Fluid control device and method of using same

Abstract

The present invention relates to an apparatus for obtaining a body fluid sample with reduced contaminants, the apparatus comprising a housing having a sequestration chamber, an inlet, and an outlet. A flow controller defines a portion of the sequestration chamber and is transitionable from a first state, in which the sequestration chamber has a first volume, to a second state, in which the sequestration chamber has a second volume greater than the first volume, in response to a suction force applied by a fluid collection device fluidly coupled to the outlet, so as to draw an initial volume of body fluid into the sequestration chamber. An actuator is coupled to the housing and is in fluid communication with the inlet and the sequestration chamber in a first configuration, and the actuator is transitioned to a second configuration to isolate the sequestration chamber from the inlet and allow a subsequent volume of body fluid to flow from the inlet to the outlet.

Description

[0001] This application is a divisional application of the invention patent application filed on March 11, 2020, with application number 202080033513.6, international application number PCT / US2020 / 022125, and entitled "Fluid Control Device and Method of Using Thereof".

[0002] Cross-reference of related applications

[0003] This application claims priority and benefit to U.S. Provisional Patent Application Serial No. 62 / 816,477, filed March 11, 2019, entitled “Fluid Control Devices and Methods of Using the Same,” the disclosure of which is incorporated herein by reference in its entirety. Technical Field

[0004] The embodiments described herein generally relate to the acquisition of bodily fluid samples, and more specifically to fluid diversion, isolation, and / or containment devices and methods for acquiring bodily fluid samples with reduced contaminants, such as skin-residing microorganisms and / or other contaminants outside the source of the bodily fluid. Background Technology

[0005] Healthcare professionals routinely use non-enteric bodily fluids to perform various types of microbial diagnostic tests and other extensive diagnostic tests on patients. With the development and advancement of advanced diagnostic technologies, the speed, accuracy (both sensitivity and specificity), and value of the information available to clinicians continue to improve. Maintaining the integrity of bodily fluid samples during and / or after collection ensures that the analytical diagnostic results represent the patient's physical condition. Examples of diagnostic technologies that rely on high-quality, uncontaminated, and / or pure bodily fluid samples include, but are not limited to, microbial detection, molecular diagnostics, gene sequencing (e.g., deoxyribonucleic acid (DNA), ribonucleic acid (RNA), next-generation sequencing (NGS), etc.), biomarker identification, and similar technologies.

[0006] Inaccurate results from such tests can be due to the presence of biological material, including cells and / or other external contaminants, outside the intended sample source, which may be unintentionally included in the body fluid sample to be analyzed. In short, when the purity of a body fluid sample is compromised during specimen acquisition, synthetic analytical test results will be inaccurate, distorted, adulterated, false positives, false negatives, and / or otherwise fail to represent the patient's actual condition. In turn, these results can lead to erroneous, inaccurate, confusing, uncertain, unconfident, and / or otherwise undesirable clinical decisions.

[0007] In some cases, devices and / or systems can be used to reduce the likelihood of contamination, adulteration, and / or similar issues in bodily fluid samples used 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 more likely to contain contaminants, such as transdermal microorganisms or the like. However, some such devices can be cumbersome, unintuitive, considered difficult to use, inappropriate for the target patient population, or unavailable, etc. Additionally, some such devices may require training, user observation, intervention by more than one user, and / or may otherwise present challenges that limit efficacy. In some cases, these and / or other challenges can complicate the collection of consistent, high-quality samples that are uncontaminated, sterile, pure, etc., which in turn can affect the validity of test results.

[0008] Some known devices and / or systems can be configured to limit the amount of user intervention by passively shunting an initial volume of body fluid; however, some such devices and / or systems may not adequately shun, isolate, and / or isolate the 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 the positive pressure (e.g., the patient's blood pressure) applied or supplied by a body fluid source. However, in some such cases, the positive pressure may be insufficient to induce the desired flow dynamics and / or flow rate, making the use of such devices practical in various clinical settings such as emergency rooms and other intensive environments.

[0009] Accordingly, there is a need for fluid control and / or diversion devices and methods for obtaining bodily fluid samples with reduced contaminants, such as skin-residing microorganisms and / or other contaminants outside the source of the bodily fluid, wherein the fluid control and / or diversion devices and methods facilitate (e.g., from general patient populations and / or challenging patient populations) consistent collection of bodily fluids. Additionally, there is a need for devices and methods that include, for example, collecting bodily fluids with the aid of various external energy sources and / or negative pressure sources. Summary of the Invention

[0010] This document describes apparatus and methods for acquiring bodily fluid samples with reduced contaminants, such as skin-residing microorganisms and / or other contaminants external to the bodily fluid source. In some embodiments, an apparatus for acquiring bodily fluid samples with reduced contaminants includes a housing, an actuator, and a flow controller. The housing forms at least a portion of an isolation chamber and has an inlet and an outlet, the inlet being configured to be fluidly coupled to a bodily fluid source, and the outlet being configured to be fluidly coupled to a fluid collection device. When the fluid collection device is fluidly coupled to the outlet, the fluid collection device applies suction in at least a portion of the housing. The actuator is coupled to the housing and has a first configuration and a second configuration, in the first configuration the inlet is in fluid communication with the isolation chamber, and in the second configuration the inlet is in fluid communication with the outlet and fluidly isolated from the isolation chamber. The flow controller is disposed in the housing and defines a portion of the isolation chamber. The flow controller can present a first state and a second state, in the first state the portion of the isolation chamber has a first volume, and in the second state the portion of the isolation chamber has a second volume larger than the first volume. When the actuator is in the first configuration, the flow controller is configured to transition from the first state to the second state in response to suction to draw an initial volume of body fluid into that portion of the isolation chamber. The actuator is configured to transition to the second configuration after the initial volume of body fluid has been drawn into the isolation chamber in order to (1) isolate the isolation chamber from the inlet and (2) allow subsequent volumes of body fluid to flow from the inlet to the outlet in response to suction. Attached Figure Description

[0011] Figure 1 This is a schematic diagram of a fluid control device according to an embodiment.

[0012] Figure 2 and Figure 3 These are, respectively, a front perspective view and a rear perspective view of the fluid control device according to the embodiment.

[0013] Figure 4 and Figure 5 They are Figure 2 Side and top views of the fluid control device.

[0014] Figure 6 yes Figure 2 An exploded perspective view of the fluid control device.

[0015] Figure 7 and Figure 8 Each is shown in its first state, respectively along... Figure 4 Line 7-7 and Figure 5 The line 8-8 in the middle is cut off Figure 2 A cross-sectional view of the fluid control device.

[0016] Figure 9 and Figure 10 Each is shown in the second state, respectively along Figure 4 Line 7-7 and Figure 5 The line 8-8 in the middle is cut off Figure 2 A cross-sectional view of the fluid control device.

[0017] Figure 11 It is shown in the second state, along Figure 5 The line 8-8 in the middle is cut off Figure 2 A partial cross-sectional view of the fluid control device.

[0018] Figure 12 and Figure 13 These are, respectively, a front perspective view and a rear perspective view of the fluid control device according to the embodiment.

[0019] Figure 14 and Figure 15 They are Figure 12 Side and top views of the fluid control device.

[0020] Figure 16 yes Figure 12 An exploded perspective view of the fluid control device.

[0021] Figure 17 and Figure 18 Each is shown in its first state, along Figure 14 Lines 17-17 and Figure 15 The line 18-18 in the middle is cut off Figure 12 A cross-sectional view of the fluid control device.

[0022] Figure 19 and Figure 20 Each is shown in the second state, along Figure 14 Lines 17-17 and Figure 15 The line 18-18 in the middle is cut off Figure 12 A cross-sectional view of the fluid control device.

[0023] Figure 21 It is shown in the second state, along Figure 15 The line 18-18 in the middle is cut off Figure 12 A partial cross-sectional view of the fluid control device.

[0024] Figure 22 and Figure 23 These are, respectively, a front perspective view and a rear perspective view of the fluid control device according to the embodiment.

[0025] Figure 24 and Figure 25 Each is shown in its first state, intercepted along line 24-24. Figure 22 A cross-sectional view of the fluid control device.

[0026] Figure 26 and Figure 27 Each is shown in its second state, intercepted along line 24-24. Figure 22 A cross-sectional view of the fluid control device.

[0027] Figure 28 It is a flowchart illustrating a method of using a fluid control device according to an embodiment. Detailed Implementation

[0028] This document describes apparatus and methods for collecting, diverting, isolating, or isolating an initial volume of bodily fluid to reduce contamination in subsequently acquired bodily fluid samples. Any fluid control device described herein can be configured to receive, acquire, and / or transfer the flow, dose, volume, etc., of bodily fluid. A first reservoir, channel, flow path, or part of the device may receive the initial volume of bodily fluid flow, which may then be substantially or completely isolated (e.g., contained or held, circumvented, isolated, separated, vaporized, separated, and / or similar) within the first reservoir, channel, flow path, or part of the device. In some cases, contaminants such as transdermal microorganisms or the like may be included and / or entrained in the initial volume of bodily fluid and similarly 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 flow may be diverted, directed, guided, and / or otherwise permitted to flow to or through a second part of the device and / or one or more additional flow paths. Based at least in part on the initial volume to be isolated, one or more subsequent volumes of bodily fluid may be substantially free of contaminants that could otherwise produce inaccurate, distorted, adulterated, and / or false results in certain diagnostic and / or testing processes. In some cases, the initial volume of bodily fluid may also be used, for example, in other tests less affected by the presence of contaminants, may be discarded as a waste volume, may be infused back into the patient, and / or may be used for any other suitable clinical application.

[0029] In some embodiments, the fluid control devices and / or methods described herein are characterized by the use of an external negative pressure source (e.g., provided by a fluid collection device or any other suitable measure) that can (1) overcome patient physical challenges that may limit and / or prevent sufficient pressure differential to fully engage the isolation chamber and / or divert fluid flow to the fluid collection device (e.g., the difference between blood pressure and ambient air pressure); (2) facilitate the appropriate filling of the isolation chamber with a clinically validated and / or desired volume of body fluid; (3) facilitate efficient, timely and / or user-acceptable consistency with the body fluid collection process; and / or (4) provide a measure to divert fluid flow (e.g., automatically or by manipulating any number of physical components of the system or by altering, switching, engaging and / or otherwise providing the desired fluid flow dynamics) to achieve initial (e.g., pre-sample) isolation and / or isolation and subsequent sample collection.

[0030] In some embodiments, for example, an apparatus for acquiring a body fluid sample with reduced contaminants includes a housing, an actuator, and a flow controller. The housing forms at least a portion of an isolation chamber and has an inlet and an outlet, the inlet being configured to be fluidly coupled to a body fluid source, and the outlet being configured to be fluidly coupled to a fluid collection device. When the fluid collection device is fluidly coupled to the outlet, the fluid collection device applies suction in at least a portion of the housing. The actuator is coupled to the housing and has a first configuration and a second configuration, in the first configuration the inlet is in fluid communication with the isolation chamber, and in the second configuration the inlet is in fluid communication with the outlet and fluidly isolated from the isolation chamber. The flow controller is disposed in the housing and defines a portion of the isolation chamber. The flow controller has a first state and a second state, in the first state the portion of the isolation chamber has a first volume, and in the second state the portion of the isolation chamber has a second volume larger than the first volume. When the actuator is in the first configuration, the flow controller transitions from the first state to the second state in response to suction to draw an initial volume of body fluid into the portion of the isolation chamber. The actuator is configured to switch to a second configuration after an initial volume of body fluid is aspirated into the isolation chamber, so as to (1) isolate the isolation chamber from the inlet and (2) allow subsequent volumes of body fluid to flow from the inlet to the outlet in response to suction.

[0031] In some embodiments, an apparatus for acquiring a body fluid sample with reduced contaminants includes a housing, an actuator, and a flow controller. The housing forms at least a portion of an isolation chamber and has an inlet and an outlet, the inlet being configured to be fluidly coupled to a body fluid source, and the outlet being configured to be fluidly coupled to a fluid collection device. When the fluid collection device is fluidly coupled to the outlet, the fluid collection device applies suction within at least a portion of the housing. The actuator is coupled to the housing and has a first configuration and a second configuration, in the first configuration the inlet is in fluid communication with the isolation chamber, and in the second configuration the inlet is in fluid communication with the outlet and fluidly isolated from the isolation chamber. The flow controller is disposed within the housing and defines a portion of the isolation chamber. The flow controller has a first state and a second state, in the first state a first side of the flow controller contacts at least a portion of a first surface of the isolation chamber, and in the second state a second side of the flow controller contacts at least a portion of a second surface of the isolation chamber opposite the first surface. When the actuator is in the first configuration, the flow controller transitions from a first state to a second state due to suction being applied to a second side of the flow controller to draw an initial volume of body fluid into a portion of an isolation chamber defined between a first surface and a first side of the flow controller. The actuator is configured to transition to the second configuration after the initial volume of body fluid has been drawn into the isolation chamber in order to (1) isolate the isolation chamber from the inlet and (2) allow subsequent volumes of body fluid to flow from the inlet to the outlet in response to suction.

[0032] In some embodiments, the fluid control device may include a housing, a flow controller, and an actuator. The housing has an inlet and an outlet and forms an isolation chamber. The inlet is configured to be in fluid communication with a source of bodily fluid. The outlet is configured to be in fluid communication with a fluid collection device configured to apply suction within at least a portion of the housing. The actuator is coupled to the housing and configured to establish fluid communication between the inlet and the isolation chamber when the actuator is in a first state and to establish fluid communication between the inlet and the outlet when the actuator is in a second state. The flow controller is disposed in the isolation chamber and configured to transition from the first state to the second state in response to suction when the actuator is in its first state, allowing an initial volume of bodily fluid to flow into a portion of the isolation chamber. This portion of the isolation chamber has a first volume when the flow controller is in the first state, and a second volume larger than the first volume when the flow controller is in the second state. The actuator is configured to transition to its second state after an initial volume of body fluid is received in this part of the isolation chamber, so as to (1) isolate the isolation chamber and (2) allow subsequent volumes of body fluid to flow from the inlet to the outlet in response to suction.

[0033] In some embodiments, a method for obtaining a bodily fluid sample with reduced contaminants using a fluid control device having a housing, an actuator, and a flow controller includes establishing fluid communication between a bodily fluid source and an inlet of the housing. A fluid collection device is coupled to an outlet of the housing, and when coupled to the outlet, the fluid collection device applies suction 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, which increases the volume of an isolation chamber jointly defined by the flow controller and a portion of the housing. In response to the increase in volume, the first portion of the isolation chamber receives a volume of air contained in 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 a first configuration to a second configuration in order to (1) isolate the isolation chamber and (2) allow subsequent volumes of bodily fluid to flow from the inlet to the outlet in response to the suction.

[0034] In some embodiments, a method for acquiring a bodily fluid sample with reduced contaminants using a fluid control device having a housing, a flow controller, and an actuator may include, for example, establishing fluid communication between a bodily fluid source and an inlet of the housing. A fluid collection device is fluidly coupled to an outlet of the housing. The flow controller transitions from a first state to a second state in response to suction applied by the fluid collection device to increase the volume of a first portion and a second portion of an isolation chamber. The first portion of the isolation chamber receives a volume of air contained in a flow path defined between the bodily fluid source and the isolation chamber in response to the increase in volume of the first and second portions of the isolation chamber. The second portion of the isolation chamber receives an initial volume of bodily fluid in response to the increase in volume of the first and second portions of the isolation chamber. After receiving the initial volume of bodily fluid in the second portion of the isolation chamber, the actuator transitions from the first state to the second state to (1) isolate the isolation chamber and (2) allow subsequent volumes of bodily fluid (e.g., bodily fluid samples) to flow from the inlet to the outlet in response to suction.

[0035] Any of the embodiments and / or methods described herein can be used to obtain pure or substantially unadulterated bodily fluid samples, such as blood samples. In some cases, bodily fluid samples (e.g., blood samples) can be tested for the presence of one or more potentially undesirable microorganisms, such as bacteria (e.g., Gram-positive and / or Gram-negative bacteria), fungi, yeasts (e.g., Candida), and / or the like. Various techniques can be employed to assist in the detection of microorganisms and other types of biological material, specific types of cells, biomarkers, proteins, antigens, enzymes, blood components, and / or the like during diagnostic testing. Examples include, but are not limited to, molecular polymerase chain reaction (PCR), magnetic resonance and other magnetic analysis platforms, automated microscopy, spatial clonal isolation, flow cytometry, whole blood (“culture-free”) specimen analysis (e.g., NGS) and related techniques, morphodynamic cell analysis, and / or other commonly used or evolving advanced techniques to characterize patient specimens and / or detect, identify, classify, categorize, and / or characterize specific organisms, antibiotic susceptibility, and / or the like.

[0036] For example, in some cases, microbial testing may include culturing a patient sample in one or more dishes that may contain a culture medium (e.g., a nutrient-rich and / or environmentally controlled culture medium that promotes growth and / or other suitable one or more culture media), common additives, and / or other types of solutions that facilitate microbial growth. Any microorganisms and / or organisms present in the patient sample will multiply and / or grow in the culture medium over a period of time (e.g., a variable timeframe from less than an hour to more than a few days, which may be longer or shorter depending on the diagnostic technique employed). The presence of microorganisms and / or organisms can be detected using automated methods, continuous monitoring methods, and / or other methods specific to analytical platforms and techniques for detection, identification, and / or similar purposes (e.g., by observing carbon dioxide levels and / or other detection methods). The presence of microorganisms and / or organisms in the culture medium suggests the presence of the same microorganisms and / or organisms in the patient sample, which in turn suggests the presence of the same microorganisms and / or organisms in the body fluids of the patient from whom the sample was obtained. In other cases, body fluid samples may be analyzed directly (i.e., without culturing) to determine the presence of microorganisms and / or organisms. When the presence of microorganisms is identified in a sample used for testing, a patient can be diagnosed and prescribed one or more antibiotics or other treatments that are specifically designed to treat the patient or otherwise remove unwanted microorganisms and / or organisms from the patient.

[0037] However, patient samples can become contaminated during acquisition and / or be otherwise susceptible to false results. For example, microorganisms from the body surface (e.g., skin-resident microorganisms) expelled during the specimen acquisition process (e.g., directly or indirectly via tissue fragments, hair follicles, sweat glands, and other skin appendages) can subsequently be transferred along with the patient sample to culture media, test bottles, or other suitable specimen collection or transfer vessels and / or otherwise included in the specimen to be analyzed. Another possible source of contamination is the personnel drawing patient samples. For example, the equipment, supplies, and / or devices used during the patient sample acquisition process often include multiple fluid interfaces (e.g., patient to needle, needle to transfer adapter, transfer adapter to sample vessel, catheter hub to syringe, syringe to transfer adapter, needle / tube to sample vessel, and / or any other fluid interface or any combination thereof), each of which can introduce a potential point of contamination. In some cases, such contaminants can multiply in culture media and / or can be identified in other ways, thereby increasing the risk or likelihood of producing false-positive microbial test results that do not accurately reflect the presence or absence of such microorganisms in the patient's body (i.e., in vivo).

