross-sectional view of the fluid control device of Figure 2, taken along line 7-7 of Figure 4, shown in the first state. [Figure 8]

[0013] It is a cross-sectional view of the fluid control device of Figure 2, taken along line 8-8 of Figure 5, shown in the first state. [Figure 9]

[0014] It is a cross-sectional view of the fluid control device of Figure 2, taken along line 7-7 of Figure 4, shown in the second state. [Figure 10]

[0014] It is a cross-sectional view of the fluid control device of Figure 2, taken along line 8-8 of Figure 5, shown in the second state. [Figure 11]

[0015] It is a partial cross-sectional view of the fluid control device of Figure 2, taken along line 8-8 of Figure 5, shown in the second state. [Figure 12]

[0016] It is a front perspective view of a fluid control device according to an embodiment. [Figure 13]

[0016] It is a rear perspective view of a fluid control device according to an embodiment. [Figure 14]

[0017] It is a side view of the fluid control device of Figure 12. [Figure 15]

[0017] It is a top view of the fluid control device of Figure 12. [Figure 16]

[0018] It is an exploded perspective view of the fluid control device of Figure 12. [Figure 17]

[0019] It is a cross-sectional view of the fluid control device of Figure 12, taken along line 17-17 of Figure 14, shown in the first state. [Figure 18]

[0019] It is a cross-sectional view of the fluid control device of Figure 12, taken along line 18-18 of Figure 15, shown in the first state. [Figure 19]

[0020] This is a cross-sectional view of the fluid control device in Figure 12 along line 17-17 in Figure 14, as shown in the second state. [Figure 20]

[0020] This is a cross-sectional view of the fluid control device of Figure 12 along line 18-18 in Figure 15, as shown in the second state. [Figure 21]

[0021] This is a partial cross-sectional view of the fluid control device in Figure 12 along line 18-18 in Figure 15, as shown in the second state. [Figure 22]

[0022] This is a front perspective view of a fluid control device according to one embodiment. [Figure 23]

[0022] This is a rear perspective view of a fluid control device according to one embodiment. [Figure 24]

[0023] This is a cross-sectional view of the fluid control device in Figure 22, shown in the first state along line 24-24. [Figure 25]

[0023] A cross-sectional view of the fluid control device of Figure 22, shown in the first state, along line 24-24. [Figure 26]

[0024] This is a cross-sectional view of the fluid control device in Figure 22, shown in the second state along line 24-24. [Figure 27]

[0024] A cross-sectional view of the fluid control device in Figure 22, shown in the second state, along line 24-24. [Figure 28]

[0025] This flowchart shows a method for using a fluid control device according to one embodiment. [Modes for carrying out the invention]

[0010] Detailed explanation

[0026] This specification describes devices and methods for collecting, diverting, isolating, separating, etc., an initial volume of body fluid to reduce contamination of subsequently acquired body fluid samples. Any of the fluid control devices described herein can be configured to receive, acquire, and / or transfer body fluid flows, boluses, volumes, etc. A first reservoir, channel, flow path, or portion of the device can receive an initial volume of body fluid flow and then substantially or completely isolate such body fluid flow therein (e.g., contain or hold, bypass, separate, detach, vapor-lock, disconnect, etc.). In some examples, skin microbiota are introduced into the initial volume of body fluid. The initial volume may contain and / or be contaminated with biological or other contaminants, which are also isolated within or by the first reservoir or first part of the device. Once the initial volume is isolated, any subsequent volume of bodily fluid can be diverted, flowed, guided, and / or otherwise allowed to flow into or through the second part of the device and / or any further flow paths. Based at least in part on the isolated initial volume, the subsequent volume of bodily fluid can be substantially free of contaminants that could otherwise lead to inaccurate, distorted, foreign, and / or false results in certain diagnostic and / or tests. In a few examples, the initial volume of body fluid can also be used in other tests, such as those not significantly affected by the presence of contaminants, can be discarded as waste, can be injected back into the patient's body, and / or can be used in any other suitable clinical application.

[0011]

[0027] In some embodiments, a feature of the fluid control devices and / or methods described herein is the use of an external negative pressure source (provided, for example, by a fluid collection device or any other suitable means) which can (1) overcome physical patient problems that may limit and / or prevent a pressure difference (e.g., the difference in blood pressure relative to ambient air pressure) sufficient to fully operate the isolation chamber and / or transfer the fluid flow to the fluid collection device; (2) ensure that the isolation chamber is properly filled with a clinically validated and / or desired volume of body fluid; (3) provide an efficient, timely and / or user-acceptable consistency with the body fluid collection process; and / or (4) provide means for transferring the fluid flow (e.g., automatically, or by operations that move any number of physical components of the system, or by changing, switching, operating, and / or providing in other ways) to enable isolation and / or separation of an initial volume (e.g., a pre-sample volume) and subsequent sample collection.

[0012]

[0028] In some embodiments, for example, a device for obtaining a sample of decontaminated bodily fluids includes a housing, an actuator, and a flow controller. The housing has an inlet configured to form at least a portion of an isolation chamber and to be fluidly coupled to a bodily fluid source, and an outlet configured to be fluidly coupled to a fluid collection device. The fluid collection device, when fluidly coupled to the outlet, exerts a suction force into at least a portion of the housing. The actuator has a first form in which it is coupled to the housing and its inlet is in fluid communication with the isolation chamber, and a second form in which its inlet is in fluid communication with the outlet and is fluidly separated from the isolation chamber. The flow controller is located 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 greater than the first volume. When the actuator is in the first state, the flow controller transitions from the first state to the second state in response to the suction force, drawing an initial volume of bodily fluids into the portion of the isolation chamber. The actuator is configured to transition to a second mode after an initial volume of bodily fluid has been drawn into the isolation chamber, in order 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 accordance with the suction force.

[0013]

[0029] In some embodiments, a device for obtaining a sample of decontaminated bodily fluids includes a housing, an actuator, and a flow controller. The housing has an inlet configured to fluidly couple to a bodily fluid source and form at least a portion of an isolation chamber, and an outlet configured to fluidly couple to a fluid collection device. The fluid collection device, when fluidly coupled to the outlet, exerts a suction force within at least a portion of the housing. The actuator has a first form in which it is coupled to the housing and its inlet is in fluid communication with the isolation chamber, and a second form in which its inlet is in fluid communication with the outlet and is fluidly separated from the isolation chamber. The flow controller is located 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 is in contact with 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 is in contact with at least a portion of a second surface of the isolation chamber opposite to the first surface. When the actuator is in the first state, the flow controller transitions from the first state to the second state as a result of an suction force being applied to the second side of the flow controller, drawing an initial volume of bodily fluid into a portion of the isolation chamber defined between the first surface and the first side of the flow controller. After the initial volume of bodily fluid has been drawn into the isolation chamber, the actuator transitions to the second state, (1) isolating the isolation chamber from the inlet, and (2) drawing in a subsequent volume of bodily fluid according to the suction force. It is configured to allow the liquid to flow from the inlet to the outlet.

[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 fluidly connected to a bodily fluid source. The outlet is configured to be fluidly connected to a fluid collection device configured to apply suction force into at least a portion of the housing. The actuator is coupled to the housing and is configured to isolate the fluid communication between the inlet and the isolation chamber when in a first state, and to establish a fluid communication between the inlet and the outlet when in a second state. The flow controller is located within the isolation chamber and is configured to transition from a first state to a second state in response to the suction force when the actuator is in its first state, allowing an initial volume of bodily 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 that is larger than the first volume when the flow controller is in the second state. The actuator is configured to transition to a second form after an initial volume of bodily fluid has been received into the aforementioned portion of the isolation chamber, in order to (1) isolate the isolation chamber, and (2) allow a subsequent volume of bodily fluid to flow from the inlet to the outlet in accordance with the suction force.

[0015]

[0031] In some embodiments, a method for obtaining a sample of decontaminated bodily fluids using a fluid control device having a housing, actuator and flow controller includes establishing a fluid communication between a bodily fluid source and the inlet of the housing. The fluid collection device is coupled to the outlet of the housing and, upon coupling 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 defined collectively by the flow controller and the portion of the housing. As the volume increases, the first portion of the isolation chamber receives a certain volume of air contained within a flow path defined between the bodily fluid source and the isolation chamber, and the second portion of the isolation chamber receives an initial volume of bodily fluid. After receiving the initial volume of bodily fluid in the second portion of the isolation chamber, the actuator transitions from the first to the second state to (1) isolate the isolation chamber and (2) allow a subsequent volume of bodily fluid to flow from the inlet to the outlet in response to the suction force.

[0016]

[0032] In some embodiments, a method for obtaining a sample of decontaminated body fluid using a fluid control device having a housing, a flow controller, and an actuator may include, for example, establishing a fluid communication between a body fluid source and the inlet of the housing. The fluid collection device is fluidically coupled to the outlet of the housing. The flow controller transitions from a first state to a second state in response to the suction force applied by the fluid collection device, increasing the volumes of the first and second portions of the isolation chamber. The first portion of the isolation chamber receives a certain volume of air contained in a defined flow path between the body fluid source and the isolation chamber, in response to the increase in the volumes of the first and second portions of the isolation chamber. The second portion of the isolation chamber receives an initial volume of body fluid, in response to the increase in the volumes of the first and second portions of the isolation chamber. After receiving the initial volume of body fluid in the second portion of the isolation chamber, the actuator transitions from a first state to a second state to (1) isolate the isolation chamber and (2) allow a subsequent volume 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 bodily fluids, such as a blood sample, that is uncontaminated or substantially free of foreign matter. In some examples, the bodily fluid sample (e.g., a blood sample) may be used to determine whether or not it contains one or more potentially undesirable microorganisms, such as bacteria (e.g., Gram-positive and / or Gram-negative bacteria), fungi, or yeasts (e.g., Candida). It is possible to test for the presence of microorganisms. During diagnostic testing, various techniques can be employed to help detect the presence of other types of biomolecules, as well as microorganisms, given types of cells, biomarkers, proteins, antigens, enzymes, blood components, etc. Examples include, but are not limited to, molecular polymerase chain reaction (PCR), magnetic resonance and other magnetic analysis platforms, automated microscopy, spatial clonal isolation, flow cytometry, whole blood ("non-cultured") sample analysis (e.g., NGS) and related techniques, morphological and kinetic cell analysis, and / or other common or evolving advanced techniques for characterizing patient samples and / or detecting, identifying, classifying, categorizing and / or characterizing given organisms, antibiotic susceptibility, etc.

[0018]

[0034] For example, in some cases, microbiological testing may involve culturing a patient sample in one or more containers that can contain a culture 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 a patient sample will thrive and / or grow in the medium over time (e.g., over a variable amount of time, from less than an hour to more than several days (which may be shorter or longer depending on the diagnostic technique employed)). The presence of microorganisms and / or organisms may be detected by automated continuous monitoring and / or other methods specific to analytical platforms or techniques used for detection, identification, etc. (e.g., by observing carbon dioxide levels and / or other detection methods). 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 fluids of the patient from whom the sample was taken. In other cases, a sample of bodily fluids can be directly analyzed (i.e., without culturing) to determine whether microorganisms and / or organisms are present. If microorganisms are determined to be present in the sample used for testing, the patient may be diagnosed and prescribed one or more antibiotics or other treatments specifically designed to treat or otherwise remove any undesirable microorganisms and / or organisms from the patient.

[0019]

[0035] However, patient samples can be contaminated during acquisition and / or may otherwise be prone to producing inaccurate results. For example, microorganisms from the body surface (e.g., commensal skin microorganisms) that are shed during the sample acquisition process (e.g., directly or indirectly via tissue fragments, hair follicles, sweat glands, and other skin appendage structures) may then be present in the sample to be transferred with the patient sample to a culture medium, test vial, or other suitable sample collection or transfer container and / or otherwise analyzed. Another possible source of contamination is from the person taking the patient sample. For example, the instruments, supplies, and / or devices used during the patient sample acquisition process often involve 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 may introduce a potential point of contamination. In some cases, such contaminants may grow in the culture medium and / or be identified in other ways, thereby increasing the risk or likelihood of false-positive microbiological test results that 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 foreign matter are problematic when attempting to diagnose or treat a wide range of suspected illnesses, diseases, infections, patient conditions, and / or other diseases. For example, incorrect results from microbiological testing may result in a patient receiving one or more antibiotic therapies unnecessarily and / or misdiagnosis and / or delay in treatment of the patient's illness, either of which may lead to serious side effects or consequences for the patient, including, for example, death. Thus, incorrect results may result in prolonged hospitalization of the patient and / or other complications associated with incorrect treatment. This can lead to unnecessary burdens and costs on the healthcare system. The use of diagnostic imaging equipment that leads to these erroneous results is problematic from both a cost and patient safety perspective, as unnecessary exposure to concentrated radiation associated with various imaging procedures (e.g., CT scans) has many known adverse effects on long-term patient health.

[0021]

[0037] As used herein and / or in any claims contained herein, the singular forms “a, an” and “the” refer to multiple objects unless otherwise clearly indicated by the context. 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 types of material.

[0022]

[0038] As used herein, “body fluids” may include any fluids obtained directly or indirectly from a patient’s body. For example, “body fluids” may include, but are not limited to, blood, cerebrospinal fluid, urine, bile, lymph, saliva, synovial fluid, serous fluid, pleural fluid, amniotic fluid, mucus, sputum, vitreous fluid, air, etc., or any combination thereof.

[0023]

[0039] As used herein, the terms “proximal” and “distal” refer to the direction closer to and away from the user who is bringing the device into contact with the patient, respectively. Therefore, for example, the end of the device that first makes contact with the patient's body is the distal end of the device, and the opposite end of the device (for example, 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 relation to a stated value and / or geometric structure or relationship, are intended to mean that the value or feature defined in this way is nominally the stated value or feature. In some examples, the terms “about,” “approximately,” and / or “substantially” can generally mean and / or generally intend that the stated value or feature is within a desired tolerance range (e.g., ±10% of the stated value or feature). For example, a value of about 0.01 may include 0.009 and 0.011, a value of about 0.5 may include 0.45 and 0.55, a value of about 10 may include 9 to 11, and a value of about 1000 may include 900 to 1100. Similarly, if the first and second surfaces are nominally parallel, the first surface may be said to be substantially parallel to the second surface. While the stated values, structures, and / or relationships may be desirable, it should be understood that some variation may occur as a result of, for example, manufacturing tolerances or other practical considerations (e.g., pressure or force applied through parts of the device, conduit, lumen, etc.). Therefore, the terms “about,” “approximately,” and / or “substantially” may be used herein to take such tolerances and / or considerations into account.

[0025]

[0041] As used herein, the terms “presample,” “first,” and / or “initial” can be used synonymously to describe the amount, portion, or volume of body fluid collected and / or isolated before obtaining the “sample” volume. The “presample,” “first,” and / or “initial” volume may be a predetermined, specified, desired, and / or given amount of body fluid. For example, a predetermined and / or desired presample volume of body fluid may be one drop, several drops, about 0.1 milliliters (mL), about 0.2 mL, about 0.3 mL, about 0.4 mL, about 0.5 mL, about 1.0 mL, about 2.0 mL, about 3.0 mL, about 4.0 mL, about 5.0 mL, about 10.0 mL, about 20.0 mL, about 50.0 mL, and / or any volume or any percentage of those volumes. In other embodiments, the presample volume may be greater than 50 mL or less than 0.1 mL. In some predetermined embodiments, the predetermined and / or desired presample volume may be about 0.1 mL to about 5.0 mL. In the application configuration, the pre-sample volume may be, for example, the combined volume of any number of lumens (e.g., lumens that form at least part of the flow path from the body fluid source to the initial collection chamber, section, reservoir, etc.).