[0038] Such inaccurate results due to contamination and / or adulteration are a problem when attempting to diagnose or treat a wide range of suspected illnesses, diseases, infections, patient conditions, and / or other ailments. For example, false results from microbiological tests can lead to unnecessary treatment of patients with one or more antimicrobial therapies and / or misdiagnosis and / or delay in treatment, either of which can cause serious side effects, including death. Accordingly, false results can create unnecessary burdens and costs on the healthcare system due to prolonged hospital stays and / or other complications associated with incorrect treatment. The use of diagnostic imaging equipment attributable to these false results is also a problem from both a cost and patient safety perspective, as unnecessary concentrated radiation exposure associated with various imaging procedures (e.g., CT scans) has many known adverse effects on patients' long-term health.

[0039] As used in this specification and any of the claims appended herein, the singular forms “an,” “a,” and “the” include plural indicators unless the context clearly indicates otherwise. Thus, for example, the term “component” is intended to mean a single component or a combination of components, and “material” is intended to mean one or more materials, and / or the like.

[0040] As used herein, “body fluid” can include any fluid obtained directly or indirectly from the patient’s body. For example, “body fluid” includes, but is not limited to, blood, cerebrospinal fluid, urine, bile, lymph, saliva, synovial fluid, serous fluid, pleural fluid, amniotic fluid, mucus, sputum, vitreous humor, air and / or similar substances or any combination thereof.

[0041] As used herein, the terms “proximal” and “distal” refer to the direction closer to and further away from the user who places the device in contact with the patient, respectively. Thus, for example, the end of the device that first touches the patient’s body will be the distal end of the device, while the opposite end of the device (e.g., the end of the device operated by the user) will be the proximal end of the device.

[0042] As used herein, the terms “about,” “approximately,” and / or “basically,” when used in conjunction with one or more stated values ​​and / or one or more geometric structures or relationships, are intended to convey that the value or feature so defined is nominally the stated value and / or the described feature. In some cases, the terms “about,” “approximately,” and / or “basically” may generally refer to and / or can generally be expected within the desired tolerances of the stated value or feature (e.g., plus or minus 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, when these surfaces are nominally parallel, a first surface may be described as substantially parallel to a second surface. While the stated values, structures, and / or relationships are desirable, it should be understood that some differences may arise due to, for example, manufacturing tolerances or other practical considerations (e.g., pressure or force applied by a part of the device, cannula, lumen, etc.). Therefore, the terms “approximately,” “approximately,” and / or “basically” may be used in this document to explain such tolerances and / or considerations.

[0043] As used herein, the terms “pre-sample,” “first,” and / or “initial” may be used interchangeably to describe the amount, portion, or volume of bodily fluid collected and / or isolated prior to obtaining a “sample” volume. “Pre-sample,” “first,” and / or “initial” can be a predetermined, defined, desired, and / or given amount of bodily fluid. For example, a predetermined and / or desired pre-sample volume of bodily fluid can be one drop, several drops, with a volume of about 0.1 mL, about 0.2 mL, about 0.3 mL, about 0.4 mL, about 0.5 mL, about 1.0 mL, about 2.0 mL, about 3.0 mL, about 4.0 mL, about 5.0 mL, about 10.0 mL, about 20.0 mL, about 50.0 mL, and / or any volume or fraction of volume between these values. In other embodiments, the pre-sample volume may be greater than 50 mL or less than 0.1 mL. In some specific embodiments, the predetermined and / or desired pre-sample volume may be between about 0.1 mL and about 5.0 mL. In other embodiments, the pre-sample volume may be, for example, a combination of volumes of any number of lumens (e.g., lumens forming at least a portion of a flow path from the body fluid source to the initial collection chamber, section, reservoir, etc.).

[0044] As used herein, the terms “sample,” “second,” and / or “subsequent” may be used interchangeably to describe the amount, portion, or volume of bodily fluid used, for example, in one or more sample tests or diagnostic tests. A “sample” volume can be a random or predetermined / desired volume of bodily fluid collected after the volume of bodily fluid collected, isolated, and / or quarantined prior to the sample. In some embodiments, the desired sample volume of bodily fluid can be from about 10 mL to about 60 mL. In other embodiments, the desired sample volume of bodily fluid can be less than 10 mL or greater than 60 mL. In some embodiments, for example, the sample volume can be at least partially based on one or more tests, assays, analyses, and / or treatments to be performed on the sample volume.

[0045] The embodiments described herein can be configured to transfer substantially contaminated bodily fluids to one or more fluid collection devices. In some embodiments, the fluid collection device may include, but is not limited to, any suitable vessel, container, reservoir, bottle, adapter, tray, vial, syringe, device, diagnostic and / or testing machine and / or the like. In some embodiments, the fluid collection device may be substantially similar to or identical to known sample containers, such as… (Manufactured by Beckton Dickinson (BD)) SN or FA (manufactured by Biomerieux Ltd.) and / or any suitable reservoir, vial, micro-vial, microliter vial, nanoliter vial, container, microcontainer, nanocontainer and / or the like. In some embodiments, the fluid collection device may be substantially similar to or identical to any sample reservoir described in U.S. Patent No. 8,197,420 (“'420 Patent”), filed December 13, 2007, entitled “Systems and Methods for Parenterally Procuring Bodily-Fluid Samples with Reduced Contamination”, the disclosure of which is incorporated herein by reference in its entirety.

[0046] In some embodiments, the fluid collection device may be empty of contents before receiving a sample volume of bodily fluid. For example, in some embodiments, the fluid collection device or reservoir may be defined and / or configured to define or generate a vacuum or suction, such as a vacuum-based collection tube (e.g., In other embodiments, the fluid collection device may include any suitable additives, culture media, substances, enzymes, oils, fluids, and / or the like. For example, the fluid collection device may be a sample or culture bottle comprising, for example, an aerobic or anaerobic culture medium. The sample or culture bottle may be configured to receive a body fluid sample, which may then be tested (e.g., after incubation via in vitro diagnostic (IVD) tests and / or any other suitable tests) to check for the presence of, for example, Gram-positive bacteria, Gram-negative bacteria, yeast, fungi, and / or any other organisms. In some cases, if such a test of the culture medium yields a positive result, the culture medium may subsequently be tested using a PCR-based system to identify the specific organism. In some embodiments, in addition to or in lieu of a culture medium, the sample container may include, for example, any suitable additives or the like. Such additives may include, for example, heparin, citrate, ethylenediaminetetraacetic acid (EDTA), oxalate, sodium polyethylene glycol sulfonate (SPS), and / or the like. In some embodiments, the fluid collection device may include any suitable additives or culture media and may be emptied and / or otherwise air-free.

[0047] While the term "culture medium" can be used to describe a substance configured to react with organisms in body fluids (e.g., microorganisms such as bacteria) and the term "additive" can be used to describe a substance configured to react with portions of body fluids (e.g., constituent cells of blood, serum, synovial fluid, etc.), it should be understood that sample reservoirs can include any suitable substance, liquid, solid, powder, lyophilized compound, gas, etc. Furthermore, when referring to "additives" within a sample reservoir, it should be understood that an additive can be a culture medium (e.g., aerobic and / or anaerobic culture medium) contained in a culture flask, an additive contained in a culture flask and / or any other suitable reservoir such as those described above, and / or any other suitable substance and / or any combination of substances. That is, the embodiments described herein can be used with any suitable fluid reservoir or the like containing any suitable substance.

[0048] The embodiments and / or portions thereof described herein may be formed or constructed from one or more biocompatible materials. In some embodiments, the biocompatible material may be selected based on one or more properties of the constituent materials, such as stiffness, toughness, hardness, bioreactivity, etc. Examples of suitable biocompatible materials include metals, glass, ceramics, or polymers. Examples of suitable metals include pharmaceutical-grade stainless steel, gold, titanium, nickel, iron, platinum, tin, chromium, copper, and / or alloys thereof. Polymer materials may be biodegradable or non-biodegradable. Examples of suitable biodegradable polymers include polylactide, polyglycolic acid, polylactide-co-glycolic acid (PLGA), polyanhydride, polyorthoester, polyether ester, polycaprolactone, polyesteramide, poly(butyric acid), poly(valeric acid), polyurethane, and / or blends and copolymers thereof. Examples of non-biodegradable polymers include nylon, polyester, polycarbonate, polyacrylate, polysiloxane (silicone), ethylene-vinyl acetate and other acyl-substituted cellulose acetate polymers, non-biodegradable polyurethane, polystyrene, polyvinyl chloride, polyvinyl fluoride, poly(vinylimidazolium), chlorosulfonate polyolefins, polyethylene oxide and / or their blends and copolymers.

[0049] The embodiments and / or portions thereof described herein may include components formed from one or more parts, features, structures, etc. When referring to such components, it should be understood that these components may be formed from a single number of parts having any number of segments, regions, portions, and / or characteristics, or may be formed from multiple parts or features. For example, when referring to a structure such as a wall or room, the structure may be considered as a single structure having multiple parts or as multiple different substructures or the like joined together to form the structure. Thus, a monolithically constructed structure may include, for example, a set of substructures. Such a set of substructures may include multiple parts that are continuous or discontinuous with each other. A set of substructures may also be made from multiple articles or components that are manufactured individually and then joined together (e.g., via welding, adhesives, and / or any suitable method).

[0050] While some embodiments are described herein as being for obtaining bodily fluids for testing one or more cultured samples, it should be understood that these embodiments are not limited to this purpose. Any embodiments and / or methods described herein can be used to transfer bodily fluids to any suitable device placed in fluid communication with it. Therefore, although specific examples are described herein, the devices, methods, and / or concepts are not intended to be limited to such specific examples.

[0051] Now refer to the attached diagram, Figure 1 This is a schematic diagram of a fluid control device 100 according to an embodiment. Typically, the fluid control device 100 (also referred to herein as a “control device” or “device”) is configured to draw bodily fluids from a patient. A first portion or volume of the drawn bodily fluid (e.g., an initial volume) is isolated from a second portion or volume of the drawn bodily fluid (e.g., a subsequent volume). In some cases, contaminants or the like may be isolated within the first portion or volume, leaving the second portion or volume substantially free of contaminants. The second portion or volume of the bodily fluid can then be used as a biological sample in one or more tests (e.g., blood culture tests or similar), as described in more detail herein. The first portion or volume of the bodily fluid can be discarded as waste, re-infused into the patient, or used in any suitable test (a test unlikely to produce erroneous, inaccurate, distorted, inconsistent, and unreliable results due to the presence of potential contaminants).

[0052] The control device 100 includes a housing 110, a flow controller 140, and an actuator 150. The housing 110 of the device 100 can be of any suitable shape, size, and / or configuration. For example, in some embodiments, the housing 110 may have dimensions that are at least partially based on the initial amount or volume of bodily fluids 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 usability associated with the device 100. Furthermore, in some embodiments, one or more portions of the housing 110 may be formed of a relatively transparent material configured to allow a user to visually inspect and / or verify the flow of bodily fluids through at least a portion of the housing 110.

[0053] The housing 110 has and / or forms an inlet 113, an outlet 114, and an isolation chamber 130. The inlet 113 is configured to be fluidly coupled to a lumen-containing device that can then position the housing 110 in fluid communication with a source of bodily fluids. For example, the housing 110 may be coupled to and / or may include a lumen-containing device that is in fluid communication with the inlet 113 and is configured to be percutaneously placed within a patient (e.g., a butterfly needle, intravenous (IV) catheter, peripherally inserted central catheter (PICC), device with an intermediate lumen, and / or the like). Thus, bodily fluids can be transferred from a patient and / or other sources of bodily fluids to the housing 110 via the inlet 113, as described further in detail herein. The outlet 114 may be positioned in fluid communication with a fluid collection device 180 (e.g., a fluid or sample reservoir, syringe, vacuum container, culture flask, etc.). As described in further detail herein, the control device 100 can be used and / or manipulated to selectively transfer a volume of bodily fluid from a bodily fluid source through inlet 113, housing 110 and outlet 114 to fluid collection device 180.

[0054] The housing 110 can define at least a portion of any number of fluid flow paths. For example, as Figure 1 As shown, housing 110 defines one or more fluid flow paths 115 between inlet 113 and isolation chamber 130 and / or one or more fluid flow paths 116 between inlet 113 and outlet 114. As described in further detail herein, control device 100 and / or housing 110 can be configured to switch between any number of states, operating modes and / or configurations to selectively control the flow of bodily fluids through at least one of fluid flow paths 115 and / or 116. Furthermore, control device 100 and / or housing 110 can be configured to switch automatically (e.g., based on differential pressure, time, electronics, membrane saturation, absorbent and / or barrier material, etc.) or via intervention (e.g., user intervention, mechanical intervention or similar intervention).

[0055] An isolation chamber 130 is placed at least temporarily in fluid communication with an inlet 113 via one or more fluid flow paths 115. As described in further detail herein, the isolation chamber 130 is configured to (1) receive a flow and / or volume of bodily fluid from the inlet 113 and (2) isolate (e.g., separate, divide, contain, retain, isolate, etc.) that flow and / or volume of bodily fluid therein. The isolation chamber 130 may have any suitable arrangement, such as those described herein with respect to specific embodiments. However, it should be understood that the control device 100 and / or housing 110 may have an isolation chamber 130 arranged in any suitable manner, and therefore, the isolation chamber 130 is not intended to be limited to those shown and described herein. For example, in some embodiments, the isolation chamber 130 may be formed at least partially by the housing 110. In other embodiments, the isolation chamber 130 may be a reservoir placed and / or disposed 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 fluid flow path 115. In other words, the housing 110 may define one or more cavities and / or may include one or more means defining cavities, which are configured to receive an initial flow or volume of bodily fluid from the inlet 113, thereby forming and / or serving as an isolation chamber 130.

[0056] The isolation chamber 130 may have any suitable volume and / or fluid capacity. For example, in some embodiments, the isolation chamber 130 may have a volume and / or fluid capacity between about 0.1 mL and about 5.0 mL. In some embodiments, the isolation chamber 130 may have a volume measured according to the amount of bodily fluid configured to be transferred into the isolation chamber 130 (e.g., the initial or first volume of bodily fluid). For example, in some embodiments, the isolation chamber 130 may have a volume sufficient to receive an initial volume of bodily fluid, which is as small as one microliter or less (e.g., as small as 20 drops, 10 drops, 5 drops, 1 drop, or any suitable volume in between). In other embodiments, the isolation chamber 130 may have a volume sufficient to receive an initial volume of bodily fluid reaching, 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 greater. In some embodiments, the volume of the isolation chamber 130 may be equal to at least some of the volumes of one or more cavities in fluid communication with a source of bodily fluid (e.g., a combined volume of the needle cavity, inlet 113, and at least a portion of the fluid flow path 115).

[0057] The outlet 114 of housing 110 is in fluid communication with and / or configured to be in fluid communication with fluid flow paths 115 and / or 116. The outlet 114 can be any suitable outlet, opening, port, stopcock, lock (e.g., Luer lock), seal, connector, valve (e.g., check valve, duckbill valve, umbrella valve, and / or the like), and is configured to be physically and / or fluidly coupled to fluid collection device 180. In some embodiments, the outlet 114 may be integrally formed with fluid collection device 180. In other embodiments, the outlet 114 may be at least temporarily coupled to fluid collection device 180 via adhesives, resistance fits, mechanical fasteners, threaded connections, puncture or perforation arrangements, multiple engagement recesses, and / or any other suitable connection or combination thereof. In still other embodiments, the outlet 114 may be via an intervention structure such as a sterile tube and / or the like. Figure 1 (Not shown) is operatively connected to the fluid collection device 180. In some embodiments, the outlet 114 is arranged such that it is physically and / or fluidly sealed before being connected to the fluid collection device 180. In some embodiments, the outlet 114 may change from a sealed configuration to an unsealed configuration in response to being connected to the fluid collection device 180 and / or in response to a negative pressure difference between the environment within the outlet 114 and / or the housing 110 and the environment within the fluid collection device 180.

[0058] Although the outlet 114 of the control device 100 and / or housing 110 is described above as being fluidly coupled to the fluid collection device 180 and / or otherwise placed in fluid communication with the fluid collection device 180, in other embodiments, the device 100 may be used in conjunction with any suitable body fluid collection device, system, adapter and / or the like. For example, in some embodiments, device 100 may be used in or with any suitable fluid transfer device and / or adapter, such as those described in U.S. Patent No. 10,123,783 (hereinafter referred to as the “'783 Patent”), filed March 3, 2015, entitled “Apparatus and Methods for Disinfection of a Specimen Container”, and / or U.S. Patent Publication No. 2015 / 0342510 (hereinafter referred to as the “'510 Publication”), filed June 2, 2015, entitled “Sterile Bodily-Fluid Collection Device and Methods”, the disclosures of each of these patents being incorporated herein by reference in their entirety.

[0059] The fluid collection device 180 can be any suitable device for at least temporarily containing bodily fluids, such as any of those described in detail above (e.g., vacuum container, sample reservoir, syringe, culture flask, etc.). In some embodiments, the fluid collection device 180 can be a sample reservoir including a vacuum seal that maintains negative pressure conditions (vacuum conditions) within the sample reservoir, which in turn facilitates the extraction of bodily fluids from the patient into the sample reservoir via vacuum or suction through the control device 100. In embodiments where the fluid collection device 180 is a vacuum container or the like, a user can connect the fluid collection device 180 to the outlet 114 to initiate the flow of bodily fluids from the patient into the device 100, such that a first or initial portion of the fluid flow is diverted to and isolated by the isolation chamber 130, and a second or subsequent portion of the fluid flow bypasses and / or is diverts away from the isolation chamber 130 into the fluid collection device 180 (e.g., via the outlet 114), as further described herein.

[0060] The flow controller 140 of the device 100 is at least partially disposed within the housing 110 and 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 may be disposed within a portion of and / or the internal volume of the isolation chamber 130 that receives the initial flow or amount of bodily fluid and / or may at least partially define a portion of and / or the internal volume of the isolation chamber 130. In some embodiments, the flow controller 140 may be disposed within the housing 110 such that one or more surfaces of the flow controller 140 and one or more inner surfaces of the housing 110 jointly define the isolation chamber 130. In other words, the flow controller 140 may be disposed within the isolation chamber 130 such that the inner surface of the housing 110 that at least partially defines the isolation chamber 130 and one or more surfaces of the flow controller 140 jointly define a portion of the isolation portion 130 and / or the volume within the isolation chamber 130. In some embodiments, the flow controller 140 may form a barrier and / or otherwise fluidly isolate at least a portion of the fluid flow path 115 from at least a portion of the fluid flow path 116. For example, the flow controller 140 may be disposed within the housing 110 such that a first side and / or surface of the flow controller 140 is in selective fluid communication with at least a portion of the fluid flow path 115 and / or inlet 113, and a second side and / or surface of the flow controller 140 is in selective fluid communication with at least a portion of the fluid flow path 116 and / or outlet 114.

[0061] The flow controller 140 can be of any suitable shape, size, and / or configuration. For example, the flow controller 140 can be, for example, a membrane, diaphragm, bladder, plunger, piston, bag, pouch, and / or any other suitable component having the desired stiffness, flexibility, and / or rigidity. In some embodiments, the flow controller 140 can be configured to transition from a first state to a second state in response to a negative pressure differential and / or suction applied to at least a portion of the flow controller 140. For example, in some embodiments, the flow controller 140 can be a bladder configured to transition or “flip” from a first state to a second state in response to a negative pressure differential and / or suction applied to the surface of the bladder, as described in further detail herein with reference to specific embodiments.

[0062] The flow controller 140 may be in a first state (e.g., a storage or non-use state) before the use device 100, and in response to the outlet 114 being fluidly connected to the fluid collection device 180 (e.g., a collection device defining or configured to define negative pressure and / or suction), the flow controller 140 may transition to a second state. In some embodiments, when the flow controller 140 is in the second state, the flow controller 140 may define at least a portion of the isolation chamber 130. In some embodiments, the flow controller 140 is arranged such that when the flow controller 140 is in the first state, the isolation chamber 130 defines and / or has a first volume and when the flow controller 140 is placed in the second state, the isolation chamber 130 defines and / or has a second volume larger than the first volume. As described further in detail herein, the increase in the volume of the isolation chamber 130 may generate suction, which is operable to draw an initial volume of bodily fluid into the isolation chamber 130. Furthermore, in some embodiments, the flow controller 140 may have dimensions, shape, and / or configuration that allow the isolation chamber 130 to receive a volume of air or gas (e.g., a volume of air disposed in a flow path between the fluid source and the isolation section) and an initial amount or volume of fluid. In such embodiments, the flow controller 140 may be configured to define any number of sections, volumes, channels, etc., that can receive and / or contain at least one of a volume of air or an initial volume of fluid.

[0063] In some embodiments, the size, shape, arrangement, and / or constituent materials of the flow controller 140 may be configured and / or otherwise selected such 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 rate. In some cases, control of the rate at which the flow controller 140 transitions from the first state to the second state may further control and / or modulate the rate at which bodily fluid flows into the isolation chamber 130 and / or the magnitude of the suction generated in the isolation chamber 130, the suction being operable to draw an initial volume of bodily fluid into the isolation chamber 130. Although in Figure 1 Not shown, but in some embodiments, housing 110 may include valves, diaphragms, porous materials, flow restrictors, orifices and / or any other suitable components, devices and / or features configured to modulate the suction applied to the surface of flow controller 140, which in turn modulates the rate at which flow controller 140 transitions from a first state to a second state.

[0064] In some cases, controlling the rate of change of the flow controller 140 and / or the magnitude of the pressure differential and / or suction generated within the isolation chamber 130 can reduce the likelihood of, for example, hemolysis and / or venous collapse in blood samples (this is particularly important, for example, when obtaining body fluid samples from vulnerable patients). In some cases, modulation of the change of the flow controller 140 and / or the pressure differential generated within the isolation chamber 130 can at least partially control the amount or volume of body fluid transferred into the isolation chamber 130 (i.e., the initial volume of body fluid can be controlled).

[0065] An actuator 150 of device 100 is at least partially disposed within housing 110 and configured to control, guide, and / or otherwise facilitate the selective flow of fluid through at least a portion of housing 110. Actuator 150 can be any suitable shape, size, and / or configuration. For example, in some embodiments, actuator 150 can be any suitable component or device configured to transition between a first state and a second state. In some embodiments, actuator 150 can be, for example, a valve, plunger, seal, diaphragm, bladder, vane, plate, rod, switch, and / or the like. In some embodiments, actuator 150 may include one or more seals configured to selectively establish fluid communication between fluid flow channels 113 and 116 when actuator 150 transitions from a first state to a second state.

[0066] Actuator 150 can be actuated and / or transitioned between a first state and a second state in any suitable manner. For example, in some embodiments, transitioning actuator 150 may include activation, pressurization, movement, translation, rotation, switching, sliding, opening, closing, and / or otherwise reconfiguring actuator 150. In some cases, actuator 150 may transition between a first state and a second state in response to manual actuation by a user (e.g., manually applying force to a button, slider, plunger, switch, valve, rotating member, cannula, etc.). In other embodiments, actuator 150 may be configured to automatically transition between a first state and a second state in response to a pressure differential (or lack thereof), a change in potential or kinetic energy, a change in composition or configuration (e.g., a portion of the actuator may at least partially dissolve or deform), and / or the like. In some other embodiments, the actuator 150 may be mechanically and / or electrically actuated or altered (e.g., via a motor and / or the like) based on a predetermined time, the volume of the received bodily fluid, the volumetric flow rate of the bodily fluid, the flow velocity of the bodily fluid, etc. While examples of actuators and / or ways in which actuators may be altered are provided, it should be understood that they have been presented by way of example only and not limitation.

[0067] In some embodiments, actuator 150 may be configured to isolate, separate, disconnect, and / or otherwise prevent fluid communication between at least a portion of fluid flow path 115 and at least a portion of fluid flow path 116 when actuator 150 is in a first state, and actuator 150 may be configured to place fluid flow path 115 (or at least a portion thereof) in fluid communication with fluid flow path 116 (or at least a portion thereof) when actuator 150 is in a second state. Additionally, actuator 150 may be configured to isolate, separate, separate, and / or otherwise prevent fluid communication between isolation chamber 130 and at least a portion of inlet 113, outlet 114, and / or fluid flow paths 115 and 116. Thus, when actuator 150 is in its second state, isolation chamber 130 may be isolated and / or fluidly disconnected from other flow paths of housing 110, and inlet 113 may be in fluid communication with outlet 114. Accordingly, actuator 150 may allow subsequent volumes of bodily fluid (e.g., volumes of bodily fluid following the initial volume of bodily fluid) to be transferred to fluid collection device 180, which is fluidly coupled to outlet 114, as described in further detail herein.

[0068] As described above, device 100 can be used to obtain bodily fluid samples with reduced contamination from microorganisms, such as skin-residing microorganisms and / or similar substances. For example, in some cases, a user such as a doctor, physician, nurse, phlebotomist, technician, etc., can manipulate device 100 to establish fluid communication between inlet 113 and a source of bodily fluid (e.g., a patient's vein, cerebrospinal fluid (CSF) from the spinal canal, urine collection, and / or the like). As a specific example, in some cases, inlet 113 may be coupled to and / or may include a needle or the like, which can be manipulated to puncture the patient's skin and insert at least a portion of the needle into the patient's vein, thereby placing inlet 113 in fluid communication with a source of bodily fluid (e.g., a vein, IV catheter, PICC, etc.).

[0069] In some embodiments, once inlet 113 is placed in fluid communication with a source of bodily fluid (e.g., a portion of a patient), outlet 114 can be fluidly coupled to fluid collection device 180. As described above, in some embodiments, fluid collection device 180 can be any suitable reservoir, container, and / or device configured to receive a volume of bodily fluid. For example, fluid collection device 180 can be an evacuated reservoir or container defining a negative pressure and / or can be a syringe that can be manipulated to generate negative pressure. In some cases, coupling outlet 114 to fluid collection device 180 selectively exposes at least a portion of fluid flow path 116 to negative pressure and / or suction within fluid collection device 180. As described above, a portion and / or surface of flow controller 140 can be in fluid communication with fluid flow path 116, and thereby negative pressure and / or suction can be applied to that portion and / or surface of flow controller 140. Negative pressure and / or suction can then be operated to switch the flow controller 140 from a first state to a second state, in which the isolation chamber 130 has a first volume and in the second state, the isolation chamber 130 has a second volume larger than the first volume. Accordingly, an initial volume of bodily fluid can be drawn into the isolation chamber 130 in response to the switch of the flow controller 140 (e.g., due to the increase in the volume of the isolation chamber 130 caused by the switch of the flow controller 140 from the first state to the second state).

[0070] In some embodiments, for example, the flow controller 140 may be a sac or the like configured to switch or “flip” in response to negative pressure. The flow controller 140 may be configured to switch in a predetermined manner and / or at a predetermined rate, which in turn may control, modulate, and / or otherwise determine one or more characteristics associated with the flow of an initial volume of bodily fluid into the isolation chamber 130. In some embodiments, the flow controller 140 and one or more inner surfaces, such as housing 110, may collectively define multiple distinct portions of the isolation chamber 130. In such embodiments, at least one of the multiple portions of the isolation chamber 130 may be configured to contain a volume of air that is immediately drawn into the isolation chamber 130 before the initial volume of bodily fluid, as described in detail above. Thus, a switch of the flow controller 140 from a first state to a second state may cause an initial portion of the volume of bodily fluid (also referred to herein as the “initial volume” or “first volume”) to flow from inlet 113 into the isolation chamber 130 through at least a portion of the fluid flow path 115. In some embodiments, switching the flow controller 140 from a first state to a second state can switch the control device 100 from a first or initial state or configuration to a second state or configuration in which an initial portion or volume of body fluid can flow into or through at least a portion of the fluid flow path 115 and into the isolation chamber 130.

[0071] The initial volume of bodily fluid can be any suitable volume of bodily fluid, as described above. For example, in some cases, the control device 100 may remain in a second state or configuration until a predetermined and / or desired volume (e.g., the initial volume) of bodily fluid is transferred to the isolation chamber 130. In some embodiments, the initial volume may be associated with 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 bodily fluid may be associated with or at least partially based on an amount or volume of bodily fluid that is equal to or greater than the volume associated with the fluid flow path defined between the bodily fluid source and the isolation chamber 130. In some other embodiments, the control device 100 may be configured to divert the flow of bodily fluids (e.g., initial volume) into the isolation chamber 130 until the pressure difference between the isolation chamber 130 and the fluid flow path 115 and / or the source of bodily fluids reaches a substantially balanced state and / or is otherwise reduced to below a desired threshold.

[0072] After the initial volume of bodily fluid has been transferred and / or diverted into the isolation chamber 130, the control device 100 can transition from a second state or configuration to a third state or configuration. For example, in some embodiments, when the initial volume of bodily fluid is transferred into the isolation chamber 130, the actuator 150 can transition from its first state to its second state, which in turn places the control device 100 into its third state. More specifically, in some embodiments, the arrangement of the control device 100 and / or the isolation chamber 130 allows the flow of bodily fluid into the isolation chamber 130 to substantially stop or slow down in response to the receipt of the initial volume. In some embodiments, for example, the isolation chamber 130 may receive the flow of bodily fluid (e.g., the initial volume of bodily fluid) until the pressure differential within the isolation chamber 130 and / or the pressure differential between the isolation chamber 130 and the fluid flow path 115 and / or the bodily fluid source is balanced. In some cases, the user may visually inspect a portion of the device 100 and / or housing 110 to determine that an initial volume of bodily fluid has been placed in the isolation chamber 130 and / or to determine that the flow of bodily fluid into the isolation chamber 130 has slowed or substantially stopped. In some embodiments, the user may apply force to the actuator 150 and / or may otherwise actuate the actuator 150 to transition the actuator 150 from its first state to its second state. In other embodiments, the actuator 150 may be transitioned automatically (e.g., without user intervention).

[0073] The transition of actuator 150 from its first state to its second state (e.g., placing control device 100 in its third state or configuration) can isolate, isolate, separate, and / or retain the initial volume of bodily fluid in isolation chamber 130. As described further in detail herein, in some cases, the initial volume of bodily fluid may contain contaminants, such as transdermal microorganisms or similar substances expelled during a venipuncture event, other external sources of contamination, colonization of catheters and PICC lines used for sample collection, and / or similar substances. Therefore, when the initial volume is isolated in isolation chamber 130, such contaminants are also isolated in isolation chamber 130.

[0074] In addition to isolating the initial volume of body fluid in the isolation chamber 130, placing the actuator 150 in its second state can also establish fluid communication between at least a portion of the fluid flow paths 115 and 116, allowing one or more subsequent volumes of body fluid to flow from the inlet 113 through at least a portion of the fluid flow paths 115 and / or 116 to the outlet 114. For example, in some embodiments, transitioning the actuator 150 from its first state to its second state can, for example, open or close a port or valve, actuate one or more seals, actuate or remove one or more obstructions, define one or more portions of the flow path, and / or the like. With the fluid collection device 180 fluidly coupled to the outlet 114 and the control device 100 in a third state or configuration, a negative pressure differential and / or suction applied in other ways to the flow controller 140 can be applied to or through at least a portion of the fluid flow paths 115 and 116. Therefore, any one or more subsequent volumes of body fluid can flow from inlet 113, through at least a portion of fluid flow paths 115 and 116, through outlet 114, and into fluid collection device 180. As described above, isolating the initial volume of body fluid in isolation chamber 130 before collecting or acquiring one or more sample volumes of body fluid (e.g., in fluid collection device 180) reduces and / or substantially eliminates the amount of contaminants in one or more sample volumes. Furthermore, in some embodiments, the arrangement of control device 100 may prevent control device 100 from transitioning to a third state before the initial volume is collected and isolated in isolation chamber 130.

[0075] Figures 2 to 11 A fluid control device 200 according to another embodiment is shown. The fluid control device 200 (also referred to herein as a “control device” or “device”) may be similar to the above references, at least in form and / or function. Figure 1 The device 100 described above. For example, as described in the above-described reference device 100, in response to being placed in fluid communication with a negative pressure source (e.g., a suction source or a vacuum source), device 200 can be configured to (1) draw bodily fluid from a bodily fluid source into device 200, (2) divert and isolate a first portion or volume of bodily fluid (e.g., an initial volume) within a portion of device 200, and (3) allow a second portion or volume of bodily fluid (e.g., a subsequent volume) to flow through device 200 (bypassing the isolated initial volume) and into a fluid collection device fluidly coupled to device 200. Accordingly, contaminants or the like can be isolated in or along with the initial volume of bodily fluid, leaving a subsequent volume of bodily fluid substantially free of contaminants.

[0076] The fluid control device 200 (also referred to herein as a “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 thereof, may be arranged in a modular configuration, wherein one or more portions of the housing 210 and / or the actuator 250 may be physically and fluidly coupled (e.g., by an end user) to collectively form the control device 200. Similarly, in some embodiments, the control device 200 may be packaged, shipped, and / or stored independently of fluid collection devices (e.g., sample reservoirs, syringes, etc.) and / or inlet devices (e.g., needles, catheters, peripheral venous lines (PIVs), peripherally inserted central catheters (PICCs), etc.) that may be coupled to the control device 200 by the user 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 as an assembled device to the supplier and / or end user. In some embodiments, the control device 200 may include a fluid collection device and / or may be pre-connected to a fluid collection device (e.g., during manufacturing and / or before delivery to the end user), such fluid collection devices are, for example, any of those described above. Similarly, in some embodiments, the control device 200 may include an inlet device and / or may be pre-connected to an inlet device, such as any of those described herein.

[0077] The housing 210 of the control device 200 can be of any suitable shape, size, and / or configuration. The housing 210 includes an actuator portion 212 and an isolation portion 220. The actuator portion 212 of the housing 210 receives at least a portion of the actuator 250. The isolation portion 220 of the housing 210 is coupled to a cover 235 and includes, receives, accommodates, and / or at least partially defines an isolation chamber 230. As further described in detail herein, the housing 210 may include and / or may 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 allow fluid flow through one or more portions of the housing 210.

[0078] like Figures 2 to 6As shown, the actuator portion 212 of the housing 210 includes an inlet 213 and an outlet 214. The inlet 213 is configured to be in fluid communication with a source of bodily fluid to receive fluid flow from that source, as described in detail above. For example, the inlet 213 may be directly or indirectly coupled to a lumen-containing device, such as a needle, IV catheter, PICC line, and / or the like, which in turn is in fluid communication with a source of bodily fluid (e.g., inserted into a patient). The outlet 214 is configured to be fluidly coupled to a fluid collection device, such as any of those described above. For example, the fluid collection device may be a sample reservoir, syringe, intermediate fluid transfer device, adapter or vessel (e.g., transfer adapters similar to those described in the '783 patent) and / or the like. Furthermore, the fluid collection device may define and / or be manipulated to define a vacuum within the fluid collection device, such that coupling the fluid collection device to the outlet 214 creates a negative pressure differential between one or more portions of the housing 210, as further described herein.

[0079] For example, such as Figures 7 to 11 As shown, actuator portion 212 defines a fluid flow path 215 in fluid communication with inlet 213 and a fluid flow path 216 in fluid communication with outlet 214. More specifically, fluid flow path 215 (e.g., a first fluid flow path) is configured to selectively place inlet 213 in fluid communication with a first port 217, and fluid flow path 216 (e.g., a second fluid flow path) is configured to selectively place outlet 214 in fluid communication with a second port 218. Additionally, after an initial volume of bodily fluid has been transferred into isolation chamber 230, fluid communication can be established between fluid flow paths 215 and 216, allowing subsequent volumes of bodily fluid to flow from inlet 213 through at least a portion of fluid flow paths 215 and 216 to outlet 214 (and / or to a fluid collection device coupled to outlet 214), as further described herein.

[0080] The isolation portion 220 of the housing 210 can be any suitable shape, size, and / or configuration. For example, as... Figures 6 to 8 As shown, the isolation portion 220 includes and / or forms an inner surface, a portion of which is arranged and / or configured to form a first contoured surface 221. At least a portion of the first contoured surface 221 may form and / or define a portion of the isolation chamber 230, as further described herein. Furthermore, a first port 217 and a second port 218 are configured to form and / or extend through a portion of the first contoured surface 221 to selectively place the isolation chamber 230 in fluid communication with fluid flow paths 215 and 216, as further described herein.

[0081] The isolation portion 220 is configured to include, form, and / or accommodate the contour member 225 and the flow controller 240. More specifically, as Figures 6 to 8 As shown, the isolation portion 220 receives and / or is coupled to the profile member 225, such that a flow controller 240 is disposed therebetween. In some embodiments, the profile member 225 may be fixedly coupled to the isolation portion 220 via adhesive, ultrasonic welding, and / or any other suitable joining method. In some embodiments, the profile member 225, the isolation portion 220, and the flow controller 240 may together form a substantially fluid-impermeable and / or air-impermeable seal that isolates the isolation portion 220 from a volume outside the isolation portion 220.

[0082] As shown, the cover 235 is configured to surround the contour member 225 such that the cover 235 and the isolation portion 220 of the housing 210 surround and / or accommodate the contour member 225 and the flow controller 240. In some embodiments, the cover 235 may be attached to the contour member 225 and / or the isolation portion 220 via adhesive, ultrasonic welding, one or more mechanical fasteners, friction fit, snap fit, threaded connection and / or any other suitable connection method. In some embodiments, the cover 235 may define an opening, window, slot, etc., configured to allow visibility of at least a portion of the isolation chamber 230. Although the contour member 225 and the cover 235 have been described above as separate parts and / or components, in other embodiments, the contour member 225 may be integrated and / or integrally formed with the cover 235.

[0083] The contour member 225 includes and / or forms a second contoured surface 226. The arrangement of the contour member 225 and the separating portion 220 of the housing 210 allows at least a portion of the first contoured surface 221 to be aligned and / or opposite to a corresponding portion of the second contoured surface 226 of the contour member 225 (see, for example...). Figure 8 Accordingly, a space, volume, opening, void, chamber, and / or similar element defined between the first profiled surface 221 and the second profiled surface 226 forms and / or defines an isolation chamber 230. Furthermore, a flow controller 240 is disposed between the first profiled surface 221 and the second profiled surface 226 and can be configured to switch between a first state and a second state in response to a negative pressure differential and / or suction applied to at least a portion of the isolation chamber 230, as described in further detail herein.