[0026]

[0042] As used herein, the terms “sample,” “second,” and / or “subsequent” can be used synonymously to describe, for example, the amount, portion, or volume of body fluid used in one or more samples or diagnostic tests. “Sample” volume may be either a random volume of body fluid collected after the collection, isolation, and / or separation of a pre-sample volume of body fluid, or a predetermined or desired volume. In some embodiments, the desired sample volume of body fluid may be approximately 10 mL to approximately 60 mL. In other embodiments, the desired sample volume of body fluid may be less than 10 mL or greater than 60 mL. In some embodiments, for example, the sample volume may be at least in part 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 fluids into one or more fluid collection devices. In some embodiments, the fluid collection device may be any suitable container, reservoir, bottle, adapter, dish, vial, syringe, device, diagnostic and / or testing equipment, etc. In some embodiments, the fluid collection device may be substantially the same as or identical to known sample containers such as 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 the "Systems and Methods for Parenterally Procuring Bodily-Fluid Samples with" filed on December 13, 2007. U.S. Patent No. 8,197,420 ("420 Patent"), titled "Reduced Contamination" Any of the sample reservoirs described in this application may be substantially the same as or identical to any of them, and the disclosures of this application are incorporated herein by reference in their entirety.

[0028]

[0044] In some embodiments, the fluid collection device may be empty before receiving a sample volume of body fluid. For example, in some embodiments, the fluid collection device or reservoir may be configured to define and / or define or generate vacuum or suction, for example, a vacuum-based collection tube (e.g., Vacutainer®), a syringe, etc. In other embodiments, the fluid collection device may include any suitable additives, culture media, substances, enzymes, oils, fluids, etc. For example, the fluid collection device may be a sample or culture bottle containing, for example, aerobic or anaerobic media. The sample or culture bottle may be configured to receive a sample of body fluid that can be tested (e.g., via in vitro diagnostic (IVD) testing and / or other suitable tests after culture) for the presence of, for example, Gram-positive bacteria, Gram-negative bacteria, yeasts, fungi, and / or any other organisms. In some examples, if testing of such media yields a positive result, the media can then be tested using a PCR-based system to identify a given organism. In some embodiments, the sample reservoir may include, for example, any suitable additives in addition to or instead of the culture media. Examples of such additives include heparin, citrate, ethylenediaminetetraacetic acid (EDTA), oxalate, and sodium polyanethole sulfonate (SPS). In some embodiments, the fluid collection device may contain any suitable additive or culture medium, and the fluid collection device can be exhausted and / or the air removed from the fluid collection device by other means.

[0029]

[0045] The term "culture medium" refers to a culture medium that reacts with biological organisms (such as bacteria and other microorganisms) in bodily fluids. The term “additive” can be used to describe a substance configured to react with a part of a body fluid (e.g., constituent cells of blood, serum, synovial fluid, etc.), but it should be understood that the sample reservoir may contain any suitable substance, liquid, solid, powder, lyophilized compound, gas, etc. Furthermore, when referring to “additives” in a sample reservoir, it should be understood that the additive may be a culture medium such as aerobic and / or 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 the one described above. In other words, the embodiments described herein can be used with any suitable fluid reservoir, etc., containing any suitable substance or combination of substances.

[0030]

[0046] The embodiments and / or parts thereof described herein may be formed from or composed of one or more biocompatible materials. In some embodiments, the biocompatible material may be selected based on one or more properties of the constituent material, such as stiffness, toughness, durometer hardness, and physiological activity. Examples of suitable biocompatible materials include metals, glass, ceramics, and polymers. Examples of suitable metals include pharmaceutical-grade stainless steel, gold, titanium, nickel, iron, platinum, tin, chromium, copper, and / or alloys thereof. Polymer materials may be biodegradable or non-biodegradable. Examples of suitable biodegradable polymers include polylactides, polyglycolides, polylactide-coglycolides (PLGA), polyanhydrides, polyorthoesters, polyetheresters, polycaprolactones, polyesteramides, poly(butyric acid), poly(valeric acid), polyurethanes, and / or blends and copolymers thereof. Examples of non-biodegradable polymers include nylon, polyester, polycarbonate, polyacrylate, polysiloxane (silicone), ethylene vinyl acetate and other acyl-substituted cellulose acetate polymers, non-biodegradable polyurethane, polystyrene, polyvinyl chloride, polyvinyl fluoride, poly(vinylimidazole), chlorosulfonate polyolefin, polyethylene oxide, and / or blends and copolymers thereof.

[0031]

[0047] Embodiments and / or parts thereof described herein may include components formed from one or more parts, features, structures, etc. When referring to such components, it should be understood that the component may be formed from a single part having any number of sections, regions, parts and / or features, or from multiple parts or features. For example, when referring to a structure such as a wall or chamber, the structure may be considered as a single structure having multiple parts, or as multiple separate substructures joined together to form the structure. Thus, a structure constructed integrally may include, for example, a set of substructures. Such a set of substructures may include multiple parts that are either continuous or discontinuous with respect to each other. A set of substructures may also be made from multiple articles or components that are manufactured separately and then joined together (for example, by welding, adhesive or any preferred method).

[0032]

[0048] While some embodiments described herein are used to obtain body fluids for the examination of one or more culture samples, it should be understood that the embodiments are not limited to such uses. Any of the embodiments and / or methods described herein can be used to transfer a flow of body fluid to any suitable device that is in fluid communication with it. Thus, while certain examples are described herein, devices, methods and / or concepts are not intended to be limited to these specific examples.

[0033]

[0049] Referring to the drawings, Figure 1 shows a fluid control device 100 according to one embodiment. This is a schematic diagram. Generally, the fluid control device 100 (also referred to herein as the “control device” or “device”) is configured to draw body fluid from a patient’s body. A first portion or volume of the drawn body fluid (e.g., initial volume) is isolated from a second portion or volume of the drawn body fluid (e.g., subsequent volume). In some examples, contaminants can be isolated within the first portion or volume, leaving a substantially contaminant-free second portion or volume. The second portion or volume of the body fluid can then be used as a biological sample in one or more tests (e.g., blood culture tests), as described in more detail herein. The first portion or volume of the body fluid can be discarded as waste or used in any suitable test where the likelihood of erroneous, inaccurate, distorted, inconsistent, or unreliable results due to potential contaminants contained therein is low.

[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 any preferred shape, size, and / or configuration. For example, in some embodiments, the housing 110 may have a size that is at least partially based on an initial amount or volume of bodily fluid configured to be transferred into and / or isolated within a portion of the housing 110. In some embodiments, the housing 110 may have a size and / or shape configured to improve the ergonomics and / or ease of use associated with the device 100. Furthermore, in some embodiments, one or more portions of the housing 110 may be formed from a relatively transparent material configured to allow a user to visually inspect and / or verify the flow of bodily fluid through at least a portion of the housing 110.

[0035]

[0051] The housing 110 has and / or forms an inlet 113, an outlet 114, and an isolation chamber 130. The inlet 113 is configured to fluidly connect to a lumen-containing device, which can further fluidly connect the housing 110 to a body fluid source. For example, the housing 110 can be connected to and / or may include a lumen-containing device (e.g., a butterfly needle, an intravenous (IV) catheter, a peripherally inserted central venous catheter (PICC), an intermediate lumen-containing device, etc.) that is configured to fluidly connect to the inlet 113 and to be positioned percutaneously within the patient's body. Thus, body fluids can be transferred from the patient and / or other body fluid sources to the housing 110 via the inlet 113, as will be described in more detail herein. The outlet 114 can fluidly connect to a fluid collection device 180 (e.g., a fluid or sample reservoir, syringe, evacuated container, culture bottle, etc.). As will be described in more detail in the specification, the control device 100 can be used and / or operated to selectively transfer a certain volume of bodily fluid from a bodily fluid source through the inlet 113, housing 110, and 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 Figure 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 further 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 forms to selectively control the flow of bodily fluids through at least one of the flow paths 115 and / or 116. Furthermore, the control device 100 and / or the housing 110 can be configured to transition automatically (e.g., based on pressure difference, based on time, electronically, based on saturation of membranes, absorbents and / or barrier materials, etc.) or via intervention (e.g., user intervention, mechanical intervention, etc.).

[0037]

[0053] The isolation chamber 130 is placed in at least temporary fluid communication with the inlet 113 via the flow path 115. As described further in this specification, the isolation chamber Chamber 130 is configured to (1) receive a flow and / or volume of bodily fluid from the inlet 113, and (2) isolate the flow and / or volume of bodily fluid therein (e.g., detach, remove, contain, hold, separate, etc.). The isolation chamber 130 can have any preferred arrangement configuration, such as those described herein with respect to a particular embodiment. However, it should be understood that the control device 100 and / or housing 110 can have an isolation chamber 130 arranged in any preferred manner, and therefore the isolation chamber 130 is not intended to be limited to those illustrated and described herein. For example, in some embodiments, the isolation chamber 130 can be formed at least partially by the housing 110. In other embodiments, the isolation chamber 130 may be a reservoir placed and / or arranged within a portion of the housing 110. In other embodiments, the isolation chamber 130 may be formed and / or defined by a portion of the flow path 115. In other words, the housing 110 includes one or more lumen defining devices configured to define one or more lumens and / or to receive an initial flow or volume of bodily fluids from the inlet 113, thereby forming and / or functioning as an 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 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 transported within the isolation chamber 130 (e.g., an initial or first volume of body fluid). For example, in some embodiments, the isolation chamber 130 can have a volume sufficient to receive an initial volume of body fluid of about microliters or less (e.g., about 20 drops of body fluid, 10 drops of body fluid, 5 drops of body fluid, 1 drop of body fluid, or any suitable volume in between). In other embodiments, the isolation chamber 130 can have a volume sufficient to receive an initial volume of body fluid of up to, for example, about 5.0 mL, 10.0 mL, 15.0 mL, 10.0 mL, 30.0 mL, 40.0 mL, 50.0 mL, or more. In some embodiments, the isolation chamber 130 may have a volume equal to at least some of the volumes of the one or more lumens that fluidly communicate the isolation chamber 130 with the body fluid source (for example, the combined volume of the lumens of at least some of the needle, inlet 113, and flow path 115).

[0039]

[0055] The outlet 114 of the housing 110 is in fluid communication with the flow paths 115 and / or 116 and / or is configured to be in fluid communication. The outlet 114 can be any suitable outlet, opening, port, plug, lock (e.g., Luer lock), seal, coupler, valve (e.g., one-way, check valve, duckbill valve, umbrella valve, 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 formed integrally with the fluid collection device 180. In other embodiments, the outlet 114 can be coupled to the fluid collection device 180 at least temporarily via adhesive, resistance fit, mechanical fastener, screw coupling, perforation or puncture configuration, multiple mating recesses, and / or any other suitable coupling or combination thereof. In yet another embodiment, the outlet 114 can be operably coupled to the fluid collection device 180 via an intervening structure (not shown in Figure 1), such as a sterile tube. In some embodiments, the outlet 114 may be configured such that it is physically and / or fluidically sealed before coupling with the fluid collection device 180. In some embodiments, the outlet 114 can be transitioned from a sealed configuration to an unsealed configuration depending on coupling with the fluid connection device 180 and / or depending on the negative pressure difference between the environment in the outlet 114 and / or the environment in the fluid collection device 180.

[0040]

[0056] While the control device 100 and / or the outlet 114 of the housing 110 are described above as being fluidically coupled to and / or otherwise fluidically connected to the fluid collection device 180, in other embodiments, the device 100 can be used with any suitable bodily fluid collection device, system, adapter, etc. For example, in some embodiments, 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, filed March 3, 2015, entitled “Apparatus and Methods for Disinfection of a Specimen Container” (hereinafter referred to as “'783 Patent”) and / or U.S. Patent Application Publication No. 2015 / 0342510, filed June 2, 2015, entitled “Sterile Bodily-Fluid Collection Device and Methods” (hereinafter referred to as “'510 Publication”), the disclosures of each of the aforementioned patents and publications being incorporated herein by reference in their entirety.

[0041]

[0057] The fluid collection device 180 may be any suitable device for at least temporarily containing body fluid, such as any of those described in detail above (e.g., vacuum blood collection tubes, sample reservoirs, syringes, culture bottles, etc.). In some embodiments, the fluid collection device 180 may be a sample reservoir including a vacuum seal that maintains a negative pressure (vacuum) state inside the sample reservoir, thereby facilitating the withdrawal of body fluid from the patient through the control device 100 into the sample reservoir via vacuum or suction force. In embodiments where the fluid collection device 180 is a vacuum blood collection tube, etc., as described in further detail herein, the user may connect the fluid collection device 180 to the outlet 114 to initiate the flow of body fluid from the patient into the device 100, so that a first or initial portion of the body fluid flow is transferred into the isolation chamber 130 and isolated by the isolation chamber 130, and a second or subsequent portion of the body fluid flow is diverted and / or otherwise separated away from the isolation chamber 130 (e.g., via the outlet 114) into the fluid collection device 180.

[0042]

[0058] The flow controller 140 of device 100 is located at least partially within the housing 110 and is configured to control, guide, and / or otherwise facilitate the selective flow of fluid through at least a portion of the housing 110. More specifically, in some embodiments, the flow controller 140 can be located within a portion of the isolation chamber 130 that receives the initial flow or volume of body fluid and / or within the internal volume of the isolation chamber 130, and / or can at least partially define such portion and / or internal volume. In some embodiments, the flow controller 140 can be located 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. In other words, the flow controller 140 can be located within the isolation chamber 130 such that an 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 a volume within the isolation chamber 130. In some embodiments, the flow controller 140 can form a barrier and / or, in other ways, fluidically separate at least a portion of the flow path 115 from at least a portion of the flow path 116. For example, the flow controller 140 can be positioned within the housing 110 such that a first side and / or first surface of the flow controller 140 selectively fluidizes with at least a portion of the flow path 115 and / or the inlet 113, and a second side and / or second surface of the flow controller 140 selectively fluidizes with at least a portion of the flow path 116 and / or the outlet 114.

[0043]

[0059] The flow controller 140 may be any preferred shape, size and / or configuration. For example, the flow controller 140 may be, for example, a membrane, diaphragm, bladder, plunger, piston, bag, pouch and / or have the desired rigidity, flexibility and / or flexibility. It may be any other suitable member having a rhomonic hardness. In some embodiments, the flow controller 140 may be configured to transition from a first state to a second state in response to a negative pressure difference and / or 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 may be a bladder configured to transition from a first state to a second state or "reverse" in response to a negative pressure difference and / or suction force being applied to the surface of the bladder.

[0044]

[0060] The flow controller 140 can be in a first state (e.g., storage or unused state) before using the device 100, and can be moved to a second state depending on whether the outlet 114 is fluidically coupled to the fluid collection device 180 (e.g., a collection device that defines or is configured to define negative pressure and / or suction force). In some embodiments, the flow controller 140 can define at least a portion of the isolation chamber 130 when the flow controller 140 is in the second state. In some embodiments, the arrangement of the flow controller 140 is such that the isolation chamber 130 defines and / or has a first volume when the flow controller 140 is in the first state, and defines and / or has a second volume that is larger than the first volume when the flow controller 140 is placed in the second state. As described further in this specification, the increase in the volume of the isolation chamber 130 can result in a suction force that can operate to draw an initial volume of body fluid into the isolation chamber 130. Furthermore, in some embodiments, the flow controller 140 may have a size, shape and / or configuration that allows the isolation chamber 130 to receive a certain volume of air or gas (for example, a certain volume of air placed in the flow path between the body fluid source and the isolation portion) and an initial amount or volume of body fluid. In such embodiments, the flow controller 140 may be configured to define any number of portions, volumetric sections, channels, etc., that can receive and / or contain at least one of the certain volume of air or the initial volume of body fluid.

[0045]

[0061] In some embodiments, the size, shape, arrangement configuration and / or constituent materials of the flow controller 140 can be configured and / or otherwise selected so that the flow controller 140 transitions from a first state to a second state in a predetermined manner and / or at a predetermined or desired speed. In some examples, by controlling the speed at which the flow controller 140 transitions from the first state to the second state, it is possible to further control and / or adjust the speed of the fluid flow into the isolation chamber 130 and / or the magnitude of the suction force generated within the isolation chamber 130, which is operable to draw an initial volume of fluid into the isolation chamber 130. Although not shown in Figure 1, in some embodiments, the housing 110 may include valves, membranes, porous materials, throttling, orifices and / or other arbitrary suitable members, devices and / or features configured to adjust the suction force applied to the surface of the flow controller 140, thereby allowing adjustment of the speed at which the flow controller 140 transitions from the first state to the second state.