[0084] Ports 217 and 218 of housing 210 can be of any suitable shape, size, and / or configuration. As described above, the first port 217 is in fluid communication with isolation chamber 230 and can selectively establish fluid communication between isolation chamber 230 and fluid flow path 215 and / or inlet 213. More specifically, the first port 217 is in fluid communication with a first portion of isolation chamber 230 defined between second profiled surface 226 and a first side of flow controller 240. As described further in detail herein, the first port 217 can be configured to provide and / or transfer fluid flow from inlet 213 and fluid flow path 215 to the first portion of isolation chamber 230 defined between second profiled surface 226 and a first side of flow controller 240 in response to a transition of flow controller 240 from a first state to a second state.

[0085] The second port 218 is in fluid communication with the isolation chamber 230 and can selectively establish fluid communication between the isolation chamber 230 and the fluid flow path 216 and / or the outlet 214. More specifically, the second port 218 is in fluid communication with a second portion of the isolation chamber 230 defined between the first profiled surface 221 and a second side (e.g., opposite to the first side) of the flow controller 240. As described further in detail herein, the second port 218 can be configured to expose the second portion of the isolation chamber 230 defined between the first profiled surface 221 and the second side of the flow controller 240 to a negative pressure differential and / or suction generated by a fluid collection device (e.g., a vacuum container, culture flask, syringe, and / or the like) fluidly coupled to the outlet 214. In turn, the negative pressure differential and / or suction can be operable to transition the flow controller 240 from its first state to its second state. In some cases, it is desirable to modulate and / or control the magnitude of the negative pressure differential. Accordingly, the second port 218 may include and / or may be coupled to a flow restrictor 219. The flow restrictor 219 can be configured to limit and / or constrain the flow of fluid (e.g., air or gas) between the second part of the isolation chamber 230 and the fluid flow path 216, thereby modulating and / or controlling the magnitude of the differential pressure and / or suction applied to or borne by the flow controller 240, as further described herein.

[0086] The flow controller 240 is disposed within the housing 210 (e.g., within the isolation chamber 230) between the isolation portion 220 and the contour member 225. The flow controller 240 can be of any suitable shape, size, and / or configuration. Similarly, the flow controller 240 can be formed of any suitable material (e.g., any suitable biocompatible material, such as those described herein and / or any other suitable material). For example, the flow controller 240 can be an impermeable fluid capsule, membrane, diaphragm, and / or the like, configured to transition from a first state and / or configuration to a second state and / or configuration. In some embodiments, the flow controller 240 (e.g., a capsule) may include any number of relatively thin and flexible portions configured to deform in response to a pressure differential across the flow controller 240. For example, in some embodiments, the flow controller 240 may be formed of or from any suitable medical-grade elastomer and / or any of the aforementioned biocompatible materials. In some embodiments, the flow controller 240 may have a hardness between about 5 Shore A and about 70 Shore A, between about 10 Shore A and about 60 Shore A, between about 20 Shore A and about 50 Shore A, between about 30 Shore A and about 40 Shore A, and / or any other suitable hardness. In some embodiments, the flow controller 240 may be formed or formed from a silicone resin having a hardness between about 20 Shore A and about 50 Shore A. More specifically, in some such embodiments, the flow controller 240 may be formed or formed from a silicone resin having a hardness of about 30 Shore A. In some embodiments, the flow controller 240 may include a relatively thin and flexible portion having a thickness between about 0.001” and about 0.1”. In other embodiments, the relatively thin and flexible portion may have a thickness of less than 0.001” or greater than 0.1”.

[0087] In some embodiments, the flow controller 240 may have dimensions and / or shape configured to facilitate, improve, and / or otherwise facilitate fluid flow having a desired set of flow characteristics. Similarly, the flow controller 240 may be formed of or derived from a material having one or more material properties and / or one or more surface finishes, said material being configured to facilitate, improve, and / or otherwise facilitate fluid flow having a desired set of flow characteristics. As further described in detail herein, this set of flow characteristics may be and / or may include relatively uniform or smooth fluid flow, substantially laminar fluid flow and / or fluid flow with relatively low turbulence, fluid flow with a substantially uniform leading edge, fluid flow that does not readily mix with other fluids (e.g., bodily fluid flow that does not mix with air flow or volume), and / or the like.

[0088] exist Figures 2 to 11 In the illustrated embodiment, the flow controller 240 is a capsule (or diaphragm) formed of silicone resin having a hardness of about 30 Shore A. The flow controller 240 (e.g., a capsule) includes a first deformable portion 241, a second deformable portion 242, and a third deformable portion 243. Additionally, the flow controller 240 defines an opening 244. For example, as... Figure 8 As shown, the flow controller 240 can be positioned within the isolation portion 220 of the housing 210 such that the first port 217 extends through the opening 244. In some embodiments, the flow controller 240 is arranged such that the surface defining the opening 244 of the flow controller 240 forms a substantially fluid-impermeable 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, the flow controller 240 may include one or more portions configured to form one or more seals with each of the contoured surfaces 221 and 226 and with the flow controller 240, and / or to form one or more seals between each of the contoured surfaces 221 and 226 and the flow controller 240, as described in further detail herein.

[0089] The deformable portions 241, 242, and 243 of the flow controller 240 can be relatively thin and flexible portions configured to deform in response to a pressure difference between a first side and a second side of the flow controller 240. More specifically, the deformable portions 241, 242, and 243 can each have a thickness of approximately 0.005 inches. For example, as... Figure 8 and Figure 10 As shown, the deformable portions 241, 242, and 243 of the flow controller 240 correspond to at least a portion of the contoured surfaces 221 and / or 226 and / or have a general shape substantially the same as at least a portion of the contoured surfaces 221 and / or 226. Accordingly, the deformable portions 241, 242, and 243 and the corresponding portions of the contoured surfaces 221 and / or 226 can collectively form and / or define one or more channels or the like, which can then receive an initial volume of bodily fluid, as further described in detail herein.

[0090] As described above, the flow controller 240 is configured to transition between a first state and a second state. For example, when the flow controller 240 is in its first state, the deformable portions 241, 242, and 243 are positioned adjacent to and / or substantially in contact with the second profiled surface 226, such as... Figure 8As shown. More specifically, the first deformable portion 241 may be configured to be adjacent to and / or substantially in contact with the first recess 227 formed by the second contoured surface 226, the second deformable portion 242 may be configured to be adjacent to and / or substantially in contact with the second recess 228 formed by the second contoured surface 226, and the third deformable portion 243 may be configured to be adjacent to and / or substantially in contact with the third recess 229 formed by the second contoured surface 226.

[0091] Accordingly, the first portion of the isolation chamber 230 (e.g., the portion defined between the second profiled surface 226 and the first surface of the flow controller 240) can have a relatively small and / or relatively negligible volume. In contrast, when the flow controller 240 transitions from its first state to its second state (e.g., in response to a negative pressure applied and / or transmitted via the second port 218), at least the deformable portions 241, 242, and 243 are configured to be adjacent to and / or substantially in contact with the first profiled surface 221. More specifically, the first deformable portion 241 may be configured to be adjacent to and / or substantially in contact with the first recess 222 formed by the first profiled surface 221, the second deformable portion 242 may be configured to be adjacent to and / or substantially in contact with the second recess 223 formed by the first profiled surface 221, and the third deformable portion 243 may be configured to be adjacent to and / or substantially in contact with, for example, a non-recessed portion of the first profiled surface 221.

[0092] Therefore, the volume of the first portion of the isolation chamber 230 when the flow controller 240 is in its second state is greater than the volume of the first portion of the isolation chamber 230 when the flow controller is in its first state. In other words, the deformable portions 241, 242, and 243 and the second contoured surface 226 may define one or more channels (e.g., the isolation chamber 230) configured to receive an initial volume of bodily fluid. In some cases, the increase in the volume of the first portion of the isolation chamber 230 may create a negative pressure or vacuum therein, which may be operable to draw an initial volume of bodily fluid into the isolation chamber 230, as described in further detail herein. Furthermore, in some embodiments, the arrangement of the deformable portions 241, 242, and / or 243 may allow a volume of air to be drawn into the isolation chamber 230 immediately before the bodily fluid flow can flow into and / or be disposed in the portions of the isolation chamber 230 corresponding to the first deformable portion 241 and / or the second deformable portion 242.

[0093] Although the above references Figures 6 to 11Flow controller 240 has been specifically described, but in other embodiments, flow controller 240 and / or isolation chamber 230 may have any suitable configuration and / or arrangement. For example, in some embodiments, contoured 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 modified. Similarly, flow controller 240 may be modified in any suitable manner to substantially correspond to the shape and / or configuration of contoured surfaces 221 and / or 226. In some embodiments, such modifications may, for example, modify one or more characteristics associated with the flow of gases (e.g., air) and / or fluids (e.g., bodily fluids), one or more characteristics and / or similar characteristics associated with the manner or rate of change by flow controller 240, as further described in detail herein.

[0094] While the flow controller 240 is described as a sac-like or similar object comprising multiple deformable portions, in other embodiments, the flow controller may be arranged and / or configured as, for example, a bellows, a flexible bag, an inflatable bag, an inflatable chamber, a plunger (e.g., similar to a syringe), and / or any other suitable reconfigurable container or similar. Additionally, the isolation chamber 230, at least partially formed by the flow controller 240, may have any suitable shape, size, and / or configuration.

[0095] The actuator 250 of the control device 200 can be of any suitable shape, size, and / or configuration. At least a portion of the actuator 250 is disposed within the actuator portion 212 of the housing 210 and configured to transition between a first state, configuration, and / or position and a second state, configuration, and / or position. Figures 2 to 11 In the illustrated embodiment, actuator 250 is configured as an actuator rod or plunger, which is configured to move relative to actuator portion 212 of housing 210. Actuator 250 includes end portion 251 disposed outside housing 210 and configured to be engaged by a user to transition actuator 250 between its first state and its second state. Figures 6 to 11As shown, a portion of the actuator 250 includes and / or is coupled to a set of seals 255. Seals 255 may be, for example, O-rings, elastomeric overmolded parts, protruding or raised dimensions or fittings, and / or the like. The arrangement of the actuator 250 and the actuator portion 212 of the housing 210 allows the inner portion of the seal 255 to form a fluid-impermeable seal with the surface of the actuator 250, and the outer portion of the seal 255 to form a fluid-impermeable seal with the inner surface of the actuator portion 212 of the housing 210. In other words, the seal 255 forms one or more fluid-impermeable seals between the actuator 250 and the inner surface of the actuator portion 212. Figures 7 to 11 As shown, actuator 250 includes and / or is coupled to four seals 255, which may be distributed along actuator 250 to selectively form and / or define one or more flow paths between them. Furthermore, actuator 250 defines a flow channel 252 defined between a pair of seals 255, which, when actuator 250 is switched to its second state, can help and / or facilitate fluid communication between fluid flow paths 215 and 216, as described in further detail herein. While actuator 250 has been described above as including four seals 255, in other embodiments, actuator 250 may include fewer than four or more seals 255.

[0096] In some embodiments, the actuator portion 212 of the housing 210 and the actuator 250 together include and / or together form a locking element. For example, as Figure 6 and Figure 8 As shown, the actuator portion 212 of the housing 210 may define an opening 238, and the actuator 250 may include a locking member, latch, protrusion, tab, and / or the like (referred to herein as “locking member 253”), configured to be at least partially disposed within the opening 238. In some embodiments, the locking member 253 may be arranged and / or disposed in the opening 238 and may restrict and / or substantially prevent the actuator 250 from being removed from the housing 210. In some embodiments, the locking member 253 may transition between a locked state and an unlocked state, in which the locking member 253 restricts and / or substantially prevents movement of the actuator 250 relative to the housing 210, and in which the actuator 250 may, for example, move between its first state and / or position and its second state and / or position. In some cases, this arrangement may restrict and / or substantially prevent the actuator 250 from being actuated, for example, before the initial volume of bodily fluid is transferred into the isolation chamber 230. In other embodiments, the locking member 253 may, for example, change from an unlocked state to a locked state after the initial volume of bodily fluid has been transferred into the isolation chamber 230.

[0097] like Figure 7 and Figure 8 As shown, when actuator 250 is positioned in its first state and / or location (e.g., prior to using device 100), fluid flow path 215 can establish fluid communication between inlet 213 and first port 217. More specifically, actuator 250 can be positioned relative to housing 210 such that each seal 255 is positioned on one side of inlet 213 opposite to the side of inlet 213 associated with first port 217. In other words, when actuator 250 is in its first state and / or location, actuator 250 and / or seal 255 do not obstruct and / or block fluid flow path 215, as... Figure 7 and Figure 8 As shown. Accordingly, when the actuator 250 is in the first state and / or position, a certain volume (e.g., initial volume) of bodily fluid can flow from the inlet 213 into the isolation chamber 230 through the fluid flow path 215 and the first port 217, as described in further detail herein.

[0098] like Figures 9 to 11 As shown, a force can be applied to the end portion 251 of the actuator 250 to place the actuator 250 in its second state and / or position. When the actuator 250 is in the second state and / or position, the inlet 213 and the outlet 214 are in fluid communication via at least a portion of the fluid flow paths 215 and 216 and / or the flow channel 252. Figure 9 and Figure 11 As shown, the actuator 250 can be positioned such that the inlet 213 and the outlet 214 are each disposed between the same pair of seals 255, thereby allowing the supply fluid to flow through. Additionally, the flow channel 252 defined by the actuator 250 aids and / or facilitates the flow of the fluid (see, for example...). Figure 11 For example, in some embodiments, flow channel 252 may establish fluid communication between a portion of fluid flow path 215 defined by inlet 213 and a portion of fluid flow path 216 defined by outlet 214. Furthermore, the arrangement of seal 255 such that the first port 217 and the second port 218 are each isolated and / or insulated from each of inlet 213 and outlet 214. Accordingly, placing actuator 250 in the second state and / or position may (1) isolate and / or insulate the isolation chamber 230 and any volume of bodily fluid disposed therein and (2) establish fluid communication between inlet 213 and outlet 214, thereby allowing a volume of bodily fluid to flow through device 200 into a fluid collection device (not shown) fluidly connected to outlet 214.

[0099] In some embodiments, the set of seals 255 may be configured to isolate, insulate, and / or seal one or more portions of the device 200 prior to establishing fluid communication between other portions of the device 200. For example, in some embodiments, when the actuator 250 is in a first state, the actuator 250 may be in a first position relative to the actuator portion 212 of the housing 210, as described above. In this case, actuating the actuator 250 (e.g., applying force to the end portion 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, wherein (1) a first seal 255 is disposed between the first port 217 and the inlet 213 and / or its cavity, (2) the inlet 213 and / or its cavity is disposed between the first seal 255 and the second seal 255, (3) the outlet 214 and / or its cavity is disposed between the second seal 255 and the third seal 255, and (4) the second port 218 is disposed between the third seal 255 and the fourth seal 255. Thus, the inlet 213 is isolated from the first port 217, the outlet 214 is isolated from the second port 218, and no fluid communication has been established between the inlet 213 and the outlet 214 (e.g., the inlet 213 is isolated from the outlet 214).

[0100] In some cases, actuating 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 the second state. Accordingly, a second seal 255 is disposed between the first port 217 and the inlet 213 and / or its cavity, each of the inlet 213 and the outlet 214 (and / or its cavity) is disposed between the second seal 255 and a third seal 255, and a second port 218 is disposed between the third seal 255 and a fourth seal 255. Thus, each of the first port 217 and the second port 218 is isolated from the inlet 213 and the outlet 214 (and / or its cavity), and fluid communication is established between the inlet 213 and the outlet (and / or its cavity) (e.g., via flow channel 252).

[0101] Although in this example the actuator 250 is described as moving between a first position, a second position, and a third position relative to actuator portion 212, it should be understood that transitioning actuator 250 from the first state to the second state may include moving actuator 250 in a substantially continuous manner from the first position relative to actuator portion 212, through the second position relative to actuator portion 212, to the third position relative to actuator portion 212. In other embodiments, actuator 250 may be actuated, moved, and / or transitioned in any number of discrete steps. For example, in some cases, actuator 250 may transition by a first predetermined amount to move actuator 250 from the first position relative to actuator portion 212 to the second position relative to actuator portion 212 and then transition (e.g., in a second and / or discrete step) by a second predetermined amount to move actuator 250 from the second position relative to actuator portion 212 to the third position relative to actuator portion 212. Although actuator 250 is described above as including four seals 255, in other embodiments, the actuator may be functionally similar to actuator 250 and may include fewer than four seals (e.g., one seal, two seals, or three seals) or more than four seals (e.g., five seals, six seals, seven seals, or more seals).

[0102] As described above, device 200 can be used to acquire bodily fluid samples with reduced contaminants (e.g., microbial contaminants, such as skin-residing microorganisms, microorganisms outside the bodily fluid source, and / or similar substances). For example, prior to use, device 200 can be in its first, initial, and / or storage state or operating mode, wherein each of flow controller 240 and actuator 250 is in its respective first or initial state. With device 200 in its first state, a user such as a doctor, physician, nurse, phlebotomist, technician, etc., can manipulate device 200 to establish fluid communication between inlet 213 and the bodily fluid source (e.g., a patient's vein). Once inlet 213 is in fluid communication with the bodily fluid source, outlet 214 can be fluidly coupled to a fluid collection device ( Figures 2 to 11 (Not shown in the image). In Figures 2 to 11 In the embodiments shown, for example, the fluid collection device may be a vacuum container, culture flask, sample reservoir, syringe, and / or any other suitable container or device configured to define or generate negative pressure, suction, vacuum, and / or energy potential.

[0103] When the actuator 250 is in a first position and / or configuration, the inlet 213 of the housing 210 is in fluid communication with, for example, a fluid flow path 215, which in turn is in fluid communication with a first port 217. The outlet 214 of the housing 210 is in fluid communication with a fluid flow path 216, which in turn is in fluid communication with a second port 218. More specifically, one or more seals 255 of the actuator 250 may be in a position relative to the actuator portion 212 of the housing 210, which (1) allows fluid communication and / or establishes fluid communication between the inlet 213, the fluid flow path 215, and the first port 217 and (2) fluidly isolates the inlet 213, the fluid flow path 215, and the first port 217 from the outlet 214, the fluid flow path 216, and the second port 218, such as Figure 7 and Figure 8 As shown. Therefore, when the control device 200 is in a first state or operating mode (e.g., when the actuator 250 and the flow controller 240 are each in their first state), fluidly connecting the fluid collection device to the outlet 214 generates and / or otherwise causes a negative pressure differential and / or suction within at least a portion of the fluid flow path 216, and consequently generates and / or otherwise causes a negative pressure differential and / or suction within a portion of the isolation chamber 230 defined between the surface of the flow controller 240 (e.g., the first surface) and the first profiled surface 221 of the housing 210.

[0104] Before the fluid collection device is connected to outlet 214, the flow controller 240 is in a first state and / or configuration. Figures 2 to 11 In the illustrated embodiment, the flow controller 240 is a sac, diaphragm, membrane, and / or similar material that is impermeable to fluids and may have a flipped, inverted, collapsed, and / or vacant configuration (e.g., a first state and / or configuration) before being coupled to the fluid collection device to the outlet 214. For example, as Figure 8 As shown, when the flow controller 240 is in its first state and / or configuration, the flow controller 240 can be configured to be adjacent to and / or in contact with the second profiled surface 226. In other words, the first side of the flow controller 240 (which is opposite to the second side) can be configured to be adjacent to and / or in contact with the second profiled surface 226.