[0046]

[0062] In some examples, the likelihood of hemolysis of blood samples and / or venous collapse can be reduced by controlling the rate at which the flow controller 140 moves and / or the magnitude of the pressure difference and / or suction force generated within the isolation chamber 130 (for example, this is particularly important when obtaining fluid samples from frail patients). In some examples, the amount or volume of fluid transferred into the isolation chamber 130 can be controlled at least partially by adjusting the movement of the flow controller 140 and / or the pressure difference generated within the isolation chamber 130 (i.e., the initial volume of fluid can be controlled).

[0047]

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

[0048]

[0064] The actuator 150 can be operated and / or transitioned between a first state and a second state in any preferred manner. For example, in some embodiments, the transition of the actuator 150 may include activating, pressing, moving, translating, rotating, switching, sliding, opening, closing, and / or reconfiguring the actuator 150 in other ways. In some examples, the actuator 150 may transition between a first state and a second state in response to manual operation by a user (e.g., applying force by hand to a button, slider, plunger, switch, valve, rotating member, conduit, etc.). In other embodiments, the actuator 150 may be configured to automatically transition between a first state and a second state in response to a pressure difference (or lack thereof), a change in position or kinetic energy, a change in composition or configuration (e.g., a part of the actuator may at least partially melt or transform), etc. In further embodiments, the actuator 150 can be operated or shifted mechanically and / or electrically (e.g., via a motor) based on the volume of bodily fluid received, the volumetric flow rate of the bodily fluid flow, the flow velocity of the bodily fluid flow, etc., for a predetermined time. While examples of actuators and / or methods by which the actuator can shift are provided, it should be understood that they are presented merely as examples and not as limitations.

[0049]

[0065] In some embodiments, the actuator 150 can be configured, when in a first state, to isolate, seize, disconnect, and / or otherwise block fluid communication between at least a portion of the flow path 115 and at least a portion of the flow path 116, and when in a second state, to place the flow path 115 (or at least a portion thereof) in a fluidically connected state with the flow path 116 (or at least a portion thereof). Furthermore, the actuator 150 can be configured to isolate, seize, disconnect, and / or otherwise block fluid communication between the isolation chamber 130 and the inlet 113, the outlet 114 and / or at least a portion of the flow paths 115 and 116. Thus, when the actuator 150 is in its second position, the isolation chamber 130 can be isolated and / or fluidically separated from other flow paths or portions of the housing 110, and the inlet 113 can be placed in a fluidly connected state with the outlet 114. Therefore, as will be described in more detail herein, the actuator 150 can be configured to transfer a subsequent volume of fluid (for example, a certain volume of fluid after the initial volume of fluid) to a fluid collection device 180 which is fluidically coupled to the outlet 114.

[0050]

[0066] As described above, the device 100 can be used to obtain a sample of bodily fluids that has been contaminated with reduced levels of microorganisms, such as commensal skin microorganisms. For example, in some cases, users such as physicians, internists, nurses, phlebotomists, and technicians can operate the device 100 to establish fluid communication between the inlet 113 and a bodily fluid source (e.g., a patient's vein, cerebrospinal fluid (CSF) from the spinal cavity, urine, etc.). In some cases, the inlet 113 involves puncturing the patient's skin and inserting at least a portion of the needle into the patient's vein. The inlet 113 can be manipulated to be in a state of fluid connection with a body fluid source (e.g., a vein, IV catheter, PICC, etc.), and / or may be coupled to a needle or the like, and / or may include such a needle or the like.

[0051]

[0067] In some embodiments, when the inlet 113 is placed in a state of fluidic connection with a body fluid source (e.g., a part of a patient), the outlet 114 can be fluidically coupled to a fluid collection device 180. As described above, in some embodiments, the fluid collection device 180 may be any suitable reservoir, container and / or device configured to receive body fluid from a certain body fluid. For example, the fluid collection device 180 may be a vacuum reservoir or container that defines a negative pressure and / or 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 negative pressure and / or suction force within the fluid collection device 180. As described above, a portion and / or surface of the flow controller 140 may be in fluid communication with the flow path 116, and thus negative pressure and / or suction force can be applied to a portion and / or surface of the flow controller 140. Furthermore, negative pressure and / or suction force may be able to operate the flow controller 140 to transition from a first state in which the isolation chamber 130 has a first volume to a second state in which the isolation chamber 130 has a second volume greater than the first volume. Thus, in response to the transition of the flow controller 140 (for example, the increase in the volume of the isolation chamber 130 as a result of the flow controller 140 transitioning from the first state to the second state), an initial volume of body fluid can be drawn into the isolation chamber 130.

[0052]

[0068] In some embodiments, for example, the flow controller 140 may be a bladder configured to transition or “reverse” in response to negative pressure. The flow controller 140 may be configured to transition in a predetermined manner and / or at a predetermined speed, thereby controlling, adjusting and / or otherwise determining one or more characteristics related to 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 may together define several different portions of the isolation chamber 130. In such embodiments, at least one of the portions of the isolation chamber 130 may be configured to accommodate a certain volume of air drawn into the isolation chamber 130 immediately before the initial volume of body fluid, as described in detail above. Thus, the transition of the flow controller 140 from a first state to a second state may cause an initial portion of the volume of body fluid (also referred herein as the “initial volume” or “first volume”) to flow from the inlet 113 through at least a portion of the flow path 115 into the isolation chamber 130. In some embodiments, the control device 100 can transition from a first state to a second state by moving the flow controller 140 from a first state to a second state, in which an initial portion or volume of bodily fluid can flow into or through at least a portion of the flow path 115 into the isolation chamber 130.

[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 embodiments, the control device 100 can remain in a second state or form until a predetermined and / or desired volume (e.g., initial volume) of 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 body fluid that is the same as or greater than the volume related to the flow path defined between the body fluid source and the isolation chamber 130. In yet another embodiment, the control device 100 determines that the pressure difference between the isolation chamber 130 and the flow path 115 and / or volume source is substantially The system can be configured to transfer the flow of body fluid (e.g., initial volume) into the isolation chamber 130 until it reaches equilibrium and / or otherwise decreases below a desired threshold.

[0054]

[0070] After the initial volume of bodily fluid has been transferred into and / or diverted into the isolation chamber 130, the control device 100 can be transitioned from a second state or form to a third state or form. For example, in some embodiments, when the initial volume of bodily fluid is transferred into the isolation chamber 130, the actuator 150 can be transitioned from its first state to a second state, thereby causing the control device 100 to enter its third state. More specifically, in some embodiments, the arrangement of the control device 100 and / or the isolation chamber 130 may be such that the flow of bodily fluid into the isolation chamber 130 substantially stops or slows down in response to receiving the initial volume. In some embodiments, for example, the isolation chamber 130 can receive the flow of bodily fluid (e.g., the initial volume of bodily fluid) until the pressure difference 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 embodiments, the user can visually inspect a portion of the device 100 and / or housing 110 to determine that an initial volume of bodily fluid is present in the isolation chamber 130 and / or that the flow of bodily fluid into the isolation chamber 130 has slowed down or substantially stopped. In some embodiments, the user can apply force to the actuator 150 and / or actuate the actuator 150 in other ways to transition the actuator 150 from its first state to its second state. In other embodiments, the actuator 150 can be transitioned automatically (for example, without user intervention).

[0055]

[0071] The actuator 150 can be moved from its first state to its second state (for example, by placing the control device 100 into its third state or configuration) to isolate, separate, detach, and / or retain the initial volume of body fluid within the isolation chamber 130. As will be further described herein, in some examples, other external sources of contamination, such as skin commensal microorganisms shed during a venipuncture event, or colonization of catheters and PICC lines used to collect samples, may be mixed into 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 bodily 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, allowing a subsequent volume of bodily fluid to flow from the inlet 113 through at least a portion of the flow paths 115 and / or 116 to the outlet 114. For example, in some embodiments, by transitioning the actuator 150 from its first state to the second state, actions can be taken, such as opening or closing a port or valve, moving one or more seals, moving or removing one or more obstructions, or defining one or more portions of a flow path. With the fluid collection device 180 fluidically coupled to the outlet 114 and the control device 100 in a third state or configuration, the negative pressure difference and / or suction force that is normally applied to the flow controller 140 can be applied to or through at least a portion of the flow paths 115 and 116. Therefore, any subsequent volume of body fluid can flow into the fluid collection device 180 from the inlet 113, through at least a portion of the flow paths 115 and 116, and through the outlet 114. As described above, by isolating the initial volume of body fluid in the isolation chamber 130 before collecting or acquiring one or more sample volumes of body fluid (for example, in the fluid collection device 180), the amount of contaminants in one or more sample volumes is reduced and / or substantially eliminated. Furthermore, in some embodiments, the arrangement of the control device 100 may be such that it cannot transition to the third state before the control device 100 collects and isolates the initial volume in the isolation chamber 130.

[0057]

[0073] Figures 2 to 11 show a fluid control device 200 according to another embodiment. The fluid control device 200 (hereinafter also referred to as the “control device” or “device”) may be similar in at least form and / or function to the device 100 described above with reference to Figure 1. For example, as described above with respect to device 100, the device 200 may be configured such that, depending on whether it is fluidly connected to a negative pressure source (e.g., suction or vacuum source), it (1) draws bodily fluid from a bodily fluid source into the device 200, (2) separates and isolates a first portion or volume (e.g., initial volume) of the bodily fluid in a part of the device 200, and (3) a second portion or volume (e.g., subsequent volume) of the bodily fluid flows through the device 200 (bypassing the isolated initial volume) into a fluid collection device fluidly coupled to the device 200. Thus, contaminants can be isolated in or with the initial volume of bodily fluid, leaving a subsequent volume of bodily fluid that is substantially free of contaminants.

[0058]

[0074] The fluid control device 200 (hereinafter also referred to 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 may be arranged in a modular configuration, where one or more parts of the housing 210 and / or actuator 250 can be physically and fluidly coupled (e.g., by the end user) to form the control device 200 together. Similarly, in some embodiments, the control device 200 may be packaged, transported and / or stored separately from fluid collection devices (e.g., sample reservoirs, syringes, etc.) and / or inlet devices (e.g., needles, catheters, peripheral intravenous lines (PIVs), peripherally inserted central venous catheters (PICCs), etc.) that the user can couple to the control device 200 before or during use. In other embodiments, the control device 200 does not need to be modular. For example, in some embodiments, the control device 200 may be assembled during manufacturing and delivered to the supplier and / or end user as an assembled device. In some embodiments, the control device 200 may include a fluid collection device, such as any of those described above, and / or may be pre-coupled to such a fluid control device (for example, during manufacturing and / or before delivery to the end user). Similarly, in some embodiments, the control device 200 may include an inlet device, such as any of those described herein, and / or may be pre-coupled to such an inlet device.

[0059]

[0075] The housing 210 of the control device 200 may be any preferred 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 a cover 235 and includes, receives, accommodates, and / or at least partially defines an isolation chamber 230. As described further in this specification, the housing 210 may 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 Figures 2 to 6, the actuator portion 212 of the housing 210 includes an inlet 213 and an outlet 214. The inlet 213 is configured to be fluidly connected to a body fluid source and to receive the flow of body fluid from there, as described in detail above. For example, the inlet 213 can be directly or indirectly connected to a lumen-containing device such as a needle, IV catheter, or PICC line, which is further in fluid communication with a body fluid source (for example, inserted into a patient's body). The outlet 214 is any of the above. The fluid collection device is configured to be fluidically coupled to a fluid collection device such as a sample reservoir, syringe, intermediate fluid transfer device, adapter, or container (e.g., a transfer adapter similar to that described in the '783 patent). Furthermore, the fluid collection device may be operated to define and / or define a vacuum within the fluid collection device, as described in further detail herein, so as to create a negative pressure difference between one or more parts of the housing 210 by coupling the fluid collection device to the outlet 214.

[0061]

[0077] For example, as shown in Figures 7 to 11, the actuator portion 212 defines a flow path 215 that is in fluid communication with an inlet 213 and a flow path 216 that is 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 a fluid connection with a first port 217, and the flow path 216 (e.g., the second flow path) is configured to selectively place the outlet 214 in a fluid connection with a second port 218. Furthermore, as will be described in more detail herein, after an initial volume of bodily fluid has been transferred into the isolation chamber 230, fluid communication can be established between the flow paths 215 and 216, thereby allowing a subsequent volume of bodily fluid to 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 may be any preferred shape, size, and / or configuration. For example, as shown in Figures 6 to 8, the isolation portion 220 includes and / or has an inner surface, a portion of which is arranged to form a first contoured surface 221. The first uneven surface 221 can form and / or define a portion of the isolation chamber 230, as will be described in more detail herein. Furthermore, as will be described in more detail herein, the first port 217 and the second port 218 are configured to form and / or extend through a portion of the first uneven surface 221, so as to place the isolation chamber 230 in a state of fluid connection with the flow paths 215 and 216.

[0063]

[0079] The isolation portion 220 includes, is formed and / or accommodates, an outer casing member 225 and a flow controller 240. More specifically, as shown in Figures 6 to 8, the isolation portion 220 accepts and / or is coupled to the outer casing member 225 such that the flow controller 240 is positioned between the isolation portion 220 and the outer casing member 225. In some embodiments, the outer casing member 225 can be fixedly bonded to the isolation portion 220 via adhesive, ultrasonic welding, and / or any other preferred bonding method. In some embodiments, the outer casing member 225, the isolation portion 220, and the flow controller 240 together can form a substantially fluid seal and / or airtight seal that separates the isolation portion 220 from the volume outside the isolation portion 220.

[0064]

[0080] As shown in the figure, the cover 235 is positioned 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 bonded to the outer member 225 and / or isolation portion 220 via adhesive, ultrasonic welding, one or more mechanical fasteners, friction fit, snap fit, screw coupling, and / or any other preferred mode of coupling. In some embodiments, the cover 235 can define openings, windows, slots, etc., configured to allow visualization of at least a portion of the isolation chamber 230. Although the outer member 225 and the cover 235 have been described above 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 casing member 225 includes and / or forms a second uneven surface 226. The arrangement of the outer casing member 225 and the isolation portion 220 of the housing 210 may be such that at least a portion of the first uneven surface 221 is aligned with and / or opposed to a corresponding portion of the second uneven surface 226 of the outer casing member 225 (see, for example, Figure 8). Thus, the space, volume, 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. Furthermore, as will be described in more detail herein, the flow controller 240 may be positioned between the first uneven surface 221 and the second uneven surface 226 and may be configured to transition between a first state and a second state in response to a negative pressure difference and / or suction force being applied to at least a portion of the isolation chamber 230.

[0066]

[0082] Ports 217 and 218 of the housing 210 may be of any preferred shape, size, and / or configuration. As described above, the first port 217 is in fluid communication with the isolation chamber 230, and a selective fluid communication can be established 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 the first portion of the isolation chamber 230 defined between the second uneven surface 226 and the first side of the flow controller 240. As described further in this specification, the first port 217 may be configured to provide and / or transfer a flow of bodily 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 of the flow controller 240, in response to the flow controller 240 transitioning from a first state to a second state.

[0067]

[0083] The second port 218 is in fluid communication with the isolation chamber 230, and selective fluid communication can be established between the isolation chamber 230 and the flow path 216 and / or 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 a second side of the flow controller 240 (for example, the side opposite to the first side). As described further in this specification, the second port 218 can be configured to expose the second portion of the isolation chamber 230 defined between the first uneven surface 221 and the second side of the flow controller 240 to a negative pressure difference and / or suction force resulting from the fluid coupling of a fluid collection device (e.g., a vacuum blood collection tube, a culture bottle, a syringe, etc.) to the outlet 214. Furthermore, the negative pressure difference and / or suction force may be operable to move the flow controller 240 from its first state to its second state. In some cases, it may be desirable to adjust and / or control the magnitude of a negative pressure difference. Therefore, the second port 218 may include and / or be coupled to a throttle 219. As described further in this specification, the throttle 219 may be configured to 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 adjusting and / or controlling the magnitude of the pressure difference and / or suction force applied to or experienced by the flow controller 240.