[0105] As described above, the flow controller 240 is configured to transition from its first state and / or configuration to its second state and / or configuration in response to a negative pressure differential and / or suction generated within a portion of the isolation chamber 230 defined between the flow controller 240 and the first profiled surface 221. For example, the flow controller 240 may be configured to switch, move, "flip," and / or otherwise reconfigure to its second state and / or configuration, 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 profiled surface 221, such as... Figure 10 As shown. In other words, the negative pressure differential and / or suction pull, drag, and / or otherwise move at least a portion of the flow controller 240 away from the second profiled surface 226 and toward the first profiled surface 221. 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 configuration.

[0106] A change in the flow controller 240 causes an increase in the internal volume of a portion of the isolation chamber 230 defined between the surface of the flow controller 240 (e.g., the first side of the flow controller 240) and the second profiled surface 226. This increase in internal volume can then create a negative pressure differential between this portion of the isolation chamber 230 (which is at least partially defined by the flow controller 240) and, for example, the inlet 213, which is operable to draw at least a portion of the initial flow, amount, or volume of bodily fluid from the inlet 213 through the fluid flow path 215 and the first port 217 into this portion of the isolation chamber 230. In some cases, the initial volume and / or flow of bodily fluid can be transferred into the isolation chamber 230 until, for example, the flow controller 240 is fully expanded, flipped, and / or changed, until the negative pressure differential decreases and / or balances, and / or until the desired volume of bodily fluid is contained within this portion of the isolation chamber 230.

[0107] In some cases, it is desirable to modulate and / or control the manner in which the flow controller 240 changes and / or the magnitude of the negative pressure differential and / or suction generated on one or both sides of the flow controller 240 within the isolation chamber 230. Figures 2 to 11 In the illustrated embodiment, for example, a second port 218 defines, includes, receives, and / or otherwise connects to a flow limiter 219, which establishes fluid communication between a fluid flow path 216 and a portion of an isolation chamber 230 defined between a flow controller 240 and a first profiled surface 221.

[0108] In some embodiments, the flow restrictor 219 may define an inner cavity or flow path having a relatively small diameter (e.g., the diameter relative to at least a portion of the fluid flow path 216). For example, in some embodiments, the flow restrictor 219 may have a diameter of about 0.0005”, about 0.001”, about 0.003”, about 0.005”, about 0.01”, about 0.1”, about 0.5”, or larger. In other embodiments, the flow restrictor 219 may have a diameter less than 0.0005” or greater than 0.5”. In some embodiments, the flow restrictor 219 may have a predetermined and / or desired length of about 0.01”, about 0.05”, about 0.1”, about 0.15”, about 0.2”, about 0.5”, or larger. In other embodiments, the flow restrictor 219 may have a predetermined length less than 0.01” or greater than about 0.5”. The flow restrictor 219 may have any suitable combination of diameter and length to allow and / or provide the desired fluid (e.g., air) flow characteristics through at least a portion of the control device 200. While the flow restrictor 219 has been described above as defining a relatively small cavity and / or flow path, in other embodiments, the flow restrictor may have any suitable shape, size, and / or configuration. For example, in some embodiments, the flow restrictor may be a porous material, a semi-permeable component or membrane, a mechanical valve, a float and / or a limiter and / or any other suitable component or device configured to modulate a pressure differential across at least a portion of it.

[0109] exist Figures 2 to 11 In the illustrated embodiment, the relatively small diameter of the flow restrictor 219 causes the magnitude of the negative pressure applied through and / or within that portion of the isolation chamber 230 to be smaller than the magnitude of the negative pressure that would be applied otherwise by means of a flow restrictor with a larger diameter, or where the second port 218 does not include or receive the flow restrictor 219. For example, in some embodiments, a fluid collection device and / or other suitable negative pressure source can define and / or generate a negative pressure differential having a magnitude (e.g., a negative magnitude) of about 0.5 pounds per square inch (PSI), about 1.0 PSI, about 2.0 PSI, about 3.0 PSI, about 4.0 PSI, about 5.0 PSI, about 10.0 PSI, about 12.5 PSI, or about 14.7 PSI (at or substantially at atmospheric pressure at sea level). In some embodiments, a fluid collection device, such as a vacuum container or the like, can have a predetermined negative pressure of about 12.0 PSI. Therefore, by controlling the diameter and / or length of the current limiter 219, the amount of negative pressure and / or the rate at which negative pressure is applied to that portion of the isolation chamber 230 is exposed can be controlled, reduced, and / or otherwise modulated. In some cases, the use of the current limiter 219 can cause the negative pressure applied to or within that portion of the isolation chamber 230 to be delayed or increased.

[0110] While the pressure modulation described above is based on the diameter of the flow restrictor 219 (i.e., a single restricted flow path), it should be understood that this is presented by way of example only and not as a limitation. Other measures to modulate the magnitude of the negative pressure in this portion of the exposed isolation chamber 230 may include, for example, porous materials, valves, membranes, diaphragms, specific restrictions, vents, deformable members, or flow paths and / or any other suitable measures. 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 may have a varying diameter. For example, in some embodiments, the control device may include up to 100 or more restricted flow paths. In such embodiments, each of the restricted flow paths may have a diameter between about 0.0005” and about 0.1”, between about 0.0005” and about 0.05”, or between about 0.0005” and about 0.01”. In some embodiments, a plurality of restricted flow paths may be configured to selectively provide a flow path between outlet 214 and this portion of isolation chamber 230, the flow path exposing this portion of isolation chamber 230 to a negative pressure differential.

[0111] In some embodiments, modulating and / or controlling the magnitude of the pressure in this portion of the isolation chamber 230 can further modulate the rate of increase of one or more volumes of the isolation chamber 230. In some cases, modulating the rate of increase of volume (and thus the suction) can modulate and / or limit the magnitude of the pressure applied to bodily fluids and / or within the patient's veins. In some cases, such pressure modulation can reduce the likelihood of, for example, hemolysis of blood samples and / or venous collapse. In some cases, the ability to modulate and / or control the amount or magnitude of negative pressure or suction can allow the control device 200 to be used for a wider range of patients who may have physiological challenges and thus often require negative pressure to facilitate the collection of bodily fluids such as blood (i.e., the pressure differential between atmospheric pressure and the patient's vascular pressure is insufficient to facilitate a sustained and sufficiently strong flow), but without pressure so high that there is no rapid force flattening, collapse, drop, and / or any other way to inhibit the patency and capacity of blood collection.

[0112] In some embodiments, the shape, size and / or arrangement of the isolation chamber 230 and / or the flow controller 240, the magnitude of the negative pressure differential or suction, and / or the manner in which the negative pressure differential or suction is applied can govern and / or control the rate and / or manner in which the flow controller 240 transitions from a first state to a second state. In some cases, control over the rate, sequence, and / or manner of transitions of the flow controller 240 can cause one or more desired flow characteristics associated with the flow of air, gas, and / or bodily fluids flowing into and / or through at least a portion of the isolation chamber 230.

[0113] For example, the arrangement included in this embodiment allows the transformation and / or flipping of the third deformable portion 243 of the flow controller 240 to be completed before the transformation and / or flipping of the first deformable portion 241 and the second deformable portion 242 are completed. In some cases, this arrangement allows a portion of the isolation chamber 230 (e.g., the first volume of the isolation chamber 230) defined by the first recess 227 of the first deformable portion 241 and the second contoured surface 226 to receive at least a portion of the volume of air in the fluid flow path between the fluid source and the isolation chamber 230 before the fluid flow path receives and / or is filled with bodily fluid. Similarly, a portion of the isolation chamber 230 (e.g., the second volume of the isolation chamber 230) defined by the second recess 228 of the second deformable portion 242 and the second contoured surface 226 can receive at least a portion of the volume of air in the fluid flow path. In other words, the flow controller 240 can discharge, empty, and / or purge air or gas from the fluid flow path between the body fluid source and the isolation chamber 230, which can then be collected, stored, and / or contained within the first and second volumes of the isolation chamber 230. Alternatively, a portion of the isolation chamber 230 (e.g., the third volume of the isolation chamber 230), defined by the third deformable portion 243 and the third recess 229 of the second contoured surface 226, can receive an initial volume of body fluid flowing through the fluid flow path between the body fluid source and the isolation chamber 230 after collecting air or gas in the first and / or second volumes of the isolation chamber 230.

[0114] In some cases, this arrangement and / or sequence of transformation by the deformable portions 241, 242, and / or 243 can facilitate the uniform flow of bodily fluid of an initial volume into a third volume, such as that of the isolation chamber 230. More specifically, the third deformable portion 243 is configured to complete or substantially complete its transformation and / or flipping from its first state and / or position before the first deformable portion 241 and / or the second deformable portion 242 have completed or substantially completed their transformation and / or flipping, which can allow bodily fluid to flow into and / or through at least a portion of the third deformable portion 243 having a substantially uniform leading edge. Thus, the third deformable portion 243 can be in a second state, configuration, and / or position before the bodily fluid flows into the isolation chamber 230. Therefore, as body fluids flow into the isolation chamber 230, the third volume of the isolation chamber 230 may have and / or may define a relatively consistent and / or uniform cross-sectional shape and / or area, which in turn may limit wicking of a portion of the body fluid flow, inconsistent local flow rates of the body fluid flow, and / or other non-uniform filling of the third volume of the isolation chamber 230.

[0115] like Figure 8 and 10As shown, the first contoured surface 221 includes recesses 222 and 223, each of which is deeper than a portion of the first contoured surface 221 that is aligned with and / or otherwise associated with the third deformable portion 243 of the flow controller 240. In other words, the distance between the first recess 222 and the second recess 223 of the first contoured surface 221 and the first recess 227 and the second recess 228 of the second contoured surface 226, respectively, is greater than the distance between this portion of the first contoured surface 221 and the third recess 229 of the second contoured surface 226. Therefore, the distance traveled when the first deformable portion 241 and the second deformable portion 242 are transformed and / or flipped is greater than the distance traveled when the third deformable portion 243 is transformed and / or flipped. 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 cases, this arrangement may allow the third deformable portion 243 to complete or substantially complete its transformation and / or flipping before each of the first deformable portion 241 and the second deformable portion 242 has completed or substantially completed its transformation and / or flipping. In other embodiments, the distance traveled by one or more of the deformable portions 241, 242 and / or 243 and / or the width of one or more of the deformable portions 241, 242 and / or 243 may be modified (increased or decreased) to modify and / or change the rate, sequence and / or order associated with the transformation and / or flipping of the deformable portions 241, 242 and / or 243 from the first state to the second state.

[0116] In some embodiments, including fewer or more deformable portions may, for example, modify the relative stiffness of each deformable portion or the relative stiffness associated with each deformable portion and / or may otherwise control the rate and / or manner of transformation or flipping by each deformable portion, which in turn may control the rate and / or manner of inflow of fluid (e.g., air and / or bodily fluids) into the isolation chamber 230. For example, in some embodiments, increasing the number of deformable portions may result in a reduction in the surface area on which a negative pressure is applied, which in turn may increase the pressure differential sufficient to transform and / or flip the deformable portions. While deformable portions 241, 242, and 243 are in Figure 8 and Figure 10While shown as having substantially the same thickness, in other embodiments, at least one deformable portion may have a thickness different from that of the other deformable portions (e.g., deformable portion 241 may have a thickness different from that of deformable portions 242 and / or 243 (or vice versa or in other combinations)). In some cases, increasing the thickness of a deformable portion relative to the thickness of other deformable portions may increase the stiffness of that deformable portion relative to the other deformable portions. In some such cases, increasing the stiffness of the thicker deformable portion may further cause other deformable portions (e.g., thinner deformable portions) to transform and / or flip before the thicker / stiffer deformable portion transforms and / or flips. In some embodiments, the deformable portion may have a varying thickness along at least a portion of the deformable portion.

[0117] In some embodiments, the size, shape, material properties, surface finish, etc., of the flow controller 240 and / or the deformable portions 241, 242, and / or 243 may also facilitate, improve, and / or otherwise induce fluid flow with a substantially uniform leading edge. For example, the third volume of the isolation chamber 230 (which is jointly defined by the third deformable portion 243 and the third recess 229 of the second profiled surface 226) may have a size, shape, diameter, perimeter, and / or cross-sectional area such that the size, shape, diameter, perimeter, and / or cross-sectional area may at least partially limit and / or substantially prevent the mixing of air with the fluid flow (e.g., the leading edge of the flow) due to the surface tension between the fluid flow and each of the third recesses 229 of the third deformable portion 243 and the second profiled surface 226. In some embodiments, for example, the third volume of the isolation chamber 230 may have a size between approximately 0.0001 square inches (in 2 ) and approximately 0.16 in 2 Between, between approximately 0.001 in 2 Approximately 0.08 inches 2 Between, between approximately 0.006 in 2 Approximately 0.06 inches 2 Between, or between approximately 0.025 inches 2 Approximately 0.04 in 2 The cross-sectional area between. In other embodiments, the third volume of the isolation chamber 230 may have a volume less than 0.0001 in. 2 or greater than 0.16in 2 The cross-sectional area.

[0118] In some embodiments, the flow controller 240 and / or the profile member 225 (or at least its second profile surface 226) may be formed of or from a material having one or more material properties and / or one or more surface finishes, said material being configured to facilitate, improve, and / or otherwise induce fluid flow having a desired set of flow characteristics. In other embodiments, the flow controller 240 and / or the second profile surface 226 may have a coating configured to induce a desired set of flow characteristics. For example, in some embodiments, the flow controller 240 and / or the second profile surface 226 may be formed of a coating of a hydrophobic or hydrophilic material and / or may otherwise include a coating of a hydrophobic or hydrophilic material. Furthermore, at least a portion of the flow controller 240 and the profile member 225 (or at least its second profile surface 226) may be formed of or from the same material and / or may include the same coating, or may be formed of or from different materials and / or may include different coatings. Similarly, the flow controller 240 and / or the second profiled surface 226 may include any suitable surface finish, which may be substantially the same or different. In some cases, a non-exhaustive list of desired flow characteristics may be and / or may include one or more of the following: relatively uniform or smooth fluid flow, substantially laminar fluid flow and / or fluid flow with relatively low turbulence, fluid flow with a substantially uniform leading edge, fluid flow that does not readily mix with other fluids (e.g., flow that does not mix with air or volumetric fluids), flow with relatively uniform velocity, and / or the like.

[0119] Although Figures 2 to 11 Certain aspects and / or features of the illustrated embodiments have been described above together with modifications and / or "tuning" of these aspects and / or features. However, it should be understood that the flow controller and / or isolation chamber (or any structure forming the isolation chamber) can have any suitable arrangement to induce a desired rate, manner, and / or sequence of delivery of an initial volume of bodily fluid into one or more portions or volumes of the isolation chamber 230. In some embodiments, the flow controller and / or isolation chamber may include and / or may incorporate any suitable combination of the foregoing aspects and / or features. Any number of the foregoing aspects and / or features may be included in the device and may act synergistically or cooperatively to induce 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 foregoing aspects and / or features are provided by way of example only and not limitation.

[0120] If the initial volume of bodily fluid has been transferred into the isolation chamber 230, a force can be applied to the end portion 251 of the actuator 250 to change and / or place the actuator 250 into its second position, state, operating mode, and / or configuration, as described above. In some cases, the actuator 250 can be changed from a locked configuration or state to an unlocked configuration or state before a force is applied to the end portion 251 of the actuator 250. Figures 2 to 11 In the illustrated embodiments, the switching of actuator 250 can be achieved through user interaction and / or manipulation of actuator 250 and / or can be otherwise caused by user interaction and / or manipulation of actuator 250. However, in other embodiments, the switching of actuator 250 may occur automatically in response to the presence of or in response to external energy within device 200 and / or to negative pressure and / or associated flow dynamics of external energy, which generates one or more dynamics or states that cause the switching of actuator 250.

[0121] like Figures 9 to 11 As shown, when each of the flow controller 240 and actuator 250 is in its second state, the control device 200 is placed in its third state. When actuator 250 transitions to its second state, position, and / or configuration, while the first port 217 and the second port 218 are isolated, shut off, and / or otherwise not in fluid communication with the inlet 213 and / or outlet 214, the inlet 213 and outlet 214 are placed in fluid communication (e.g., via a portion of fluid flow paths 215 and 216 and / or flow channel 252). Accordingly, the initial volume of body fluid is isolated in this portion of the isolation chamber 230 (e.g., the third volume of the isolation chamber 230, as described above). Furthermore, in some cases, contaminants such as skin-residing microorganisms and / or any other contaminants may be entrained and / or contained in the initial volume of body fluid, and thus the contaminants are isolated in the isolation chamber 230 when the initial volume of body fluid is isolated in the isolation chamber 230. Accordingly, the negative pressure previously applied to or through fluid flow path 216 and second port 218 is now applied to or through outlet 214 and inlet 213 via, for example, at least a portion of fluid flow paths 215 and 216 and / or flow channel 252 of actuator 250. Figure 11 In response, bodily fluids can flow from inlet 213, through actuator portion 212 of housing 210, through outlet 214, and into a fluid collection device coupled to outlet 214. Therefore, device 200 can be used in accordance with the above-mentioned references. Figure 1 The device 100 described in detail functions in a manner that is basically similar to that described above.

[0122] Figures 12 to 21A fluid control device 300 according to yet another embodiment is shown. The fluid control device 300 (also referred to herein as a “control device” or “device”) may be similar in form and / or function to the devices 100 and / or 200 described above. For example, as described above with reference to devices 100 and 200, in response to being placed in fluid communication with a negative pressure source (e.g., a suction source or a vacuum source), device 300 may be configured to (1) draw bodily fluid from a bodily fluid source into device 300, (2) divert and isolate a first portion or volume (e.g., an initial volume) of the bodily fluid in a portion of device 300, and (3) allow a second portion or volume (e.g., a subsequent volume) of the bodily fluid to flow through device 300 (bypassing the isolated initial volume) and into a fluid collection device fluidly coupled to device 300. Accordingly, contaminants or the like may be isolated in or along with the initial volume of bodily fluid, leaving a subsequent volume of bodily fluid substantially free of contaminants. In some embodiments, portions and / or aspects of control device 300 may be similar to those described above with reference to devices 100 and 200. Figures 2 to 11 The parts and / or aspects of the control device 200 described are similar and / or substantially the same. Therefore, such similar parts and / or aspects will not be described in further detail herein.

[0123] The fluid control device 300 (also referred to herein as a “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 thereof, may be arranged in a modular configuration, wherein one or more portions of the housing 310 and / or the actuator 350 may be physically and fluidly coupled (e.g., by an end user) to collectively form the control device 300. Similarly, in some embodiments, the control device 300 may be packaged, shipped, and / or stored independently of fluid collection devices (e.g., sample reservoirs, syringes, etc.) and / or inlet devices (e.g., needles, catheters, PIVs, PICCs, etc.) that may be coupled to the control device 300 by a user 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 as an assembled device to the supplier and / or end user. In some embodiments, the control device 300 may include a fluid collection device and / or may be pre-connected to a fluid collection device (e.g., during manufacturing and / or before delivery to the end user), such fluid collection devices being any of those described above. Similarly, in some embodiments, the control device 300 may include an inlet device and / or may be pre-connected to an inlet device, such as any of those described herein.

[0124] The housing 310 of the control device 300 can be of any suitable shape, size, and / or configuration. The housing 310 includes an actuator portion 312 and an isolation portion 320. The actuator portion 312 receives at least a portion of the actuator 350. The isolation portion 320 is coupled to a cover 335 and includes, receives, accommodates, and / or at least partially defines an isolation chamber 330. As further described in detail herein, 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 allow fluid flow through one or more portions of the housing 310.

[0125] like Figures 12 to 16 As shown, the actuator portion 312 of the housing 310 includes an inlet 313 and an outlet 314, and defines a fluid flow path 315 (e.g., a first fluid flow path) and a fluid flow path 316 (e.g., a second fluid flow path). The fluid flow path 315 is configured to selectively place the inlet 313 in fluid communication with a first port 317, and the fluid flow path 316 is configured to selectively place the outlet 314 in fluid communication with a second port 318. The inlet 313 of the housing 310 is configured to be in fluid communication with a source of bodily fluid (e.g., via a needle, IV catheter, PICC line, etc., in fluid communication with a patient) to receive bodily fluid flow therefrom, as described in detail above. The outlet 314 is configured to be fluidly coupled to a fluid collection device, such as any of those described above (e.g., a sample reservoir, syringe, culture flask, intermediate bodily fluid transfer device or adapter, and / or the like). The fluid collection device can be defined and / or manipulated to define a vacuum or negative pressure, which creates a negative pressure difference between desired portions of housing 310 when the fluid collection device is coupled to outlet 314. Additionally, after an initial volume of bodily fluid has been transferred to isolation chamber 330, fluid communication can be established between fluid flow paths 315 and 316 to allow subsequent volumes of bodily fluid (e.g., bodily fluid samples) to flow through device 300 into the fluid collection device. Therefore, the actuator portion 312 of housing 310 can be substantially similar, at least in form and / or function, to the actuator portion 212 of housing 210, and thus will not be described in further detail herein.

[0126] The isolation portion 320 of the housing 310 can be any suitable shape, size, and / or configuration. For example, as Figures 16 to 18As shown, the isolation portion 320 includes and / or forms an inner surface, a portion of which is arranged and / or configured to form a first profiled surface 321. At least a portion of the first profiled surface 321 may form and / or define a portion of the isolation chamber 330, as further described herein. Furthermore, a first port 317 and a second port 318 are configured to form and / or extend through a portion of the first profiled surface 321 to selectively place the isolation chamber 330 in fluid communication with fluid flow paths 315 and 316, as further described herein.

[0127] The isolation portion 320 is configured to include, form, and / or accommodate the profile member 325 and the flow controller 340. More specifically, as Figures 16 to 18 As shown, the isolation portion 320 receives and / or is coupled to the profile member 325 such that a flow controller 340 is disposed therebetween. In some embodiments, the profile member 325 may be fixedly coupled to the isolation portion 320 via adhesive, ultrasonic welding, and / or any other suitable joining method. In some embodiments, the profile member 325, the isolation portion 320, and the flow controller 340 may together form a substantially fluid-impermeable and / or air-impermeable seal that isolates the isolation portion 320 from a volume outside the isolation portion 320.

[0128] As shown, the cover 335 is configured to surround the contour member 325, such that the cover 335 and the isolation portion 320 of the housing 310 surround and / or accommodate the contour member 325 and the flow controller 340. In some embodiments, the cover 335 may be attached to the contour member 325 and / or the isolation portion 320 via adhesive, ultrasonic welding, one or more mechanical fasteners, friction fit, snap fit, threaded connection, and / or any other suitable connection method. In some embodiments, the cover 335 may define an opening, window, slot, etc., configured to allow visibility of at least a portion of the isolation chamber 330. Although the contour member 325 and the cover 335 have been described above as separate parts and / or components, in other embodiments, the contour member 325 may be integrated and / or integrally formed with the cover 335.

[0129] The contour member 325 includes and / or forms a second contoured surface 326. The arrangement of the contour member 325 and the separating portion 320 of the housing 310 allows at least a portion of the first contoured surface 321 to be aligned and / or opposite to a corresponding portion of the second contoured surface 326 of the contour member 325 (see, for example...). Figure 18Accordingly, a space, volume, opening, void, chamber, and / or similar element defined between the first profiled surface 321 and the second profiled surface 326 forms and / or defines an isolation chamber 330. Furthermore, a flow controller 340 is disposed between the first profiled surface 321 and the second profiled surface 326 and can be configured to switch between a first state and a second state in response to a negative pressure differential and / or suction applied to at least a portion of the isolation chamber 330, as described in further detail herein.

[0130] Ports 317 and 318 of housing 310 can be of any suitable shape, size, and / or configuration. As described above in detail with reference to first port 217, first port 317 is in fluid communication with a first portion of isolation chamber 330 defined between second profiled surface 326 and a first side of flow controller 340, and first port 317 is configured to provide and / or transfer fluid flow from inlet 313 and / or fluid flow path 315 to the first portion of isolation chamber 330 in response to a transition of flow controller 340 from a first state to a second state. As described above with reference to second port 218, second port 318 is in fluid communication with a second portion of isolation chamber 330 defined between first profiled surface 321 and a second side of flow controller 340 (e.g., opposite to the first side). Accordingly, the second port 318 can be configured to expose a second portion of the isolation chamber 330 to a negative pressure differential and / or suction force generated by a fluid collection device operable to transition the flow controller 340 from its first state to its second state, as described in detail in the reference device 200 above. Additionally, the second port 318 may include and / or be coupled to a flow restrictor 319 configured to limit and / or constrain the flow of fluid (e.g., air or gas) between the second portion of the isolation chamber 330 and the fluid flow path 316, thereby modulating and / or controlling the magnitude of the pressure differential and / or suction force applied to or experienced by the flow controller 340, as described in detail in the flow restrictor 219 of the reference device 200 above.

[0131] The flow controller 340 disposed in the isolation portion 320 of the housing 310 can be of any suitable shape, size, and / or configuration. Similarly, the flow controller 340 can be formed of any suitable material (e.g., any suitable biocompatible material, such as those described herein and / or any other suitable material). For example, the flow controller 340 can be a sac of impermeable fluid configured to transition from a first state and / or configuration to a second state and / or configuration. In some embodiments, the flow controller 340 (e.g., a sac) can include any number of relatively thin and flexible portions configured to deform in response to a pressure differential across the flow controller 340. In some embodiments, the flow controller 340 can be at least in form and / or function similar to the above-referenced... Figures 2 to 11 The flow controller 240 described in detail is substantially similar. For example, in some embodiments, the flow controller 340 may be formed of or from any suitable material and / or may have any suitable hardness, such as the material and / or hardness described above with reference to flow controller 240. Similarly, the flow controller 340 may have dimensions, shape, surface finish, and / or one or more material properties that are configured to facilitate, improve, and / or otherwise induce fluid flow with a desired set of flow characteristics, as described above with reference to flow controller 240. Therefore, parts of the flow controller 340 may not be described in further detail herein.

[0132] exist Figures 12 to 21 In the illustrated embodiment, the flow controller 340 is a capsule formed from or formed of silicone resin having a hardness of about 30 Shore A. The flow controller 340 (e.g., the capsule) includes a first deformable portion 341 and a second deformable portion 342. Additionally, the flow controller 340 defines an opening 344 configured to receive at least a portion of a first port 317, as described above with reference to flow controller 240. In some embodiments, the flow controller 340 may include one or more portions configured to form one or more seals with each of the contoured surfaces 321 and 326 and the flow controller 340, and / or to form one or more seals between each of the contoured surfaces 321 and 326 and the flow controller 340, as further described in detail herein.

[0133] The deformable portions 341 and 342 of the flow controller 340 can be relatively thin and flexible portions configured to deform in response to a pressure difference between a first side and a second side of the flow controller 340. More specifically, the deformable portions 341 and 342 can each have a thickness of approximately 0.005”. For example, as Figure 18 and Figure 20 As shown, the deformable portions 341 and 342 of the flow controller 340 correspond to at least a portion of the contoured surfaces 321 and / or 326 and / or have a general shape substantially the same as at least a portion of the contoured surfaces 321 and / or 326. Accordingly, the deformable portions 341 and 342 and one or more corresponding portions of the contoured surfaces 321 and / or 326 can collectively form and / or define one or more channels, volumes and / or the like, which can then receive an initial volume of bodily fluid, as further described in detail herein.

[0134] As described above with reference to flow controller 240, flow controller 340 is configured to transition between a first state and a second state. For example, when flow controller 340 is in its first state, a first deformable portion 341 may be configured to be adjacent to and / or substantially in contact with a first recess 327 formed by a second profiled surface 326, and a second deformable portion 342 may be configured to be adjacent to and / or substantially in contact with a second recess 328 formed by a second profiled surface 326. Accordingly, a first portion of isolation chamber 330 (e.g., the portion defined between the second profiled surface 326 and the first surface of flow controller 340) may have a relatively small and / or relatively negligible volume. In contrast, when the flow controller 340 transitions from its first state to its second state (e.g., in response to a negative pressure applied and / or transmitted via the second port 318), the first deformable portion 341 can be configured to be adjacent to and / or substantially in contact with the first recess 322 formed by the first profiled surface 321, and the second deformable portion 342 can be configured to be adjacent to and / or substantially in contact with the second recess 323 formed by the first profiled surface 321. Therefore, the volume of the first portion of the isolation chamber 330 when the flow controller 340 is in its second state is greater than the volume of the first portion of the isolation chamber 330 when the flow controller is in its first state. As described above in detail with reference to the isolation chamber 230 and the flow controller 240, increasing the volume of the first portion of the isolation chamber 330 can induce a negative pressure or vacuum therein, which can be operable to draw a certain volume of air or gas and an initial volume of bodily fluid into the isolation chamber 330.

[0135] While flow controller 340 is specifically shown and described, in other embodiments, flow controller 340 and / or isolation chamber 330 may have any suitable configuration and / or arrangement. For example, in some embodiments, contoured 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 modified. Similarly, flow controller 340 may be modified in any suitable manner to substantially correspond to the shape and / or configuration of contoured surfaces 321 and / or 326. While flow controller 340 is described as a sac or the like comprising multiple deformable portions, in other embodiments, flow controller may be arranged and / or configured as, for example, a bellows, a flexible bag, an inflatable bag, an inflatable chamber, a plunger (e.g., similar to a syringe), and / or any other suitable reconfigurable container or the like. Additionally, isolation chamber 330, at least partially formed by flow controller 340, may have any suitable shape, size, and / or configuration.

[0136] The actuator 350 of the control device 300 can be of any suitable shape, size, and / or configuration. At least a portion of the actuator 350 is disposed within the actuator portion 312 of the housing 310 and configured to transition between a first state, configuration, and / or position and a second state, configuration, and / or position. Figures 12 to 21 In the illustrated embodiment, actuator 350 is configured as an actuator rod or plunger, which is configured to move relative to actuator portion 312 of housing 310. Actuator 350 includes a set of seals 355 and defines a flow passage 352. Actuator 350 also includes an end portion 351 disposed outside housing 310 and configured to be engaged by a user to change actuator 350 between its first state and its second state, in which fluid flow path 315 can establish fluid communication between inlet 313 and first port 317, and in the second state (1) first port 317 (and thus isolation chamber 330) is isolated and / or fluidly isolated and (2) inlet 313 and outlet 314 are placed in fluid communication via at least a portion of fluid flow paths 315 and 316 and / or flow passage 352 of actuator 350. Accordingly, actuator 350 is similar in form and / or function to the above reference. Figures 2 to 11 The actuator 250 is described. Therefore, the actuator 350 will not be described in further detail herein.

[0137] Device 300 can be used to acquire bodily fluid samples with reduced contaminants (e.g., microbial contaminants, such as skin-residing microorganisms, microorganisms outside the bodily fluid source, and / or the like) in a manner substantially similar to that described above for reference device 200. For example, prior to use, device 300 may be in its first, initial, and / or storage state or operating mode, wherein each of flow controller 340 and actuator 350 is in its respective first or initial state. With device 300 in the first state, a user such as a doctor, physician, nurse, phlebotomist, technician, etc., can manipulate device 300 to establish fluid communication between inlet 313 and the bodily fluid source (e.g., a patient's vein). Once inlet 313 is in fluid communication with the bodily fluid source, outlet 314 can be fluidly coupled to a fluid collection device ( Figures 12 to 21 (Not shown in the image). In Figures 12 to 21 In the embodiments shown, for example, the fluid collection device may be a vacuum container, culture flask, sample reservoir, syringe, and / or any other suitable container or device configured to define or generate negative pressure, suction, vacuum, and / or energy potential.

[0138] When the actuator 350 is in the first position and / or configuration, the inlet 313 of the housing 310 is in fluid communication with, for example, a fluid flow path 315, which in turn is in fluid communication with the first port 317 (see, for example...). Figure 17 and Figure 18 The outlet 314 of the housing 310 is in fluid communication with a fluid flow path 316, which in turn is in fluid communication with a second port 318 (see example). Figure 17 and Figure 18 As described in detail above, when the control device 300 is in a first state or operating mode (e.g., when the actuator 350 and the flow controller 340 are each in their first state), fluidly connecting the fluid collection device to the outlet 314 generates and / or otherwise causes a negative pressure differential and / or suction within at least a portion of the fluid flow path 316, and consequently generates and / or otherwise causes a negative pressure differential and / or suction within a portion of the isolation chamber 330 defined between the surface of the flow controller 340 (e.g., the first surface) and the first profiled surface 321 of the housing 310.

[0139] Before the fluid collection device is connected to the outlet 314, the flow controller 340 is in a first state and / or configuration. Figures 12 to 21 In the illustrated embodiment, the flow controller 340 is a sac-like and / or similar object that is impermeable to fluid and may have a flipped, inverted, collapsed, and / or vacant configuration (e.g., a first state and / or configuration) before the fluid collection device is coupled to the outlet 314. For example, as Figure 18As shown, when the flow controller 340 is in its first state and / or configuration, the flow controller 340 can be configured to be adjacent to and / or in contact with the second profiled surface 326.

[0140] As described above, the flow controller 340 is configured to transition from its first state and / or configuration to its second state and / or configuration in response to a negative pressure difference and / or suction generated within a portion of the isolation chamber 330 defined between the flow controller 340 and the first profiled surface 321. For example, when the flow controller 340 is in its first state, the flow controller 340 may be configured to be adjacent to and / or in contact with the second profiled surface 326. Figure 18 The flow controller 340 can be transformed, moved, "flipped," placed, and / or otherwise reconfigured into its second state, in which the flow controller 340 is positioned adjacent to and / or in contact with the first profiled surface 321. Figure 20 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 configuration.

[0141] A change in the flow controller 340 causes an increase in the internal volume of a portion of the isolation chamber 330 defined between the surface of the flow controller 340 (e.g., a second surface opposite the first surface) and the second profiled surface 326. As described in detail above with reference device 200, this increase in internal volume can, in turn, create a negative pressure differential between this portion of the isolation chamber 330 (which is at least partially defined by the flow controller 340) and, for example, the inlet 313. This negative pressure differential is operable to draw at least a portion of the initial flow, amount, or volume of bodily fluid from the inlet 313 through the fluid flow path 315 and the first port 317 into this portion of the isolation chamber 330. In some cases, the initial volume and / or flowing bodily fluid can be transferred into the isolation chamber 330 until, for example, the flow controller 340 is fully expanded, flipped, and / or changed, until the negative pressure differential decreases and / or balances, and / or until the desired volume of bodily fluid is contained within this portion of the isolation chamber 330. Furthermore, the flow restrictor 319 can be configured to constrain, limit, control, and / or modulate the magnitude of the negative pressure differential and / or suction generated within the isolation chamber 330 and / or on the surface of the flow controller 340, which in turn can modulate the suction within one or more flow paths and / or a source of bodily fluid (e.g., a patient's vein), as described in the above-described reference device 200. In other embodiments, the second port 318 and / or any suitable portion of the device 300 can be configured to modulate the suction within one or more portions of the isolation chamber 330 in any suitable manner, such as those described in the above-described reference device 200.

[0142] In some embodiments, the shape, size and / or arrangement of the isolation chamber 330 and / or the flow controller 340, the magnitude of the negative pressure differential or suction and / or the manner in which the negative pressure differential or suction is applied can govern and / or control the rate 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 is described above as including a first deformable portion 241, a second deformable portion 242 and a third deformable portion 243, in Figures 12 to 21 The flow controller 340 in the illustrated embodiment includes only the first deformable portion 341 and the second deformable portion 342. Furthermore, as... Figure 18 and Figure 20 As shown, the recesses 322 and 323 of the first contoured surface 321 have substantially the same depth. In some embodiments, such an arrangement can, for example, limit and / or reduce the amount of negative pressure and / or suction sufficient to change and / or flip 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 sufficient to change and / or flip the first deformable portion 341.

[0143] As described above, in some embodiments, the thickness and / or stiffness of the first deformable portion 341 may be greater than the thickness and / or stiffness of the second deformable portion 342, such that the second deformable portion 342 completes its transformation and / or flipping before the first deformable portion 341 completes or substantially completes its transformation and / or flipping. In other embodiments, the flow controller 340 may include any suitable features, construction, material properties, surface finish, and / or the like, and / or any other part of the device 300 may include any suitable features, construction, etc., configured to control the sequence and / or manner in which the flow controller 340 transitions from a first state to a second state, for example, any of those described above with reference to the flow controller 240. In some embodiments, the arrangement of the flow controller 340 may facilitate compatibility of the device 300 with fluid collection devices having relatively low negative pressure volumes. In some embodiments, such an arrangement may also facilitate and / or simplify one or more manufacturing processes and / or the like. In some cases, controlling the rate, sequence, and / or manner can cause one or more desired flow characteristics associated with the flow of air, gas, and / or bodily fluids into and / or through at least a portion of the isolation chamber 230.

[0144] As described above with reference to deformable portions 241 and 242, a first recess 327 of the first deformable portion 341 and the second contoured surface 326 (e.g., a first volume of the isolation chamber 330) can be configured to receive a volume of air within the fluid flow path between the fluid source and the isolation chamber 330 before receiving and / or filling with a flow of bodily fluid. In other words, a change in the flow controller 340 can vent or purge air or gas from the fluid flow path between the fluid source and the isolation chamber 330, which can then be stored or contained within the first and second volumes of the isolation chamber 330. On the other hand, a portion of the isolation chamber 330 (e.g., a second volume of the isolation chamber 330) defined by the second deformable portion 342 and the second recess 328 of the second contoured surface 326 can be configured to receive an initial volume of bodily fluid flowing through the fluid flow path between the fluid source and the isolation chamber 330 after the air or gas has been vented and / or purged. Therefore, as described in the above reference device 200, the initial volume of bodily fluid can be transferred into the isolation chamber 330.