[0068]

[0084] The flow controller 240 is located between the isolation portion 220 and the outer member 225 within the housing 210 (for example, within the isolation chamber 230). The flow controller 240 can be any preferred shape, size and / or configuration. Similarly, the flow controller 240 can be formed from any preferred material (for example, any preferred biocompatible material such as those described herein, and / or any other preferred material). For example, the flow controller 240 may 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 (for example, a bladder) may include any number of relatively thin and flexible portions configured to deform in response to a pressure difference across the flow controller 240. For example, in some embodiments, the flow controller The roller 240 can be formed from or of any suitable medical-grade elastomer and / or any of the biocompatible materials described above. In some embodiments, the flow controller 240 can have a durometer hardness of about 5 Shore A to about 70 Shore A, about 10 Shore A to about 60 Shore A, about 20 Shore A to about 50 Shore A, 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 from or of silicone having a durometer hardness of about 20 Shore A to about 50 Shore A. More specifically, in some such embodiments, the flow controller 240 can be formed from or of silicone having a durometer hardness of about 30 Shore A. In some embodiments, the flow controller 240 may include a relatively thin and flexible portion having a thickness of about 0.001 inches to about 0.1 inches. In other embodiments, the relatively thin and flexible portion may have a thickness of less than 0.001 inches or more than 0.1 inches.

[0069]

[0085] In some embodiments, the flow controller 240 may have a size and / or shape configured to facilitate, promote, and / or otherwise bring forth a fluid flow having a desired set of flow characteristics. Similarly, the flow controller 240 may 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 bring forth a fluid flow having a desired set of flow characteristics. As described further in this specification, the set of flow characteristics may include, and / or include, a relatively uniform or smooth fluid flow, a substantially laminar fluid flow and / or a relatively low turbulent fluid flow, a fluid flow having a substantially uniform front, a fluid flow that does not readily mix with other fluids (e.g., a flow of air or a flow of a body fluid that does not mix with a certain volume of air).

[0070]

[0086] In the embodiments shown in Figures 2 to 11, the flow controller 240 is a bladder (or diaphragm) made 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. Furthermore, the flow controller 240 defines an opening 244. As shown in Figure 8, for example, the flow controller 240 can be positioned within an isolation portion 220 of the housing 210 such that a 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 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). Furthermore, as described in more detail herein, the flow controller 240 may include one or more parts configured to form one or more seals between the flow controller 240 and each of the uneven surfaces 221 and 226, and / or between the flow controller 240 and each of the uneven surfaces 221 and 226.

[0071]

[0087] The deformable portions 241, 242, and 243 of the flow controller 240 may be relatively thin and flexible portions configured to deform in response to a pressure difference between the first side and the second side of the flow controller 240. More specifically, each of the deformable portions 241, 242, and 243 may have a thickness of about 0.005 inches. For example, as shown in Figures 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 uneven surfaces 221 and / or 226. Thus, as will be described in more detail herein, the deformable portions 241, 242, and 243 and the corresponding portions of the uneven surfaces 221 and / or 226 together may form and / or define one or more channels, etc., which further receive an initial volume of body fluid. It is possible.

[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 Figure 8, when the flow controller 240 is in its first state, the deformable parts 241, 242, and 243 are positioned adjacent to and / or substantially in contact with the second uneven surface 226. More specifically, the first deformable part 241 can be positioned adjacent to and / or substantially in contact with the first recess 227 formed by the second uneven surface 226, the second deformable part 242 can be positioned adjacent to and / or substantially in contact with the second recess 228 formed by the second uneven surface 226, and the third deformable part 243 can be positioned adjacent to and / or substantially in contact with the third recess 229 formed by the second uneven surface 226.

[0073]

[0089] Therefore, the first portion of the isolation chamber 230 (for example, 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 very small volume. In contrast, when the flow controller 240 transitions from its first state to its second state (for example, in response to negative pressure applied and / or transmitted through the second port 218), at least the deformable portions 241, 242 and 243 are positioned adjacent to and / or substantially in contact with the first uneven surface 221. More specifically, the first deformable portion 241 can be positioned adjacent to and / or substantially in contact with the first recess 222 formed by the first uneven surface 221, the second deformable portion 242 can be positioned adjacent to and / or substantially in contact with the second recess 223 formed by the first uneven surface 221, and the third deformable portion 243 can be positioned adjacent to and / or substantially in 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 bodily fluid. In some examples, as will be described in more detail herein, increasing the volume of the first portion of the isolation chamber 230 can create a negative pressure or vacuum within which it may be operable to draw an initial volume of bodily fluid into the isolation chamber 230. Furthermore, in some embodiments, the arrangement of the deformable portions 241, 242, and / or 243 may be such that a certain volume of air drawn into the isolation chamber 230 immediately before the flow of bodily fluid can flow into and / or be placed within the portions of the isolation chamber 230 corresponding to the first deformable portion 241 and / or the second deformable portion 242.

[0075]

[0091] While the flow controller 240 has been described in detail above with reference to Figures 6 to 11, in other embodiments, the flow controller 240 and / or the isolation chamber 230 may have any preferred configuration and / or arrangement. For example, in some embodiments, the uneven surfaces 221 and / or 226 may 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 recesses may be changed. Similarly, the flow controller 240 may be modified in any preferred manner to substantially correspond to the shape and / or configuration of the uneven surfaces 221 and / or 226. In some embodiments, such modifications may 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 way and speed at which the flow controller 240 moves, etc., as will be described in further detail herein.

[0076]

[0092] Regarding the flow controller 240, it is a bladder, etc., which includes multiple deformable parts. Although described as such, in other embodiments the flow controller may 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. Furthermore, the isolation chamber 230, at least partially formed by the flow controller 240, may have any suitable shape, size, and / or configuration.

[0077]

[0093] The actuator 250 of the control device 200 may be of any preferred shape, size, and / or configuration. At least a portion of the actuator 250 is located 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 Figures 2 to 11, the actuator 250 is configured as an actuator rod or plunger configured to move relative to the actuator portion 212 of the housing 210. The actuator 250 is located outside the housing 210 and includes an end portion 251 configured to be operated by a user to transition the actuator 250 between its first state and its second state. As shown in Figures 6 to 11, a portion of the actuator 250 includes and / or is coupled to a pair of seals 255. The seals 255 may be, for example, O-rings, elastomer overmoldes, raised or protruding portions, or fittings. The arrangement of the actuator 250 and the housing 210 actuator portion 212 may be such that the inner portion of the seal 255 forms a fluid seal with the surface of the actuator 250, and the outer portion of the seal 255 forms a fluid 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 seals between the actuator 250 and the inner surface of the actuator portion 212. As shown in Figures 7 to 11, the actuator 250 includes and / or is coupled to four seals 255, and the four seals 255 can be distributed along the actuator 250 to selectively form and / or define one or more flow paths between the actuator 250 and them. Furthermore, as will be described in more detail herein, the actuator 250 defines a defined flow channel 252 between a pair of seals 255 that can assist and / or facilitate fluid communication between 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 may include fewer than four seals 255 or more than four seals 255.

[0078]

[0094] In some embodiments, the actuator portion 212 and actuator 250 of the housing 210 include and / or form a lock together. For example, as shown in Figures 6 and 8, the actuator portion 212 of the housing 210 may define an opening 238, and the actuator 250 may include a locking member, latch, projection, tab, etc. (referred to herein as “lock 253”) configured to be at least partially positioned within the opening 238. In some embodiments, the lock 253 may be aligned and / or positioned 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 may be able to transition between a locked state in which the actuator 250 restricts and / or substantially prevents movement of the actuator 250 relative to the housing 210 and an unlocked state in which the actuator 250 can be moved, for example, between a first state and / or position and a second state and / or position. In some examples, such configurations can restrict and / or substantially prevent the actuator 250 from operating before, for example, the initial volume of bodily fluid is transferred into the isolation chamber 230. In other embodiments, the lock 253 can transition from an unlocked state to a locked state after, for example, the initial volume of bodily fluid has been transferred into the isolation chamber 230. ru.

[0079]

[0095] As shown in Figures 7 and 8, when the actuator 250 is positioned in a first state and / or position (for example, before using device 100), the flow path 215 can establish fluid communication between the inlet 213 and the first port 217. More specifically, the actuator 250 may be positioned relative to the housing 210 such that each of the seals 255 is positioned on the side of the inlet 213 opposite to the side of the inlet 213 associated with the first port 217. In other words, the actuator 250 and / or 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 Figures 7 and 8. Thus, as will be described in further detail herein, when the actuator 250 is in the first state and / or position, a certain volume (for example, an initial volume) of bodily fluid can flow from the inlet 213 through the flow path 215 and the first port 217 into the isolation chamber 230.

[0080]

[0096] As shown in Figures 9 to 11, a force can be applied to the end 251 of the actuator 250 to place the actuator 250 into its second state and / or position. When in the second state and / or position, the inlet 213 and outlet 214 are placed in a state where they are fluidly connected via at least a portion of the flow paths 215 and 216 and / or the flow channel 252. As shown in Figures 9 and 11, the inlet 213 and outlet 214 are each positioned between the same pair of seals 255, thereby positioning the actuator 250 to allow the flow of bodily fluids through them. Furthermore, the flow channel 252 defined by the actuator 250 assists and / or facilitates the flow of bodily fluids (see, for example, Figure 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. Furthermore, the arrangement of the seal 255 is such that the first port 217 and the second port 218 are isolated and / or separated from the inlet 213 and the outlet 214, respectively. Thus, by moving the actuator 250 to the second state and / or position, (1) the isolation chamber 230 and any volume of bodily fluid contained therein can be isolated and / or separated, and (2) fluid communication can be established between the inlet 213 and the outlet 214, thereby allowing a certain volume of bodily fluid to flow through the device 200 into a fluid collection device (not shown) fluidically coupled to the outlet 214.

[0081]

[0097] In some embodiments, the set of seals 255 may be configured to isolate, separate, and / or seal one or more parts of the device 200 before establishing fluid communication between the other parts of the device 200. For example, in some embodiments, as described above, the actuator 250 may be in a first position relative to the actuator portion 212 of the housing 210 when in the first state. In such examples, activating the actuator 250 (for example, by applying force to the end 251 of the actuator 250) may 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, where (1) the first seal 255 is located between the first port 217 and the inlet 213 and / or its lumen; (2) the inlet 213 and / or its lumen is located between the first seal 255 and the second seal 255; (3) the outlet 214 and / or its lumen is located between the second seal 255 and the third seal 255; and (4) the second port 218 is located 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 (for example, the inlet 213 is isolated from the outlet 214).

[0082]

[0098] In some examples, the operation of the actuator 250 may 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 in which the actuator 250 is in a second state. Thus, the second seal 255 is located between the first port 217 and the inlet 213 and / or its lumen, each of the inlet 213 and outlet 214 (and / or their lumen) is located between the second seal 255 and the third seal 255, and the second port 218 is located between the third seal 255 and the fourth seal 255. Thus, each of the first port 217 and the second port 218 is isolated from the inlet 213 and outlet 214 (and / or their lumen), and fluid communication is established between the inlet 213 and outlet (and / or their lumen) (for example, via the flow channel 252).

[0083]

[0099] Although the actuator 250 is described in this example as moving between a first, second, and third position relative to the actuator portion 212, it should be understood that transitioning the actuator 250 from the first state to the second state may 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 may be operated, moved, and / or transitioned in any number of discontinuous steps. For example, in some examples, the actuator 250 may be transitioned by a first predetermined amount so as 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 may be transitioned by a second predetermined amount (e.g., in a second and / or discontinuous step) so as 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 may be functionally similar to the actuator 250 and may include fewer than four seals (e.g., one, two, or three seals) or more than four seals (e.g., five, six, seven, or more seals).

[0084]

[0100] As described above, the device 200 can be used to obtain a sample of body fluid with reduced contamination (e.g., contamination from microorganisms such as commensal skin microorganisms or microorganisms outside the body fluid source). For example, before use, the device 200 may be in its first, initial and / or storage state or operating mode, with each of the flow controller 240 and actuator 250 in its respective first or initial state. With the device 200 in the first state, a user such as a physician, internist, nurse, phlebotomist, or technician can operate the device 200 to establish fluid communication between the inlet 213 and the body fluid source (e.g., a patient's vein). Once the inlet 213 is in a state of fluidic connection with the body fluid source, the outlet 214 can be fluidicated to a fluid collection device (not shown in Figures 2 to 11). In the embodiments shown in Figures 2 to 11, for example, the fluid collection device may 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 force, 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, which 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, which is further in fluid communication with the second port 218. More specifically, as shown in Figures 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) connect the inlet 213, the flow path 215 and the first port 217 to the outlet 214, the flow path 216 and It may be located relative to the actuator portion 212 of the housing 210, fluidically separated from the second port 218. Thus, when the control device 200 is in a first state or operating mode (for example, when the actuator 250 and the flow controller 240 are in their respective first states), by fluidically coupling the fluid collection device to the outlet 214, a negative pressure difference and / or suction force is generated and / or otherwise brought about in at least a portion of the flow path 216, and further, in a portion of the isolation chamber 230 defined between the surface of the flow controller 240 (for example, the first surface) and the first uneven surface 221 of the housing 210.

[0086]

[0102] The flow controller 240 is in a first state and / or form before the fluid collection device is coupled to the outlet 214. In the embodiments shown in Figures 2 to 11, the flow controller 240 is a fluid-impermeable bladder, diaphragm, membrane, etc., which can have an inverted, reversed, crushed, and / or empty form (e.g., the first state and / or form) before the fluid collection device is coupled to the outlet 214. For example, as shown in Figure 8, when the flow controller 240 is in its first state and / or form, the flow controller 240 can be positioned adjacent to and / or in contact with the second uneven surface 226. In other words, the first side (opposite to the second side) of the flow controller 240 can be positioned adjacent to and / or in contact with the second uneven surface 226.

[0087]

[0103] As described above, the flow controller 240 is configured to transition from a first state and / or form to a second state and / or form in response to a negative pressure difference and / or suction force being generated within the portion of the isolation chamber 230 defined between the flow controller 240 and the first uneven surface 221. For example, as shown in Figure 10, the flow controller 240 may be configured to transition, move, "reverse" and / or reconfigure to a second state and / or form in which the flow controller 240 and / or the second side of the flow controller 240 (opposite to the first side) is positioned adjacent to and / or in contact with the first uneven surface 221. In other words, the negative pressure difference and / or suction force pulls, pulls, and / or moves at least a portion of the flow controller 240 toward the first uneven surface 221 and away from the second uneven surface 226. Furthermore, 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] The transition of the flow controller 240 increases the internal volume of the 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. This increase in internal volume can create a negative pressure difference between the portion of the isolation chamber 230 (at least partially defined by the flow controller 240) and, for example, the inlet 213, which is operational when drawing at least a portion of the initial flow, amount, or volume of body fluid from the inlet 213 into the portion of the isolation chamber 230 through the flow path 215 and the first port 217. In some examples, the initial volume and / or flow of body fluid can be transferred into the isolation chamber 230 until, for example, the flow controller 240 is fully expanded, inverted, and / or transitioned, until the negative pressure difference decreases and / or equalizes, and / or until a desired volume of body fluid is placed in the portion of the isolation chamber 230.

[0089]

[0105] In some examples, it may be desirable to adjust and / or control the way the flow controller 240 transitions 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 Figures 2 to 11, for example, the second port 218 is located between the flow path 216 and the portion of the isolation chamber 230 defined between the flow controller 240 and the first uneven surface 221. A restrictor 219 is defined, contains, accepts, and / or is otherwise coupled to the restrictor 219, establishing fluid communication between the two.

[0090]

[0106] In some embodiments, the constrictor 219 can define a lumen or flow path having a relatively small diameter (for example, relative to the diameter of at least a portion of the flow path 216). For example, in some embodiments, the constrictor 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 constrictor 219 can have a diameter of less than 0.0005 inches or greater than 0.5 inches. In some embodiments, the constrictor 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 constrictor 219 can have a predetermined and / or desired length of less than 0.01 inches or greater than about 0.5 inches. Furthermore, in some embodiments, the throttling 219 may have any preferred combination of diameter and length that enables and / or provides the desired fluid (e.g., air) flow characteristics through at least a portion of the control device 200. While the throttling 219 has been described above as defining a relatively small lumen and / or flow path, in other embodiments, the throttling may have any preferred shape, size and / or configuration. For example, in some embodiments, the throttling may be any other preferred member or device configured to adjust the pressure difference across at least a portion of a porous material, a semipermeable member or membrane, a mechanical valve, a suspended solid and / or limiter and / or at least a portion of itself.

[0091]

[0107] In the embodiments shown in Figures 2 to 11, the relatively small diameter of the throttling 219 results in a lower negative pressure being applied through and / or within the aforementioned portion of the isolation chamber 230 than would be applied by a throttling with a larger diameter, or than if the second port 218 did not include or accept the throttling 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 difference having a magnitude (e.g., negative magnitude) of about 0.5 pounds / 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 (at or substantially such atmospheric pressure at 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. Therefore, by controlling the diameter and / or length of the throttling 219, the amount of negative pressure to which the above portion of the isolation chamber 230 is subjected, 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 throttling 219 can cause the negative pressure applied over or inside the above portion of the isolation chamber 230 to be delayed or increased.

[0092]

[0108] The pressure regulation described above is based on the diameter of the throttle 219 (i.e., a single restricted flow path), but it should be understood that this is presented merely as an example and not an limitation. Other means of adjusting the magnitude of the negative pressure to which the above portion of the isolation chamber 230 is subjected 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 may include any suitable number of restricted flow paths, each of which may have substantially the same diameter or different diameters. For example, in some embodiments, the control device may include up to 100 or more restricted flow paths. In such embodiments, each restricted flow path may have a diameter of about 0.0005 inches to about 0.1 inches, about 0.0005 inches to about 0.05 inches, or about 0.0005 inches to about 0.01 inches. In some embodiments, multiple restricted flow paths connect the outlet 214 and the isolation chamber. The system can be configured to selectively provide a flow path between the above-mentioned portion of the isolation chamber 230 and the above-mentioned portion of the isolation chamber 230 that exposes that portion to a negative pressure difference.

[0093]

[0109] In some embodiments, the rate at which the volume of one or more isolation chambers 230 increases can be adjusted by adjusting and / or controlling the magnitude of the pressure to which the above portion of the isolation chamber 230 is subjected. In some examples, the magnitude of the pressure applied to body fluids and / or into the patient's veins can be adjusted and / or limited by adjusting the rate of volume increase (and therefore the suction force). In some examples, such pressure adjustment can reduce the possibility of hemolysis of blood samples and / or vein collapse, for example. In some examples, by adjusting and / or controlling the amount or magnitude of negative pressure or suction, the control device 200 can be used over a wide range of patients who may have physiological challenges where negative pressure is necessary to facilitate the collection of body fluids, such as blood (i.e., the pressure difference between atmospheric pressure and the patient's vascular pressure is not sufficient to facilitate a consistent and sufficiently strong flow), but the rapid force is not so strong that it reduces, collapses, dents, and / or otherwise hinders the patency and ability to collect blood.

[0094]

[0110] In some embodiments, 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 way 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 240 transitions from a first state to a second state. In some examples, controlling the speed, sequence, and / or manner in which the flow controller 240 transitions can result in one or more desired flow characteristics related to the flow of air, gas, and / or bodily fluids into and / or through at least a portion of the isolation chamber 230.

[0095]

[0111] For example, an arrangement configuration included in this embodiment may be such that the transition and / or inversion of the third deformable portion 243 of the flow controller 240 is completed before the transition and / or inversion of the first deformable portion 241 and the second deformable portion 242 is completed. In some examples, this arrangement configuration may be such that a portion of the isolation chamber 230 defined collectively by the first deformable portion 241 and the first recess 227 of the second uneven surface 226 (e.g., a first volume portion of the isolation chamber 230) receives at least a portion of a certain volume of air that was in the flow path between the bodily fluid source and the isolation chamber 230 before the flow path receives and / or is filled with bodily fluid. Similarly, a portion of the isolation chamber 230 defined collectively by the second deformable portion 242 and the second recess 228 of the second uneven surface 226 (e.g., a second volume portion of the isolation chamber 230) can receive at least a portion of the same volume of air that was in the flow path. In other words, the transition of the flow controller 240 allows air or gas to be exhausted, discharged and / or purged from the flow path between the body fluid source and the isolation chamber 230, and such air or gas can then be collected, stored and / or contained in the first and second volume sections of the isolation chamber 230. Meanwhile, a portion of the isolation chamber 230 defined collectively by the third deformable portion 243 and the third recess 229 of the second uneven surface 226 (for example, the third volume section of the isolation chamber 230) can receive the initial volume of body fluid flowing through the flow path between the body fluid source and the isolation chamber 230 after the air or gas has been collected in the first and / or second volume sections of the isolation chamber 230.

[0096]

[0112] In some examples, the arrangement and / or transition sequence of the deformable parts 241, 242 and / or 243 can result in, for example, a uniform flow of the initial volume of body fluid into the third volume section of the isolation chamber 230. More specifically, the third deformable part 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 the first deformable part 241 and / or the second deformable part 242, thereby allowing the body fluid to The fluid can flow into and / or through at least a portion of the third deformable portion 243 with a substantially uniform surface. Thus, the third deformable portion 243 can be in a second state, shape and / or position before the fluid flow enters the isolation chamber 230. Therefore, the third volume 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 fluid flow enters the isolation chamber 230, thereby limiting partial aspiration of the fluid flow, inconsistent local flow velocities of the fluid flow, and / or uneven filling of the third volume of the isolation chamber 230 in other embodiments.

[0097]

[0113] As shown in Figures 8 and 10, the first uneven surface 221 includes recesses 222 and 223, each deeper than the portion of the first uneven surface 221 that is aligned with and / or otherwise associated with the deformable portion 243 of the flow controller 240. In other words, the distance between the first recesses 222 and 223 of the first uneven surface 221 and the first recesses 227 and 228 of the second uneven surface 226 is greater than the distance between the aforementioned portion of the first uneven surface 221 and the third recess 229 of the second uneven surface 226. Therefore, 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. Furthermore, the widths of the first deformable portion 241 and the second deformable portion 242 may be similar to or smaller than the width of the third deformable portion 243. In some examples, such arrangements allow the third deformable portion 243 to complete or substantially complete its transition and / or reversal before each of the first deformable portion 241 and the second deformable portion 242 has completed or substantially completed its transition and / or reversal. In other embodiments, the distance and / or width of one or more of the deformable portions 241, 242 and / or 243 to move can be modified (increased or decreased) to change and / or alter the speed, order and / or arrangement associated with the deformable portions 241, 242 and / or 243 transitioning and / or reversing from a first state to a second state.

[0098]

[0114] In some embodiments, by including fewer or more deformable parts, the relative stiffness of each deformable part or associated therewith can be changed, for example, and / or the speed and / or manner in which each deformable part moves or inverts can be controlled in other ways, thereby changing the speed and / or manner in which a fluid (e.g., air and / or volume) flows into the isolation chamber 230. For example, in some embodiments, by increasing the number of deformable parts, the surface area to which negative pressure is applied can be reduced, thereby increasing the pressure difference sufficient to move and / or invert the deformable parts. In Figures 8 and 10, deformable parts 241, 242 and 243 are shown as having substantially the same thickness, but in other embodiments, at least one deformable part may have a different thickness from the other deformable parts (for example, deformable part 241 may have a different thickness from deformable parts 242 and / or deformable parts 243 (or vice versa, or in other combinations)). In some examples, the stiffness of a deformable portion can be increased relative to the stiffness of other deformable portions by increasing the thickness of one deformable portion relative to the thickness of another. In some such examples, the increased stiffness of the thicker deformable portion allows other deformable portions (e.g., thinner deformable portions) to transition and / or invert before the thicker / stiffer deformable portion transitions and / or inverts. In some embodiments, a deformable portion may have different thicknesses along at least a portion of its length.

[0099]

[0115] In some embodiments, the size, shape, material properties, surface finish, etc. of the flow controller 240 and / or deformable parts 241, 242 and / or 243 may also facilitate, promote, and / or otherwise bring about a fluid flow having a substantially uniform surface. possible. For example, the third volume of the isolation chamber 230 (collectively defined by the third deformable portion 243 and the third recess 229 of the second uneven surface 226) may, at least in part, due to the surface tension between the flow of bodily fluid and each of the third deformable portion 243 and the third recess 229 of the second uneven surface 226, have a size, shape, diameter, perimeter and / or cross-sectional area that can limit and / or substantially prevent air from mixing with the bodily fluid flow (e.g., the front of the flow). In some embodiments, for example, the third volume of the isolation chamber 230 is about 0.0001 square inches (in 2 ) to about 0.16 in 2 , about 0.001 in 2 to about 0.08 in 2 , about 0.006 in 2 to about 0.06 in 2 , or about 0.025 in 2 to about 0.04 in 2 cross-sectional area. In other embodiments, the third volume of the isolation chamber 230 may have a cross-sectional area 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 textured member 225 (or at least its second textured surface 226) may 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 bring forth a fluid flow having a desired set of flow properties. In other embodiments, the flow controller 240 and / or the second textured surface 226 may have a coating configured to bring forth a desired set of flow properties. For example, in some embodiments, the flow controller 240 and / or the second textured surface 226 may be formed of and / or otherwise include a coating of a hydrophobic or hydrophilic material. Furthermore, at least a portion of the flow controller 240 and the textured member 225 (or at least its second textured surface 226) may be formed of or from the same material and / or include the same coating, or may be formed of or from different materials and / or include different coatings. Similarly, the flow controller 240 and / or the second uneven surface 226 may include any preferred surface finish that may be substantially the same or different. In some examples, a non-exclusive list of a desired set of flow characteristics may include one or more of the following: relatively uniform or smooth fluid flow, substantially laminar fluid flow and / or relatively low turbulent fluid flow, fluid flow with a substantially uniform front surface, fluid flow that does not readily mix with other fluids (e.g., air flow or a flow of body fluid that does not mix with a certain volume of air), relatively uniform velocity flow, and / or may include one or more of these.

[0101]

[0117] While some aspects and / or features of the embodiments shown in Figures 2 to 11 are described above, along with methods for modifying and / or "adjusting" such aspects and / or features, it should be understood that the flow controller and / or isolation chamber (or any structure forming the isolation chamber) may have any preferred arrangement configuration that results in a desired rate, manner and / or sequence for transporting an initial volume of bodily fluid into one or more portions or volumetric sections of the isolation chamber 230. In some embodiments, the flow controller and / or isolation chamber may include and / or incorporate any preferred combination of the aspects and / or features described above. Any number of the aspects and / or features described above may be included in the device, and such aspects and / or features may work together or cooperate to produce a desired fluid flow and / or desired fluid flow characteristics through at least a portion of the isolation chamber. Furthermore, it should be understood that the aspects and / or features described above are provided merely as examples and not as limitations.

[0102]

[0118] Once the initial volume of bodily fluid is transferred to the isolation chamber 230, as described above, force can be applied to the end 251 of the actuator 250 to move and / or set the actuator 250 to its second position, state, operating mode and / or form. In some examples, the actuator 250 can be moved from a locked form or state to an unlocked form or state before force is applied to the end 251 of the actuator 250, as shown in Figures 2 to 11. In some embodiments, the transition of actuator 250 can be achieved by user interaction with and / or operation of actuator 250, and / or brought about by such interaction in other ways. However, in other embodiments, the transition of actuator 250 can occur automatically in response to the dynamics of negative pressure and / or associated flow within 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 result in the transition of actuator 250.

[0103]

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

[0104]

[0120] Figures 12 to 21 show a fluid control device 300 according to another embodiment. The fluid control device 300 (hereinafter also referred to as the “control device” or “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, the device 300 may be configured such that, depending on whether it is fluidly connected to a negative pressure source (e.g., suction or vacuum source), it (1) draws bodily fluid from a bodily fluid source into the device 300, (2) separates and isolates a first portion or volume (e.g., initial volume) of the bodily fluid in a part of the device 300, and (3) a second portion or volume (e.g., subsequent volume) flows through the device 300 (bypassing the isolated initial volume) into a fluid collection device fluidly coupled to the device 300. Thus, contaminants can be isolated in or with the initial volume of bodily fluid, leaving a subsequent volume of bodily fluid that is substantially free of contaminants. In some embodiments, parts and / or aspects of the control device 300 may be similar to and / or substantially identical to parts and / or aspects of the control device 200 described above with reference to Figures 2 to 11. Therefore, such similar parts and / or aspects may not be described in further detail in this specification.

[0105]

[0121] The fluid control device 300 (hereinafter also referred to as the “control device” or “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 parts of the housing 310 and / or actuator 350 can be physically and fluidly coupled (e.g., by the end user) to form the control device 300 together. Similarly, several In one embodiment, the control device 300 may be packaged, transported, and / or stored separately from fluid collection devices (e.g., sample reservoir, syringe, etc.) and / or inlet devices (e.g., needle, catheter, PIV, PICC, etc.) that the user can combine with the control device 300 before or during use. In other embodiments, the control device 300 does not need to be modular. For example, in some embodiments, the control device 300 may be assembled during manufacturing and delivered to the supplier and / or end user as an assembled device. In some embodiments, the control device 300 may include a fluid collection device such as any of those described above and / or may be pre-combined 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 may include an inlet device such as any of those described herein and / or may be pre-combined to such an inlet device.

[0106]

[0122] The housing 310 of the control device 300 may be any preferred 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, receives, accommodates, and / or at least partially defines the isolation chamber 330. As described further in this specification, the housing 310 may 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 Figures 12 to 16, the actuator portion 312 of the housing 310 includes an inlet 313 and an outlet 314, defining a flow path 315 (e.g., a first flow path) configured to selectively place the inlet 313 in a fluidically connected state with a first port 317, and a flow path 316 (e.g., a second flow path) configured to selectively place the outlet 314 in a fluidically connected state with a second port 318. The inlet 313 of the housing 310 is configured to be fluidly connected to a body fluid source (e.g., fluidly communicating with the patient via a needle, IV catheter, PICC line, etc.) and to receive a flow of body fluid from there, as described in detail above. The outlet 314 is configured to be fluidly coupled to a fluid collection device such as any of the above (e.g., a sample reservoir, syringe, culture bottle, intermediate body fluid transfer device, or adapter, etc.). The fluid collection device can define and / or be operated to define a vacuum or negative pressure, which results in a negative pressure difference between desired portions of the housing 310 when the fluid collection device is coupled to the outlet 314. Furthermore, after an initial volume of body fluid has been transferred into the isolation chamber 330, fluid communication can be established between the passages 315 and 316 so that a subsequent volume (e.g., a sample of body fluid) flows through the device 300 into the fluid collection device. Thus, the actuator portion 312 of the housing 310 can be substantially similar, at least in form and / or function, to the actuator portion 212 of the housing 210, and therefore will not be described in further detail herein.

[0108]

[0124] The isolation portion 320 of the housing 310 may be any preferred shape, size, and / or configuration. For example, as shown in Figures 16 to 18, the isolation portion 320 includes and / or has an inner surface, and a portion of the inner surface is arranged and / or configured to form the first uneven surface 321. As will be described in more detail herein, at least a portion of the first uneven surface 321 may form and / or define a portion of the isolation chamber 330. Furthermore, as will be described in more detail herein, the first port 317 and the second port 318 form and / or extend through a portion of the first uneven surface 321 so as to selectively place the isolation chamber 330 in a fluidly connected state with the flow paths 315 and 316. It is structured in this way.

[0109]

[0125] The isolation portion 320 includes, is formed and / or accommodates, an outer casing member 325 and a flow controller 340. More specifically, as shown in Figures 16 to 18, the isolation portion 320 accepts and / or is coupled to the outer casing member 325 such that the flow controller 340 is positioned between the isolation portion 320 and the outer casing member 325. In some embodiments, the outer casing member 325 can be fixedly bonded to the isolation portion 320 via adhesive, ultrasonic welding, and / or any other preferred bonding method. In some embodiments, the outer casing member 325, the isolation portion 320 and the flow controller 340 together can form a substantially fluid seal and / or airtight seal that separates the isolation portion 320 from the volume outside the isolation portion 320.

[0110]

[0126] As shown in the figure, the cover 335 is positioned around the outer member 325, and the cover 335 and the isolation portion 320 of the housing 310 are configured to surround and / or house the outer member 325 and the flow controller 340. In some embodiments, the cover 335 can be bonded to the outer member 325 and / or isolation portion 320 via adhesive, ultrasonic welding, one or more mechanical fasteners, friction fit, snap fit, screw coupling, and / or any other preferred bonding method. In some embodiments, the cover 335 can define openings, windows, slots, etc., configured to allow visualization of at least a portion of the isolation chamber 330. Although the outer member 325 and the cover 335 have been described above 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 casing member 325 includes and / or forms a second uneven surface 326. The arrangement of the outer casing member 325 and the isolation portion 320 of the housing 310 may 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 casing member 325 (see, for example, Figure 18). Thus, the 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. Furthermore, as will be described in more detail herein, the flow controller 340 may be positioned between the first uneven surface 321 and the second uneven surface 326 and may be configured to transition between a first state and a second state in response to a negative pressure difference and / or suction force being applied to at least a portion of the isolation chamber 330.