[0145] In some cases, the arrangement of the isolation chamber 330 and / or the flow controller 340 can facilitate the uniform flow of an initial volume of bodily fluid into, for example, a second volume of the isolation chamber 330. For example, as described in detail in the above reference device 200, the isolation chamber 330 and / or the flow controller 340 can be configured and / or arranged such that bodily 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 a uniform flow front and substantially without mixing with the volume of air in the isolation chamber 330. In other embodiments, the flow controller can have any other suitable arrangement to cause the initial volume of bodily fluid to be delivered to one or more portions or volumes of the isolation chamber 330 at a desired rate, manner, and / or sequence, for example, any of those described in the above reference device 200.

[0146] If the initial volume of bodily fluid has been transferred into the isolation chamber 330, a force can be applied to the end portion 351 of the actuator 350 to change and / or place the actuator 350 into its second position, state, operating mode, and / or configuration, as described above. In some cases, the actuator 350 can be changed from a locked configuration or state to an unlocked configuration or state before a force is applied to the end portion 351 of the actuator 350. Figures 12 to 21In the illustrated embodiment, the switching of actuator 350 can be achieved through user interaction and / or manipulation of actuator 350 and / or can be otherwise caused by user interaction and / or manipulation of actuator 350. However, in other embodiments, the switching of actuator 350 may occur automatically in response to the presence of or in response to external energy within device 300 and / or to negative pressure and / or associated flow dynamics of external energy, which generates one or more dynamics or states that cause the switching of actuator 350.

[0147] like Figures 19 to 21 As shown, when each of the flow controller 340 and actuator 350 is in its second state, the control device 300 is placed in its third state. When actuator 350 transitions to its second state, position, and / or configuration, while fluid flow path 315 and / or first port 317 are isolated, shut off, and / or otherwise not in fluid communication with inlet 313 and / or outlet 314, inlet 313 and outlet 314 are placed in fluid communication (e.g., via fluid flow path 316 and / or flow channel 352). Accordingly, the initial volume of body fluid is isolated in this portion of isolation chamber 330 (e.g., the third volume of isolation chamber 330, as described above). Furthermore, in some cases, contaminants such as skin-residing microorganisms and / or any other contaminants may be entrained and / or contained in the initial volume of body fluid, and thus said contaminants are isolated in isolation chamber 330 when the initial volume of body fluid is isolated in isolation chamber 330. Accordingly, the negative pressure otherwise applied to or through the fluid flow path 316 and the second port 318 is now applied to or through the outlet 314 and the inlet 313 via, for example, at least a portion of the fluid flow paths 315 and 316 and / or the flow channel 352 of the actuator 350. Figure 21 In response, bodily fluids can flow from inlet 313, through actuator portion 312 of housing 310, through outlet 314, and into a fluid collection device coupled to outlet 314. Therefore, device 300 can function in a manner substantially similar to that of devices 100 and / or 200 described in detail above.

[0148] Figures 22 to 27A fluid control device 400 according to yet another embodiment is shown. The fluid control device 400 (also referred to herein as a “control device” or “device”) may be similar in form and / or function to the devices 100, 200, and / or 300 described above. For example, as described in the above-described reference devices 100, 200, and / or 300, in response to being placed in fluid communication with a negative pressure source (e.g., a suction source or a vacuum source), the device 400 may be configured to (1) draw bodily fluid from a bodily fluid source into the device 400, (2) divert and isolate a first portion or volume (e.g., an initial volume) of the bodily fluid within a portion of the device 400, and (3) allow a second portion or volume (e.g., a subsequent volume) of the bodily fluid to flow through the device 400 (bypassing the isolated initial volume) and into a fluid collection device fluidly coupled to the device 400. Accordingly, contaminants or the like may be isolated in or along with the initial volume of bodily fluid, leaving a subsequent volume of bodily fluid substantially free of contaminants. In some embodiments, portions and / or aspects of the control device 400 may be related to at least the above references. Figures 2 to 11 The parts and / or aspects of the control device 200 described are similar and / or substantially the same. Therefore, such similar parts and / or aspects will not be described in further detail herein.

[0149] The fluid control device 400 includes a housing 410, a flow controller 440, and an actuator 450. In some embodiments, the control device 400, or at least a portion thereof, may be arranged in a modular configuration (e.g., including one or more subsequently assembled separate or discrete components) or in an integrated or at least partially integrated configuration (e.g., including one or more pre-assembled or pre-coupled components), as described above with reference to device 200. For example, in some embodiments, the control device 400 may include and / or be coupled to a fluid collection device and / or an inlet device, such as any of those described above.

[0150] The housing 410 of the control device 400 can be of any suitable shape, size, and / or configuration. Generally, the housing 410 can be substantially similar to the housing 210, at least in form and / or function. Therefore, although certain parts, features, aspects, and / or functions of the housing 410 are identified in the drawings and discussed below, such similarities are not described in further detail herein and should be regarded as similar to the corresponding parts, features, aspects, and / or functions described above for the reference device 200, unless explicitly stated otherwise.

[0151] 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 a cover 435 and includes, receives, accommodates, and / or at least partially defines an isolation chamber 430. As further described in detail herein, 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 housing 410 to selectively control and / or allow fluid flow through one or more portions of housing 410.

[0152] The actuator portion 412 of housing 410 includes an inlet 413 and an outlet 414, and defines a fluid flow path 415 (e.g., a first fluid flow path) and a fluid flow path 416 (e.g., a second fluid flow path), wherein the fluid flow path 415 is configured to selectively place the inlet 413 in fluid communication with a first port 417, and the fluid flow path 416 is configured to selectively place the outlet 414 in fluid communication with a second port 418. The actuator portion 412 of housing 410 may be substantially similar to the actuator portion 212 of housing 210, at least in form and / or function, and is therefore not described in further detail herein.

[0153] The isolation portion 420 of housing 410 can be of any suitable shape, size, and / or configuration. Isolation portion 420 is configured to include, form, and / or accommodate contour member 425 and flow controller 440. More specifically, cover 435 is configured to surround contour member 425 such that cover 435 and isolation portion 420 of housing 410 enclose and / or accommodate contour member 425 and flow controller 440. Isolation portion 420 of housing 410 and / or its components or components connected thereto can be substantially similar in form and / or function to isolation portion 220 of housing 210 (and / or its components or components connected thereto), and therefore will not be described in further detail herein.

[0154] For example, such as Figures 24 to 27 As shown, the isolation portion 420 includes and / or forms an inner surface, a portion of which is arranged and / or configured to form a first profiled surface 421. At least a portion of the first profiled surface 421 may form and / or define a portion of an isolation chamber 430, as described in further detail herein. Furthermore, a first port 417 and a second port 418 are configured to form and / or extend through a portion of the first profiled surface 421 to selectively place the isolation chamber 430 in fluid communication with fluid flow paths 415 and 416, as described in the reference device 200 above.

[0155] The first contoured surface 421 can be of any suitable shape, curvature, and / or texture, and can be substantially similar to, for example, the first contoured surface 221 of the housing 220. For example, the first contoured surface 421 includes and / or forms at least a first recess 422 and a second recess 423. However, the first contoured surface 421 can differ from the first contoured surface 221 by including any number of ventilation ridges 424, such as... Figures 24 to 27 As shown. The distribution of ventilation ridges 424 on the first contoured surface 421 can include various arrangements. For example, the first contoured surface 421 may have: a ventilation ridge 424 disposed within and / or formed by the first recess 422 of the first contoured surface 421, multiple ventilation ridges 424, multiple concentric ventilation ridges 424, etc.; and / or a ventilation ridge 424 disposed within and / or formed by the second recess 423 of the first contoured surface 421, multiple ventilation ridges 424, or multiple concentric ventilation ridges 424, such as... Figure 25 and Figure 27 As shown. In some embodiments, the ventilation ridge 424 is configured to reduce and / or control the ability or possibility for the flow controller 440 or a portion thereof to form a seal in response to a negative pressure (e.g., a negative pressure in the volume between the first profiled surface 421 and the flow controller 440) applied and / or transmitted via the second port 418 when the flow controller 440 or a portion thereof is placed in contact with the first profiled surface 421. In other words, the ventilation ridge 424 may form an interruption along one or more portions of the first profiled surface 421, which, for example, can prevent air from being trapped in a localized area between the flow controller 440 and one or more portions of the first profiled surface 421 by allowing air to flow freely between the flow controller 440 and one or more portions of the first profiled surface 421, as described in further detail herein.

[0156] like Figures 24 to 27 As shown, the isolation portion 420 receives and / or is coupled to the contour member 425 such that a flow controller 440 is disposed therebetween. In some embodiments, the contour member 425 may be substantially similar to the contour member 225 described above for reference device 200, at least in form and / or function. For example, the contour member 425 includes and / or forms a second contoured surface 426. The second contoured surface 426 may be any suitable shape, curvature, and / or texture, and may be substantially similar to, for example, the second contoured surface 226 of housing 220. For example, the second contoured surface 426 includes and / or forms a first recess 427, a second recess 428, and a third recess 429. However, the second contoured surface 426 may differ from the second contoured surface 226 by including any number of ventilation channels 431, such as Figures 24 to 27As shown. The distribution of ventilation channels 431 on the second contoured surface 426 can include various arrangements. For example, the second contoured surface 426 can be configured to have: a ventilation channel 431 disposed within and / or formed by the first recess 427 of the second contoured surface 426, a plurality of ventilation channels 431, or a plurality of concentric ventilation channels 431; and / or a ventilation channel 431 disposed within and / or formed by the second recess 428 of the second contoured surface 426, a plurality of ventilation channels 431, or a plurality of concentric ventilation channels 431, such as... Figure 25 and Figure 27 As shown. The ventilation duct 431 is configured to reduce and / or control the ability or possibility of the flow controller 440 or a portion thereof to form a seal in response to positive pressure (e.g., in the volume between the first profiled surface 421 and the flow controller 440) when the flow controller 440 or a portion thereof is placed in contact with the second profiled surface 426, as described above with reference to the ventilation ridge 424.

[0157] While the first profiled surface 421 has been described above as including a ventilation ridge 424 and the second profiled surface 426 has been described above as including a ventilation channel 431, it should be understood that the ventilation ridge 424 and ventilation channel 431 have been presented by way of example only and not limitation. Various alternatives and / or combinations are contemplated. For example, in some embodiments, the first profiled surface 421 may include a ventilation channel, while the second profiled surface 426 may include a ventilation ridge. In other embodiments, the first profiled surface 421 and / or the second profiled surface 426 may include a combination of a ventilation channel and a ventilation ridge. Accordingly, profiled surfaces 421 and 426 may include one or more discontinuities having any suitable shape, size, and / or configuration that may allow and / or otherwise ensure airflow between the flow controller 440 and profiled surfaces 421 and 426. Furthermore, although each of the contoured surfaces 421 and 426 is shown to include a ventilation feature or discontinuity, in other embodiments, the first contoured surface 421 may include a ventilation feature or discontinuity while the second contoured surface 426 may not include a ventilation feature or discontinuity, or vice versa.

[0158] The flow controller 440 disposed in the isolation portion 420 of the housing 410 can be of any suitable shape, size, and / or configuration. Similarly, the flow controller 440 can be formed of any suitable material (e.g., any suitable biocompatible material, such as those described herein and / or any other suitable material). For example, the flow controller 440 can be a sac of impermeable fluid configured to transition from a first state and / or configuration to a second state and / or configuration. In some embodiments, the flow controller 440 (e.g., a sac) can include any number of relatively thin and flexible portions configured to deform in response to a pressure differential across the flow controller 440. In some embodiments, the flow controller 440 can be at least in form and / or function similar to the above-referenced... Figures 2 to 11 The flow controller 240 described in detail is substantially similar. For example, in some embodiments, the flow controller 440 may be formed of or from any suitable material and / or may have any suitable hardness, such as the material and / or hardness described above with reference to flow controller 240. Similarly, the flow controller 440 may have dimensions, shape, surface finish, and / or one or more material properties that are configured to facilitate, improve, and / or otherwise induce fluid flow with a desired set of flow characteristics, as described above with reference to flow controller 240. Therefore, parts of the flow controller 440 may not be described in further detail herein.

[0159] exist Figures 22 to 27 In the illustrated embodiment, the flow controller 440 is a capsule formed from or formed of silicone resin having a hardness of about 30 Shore A. The flow controller 440 (e.g., the capsule) includes a first deformable portion 441, a second deformable portion 442, and a third deformable portion 443. Additionally, the flow controller 440 defines an opening 444 configured to receive at least a portion of a first port 417, as described above with reference to flow controller 240. In some embodiments, the flow controller 440 may include one or more portions configured to form one or more seals with each of the contoured surfaces 421 and 426 and the flow controller 440, and / or to form one or more seals between each of the contoured surfaces 421 and 426 and the flow controller 440. For example, as... Figures 24 to 27As shown, the deformable portions 441, 442, and 443 of the flow controller 440 correspond to at least a portion of the contoured surfaces 421 and / or 426 and / or have a generally identical shape to at least a portion of the contoured surfaces 421 and / or 426. Accordingly, the deformable portions 441, 442, and 443 and one or more corresponding portions of the contoured surfaces 421 and / or 426 can collectively form and / or define one or more volumes and / or similar structures, which can then receive an initial volume of bodily fluid, as further described in detail herein.

[0160] As described above with reference to flow controller 240, flow controller 440 is configured to transition between a first state and a second state. For example, when flow controller 440 is in its first state, a first deformable portion 441 may be configured to be adjacent to and / or substantially in contact with a first recess 427 formed by a second profiled surface 426, a second deformable portion 442 may be configured to be adjacent to and / or substantially in contact with a second recess 428, and a third deformable portion 443 may be configured to be adjacent to and / or substantially in contact with a second recess 429 formed by a second profiled surface 426. Accordingly, a first portion of isolation chamber 430 (e.g., the portion defined between the second profiled surface 426 and the first surface of flow controller 440) may have a relatively small and / or relatively negligible volume. In contrast, when the flow controller 440 transitions from its first state to its second state (e.g., in response to a negative pressure applied and / or transmitted via the second port 418), at least the deformable portions 441, 442, and 443 are configured to be adjacent to and / or substantially in contact with the first profiled surface 421. More specifically, the first deformable portion 421 may be configured to be adjacent to and / or substantially in contact with a first recess 422 formed by the first profiled surface 421, the second deformable portion 442 may be configured to be adjacent to and / or substantially in contact with a second recess 423 formed by the first profiled surface 421, and the third deformable portion 243 may be configured to be adjacent to and / or substantially in contact with, for example, a non-recessed portion of the first profiled surface 421, as described above with reference to the flow controller 240.

[0161] The actuator 450 of the control device 400 can be of any suitable shape, size, and / or configuration. At least a portion of the actuator 450 is disposed within the actuator portion 412 of the housing 410 and configured to transition between a first state, configuration, and / or position and a second state, configuration, and / or position. Figures 22 to 27In the illustrated embodiment, actuator 450 is configured as an actuator rod or plunger, which is configured to move relative to actuator portion 412 of housing 410. Actuator 450 includes a set of seals 455 and defines a flow passage 452. Actuator 450 also includes an end portion 451 disposed outside housing 410 and configured to be engaged by a user to change actuator 450 between its first state and its second state, in which fluid flow path 415 can establish fluid communication between inlet 413 and first port 417, and in the second state (1) first port 417 (and thus isolation chamber 430) is isolated and / or fluidly isolated and (2) inlet 413 and outlet 414 are placed in fluid communication via at least a portion of fluid flow paths 415 and 416 and / or flow passage 452 of actuator 450. Accordingly, actuator 450 is similar in form and / or function to the above reference. Figures 2 to 11 The actuator 250 is described. Therefore, the actuator 450 will not be described in further detail herein.

[0162] Device 400 can be used to acquire bodily fluid samples with reduced contaminants (e.g., microbial contaminants, such as skin-residing microorganisms, microorganisms outside the bodily fluid source, and / or similar substances) in a manner substantially similar to that described above with reference device 200. For example, prior to use, device 400 may be in its first, initial, and / or storage state or operating mode, wherein each of flow controller 440 and actuator 450 is in its respective first or initial state. With device 400 in the first state, a user such as a doctor, physician, nurse, phlebotomist, technician, etc., can manipulate device 400 to establish fluid communication between inlet 413 and the bodily fluid source (e.g., a patient's vein). Once inlet 413 is in fluid communication with the bodily fluid source, outlet 414 can be fluidly coupled to a fluid collection device ( Figures 22 to 27 (Not shown in the image). In Figures 22 to 27 In the embodiments shown, for example, the fluid collection device may be a vacuum container, culture flask, sample reservoir, syringe, and / or any other suitable container or device configured to define or generate negative pressure, suction, vacuum, and / or energy potential.

[0163] When the actuator 450 is in the first position and / or configuration, the inlet 413 of the housing 410 is in fluid communication with, for example, a fluid flow path 415, which in turn is in fluid communication with a first port 417. The outlet 414 of the housing 410 is in fluid communication with a fluid flow path 416, which in turn is in fluid communication with a second port 418 (see, for example...). Figure 24As described in detail above, when the control device 400 is in a first state or operating mode (e.g., when the actuator 450 and the flow controller 440 are each in their first state), fluidly connecting the fluid collection device to the outlet 414 generates and / or otherwise causes a negative pressure differential and / or suction within at least a portion of the fluid flow path 416, and consequently generates and / or otherwise causes a negative pressure differential and / or suction within a portion of the isolation chamber 430 defined between the surface of the flow controller 440 (e.g., the first surface) and the first profiled surface 421 of the housing 410.

[0164] Before the fluid collection device is connected to the outlet 414, the flow controller 440 is in a first state and / or configuration. Figures 22 to 27 In the illustrated embodiment, the flow controller 440 is a sac-like or similar object that is impermeable to fluid and may have a flipped, inverted, collapsed, and / or vacant configuration (e.g., a first state and / or configuration) before the fluid collection device is coupled to the outlet 414. For example, as Figure 24 and Figure 25 As shown, when the flow controller 440 is in its first state and / or configuration, the flow controller 440 can be configured to be adjacent to and / or in contact with the second profiled surface 426.

[0165] As described above, the controller 440 is configured to transition from its first state and / or configuration to its second state and / or configuration in response to a negative pressure differential and / or suction generated within a portion of the isolation chamber 430 defined between the flow controller 440 and the first profiled surface 421. For example, when the flow controller 440 is in its first state, the flow controller 440 may be configured to be adjacent to and / or in contact with the second profiled surface 426. Figure 24 and Figure 25 The flow controller 440 can be transformed, moved, "flipped," placed, and / or otherwise reconfigured into its second state, in which the flow controller 440 is positioned adjacent to and / or in contact with the first profiled surface 421. Figure 26 and Figure 27Furthermore, the ventilation channel 431 formed by the second profiled surface 426 can allow air to flow between the second profiled surface 426 and the flow controller 440, which in some cases can reduce the possibility of air pockets being trapped between the second profiled surface 426 and the flow controller 440 if positive pressure is applied via port 418 in the volume between the flow controller 440 and the first profiled surface 421 (e.g., positive pressure such as driving and / or pushing the flow controller 440 toward the second profiled surface 426 during manufacturing, testing and / or use).