[0112]

[0128] Ports 317 and 318 of the housing 310 may be of any preferred shape, size, and / or configuration. As described in detail 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 bodily fluid from the inlet 313 and / or the flow path 315 to the first portion of the isolation chamber 330 as the flow controller 340 transitions from a first state to a 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 of the flow controller 340 (for example, the side opposite to the first side). Therefore, as described in detail with respect to 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 the fluid collection device, which is operable to cause the flow controller 340 to transition from its first state to its second state. Furthermore, the second port 318 can include and / or be coupled to a throttle 319, which restricts and / or limits the flow of fluid (e.g., air or gas) between the second portion of the isolation chamber 330 and the flow path 316, as described in detail with respect to the throttle 219 of device 200, thereby enabling the flow controller 340 to It is configured to adjust and / or control the magnitude of the pressure difference and / or suction force that is applied or received by the flow controller 340.

[0113]

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

[0114]

[0130] In the embodiments shown in Figures 12 to 21, the flow controller 340 is a bladder formed of or 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. Furthermore, 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 further detail herein, the flow controller 340 may include one or more portions configured to form one or more seals between the flow controller 340 and each of the uneven surfaces 321 and 326, and / or between the flow controller 340 and each of the uneven surfaces 321 and 326.

[0115]

[0131] The deformable portions 341 and 342 of the flow controller 340 may be relatively thin and flexible portions configured to deform in response to a pressure difference between the first side and the second side of the flow controller 340. More specifically, each of the deformable portions 341 and 342 may have a thickness of about 0.005 inches. For example, as shown in Figures 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 uneven surfaces 321 and / or 326. Thus, as will be described in more detail herein, the deformable portions 341 and 342 and the corresponding portions of the uneven surfaces 321 and / or 326 together may form and / or define one or more channels, volumetric portions, 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 positioned adjacent to and / or substantially in contact with the first recess 327 formed by the second uneven surface 326, and the second deformable portion 342 can be positioned adjacent to and / or substantially in contact with the second recess 328 formed by the second uneven surface 326. Thus, isolation channels The first portion of 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 very small volume. In contrast, when the flow controller 340 transitions from its first state to its second state (for example, in response to negative pressure applied and / or transmitted through the second port 318), the first deformable portion 341 can be positioned adjacent to and / or substantially in contact with the first recess 322 formed by the first uneven surface 321, and the second deformable portion 342 can be positioned adjacent to and / or substantially in 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, increasing the volume of the first portion of the isolation chamber 330 can create a negative pressure or vacuum that can be operated to draw an initial volume of body fluid into the isolation chamber 330 along with a certain volume of air or gas.

[0117]

[0133] While the flow controller 340 has been specifically described, in other embodiments, the flow controller 340 and / or the isolation chamber 330 may have any preferred configuration and / or arrangement. For example, in some embodiments, the uneven surfaces 321 and / or 326 may 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 recesses may be varied. Similarly, the flow controller 340 may be modified in any preferred manner to substantially correspond to the shape and / or configuration of the uneven surfaces 321 and / or 326. While the flow controller 340 has been described as a bladder, etc., including multiple deformable parts, in other embodiments, the flow controller may 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 preferred reconfigurable container, etc. Furthermore, the isolation chamber 330, at least partially formed by the flow controller 340, can have any preferred shape, size, and / or configuration.

[0118]

[0134] The actuator 350 of the control device 300 may be of any preferred shape, size, and / or configuration. At least a portion of the actuator 350 is located 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 Figures 12 to 21, the actuator 350 is configured as an actuator rod or plunger 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 located outside the housing 310, the end 351 being configured to cause the actuator 350 to be operated by a user to transition between a first state in which the flow path 315 can establish fluid communication between the inlet 313 and the first port 317 and a 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 outlet 314 are fluidly connected via the flow paths 315 and 316 and / or at least a portion of 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 Figures 2 to 11. Therefore, the actuator 350 will not be described in further detail herein.

[0119]

[0135] Using device 300, a sample of body fluid with reduced contamination (e.g., contamination from microorganisms such as commensal skin microorganisms, microorganisms outside the body fluid source, etc.) can be obtained in substantially the same manner as described above with respect to device 200. For example, using Previously, device 300 can be in its first, initial and / or storage state or operating mode, with each of the flow controller 340 and actuator 350 in its respective first or initial state. With device 300 in the first state, a user such as a physician, internist, nurse, phlebotomist, or technician can operate device 300 to establish fluid communication between the inlet 313 and a body fluid source (e.g., a patient's vein). Once the inlet 313 is in a state of fluidic connection with the body fluid source, the outlet 314 can be fluidicated to a fluid collection device (not shown in Figures 12 to 21). In the embodiments shown in Figures 12 to 21, for example, the fluid collection device may 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 force, vacuum, and / or energy potential.

[0120]

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

[0121]

[0137] The flow controller 340 is in a first state and / or form before the fluid collection device is coupled to the outlet 314. In the embodiments shown in Figures 12 to 21, the flow controller 340 is a fluid-impermeable bladder, etc., which can have an inverted, reversed, crushed, and / or empty form (e.g., the first state and / or form) before the fluid collection device is coupled to the outlet 314. For example, as shown in Figure 18, when the flow controller 340 is in its first state and / or form, the flow controller 340 can be positioned adjacent to and / or in contact with the second uneven surface 326.

[0122]

[0138] As described above, the flow controller 340 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 the portion of the isolation chamber 330 defined between the flow controller 340 and the first uneven surface 321. For example, when the flow controller 340 is in its first state (Figure 18), it can be positioned adjacent to and / or in contact with the second uneven surface 326, and it can transition, move, "reverse", place, and / or reconfigure in other ways to its second state (Figure 20) where the flow controller 340 is positioned adjacent to and / or in contact with the first uneven surface 321. Furthermore, when the actuator 350 is in its first state and the flow controller 340 is in its second state, the control device 300 is placed in its second state and / or form.

[0123]

[0139] The transition of the flow controller 340 increases the internal volume of the portion of the isolation chamber 330 defined between the surface of the flow controller 340 (for example, the second surface opposite to the first surface) and the second uneven surface 326. As described in detail with respect to device 200, the increase in internal volume can result in a negative pressure difference between the portion of the isolation chamber 330 (at least partially defined by the flow controller 340) and, for example, the inlet 313, which is operable when drawing 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 portion of the isolation chamber 330. In some examples, for example, the flow controller 340 expands completely, The initial volume and / or flow of body fluid can be transferred into the isolation chamber 330 until it reverses and / or transitions, until the negative pressure difference decreases and / or equalizes, and / or until a desired volume of body fluid is placed in the portion of the isolation chamber 330. Furthermore, as described above with respect to device 200, the throttle 319 can be configured to limit, restrict, control and / or adjust the magnitude of the negative pressure difference and / or suction force generated in the isolation chamber 330 and / or on the surface of the flow controller 340, thereby adjusting the suction force in one or more flow paths and / or body fluid sources (e.g., patient veins). In other embodiments, the second port 318 and / or any preferred portion of device 300 can be configured to adjust the suction force in one or more portions of the isolation chamber 330 in any preferred manner, such as the embodiment described above with respect to 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 way in which the negative pressure difference or suction force is applied can be used to instruct and / or control the speed and / or manner in which the flow controller 340 transitions from a first state to a second state. For example, although the flow controller 240 has been described above as including a first deformable portion 241, a second deformable portion 242, and a third deformable portion 243, the flow controller 340 included in the embodiments shown in Figures 12 to 21 includes only the first deformable portion 341 and the second deformable portion 342. Furthermore, as shown in Figures 18 and 20, the recesses 322 and 323 of the first uneven surface 321 have substantially the same depth. In some embodiments, such arrangements can, for example, limit and / or reduce the amount of negative pressure and / or suction force sufficient to move and / or reverse the first deformable portion 341 and the second deformable portion 342 of the flow controller 340, relative to the amount of negative pressure and / or suction force sufficient to move and / or reverse the first deformable portion 341 and / or reverse the second deformable portion 342 of the flow controller 340.

[0125]

[0141] As described above, in some embodiments, the first deformable portion 341 may have a thickness and / or stiffness greater than that of the second deformable portion 342, so 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 controller 340 may include any preferred features, structures, material properties, surface finishes, etc., and / or any other part of the device 300 may include any preferred features, structures, etc., configured to control the order and / or manner in which the flow controller 340 transitions from a first state to a second state, such as any of those described above with respect to the flow controller 240. In some embodiments, the arrangement configuration of the flow controller 340 may make the device 300 compatible with fluid collection devices having a relatively low amount of negative pressure. In some embodiments, such arrangement configurations may also facilitate and / or simplify one or more manufacturing processes, etc. In some examples, controlling the speed, sequence, and / or manner can result in one or more desired flow characteristics related to the flow of air, gases, and / or bodily fluids into and / or through at least a portion of the isolation chamber 230.

[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 (for example, the first volume portion of the isolation chamber 330) can be configured to receive a certain volume of air that was 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 shifting the flow 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 such air or gas can then be stored and / or contained in the first and second volume portions of the isolation chamber 330. On the other hand, the portion of the isolation chamber 330 defined collectively by the second deformable portion 342 and the second recess 328 of the second uneven surface 326 (for example, the portion of the isolation chamber 330) The second volume section can be configured to receive an initial volume of body fluid flowing through a channel 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 arrangement configuration of the isolation chamber 330 and / or the flow controller 340 can result in a uniform flow of an initial volume of body fluid into, for example, the second volume of the isolation chamber 330. For example, as described in detail 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 of the isolation chamber 330 (e.g., the second volume of the isolation chamber 330) with respect to a uniform flow front and without substantially mixing with the volume of air that is inside the isolation chamber 330. In other embodiments, the flow controller may have any other preferred arrangement configuration to result in a desired rate, manner and / or sequence of transporting an initial volume of body fluid into one or more portions or volume sections of the isolation chamber 330, such as any of those described above with respect to device 200.

[0128]

[0144] Once the initial volume of bodily fluid is transferred into the isolation chamber 330, as described above, force can be applied to the end 351 of the actuator 350 to move and / or place the actuator 350 into its second position, state, operating mode and / or form. In some examples, the actuator 350 can be moved from a locked form or state to an unlocked form or state before force is applied to the end 351 of the actuator 350. In the embodiments shown in Figures 12 to 21, the movement of the actuator 350 can be achieved and / or otherwise may occur by user interaction and / or operation of the actuator 350. However, in other embodiments, the movement of the actuator 350 can occur automatically in response to the dynamics of negative pressure and / or associated flow within the device 300 and / or can be carried out by or in response to an external energy source that generates one or more dynamics or states resulting in the movement of the actuator 350.

[0129]

[0145] As shown in Figures 19 to 21, when the flow controller 340 and actuator 350 are each in their second state, the control device 300 is placed in its third state. When actuator 350 transitions from its second state, position and / or form, the inlet 313 and outlet 314 are placed in a fluidically connected state (e.g., via the flow path 316 and / or flow channel 352), while the flow path 315 and / or first port 317 are isolated, separated, and / or not in fluid communication with the inlet 313 and / or outlet 314 in any other way. Thus, the 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). Furthermore, in some examples, contaminants such as commensal skin microorganisms and / or other arbitrary contaminants may be mixed into and / or contained in the initial volume of body fluid, and therefore, when the initial volume is isolated within the isolation chamber 330, these contaminants are isolated within that isolation chamber 330. Therefore, the negative pressure that was otherwise applied over or through the flow path 316 and through the second port 318 is now applied to or through the outlet 314 and inlet 313, for example, through at least a portion of the flow channels 352 of the actuator 350 (Figure 21). Accordingly, the bodily fluid can flow from the inlet 313, through the actuator portion 312 of the housing 310, through the outlet 314, and into the fluid collection device coupled to the outlet 314. Thus, device 300 can function in substantially the same manner as 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 (hereinafter also referred to herein as the “control device” or “device”) may be similar in at least form and / or function to the devices 100, 200 and / or 300 described above. For example, as described above with respect to devices 100, 200 and / or 300, the device 400 may be configured such that, depending on whether it is fluidly connected to a negative pressure source (e.g., suction or vacuum source), it (1) draws body fluid from a body fluid source into the device 400, (2) separates and isolates a first portion or volume (e.g., initial volume) of the body fluid in a portion of the device 400, and (3) a second portion or volume (e.g., subsequent volume) of the body fluid flows through the device 400 (bypassing the isolated initial volume) into a fluid collection device fluidly coupled to the device 400. Therefore, contaminants can be isolated in or with the initial volume of body fluid, leaving a subsequent volume of body fluid that is substantially free of contaminants. In some embodiments, parts and / or aspects of the control device 400 may be similar to and / or substantially identical to parts and / or aspects of the control device 200 described above with reference to at least Figures 2 to 11. Therefore, such similar parts 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 portion of the control device 400 may be arranged in a modular configuration (for example, including one or more independent or distinct components that are assembled later), or in an integrated or at least partially integrated configuration (for example, including one or more components that are pre-assembled or pre-coupled). For example, in some embodiments, the control device 400 may include and / or be coupled to a fluid collection device and / or inlet device, such as any of the above.

[0132]

[0148] The housing 410 of the control device 400 may be any preferred shape, size, and / or configuration. Generally, the housing 410 may be substantially similar to the housing 210, at least in form and / or function. Accordingly, some components, features, aspects, and / or functions of the housing 410 are identified in the drawings and described below, but these similarities are not described in further detail herein, and these similarities should be considered in the same way as the corresponding components, features, aspects, and / or functions of the device 200 described above, unless explicitly stated 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, accommodates, and / or at least partially defines the isolation chamber 430. As described further in this specification, the housing 410 may 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, defining a flow path 415 (e.g., a first flow path) configured to selectively place the inlet 413 into a fluidized state with a first port 417, and a flow path 416 (e.g., a second flow path) configured to selectively place the outlet 414 into a fluidized state with a second port 418. The actuator portion 412 of the housing 410 is substantially similar to the actuator portion 212 of the housing 210, at least in form and / or function. This is possible, and therefore, this specification will not provide further details.

[0135]

[0151] The isolation portion 420 of the housing 410 may be any preferred shape, size, and / or configuration. The isolation portion 420 includes, is formed, and / or accommodates the outer member 425 and the flow controller 440. More specifically, the cover 435 is positioned around the outer member 425 so that the cover 435 and the isolation portion 420 of the housing 410 surround and / or accommodate the outer 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 may be substantially similar, at least in 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 therefore will not be described in further detail herein.

[0136]

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

[0137]

[0153] The first uneven surface 421 can have any preferred shape, curves, and / or texture, and may 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, the first contour surface 421 may differ from the first uneven surface 221 by including any number of ventilation ridges 424, as shown in Figures 24 to 27. The distribution of ventilation ridges 424 on the first contour surface 421 may include multiple arrangements. For example, as shown in Figures 25 and 27, the first contour surface 421 may have one ventilation ridge 424, multiple ventilation ridges 424, multiple concentric ventilation ridges 424, etc., located within and / or formed by the first recess 422, and / or having one ventilation ridge 424, multiple ventilation ridges 424, multiple concentric ventilation ridges 424, etc., located within and / or formed by the second recess 423 of the first contour surface 421. In some embodiments, the ventilation ridges 424 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 first contour surface 421 in response to negative pressure (e.g., negative pressure in the volume between the first contour surface 421 and the flow controller 440) being applied and / or transmitted via the second port 418. In other words, the ventilation ridges 424 can form discontinuities along one or more portions of the first contour surface 421, as described in further detail herein, which can prevent air from being trapped in a local area between the flow controller 440 and one or more portions of the first contour surface 421, for example, by allowing air to flow freely between the flow controller 440 and one or more portions of the first contour surface 421.

[0138]

[0154] As shown in Figures 24 to 27, the isolation portion 420 receives and / or is coupled to the outer casing member 425 such that the flow controller 440 is positioned between the isolation portion 420 and the outer casing member 425. In some embodiments, the outer casing member 425 may be substantially similar in at least form and / or function to the outer casing member 225 described above with respect to the device 200. For example, the contoured member 425 includes and / or forms a second contoured surface 426. The second contoured surface 426 may have any preferred shape, curved portion and / or texture The second contour surface 426 can be substantially similar to, for example, the second contour surface 226 of the housing 220. For example, the second contour 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 may differ from the second contour surface 226 by including any number of ventilation channels 431, as shown in Figures 24 to 27. The distribution of ventilation channels 431 on the second contour surface 426 can include multiple arrangements. For example, as shown in Figures 25 and 27, the second contour surface 426 may be configured to have one ventilation channel 431, multiple ventilation channels 431, or multiple concentric ventilation channels 431 located within and / or formed by the first recess 427, and / or one ventilation channel 431, multiple ventilation channels 431, or multiple concentric ventilation channels 431 located within and / or formed by the second recess 428 of the second contour surface 426. The ventilation channels 431 are configured such that, as described above with respect to the ventilation ridge 424, when brought into contact with the second contour surface 426 in response to negative pressure (for example, in the volume between the first uneven surface 421 and the flow controller 440), they reduce and / or control the ability or possibility of the flow controller 440 or a part thereof to form a seal.

[0139]

[0155] While the first contour surface 421 is described above as including a ventilation bulge 424, and the second contour surface 426 is described above as including a ventilation channel 431, it should be understood that the ventilation bulge 424 and the ventilation channel 431 are presented merely as examples and not as limitations. Various alternative forms and / or combinations are contemplated. For example, in some embodiments, the first contour surface 421 may include a ventilation channel and the second contour surface 426 may include a ventilation bulge. In other embodiments, the first contour surface 421 and / or the second contour surface 426 may include a combination of a ventilation channel and a ventilation bulge. Thus, the contour surfaces 421 and 426 may include one or more discontinuities having any preferred shape, size and / or configuration that can enable and / or ensure that air can flow between the flow controller 440 and the contour surfaces 421 and 426. Furthermore, although each of the contour surfaces 421 and 426 is shown as including a ventilation feature or discontinuity, in other embodiments, the first contour surface 421 may include a ventilation feature or discontinuity, while the second contour surface 426 may not, and vice versa.

[0140]

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

[0141]

[0157] In the embodiments shown in Figures 22 to 27, the flow controller 440 is approximately 30 shots. A is a bladder made of or from silicone having a durometer hardness of A. The flow controller 440 (for example, the bladder) includes a first deformable portion 441, a second deformable portion 442, and a third deformable portion 443. Furthermore, 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 may include one or more portions configured to form one or more seals between the flow controller 440 and each of the uneven surfaces 421 and 426, and / or between the flow controller 440 and each of the uneven surfaces 421 and 426. For example, as shown in Figures 24 to 27, the deformable portions 441, 442, and 443 of the flow controller 440 correspond to at least a portion of the uneven surface 421 and / or 426, and / or have substantially the same overall shape as that portion. Accordingly, as will be described in more detail herein, the deformable portions 441, 442 and 443 and the corresponding portions of the uneven surfaces 421 and / or 426 can together form and / or define one or more volumetric portions, etc., which can further receive an initial volume of bodily 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 positioned adjacent to and / or substantially in contact with the first recess 427 formed by the second uneven surface 426, the second deformable portion 442 can be positioned adjacent to and / or substantially in contact with the second recess 428, and the third deformable portion 443 can be positioned adjacent to and / or substantially in contact with the second recess 429 formed by the second uneven surface 426. Thus, the first portion of the isolation chamber 430 (for example, 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 very small volume. In contrast, when the flow controller 440 transitions from its first state to a second state (for example, in response to negative pressure applied and / or transmitted via the second port 418), at least the deformable portions 441, 442 and 443 are positioned adjacent to and / or substantially in contact with the first uneven surface 421. More specifically, as described above with respect to the flow controller 240, the first deformable portion 421 may be positioned adjacent to and / or substantially in contact with a first recess 422 formed by the first uneven surface 421, the second deformable portion 442 may be positioned adjacent to and / or substantially in contact with a second recess 423 formed by the first uneven surface 421, and the third deformable portion 243 may be positioned adjacent to and / or substantially in contact with, for example, a non-recessed portion of the first uneven surface 421.

[0143]

[0159] The actuator 450 of the control device 400 may be of any preferred shape, size, and / or configuration. At least a portion of the actuator 450 is located 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 Figures 22 to 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 located outside the housing 410, the end 451 being configured to be operated by a user to cause the actuator 450 to transition between a first state in which the flow path 415 can establish fluid communication between the inlet 413 and the first port 417 and a 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 outlet 414 are fluidly connected via the flow paths 415 and 416 and / or at least a portion of the flow channel 452 of the actuator 450. It is placed in [location]. Therefore, the actuator 450 is similar in form and / or function to the actuator 250 described above with reference to Figures 2 to 11. Therefore, the actuator 450 will not be described in further detail in this specification.

[0144]

[0160] Using device 400, a sample of body fluid with reduced contamination (e.g., contamination from microorganisms such as commensal skin microorganisms or microorganisms outside the body fluid source) can be obtained in substantially the same manner as described above with respect to device 200. For example, before use, device 400 may be in its first, initial and / or storage state or operating mode, with each of the flow controller 440 and actuator 450 in its respective first or initial state. With device 400 in the first state, a user such as a physician, internist, nurse, phlebotomist, or technician can operate device 400 to establish fluid communication between the inlet 413 and the body fluid source (e.g., a patient's vein). Once the inlet 413 is in a state of fluidic connection with the body fluid source, the outlet 414 can be fluidicated to a fluid collection device (not shown in Figures 22-27). In the embodiments shown in Figures 22 to 27, for example, the fluid collection device may 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 force, vacuum, and / or energy potential.

[0145]

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

[0146]

[0162] The flow controller 440 is in a first state and / or form before the fluid collection device is coupled to the outlet 414. In the embodiments shown in Figures 22 to 27, the flow controller 440 is a fluid-impermeable bladder, etc., which can have an inverted, reversed, crushed, and / or empty form (e.g., the first state and / or form) before the fluid collection device is coupled to the outlet 414. For example, as shown in Figures 24 and 25, when the flow controller 440 is in its first state and / or form, the flow controller 440 can be positioned adjacent to and / or in contact with the second uneven surface 426.

[0147]

[0163] As described above, the controller 440 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 the portion of the isolation chamber 430 defined between the flow controller 440 and the first uneven surface 421. For example, when the flow controller 440 is in its first state (Figures 24 and 25), it can be positioned adjacent to and / or in contact with the second uneven surface 426, and it can transition, move, "reverse", place, and / or reconfigure in other ways to its second state in which the flow controller is positioned adjacent to and / or in contact with the first uneven surface 421. Furthermore, the ventilation channel 431 formed by the second contour surface 426 allows air to flow between the second uneven surface 426 and the flow controller 440, thereby, in some examples, when positive pressure (for example, positive pressure that drives and / or biases the flow controller 440 toward the second uneven surface 426 during manufacturing, inspection and / or use, etc.) is applied and / or when positive pressure is applied in the volume between the flow controller 440 and the first uneven surface 421 via the port 418, the air pocket becomes the The possibility of being trapped between the uneven surface 426 and the flow controller 440 can be reduced.

[0148]

[0164] When actuator 450 is in its first state and flow controller 440 is in its second state, control device 400 is placed in its second state and / or configuration. The transition of flow controller 440 increases the internal volume of the portion of isolation chamber 430 defined between the surface of flow controller 440 (e.g., the second surface opposite to the first surface) and the second uneven surface 426. As described in detail with respect to device 200, the increase in internal volume can result in a negative pressure difference between the portion of isolation chamber 430 (at least partially defined by flow controller 440) and, for example, the inlet 413, which is operational when drawing at least a portion of the initial flow, amount, or volume of bodily fluid from the inlet 413 through the flow path 415 and the first port 417 into the portion of isolation chamber 430. In some embodiments, for example, the initial volume and / or flow of body fluid can be transferred into the isolation chamber 430 until the flow controller 440 is fully expanded, inverted and / or transitioned, until the negative pressure difference decreases and / or equalizes, and / or until a desired volume of body fluid is placed in the portion of the isolation chamber 430. Furthermore, as described above with respect to device 200, the throttle 419 can be configured to limit, restrict, control and / or adjust the magnitude of the negative pressure difference and / or suction force generated in the isolation chamber 430 and / or on the surface of the flow controller 440, thereby adjusting the suction force in one or more flow paths and / or body fluid sources (e.g., a patient's vein). In other embodiments, the second port 418 and / or any preferred portion of device 400 can be configured to adjust the suction force in one or more portions of the isolation chamber 30 in any preferred manner, such as the embodiment described above with respect to device 200.

[0149]

[0165] In some embodiments, 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 rise 424, the magnitude of the negative pressure difference or suction force, and / or the way in which the negative pressure difference or suction force is applied can define and / or control the speed, sequence, and / or manner in which the flow controller 440 transitions from a first state to a second state. In some examples, controlling the speed, sequence, and / or method of transition of the flow controller 440 can result in one or more desired flow characteristics relating to the flow of air, gas, and / or bodily fluids into and / or through at least a portion of the isolation chamber. For example, an arrangement configuration included in this embodiment may be such that the transition and / or reversal of the third deformable portion 443 of the flow controller 440 is completed before the transition and / or reversal of the first deformable portion 441 and the second deformable portion 442 is completed. Furthermore, the arrangement of the ventilation ridges 424 along the first uneven surface 421 can increase the likelihood, and / or ensure, that the flow controller 440 moves and / or reverses in a desired manner or order by blocking possible flow restrictors and / or seals (which could potentially prevent negative pressure differences or suction forces from moving the portion of the flow controller 440 located on the opposite side of the restrictor or seal).

[0150]

[0166] This configuration may be such that a portion of the isolation chamber 430 defined collectively by the first deformable portion 441 and the first recess 427 of the second uneven surface 426 (for example, the first volume portion of the isolation chamber 430) 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 receives and / or is filled with body fluid. Similarly, a portion of the isolation chamber 430 defined collectively by the second deformable portion 442 and the second recess 428 of the second uneven surface 426 (for example, the second volume portion of the isolation chamber 430) can receive at least a portion of the aforementioned volume of air that was in the flow path. Alternative configurations for the isolation chamber 430 and / or the flow controller 440 are as described above with respect to the isolation chamber 230 and / or the flow controller 240. They can be similar in form and function, and therefore, they are not described in further detail in this specification.

[0151]

[0167] Once the initial volume of bodily fluid is transferred into the isolation chamber 430, as described above, force can be applied to the end 451 of the actuator 450 to move and / or place the actuator 450 into its second position, state, operating mode and / or form. In some examples, the actuator 450 can be moved from a locked form or state to an unlocked form or state before force is applied to the end 451 of the actuator 450. In the embodiments shown in Figures 22 to 27, the transition of the actuator 450 can be achieved and / or otherwise may occur by user interaction and / or operation of the actuator 450. However, in other embodiments, the transition of the actuator 450 can occur automatically in response to the dynamics of negative pressure and / or associated flow within the device 400 and / or can be carried out by or in response to an external energy source that generates one or more dynamics or states resulting in the transition of the actuator 450.

[0152]

[0168] As shown in Figures 26 and 27, when the flow controller 440 and actuator 450 are in their second state, the control device 400 is placed in its third state. When actuator 450 transitions from its second state, position and / or form, the inlet 413 and outlet 414 are placed in a fluidically connected state (e.g., via the flow path 416 and / or flow channel 452), while the flow path 415 and / or first port 417 are isolated, separated, and / or not in fluid communication with the inlet 413 and / or outlet 414 in any other way. Thus, the initial volume of body fluid is isolated within a portion of the isolation chamber 430. Furthermore, in some examples, contaminants such as commensal skin microorganisms and / or other arbitrary contaminants may be mixed into and / or contained in the initial volume of body fluid, and therefore, when the initial volume is isolated within the isolation chamber 430, these contaminants are also isolated within that isolation chamber 430. Therefore, 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 inlet 413, for example, through at least a portion of the flow channels 415 and 416 and / or the flow channel 452 of the actuator 450. Accordingly, the bodily fluid can flow from the inlet 413, through the actuator portion 412 of the housing 410, through the outlet 414, and into the fluid collection device coupled to the outlet 414. Thus, device 400 can function in substantially the same manner as devices 100 and / or 200 described in detail above.

[0153]

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

[0154]

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

[0155]

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

[0156]

[0172] In 14, the first portion of the isolation chamber receives a certain volume of air contained in a defined flow path between the body fluid source and the isolation chamber, in proportion to the 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 lumen-containing device, which is further inserted into a portion 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 one or more lumenes such as flow paths, channels, openings, ports 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 may be, for example, the center or central portion of the isolation chamber. In some embodiments, the first portion of the isolation chamber may be formed by any number of regions, volumes and / or compartments (similar to, for example, isolation chambers 230 and / or 430 described above). In other embodiments, the first portion of the isolation chamber may be a single and / or continuous portion (similar to, for example, isolation chamber 330 described above). In yet another embodiment, the first portion and the second portion of the isolation chamber may be "inline" 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 is as described in U.S. Patent Application Publication No. 2019 / 0 entitled "Fluid Control Devices and Methods of Using the Same," filed September 12, 2018. Details are provided in Publication No. 076074 (hereinafter referred to as "Publication No. 074"). It may have a similar shape and / or arrangement configuration, the disclosure of which application is incorporated herein by reference in whole.

[0158]

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

[0159]

[0175] After receiving an initial volume of bodily fluid, in 16, the actuator of the device transitions from a first to a second state to (1) isolate the isolation chamber and (2) allow a subsequent volume of bodily fluid to flow from the inlet to the outlet in response to the suction force. In some embodiments, the actuator can transition from a first state to a second state to automatically isolate the initial volume of bodily 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 may be a rod or plunger including one or more seals, etc., that can (1) fluidically separate at least a portion of the flow path between the inlet and the isolation chamber, (2) fluidically 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 so that a subsequent volume of bodily fluid flows between them.

[0160]

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

[0161]

[0177] While various embodiments have been described above, it should be understood that they are presented merely as examples and not as limitations. Where the schematic diagrams and / or embodiments described above show some components arranged in some orientation or position, the arrangement of those components can be changed. While embodiments have been specifically illustrated and described, it should be understood that various modifications of form and detail are possible. While various embodiments have been described as having specific features, concepts and / or combinations of components, other embodiments are possible having any features, concepts and / or any combination or subcombination of components from any of the embodiments described herein.

[0162]

[0178] In some embodiments, the specific configuration of various components can also be modified. For example, the size and specific shape of various components may differ from those in the illustrated embodiments, while still providing the functions described herein. In some embodiments, by changing the size and / or shape of these 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 the desired or intended use. For example, in some embodiments, a device such as the one described herein can be configured for use in or against a superficially healthy adult patient. In such embodiments, the device may include an isolation chamber having a first volume (e.g., about 0.5 ml to about 5.0 ml). In other embodiments, a device such as the one described herein can be configured for use in, for example, a critically ill patient and / or a pediatric patient. In such embodiments, the device may include an isolation chamber having a second volume smaller than the first volume (e.g., less than about 0.5 ml). Therefore, unless otherwise explicitly stated in the context, it should be understood that the size, shape and / or arrangement of the embodiments and / or their components can be adapted for a given use.

[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 the fluid reservoir described in the '420 patent. In some cases, any of the embodiments described herein can be used with devices described in the '783 patent, '510 publication, '074 publication, and / or U.S. Patent No. 8,535,24 filed on October 22, 2012, entitled "Fluid Diversion Mechanism for Bodily-Fluid Sampling". U.S. Patent No. 1, filed on May 29, 2013, titled "Fluid Diversion Mechanism for Bodily-Fluid Sampling," U.S. Patent No. 9,060,724, was granted on December 2, 2013. The requested "Syringe-Based Fluid Diversion Mechanism for Bodily-Fluid Sampling" U.S. Patent No. 9,155,495, filed on June 23, 2016, is titled "Devices and Methods for Syringe Based Fluid Transfer for Bodily-Fluid Sampling". Any of the devices described in U.S. Patent Application Publication No. 2016 / 0361006, U.S. Patent Application Publication No. 2018 / 0140240, filed on November 20, 2017, entitled "Systems and Methods for Sample Collection with Reduced Hemolysis," and / or U.S. Patent No. 9,950,084, filed on September 6, 2016, entitled "Apparatus and Methods for Maintaining Sterility of a SpecimenContainer." It 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 incorporated herein by reference in their entirety.

[0164]

[0180] While control devices 100, 200, 300 and / or 400 are described as transferring body fluid into the device as a result of negative pressure within the fluid collection device, in other embodiments, the devices described herein can be used with any suitable device configured to establish a negative pressure difference, suction force, etc., such as a syringe or pump. In other embodiments, the control device may include a pre-loaded isolation chamber, an evacuated isolation chamber, a manually activated 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 difference within a portion of the control device. Furthermore, the control device can be coupled to such collection device by a user (e.g., a physician, nurse, technician, physician, etc.) or can be coupled or assembled during manufacturing. In some embodiments, pre-assembling the control device and collection device (e.g., a sample container or syringe) can enforce compliance with a sample acquisition protocol that requires isolation of an initial volume of body fluid before collecting a sample volume of body fluid.

[0165]

[0181] Some of the embodiments described above are flow with a specific configuration and / or arrangement. The fluid control device includes a flow controller and / or actuator, but in other embodiments, the fluid control device may include any suitable flow controller and / or actuator configured to selectively control the flow of a bodily fluid through one or more parts of the fluid control device. For example, some embodiments include an actuator having one or more seals arranged as O-rings or elastomer overmoldes that move with the actuator and relative to a part of the device (e.g., the inner surface of the housing), but in other embodiments, the fluid control device may include one or more seals having any suitable configuration. For example, in some embodiments, the fluid control device may include one or more seals arranged as elastomer sheets, etc., fixedly coupled to a part of the control device. In such embodiments, a part of the actuator, such as a pin or rod, may extend through an opening defined in one or more elastomer sheets, and one or more elastomer sheets may form a substantially fluid-sealed seal with the outer surface of the pin or rod. Thus, at least a part of the actuator may move relative to one or more elastomer sheets, and one or more elastomer sheets may remain in a substantially fixed position relative to the aforementioned part of the control device. In some embodiments, fluid flow through an opening that was originally blocked by that part of the actuator can be enabled by removing the aforementioned portion of the actuator from an opening defined by one or more elastomer sheets. Thus, one or more elastomer sheets can function in a manner similar to any of the seals described herein. Furthermore, in some embodiments, such arrangements can reduce the amount of friction relating to forming a desired fluid-sealing seal, thereby further avoiding the use of lubricants that would normally be used to facilitate the movement of the seal within the control device.

[0166]

[0182] In some embodiments, the device and / or flow controller may include one or more vents, membranes, members, semipermeable 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 is described above as receiving and retaining a certain volume of air discharged, exhausted and / or purged from a flow path between the body fluid source and the isolation chamber 230, but in other embodiments, the isolation chamber 230 may include vents or selectively permeable membranes configured to allow air to exit the isolation chamber 230. For example, in some embodiments, a bladder or diaphragm (or a portion thereof) may be formed of or from a semipermeable material through which air can flow but body fluid cannot. In other embodiments, a semipermeable material may be placed in or along a flow path between the isolation chamber and at least one of the outlet or inlet to selectively allow air and / or body fluid to flow between them. In some embodiments, the fluid control device may include a semipermeable member and / or membrane, which may be similar in form and / or function to a semipermeable member and / or membrane (e.g., a flow controller) described in Publication 074, which is referenced above.

[0167]

[0183] While flow controllers 240, 340, and 440 are described as bladders configured to transition, move, reverse, and / or reconfigure in response to a negative pressure exceeding a threshold amount of negative pressure applied to the bladder surface, in other embodiments, the fluid control device may include any suitable flow controller, actuator, semi-permeable (e.g., air-permeable and liquid-impermeable) member, etc., configured to transition, move, reverse, and / or reconfigure in any preferred manner in response to exposure to a desired and / or predetermined amount of negative pressure. In other embodiments, the control device may be configured to reverse from a first state to a second state (e.g., transition relatively rapidly and / or substantially uniformly) in response to exposure to a negative pressure difference. The bladder (or flow controller) may be configured to transition gradually (for example, unfolding (from a rolled state), unfolding (from a folded state), unfolding (from a folded state), and / or reconfiguring in other ways). In some examples, controlling the rate at which the bladder (or flow controller) transitions can allow for adjustment and / or control of the negative pressure difference generated within the isolation chamber, as well as the magnitude of the suction force applied to the patient's veins and / or other suitable fluid sources.

[0168]

[0184] Some of the embodiments described above include a flow controller and / or actuator that physically and / or mechanically isolates one or more parts of the fluid control device, but in other embodiments, the fluid control device does not need to physically and / or mechanically isolate one or more parts 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 fluid can flow from the inlet to the isolation chamber or part to a second state in which (1) the isolation chamber or part 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 part of the fluid control device can be transitioned from a first state in which an initial volume of fluid can flow from the inlet to the isolation chamber or part to a second state in which the inlet is fluidly connected to the outlet without physically and / or mechanically isolating (or separating) the isolation chamber or part. When such a control device is in the second state, one or more features and / or geometric shapes of the control device allow a preferential flow of bodily fluids from inlet to outlet, and the initial volume of bodily fluids can be retained within the isolation chamber or portion without being physically and / or mechanically isolated or separated.

[0169]

[0185] While the throttle 219 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 (for example, within the isolation chamber 230 and / or otherwise on the flow controller 240), in other embodiments the control device may include any preferred features, mechanisms and / or devices configured to adjust, bring about and / or otherwise control one or more pressure differences through at least a portion of the control device. For example, in some embodiments, the user may move and / or relocate an actuator to change the size (e.g., reduce or increase) one or more portions of a flow path or fluid flow interface within a portion of the control device in order to manually adjust and / or otherwise control the amount and magnitude of the negative pressure within one or more portions of the control device.

[0170]

[0186] Although not shown in the illustrations, any of the devices described herein may include openings, ports, couplers, partitions, Luer-Loks, gaskets, valves, screw connectors, standard fluid interfaces, etc. (referred to as "ports" for simplicity) that communicate fluidly with the isolation chamber. In some such embodiments, the ports may be configured to connect to any suitable device, reservoir, pressure source, etc. For example, in some embodiments, the ports may be configured to connect to a reservoir so that a larger volume of body fluid can be diverted and / or transferred to the isolation chamber. In other embodiments, the ports may be connected 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 into the isolation chamber, channel, reservoir, etc., and the ports may use that volume of body fluid (e.g., pre-sample volume) for further clinical and / or in vitro diagnostic testing purposes. In other embodiments, the port may be configured to receive probes, sample collection devices, testing devices, etc., which can be used to perform one or more tests (e.g., tests less susceptible to potential contamination) on the initial volume while the initial volume is located or isolated within the isolation chamber. In yet another embodiment, the port may be (e.g., In cases such as pediatric patients, critically ill patients, or patients with low blood volume, the isolation chamber can be coupled to any suitable pressure source or infusion device configured to inject an initial volume of body fluid isolated within the isolation chamber back into the patient's body and / or body fluid source. In other embodiments, the isolation channel, chamber and / or reservoir can be configured to accommodate additional diagnostic testing components (e.g., dipstick tests) integrated within the chamber, so that the initial body fluid is used for those tests.

[0171]

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

[0172]

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

[0173]

[0189] In some embodiments, the method of using a fluid control device such as those described herein may include a sequence of steps to establish fluid communication between a body fluid source (e.g., a patient's vein) and the inlet of the fluid control device. The outlet of the fluid control device is then placed in a state of fluid connection to and / or engagement with a negative pressure source. Such a negative pressure source may be a sample reservoir, syringe, vacuum blood collection tube, intermediate transfer device, etc. When the outlet of the fluid control device is coupled to the negative pressure source, it can enter a first state or operating mode, and thus a negative pressure difference 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, negative pressure in a sample reservoir may be operational when drawing an initial volume of body fluid from the patient into the isolation chamber. Once the initial volume of body fluid is placed in the isolation chamber, the fluid control device automatically or through user intervention transitions from the first state or operating mode to a second state or operating mode so that (1) the initial volume is isolated in the isolation chamber and (2) fluid communication is established between the inlet and the outlet. Initial volume isolation may involve the isolation of contaminants introduced into the initial volume flow within an isolation chamber. With the initial volume of bodily fluids isolated within the isolation chamber and fluid communication established between the inlet and outlet, a substantially uncontaminated subsequent volume of bodily fluids can be collected into one or more sample reservoirs.

[0174]

[0190] While the methods of using the fluid control device are explicitly described as including the enumerated order, in other embodiments, the ordering of some events and / or procedures in any of the methods or processes described herein can be changed, and such changes constitute a variation of the present invention. Furthermore, some events and / or procedures can be performed simultaneously in parallel processes where possible, as well as sequentially as described above. Some steps can be partially completed or omitted before proceeding to subsequent steps. For example, while the device is described herein as transitioning from a first state to a second state in a discontinuous operation, etc., it should be understood that the devices described herein can be configured to transition automatically and / or passively from a first state to a second state, and such transitions can occur over a period of time. In other words, the transition from a first state to a second state may be relatively gradual, such as in some examples, when at least a portion of the initial volume of fluid has been transferred into the isolation chamber, the housing begins the transition from the first state to the second state. In some examples, the rate of change when transitioning from a first state to a second state can be selectively controlled to achieve one or more desired characteristics associated with the transition. Furthermore, in some such examples, the inflow of the final portion of the initial volume can limit and / or substantially prevent the leakage of bodily fluids already placed within the isolation chamber. Thus, although the transition from the first state to the second state may occur over a given amount of time, the isolation chamber can nevertheless isolate the volume of bodily fluids placed within it.

Claims

1. A device for collecting samples of body fluids with minimal contamination, A housing forming at least a portion of an isolation chamber, having an inlet configured to be fluidly connected to a bodily fluid source and an outlet configured to be fluidly connected to a fluid collection device, wherein the fluid collection device, when fluidly connected to the outlet, exerts a suction force within at least a portion of the housing, An actuator coupled to the housing, having a first form in which the inlet is fluidly connected to the isolation chamber, and a second form in which the inlet is fluidly connected to the outlet and fluidly separated from the isolation 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 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, Equipped with, The flow controller, when the actuator is in the first configuration, transitions from the first state to the second state in accordance with the suction force, drawing an initial volume of the bodily fluid into the portion of the isolation chamber. The actuator is configured to transition to the second state after the initial volume of bodily fluid has been drawn into the isolation chamber, (1) to isolate the isolation chamber from the inlet, and (2) to allow the subsequent volume of bodily fluid to flow from the inlet to the outlet in accordance with the suction force.

2. The housing includes a first port and a second port, The apparatus according to claim 1, wherein, when the actuator is in the first configuration, the first port is configured such that its inlet is fluidly connected to the first portion of the isolation chamber, and the second port is configured such that its outlet is fluidly connected to the second portion of the isolation chamber.

3. The apparatus according to claim 1, wherein the flow controller includes a plurality of deformable parts, and each of the plurality of deformable parts is configured to deform in accordance with the suction force, thereby transitioning the flow controller from a first state to a second state.

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

5. The apparatus according to claim 1, wherein the portion of the isolation chamber is a first portion of the isolation chamber at least partially defined by a first deformable portion of the flow controller, and the second portion of the isolation chamber at least partially defined by a second deformable portion of the flow controller is configured to receive a certain volume of air before the first portion of the isolation chamber receives the initial volume of the body fluid.

6. The apparatus according to claim 5, wherein the first deformable portion and the second deformable portion 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 has deformed.

7. When the flow controller is in the first state, the first side of the flow controller is in contact with at least a portion of the first surface of the isolation chamber, and the flow controller The apparatus according to claim 1, wherein, when in state 2, the second side of the flow controller is in contact with at least a portion of the second surface of the isolation chamber, and the second surface is on the opposite side from the first surface.

8. The apparatus according to 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 airflow to pass between the first surface of the isolation chamber and the first side of the flow controller.

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

10. The apparatus according to 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. The apparatus according to claim 10, wherein the 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. A device for collecting samples of body fluids with minimal contamination, A housing forming at least a portion of an isolation chamber, having an inlet configured to be fluidly connected to a bodily fluid source and an outlet configured to be fluidly connected to a fluid collection device, wherein the fluid collection device, when fluidly connected to the outlet, exerts a suction force within at least a portion of the housing, An actuator coupled to the housing, having a first form in which the inlet is fluidly connected to the isolation chamber, and a second form in which the inlet is fluidly connected to the outlet and fluidly separated from the isolation chamber, A flow controller disposed within the housing and defining a portion of the isolation chamber, having a first state in which a first side of the flow controller is in contact with at least a portion of the first surface of the isolation chamber, and a second state in which a second side of the flow controller is in contact with at least a portion of the second surface of the isolation chamber, wherein the second surface is on the opposite side from the first surface, Equipped with, When the actuator is in the first configuration, 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, 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 apparatus is configured such that the actuator transitions to the second state after the initial volume of the bodily fluid has been drawn into the portion of the isolation chamber, (1) isolating the isolation chamber from the inlet, and (2) allows a subsequent volume of bodily fluid to flow from the inlet to the outlet in accordance with the suction force.

13. The apparatus according to claim 12, wherein the flow controller is a fluid-impermeable bladder.

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

15. The apparatus according to claim 12, wherein the portion of the isolation chamber is a first portion of the isolation chamber at least partially defined by a first deformable portion of the flow controller, and the second portion of the isolation chamber at least partially defined by a second deformable portion of the flow controller is configured to receive a certain volume of air before the first portion of the isolation chamber receives the initial volume of bodily fluids.

16. The first surface of the isolation chamber forms at least one discontinuity configured to allow 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, The apparatus according to claim 12, wherein the second surface of the isolation chamber forms at least one discontinuity configured to allow airflow 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. The apparatus according to claim 12, wherein the housing defines a first flow path that places the isolation chamber fluidly connected to the inlet when the actuator is in the first configuration, and the housing defines a second flow path that places the outlet fluidly connected to the inlet when the actuator is in the second configuration.

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

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

20. A method for obtaining a sample of body fluid with minimal contamination using a fluid control device having a housing, actuator, and flow controller, The fluid connection between the bodily fluid source and the inlet of the housing, Connecting a fluid collection device to the outlet of the housing, wherein the fluid collection device, when connected to the outlet, exerts an attractive force within at least a portion of the housing. The flow controller is moved from a first state to a second state in accordance with the suction force, and the volume of the isolation chamber defined by the flow controller and the part of the housing is increased. In accordance with the increase in volume, the first portion of the isolation chamber receives a certain volume of air contained within a flow path defined between the body fluid source and the isolation chamber, In accordance with the increase in volume, the second portion of the isolation chamber receives the initial volume of the body fluid, After receiving the initial volume of the bodily fluid into the second portion of the isolation chamber, the actuator is moved from the first to the second mode to (1) isolate the isolation chamber, and (2) allow the subsequent volume of the bodily fluid to flow from the inlet to the outlet in accordance with the suction force. Methods that include...

21. The method according to claim 20, wherein the flow controller is a bladder including a plurality of deformable parts, and each of the plurality of deformable parts is configured to deform in accordance with the suction force to transition the bladder from a first state to a second state.

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

23. The method according to claim 22, wherein the second deformable portion of the plurality of deformable portions is completely deformed before the first deformable portion of the plurality of deformable portions is completely deformed.

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

25. The method according to claim 24, wherein the actuator in the first embodiment fluidly connects (1) the inlet and the first and second portions of the isolation chamber and (2) the outlet and the third portion of the isolation chamber.

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

27. The fluid control device includes a flow limiter positioned in a flow path defined between the third portion of the isolation chamber and the outlet when the actuator is in the first embodiment, and the method is The method according to claim 26, further comprising adjusting the suction force applied to the second side of the flow controller when the actuator is in the first embodiment.

28. The method according to claim 26, wherein the first surface of the isolation chamber forms at least one discontinuity configured to allow airflow to pass 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.

29. The method according to claim 26, wherein the second surface of the isolation chamber forms at least one discontinuity configured to allow airflow 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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