[0166] 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 change in flow controller 440 causes an increase in the internal volume of a portion of the isolation chamber 430 defined between the surface of flow controller 440 (e.g., the second surface opposite the first surface) and the second profiled surface 426. As described in detail above with reference device 200, this increase in internal volume can then create a negative pressure differential between this portion of isolation chamber 430 (which is at least partially defined by flow controller 440) and, for example, inlet 413, which is operable to draw at least a portion of the initial flow, amount, or volume of bodily fluid from inlet 413 through fluid flow path 415 and first port 417 into this portion of isolation chamber 430. In some cases, an initial volume and / or flowing body fluid may be transferred into the isolation chamber 430 until, for example, the flow controller 440 is fully expanded, inverted, and / or switched, until the negative pressure differential decreases and / or balances, and / or until the desired volume of body fluid is contained within that portion of the isolation chamber 430. Furthermore, the flow restrictor 419 may be configured to constrain, limit, control, and / or modulate the magnitude of the negative pressure differential and / or suction generated within the isolation chamber 430 and / or on the surface of the flow controller 440, which in turn may modulate the suction within one or more flow paths and / or body fluid sources (e.g., a patient's vein), as described above in reference device 200. In other embodiments, the second port 418 and / or any suitable portion of the device 400 may be configured to modulate the suction within one or more portions of the isolation chamber 30 in any suitable manner, such as those described above in reference device 200.

[0167] In some embodiments, the shape, size, and / or arrangement of the isolation chamber 430 and / or flow controller 440, ventilation duct 431, and / or ventilation ridge 424, the magnitude of the negative pressure differential or suction, and / or the manner in which the negative pressure differential or suction is applied can govern and / or control the rate and / or manner in which the flow controller 440 transitions from a first state to a second state. In some cases, control over the rate, sequence, and / or manner of transition of the flow controller 440 can cause one or more desired flow characteristics associated with the flow of air, gas, and / or bodily fluids flowing into and / or through at least a portion of the isolation chamber. For example, the arrangement included in this embodiment allows the transition and / or flipping of the third deformable portion 443 of the flow controller 440 to be completed before the transition and / or flipping of the first deformable portion 441 and the second deformable portion 442 is completed. Furthermore, the arrangement of the ventilation ridge 424 along the first contoured surface 421 can increase the possibility and / or ensure that the flow controller 440 is switched and / or flipped in a desired manner or sequence by preventing potential flow restriction and / or sealing. This can also prevent negative pressure differentials or suction from causing a portion of the flow controller 440 located on the opposite side of the restriction or sealing to switch and / or flip.

[0168] This arrangement allows a portion of the isolation chamber 430 (e.g., a first volume of the isolation chamber 430) defined by the first deformable portion 441 and the first recess 427 of the second contoured surface 426 to receive at least a portion of the volume of air within the fluid flow path between the fluid source and the isolation chamber 430 before the fluid flow path receives and / or is filled with bodily fluid. Similarly, a portion of the isolation chamber 430 (e.g., a second volume of the isolation chamber 430) defined by the second deformable portion 442 and the second recess 428 of the second contoured surface 426 can receive at least a portion of the volume of air within the fluid flow path. Alternative arrangements of the isolation chamber 430 and / or the flow controller 440 may be similar in form and function to those described above with reference to the isolation chamber 230 and / or the flow controller 240, and thus will not be described in further detail herein.

[0169] If the initial volume of bodily fluid has been transferred into the isolation chamber 430, a force can be applied to the end portion 451 of the actuator 450 to change and / or place the actuator 450 into its second position, state, operating mode, and / or configuration, as described above. In some cases, the actuator 450 can be changed from a locked configuration or state to an unlocked configuration or state before a force is applied to the end portion 451 of the actuator 450. Figures 22 to 27In the illustrated embodiment, the switching of actuator 450 can be achieved through user interaction and / or manipulation of actuator 450 and / or can be otherwise caused by user interaction and / or manipulation of actuator 450. However, in other embodiments, the switching of actuator 450 may occur automatically in response to the presence of or in response to external energy within device 400 and / or to negative pressure and / or associated flow dynamics of external energy, which generates one or more dynamics or states that cause the switching of actuator 450.

[0170] like Figure 26 and Figure 27 As shown, when each of the flow controller 440 and actuator 450 is in its second state, the control device 400 is placed in its third state. When actuator 450 transitions to its second state, position, and / or configuration, while fluid flow path 415 and / or first port 417 are isolated, shut off, and / or otherwise not in fluid communication with inlet 413 and / or outlet 414, inlet 413 and outlet 414 are placed in fluid communication (e.g., via fluid flow path 416 and / or flow channel 452). Accordingly, the initial volume of body fluid is isolated in this portion of the isolation chamber 430. Furthermore, in some cases, contaminants such as skin-residing microorganisms and / or any other contaminants may be entrained and / or contained in the initial volume of body fluid, and thus said contaminants are isolated in the isolation chamber 430 when the initial volume of body fluid is isolated in the isolation chamber 430. Accordingly, the negative pressure otherwise applied to or through the fluid flow path 416 and the second port 418 is now applied to or through the outlet 414 and the inlet 413 via, for example, at least a portion of the fluid flow paths 415 and 416 and / or the flow channel 452 of the actuator 450. In response, bodily fluids may flow from the inlet 413, through the actuator portion 412 of the housing 410, through the outlet 414, and into a fluid collection device coupled to the outlet 414. Thus, the device 400 can function in a manner substantially similar to that of the devices 100 and / or 200 described in detail above.

[0171] Referring now to 28, a flowchart is presented illustrating method 10 of obtaining a bodily fluid sample with reduced contaminants using a fluid control device according to an embodiment. The fluid control device may be similar to and / or substantially the same as any of the fluid control devices 100, 200, 300, and / or 400 described in detail above. Thus, the fluid control device (also referred to herein as a “control device” or “device”) may include a housing, a flow controller, and an actuator. At 11, method 10 includes establishing fluid communication between a bodily fluid source and an inlet to the housing. For example, in some embodiments, a user may manipulate the fluid control device to physically and / or fluidly connect the inlet to a device containing a lumen (e.g., a needle, IV, PICC line, etc.), which is then in fluid communication with a patient. In other embodiments, the bodily fluid source may be a source other than a patient (e.g., a reservoir, container, etc.).

[0172] At point 12, a fluid collection device is connected to the outlet of the housing. The connection between the fluid collection device and the outlet is configured to induce and / or otherwise generate a negative pressure differential within at least a portion of the fluid control device, as described in detail above for reference devices 100, 200, 300, and / or 400. In some embodiments, the fluid collection device may be, for example, a vacuum container, a sample or culture flask defining a negative pressure, a syringe, and / or the like. At point 13, in response to suction applied by the fluid collection device, the flow controller of the control device is switched from a first state to a second state to increase the volume of the isolation chamber jointly defined by the flow controller and a portion of the housing. For example, in some embodiments, the flow controller may be an impermeable fluid capsule or the like (similar to the flow controllers 240, 340, and / or 440 described in detail above), which is disposed within the isolation chamber.

[0173] A flow controller (e.g., a bladder) may define any number of deformable portions configured to shift, deform, flip, and / or otherwise reconfigure in response to suction. In some embodiments, a first portion of the isolation chamber may be associated with and / or at least partially defined by a first deformable portion of the flow controller, and a second portion of the isolation chamber may be associated with and / or at least partially defined by a second deformable portion of the flow controller. In some embodiments, the flow controller is arranged within the isolation chamber such that the first and second portions of the isolation chamber are on a first side of the flow controller (e.g., an impermeable fluid bladder), and a third portion of the isolation chamber is on a second side of the flow controller opposite to the first side. As described above with reference to at least devices 200, 300, and / or 400, the arrangement of the housing, flow controller, and actuator allows the inlet to be in fluid communication with a first and / or second portion of the isolation chamber (e.g., via a port similar to the first ports 217, 317, and / or 417 described above) and the outlet to be in fluid communication with a third portion of the isolation chamber (e.g., via a port similar to the second ports 217, 317, and / or 417 described above) when the actuator is in a first state and / or configuration. Accordingly, the third portion of the isolation chamber may be exposed to at least a portion of the suction generated by the fluid collection device, which in turn is operable to change the flow controller from its first state to its second state.

[0174] At point 14, in response to an increase in the volume of the isolation chamber, a first portion of the isolation chamber receives a volume of air contained within a flow path defined between the source of the bodily fluid and the isolation chamber. For example, in some embodiments, the inlet of the housing may be fluidly coupled to a needle or a lumen-containing device, which is then inserted into a portion of the patient's body. Accordingly, for example, the lumen of the needle or lumen-containing device, the lumen of the inlet of the housing, and the lumen of one or more flow paths, channels, openings, or ports defined by the housing may collectively define the flow path. In other words, the control device may be configured to purify the air flow path before transferring the bodily fluid into the isolation chamber.

[0175] 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 segments (e.g., similar to 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 (e.g., similar to isolation chamber 330 described above). In still other embodiments, the first and second portions 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 may have a similar shape and / or arrangement to those described in detail in U.S. Patent Publication Serial No. 2019 / 0076074, filed September 12, 2018, entitled “Fluid Control Devices and Methods of Using the Same” (referred to herein as “'074 Publication”), the disclosure of which is incorporated herein by reference in its entirety.

[0176] At point 15, in response to an increase in the volume of the isolation chamber, the second portion of the isolation chamber receives an initial volume of body fluid. More specifically, after receiving that volume of air in the first portion of the isolation chamber, the second portion of the isolation chamber may receive an initial volume of body fluid. In some embodiments, the initial volume of body fluid may be a volume 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 flowing into the second portion of the isolation chamber when the negative pressure differential (e.g., caused by the increase in volume) is below a threshold order of magnitude or amount. In other embodiments, body fluid may flow into the second portion of the isolation chamber until the pressure within the isolation chamber and / or in the flow path between the body fluid source and the isolation chamber is equalized. In still other embodiments, the initial volume may be any suitable amount or volume of body fluid, such as any of the amounts or volumes described in detail herein. In some cases, the filling or substantial filling of the second portion of the isolation chamber may be operable to isolate, retain, and / or fluidly lock a volume of air in the first portion of the isolation chamber.

[0177] At point 16, after receiving an initial volume of bodily fluid, the actuator of the device is switched from a first configuration to a second configuration in order to (1) isolate the isolation chamber and (2) allow subsequent volumes of bodily fluid to flow from the inlet to the outlet in response to suction. In some embodiments, the actuator may switch from a first state to a second state to automatically isolate the initial volume of bodily fluid in the isolation section. In other embodiments, the actuator may switch from a first state to a second state in response to a force applied by a user, as described above with reference to actuators 250, 350, and / or 450. For example, in some embodiments, the actuator may be a rod or plunger comprising one or more seals or the like that may (1) fluidly isolate at least a portion of the flow path between the inlet and the isolation chamber, (2) fluidly isolate at least a portion of the flow path between the outlet and the isolation chamber, and (3) establish fluid communication between the inlet and the outlet to allow subsequent volumes of bodily fluid to flow between the inlet and the outlet.

[0178] When the fluid collection device is fluidly connected to the outlet of the housing, subsequent volumes (e.g., one or more sample volumes) of body fluid can be delivered into the fluid collection device and used, for example, for any suitable test, such as those described herein. As described in detail above, in some cases, isolating the initial volume of body fluid in an isolation section of the device can isolate any contaminants contained in the initial volume. Therefore, contaminants in subsequent volumes of body fluid that could otherwise lead to erroneous or inaccurate results in the test can be reduced or substantially eliminated.

[0179] While various embodiments have been described above, it should be understood that they are presented by way of example only and not as limitation. Where certain components are arranged in certain orientations or positions as indicated by the above schematic diagrams and / or embodiments, modifications to the arrangement of components are possible. Although embodiments have been specifically shown and described, it should be understood that various changes in form and detail may be made. Although various embodiments have been described as having specific combinations of features, concepts, and / or components, other embodiments are possible having any combination or sub-combination of any features, concepts, and / or components from any embodiment described herein.

[0180] In some embodiments, the specific configuration of the individual components may also be changed. For example, the size and specific shape of the individual components may differ from the illustrated embodiments while still providing the functionality described herein. In some embodiments, changing the size and / or shape of such components may reduce the overall size of the device and / or improve the ergonomics of the device without changing its functionality. In some embodiments, the size and / or shape of the individual components may be specifically selected according to the desired or intended use. For example, in some embodiments, devices such as those described herein may be configured for use with or on a seemingly healthy adult patient. In such embodiments, the device may include an isolation chamber having a first volume (e.g., about 0.5 ml to about 5.0 ml). In other embodiments, devices such as those described herein may be configured for use with or on, for example, seriously ill patients and / or pediatric patients. In such embodiments, the device may include an isolation chamber having a second volume smaller than the first volume (e.g., less than about 0.5 ml). Therefore, it should be understood that the size, shape, and / or arrangement of embodiments and / or their components may be adapted to a given use unless the context explicitly clarifies otherwise.

[0181] Any of the embodiments described herein can be used in conjunction with any suitable fluid transfer, fluid collection and / or fluid storage device, such as the fluid reservoir described in '420 patent. In some cases, any embodiment described herein can be used in conjunction with any suitable transfer adapter, fluid transfer device, fluid collection device, and / or fluid storage device, such as those described in '783 Patent, '510 Publication, '074 Publication, and / or U.S. Patent No. 8,535,241, filed October 22, 2012, entitled "Fluid Diversion Mechanism for Bodily-Fluid Sampling"; U.S. Patent No. 9,060,724, filed May 29, 2013, entitled "Fluid Diversion Mechanism for Bodily-Fluid Sampling"; U.S. Patent No. 9,155,495, filed December 2, 2013, entitled "Syringe-Based Fluid Diversion Mechanism for Bodily-Fluid Sampling"; and U.S. Patent No. 9,155,495, filed June 23, 2016, entitled "Devices U.S. Patent Publication No. 2016 / 0361006, entitled "Systems and Methods for SyringeBased Fluid Transfer for Bodily-Fluid Sampling"; U.S. Patent Publication No. 2018 / 0140240, filed November 20, 2017, entitled "Systems and Methods for Sample Collection with Reduced Hemolysis"; and / or any apparatus described in U.S. Patent No. 9,950,084, filed September 6, 2016, entitled "Apparatus and Methods for Maintaining Sterility of a Specimen Container," the disclosures of which are incorporated herein by reference in their entirety.

[0182] While control devices 100, 200, 300, and / or 400 are described as transferring bodily fluids into the device due to negative pressure within the fluid collection device, in other embodiments, the devices described herein can be used with any suitable device (e.g., a syringe or pump) configured to establish a negative pressure differential, suction, and / or the like. In other embodiments, the control device may include a pre-filled isolation chamber, a ventilated isolation chamber, a manually actuated device configured to generate negative pressure, an energy source (e.g., chemical, kinetic, and / or the like), and / or any other suitable device that defines and / or forms a pressure differential within a portion of the control device. Furthermore, the control device may be coupled to such a collection device by a user (e.g., a doctor, nurse, technician, physician, etc.) or may be coupled or assembled during manufacturing. In some embodiments, pre-assembling the control device and collection device (e.g., a sample container or syringe) may, for example, enforce compliance with a sample acquisition protocol that requires the isolation of an initial volume of bodily fluid before collecting a sample volume of bodily fluid.

[0183] While some of the above embodiments include flow controllers and / or actuators with specific configurations and / or arrangements, in other embodiments, the fluid control device may include any suitable flow controller and / or actuator configured to selectively control the flow of bodily fluids through one or more portions of the fluid control device. For example, while some embodiments include actuators with one or more seals arranged as O-rings or elastomeric overmolded parts that move with the actuator relative to a portion of the device (e.g., the inner surface of a housing or the like), in other embodiments, the fluid control device may include one or more seals with any suitable configuration. For example, in some embodiments, the fluid control device may include one or more seals arranged as elastomeric sheets or the like, which are fixedly coupled to a portion of the control device. In such embodiments, a portion of an actuator, such as a pin or rod, may extend through an opening defined in one or more elastomeric sheets, which in turn form a substantially fluid-impermeable seal with the outer surface of the pin or rod. Accordingly, at least a portion of the actuator may move relative to one or more elastomeric sheets, which in turn remain in a substantially fixed position relative to that portion of the control device. In some embodiments, removing this portion of the actuator from an opening defined by one or more elastomeric sheets can allow fluid to flow through the opening, which is otherwise blocked by that portion of the actuator. Thus, the one or more elastomeric sheets can function in a manner similar to any seal described herein. Furthermore, in some embodiments, this arrangement can, for example, reduce the amount of friction associated with forming the desired fluid-impermeable seal, which in turn can eliminate the need for lubricants that are otherwise used to facilitate the movement of the seal within the control device.

[0184] In some embodiments, the device and / or flow controller may include one or more vents, membranes, components, semi-permeable barriers, and / or the like, configured to at least partially control the flow of fluid through the device, flow controller, and / or actuator. For example, while multiple portions of the isolation chamber 230 have been described above as receiving and retaining volumes of air extracted, discharged, and / or cleared from the fluid flow path between the body fluid source and the isolation chamber 230, in other embodiments, the isolation chamber 230 may include vents or selectively permeable components configured to allow air to exit the isolation chamber 230. For example, in some embodiments, a sac or diaphragm (or a portion thereof) may be formed of or from a semi-permeable material that allows air flow but not body fluid flow. In other embodiments, the semi-permeable material may be disposed in or along the fluid flow path between at least one of the outlet or inlet and the isolation chamber to selectively allow air and / or body fluid flow therethrough. In some embodiments, the fluid control device may include a semi-permeable component and / or membrane that may be similar in form and / or function to the semi-permeable component and / or membrane (e.g., a flow controller) described in the above-incorporated '074 publication by reference.

[0185] While flow controllers 240, 340, and 440 are described above as bladders configured to change, move, flip, and / or otherwise reconfigure in response to a negative pressure applied to the surface of the bladder exceeding a threshold negative pressure, in other embodiments, the fluid control device may include any suitable flow controller, actuator, semi-permeable component (e.g., air-permeable and liquid-impermeable) and / or the like, configured to change, move, flip, and / or otherwise reconfigure in any suitable manner in response to exposure to a desired and / or predetermined negative pressure. In other embodiments, the control device may include a bladder (or flow controller) configured to "flip" (e.g., change relatively quickly and / or substantially uniformly) or configured to gradually change from a first state (e.g., unfold, expand, unfurl, and / or otherwise reconfigure) to a second state in response to exposure to a negative pressure differential. In some cases, control of the rate of change by the sac (or flow controller) can allow for modulation and / or control of the negative pressure differential generated in the isolation chamber, and consequently, modulation and / or control of the magnitude of suction applied to the patient's veins and / or other suitable sources of bodily fluids.

[0186] While some of the above embodiments include flow controllers and / or actuators that physically and / or mechanically isolate one or more parts of the fluid control device, in other embodiments, the fluid control device does not require physical and / or mechanical isolation of one or more parts of the fluid control device. For example, in some embodiments, an actuator such as actuator 250 can transition from a first state to a second state in which an initial volume of bodily fluid can flow from an inlet to an isolation chamber or portion, and in the second state (1) the isolation chamber or portion is physically and / or mechanically isolated and (2) the inlet is in fluid communication with the outlet of the fluid control device. However, in other embodiments, the actuator and / or any other suitable part of the fluid control device can transition from a first state to a second state in which an initial volume of bodily fluid can flow from an inlet to an isolation chamber or portion, and in the second state, the inlet is placed in fluid communication with the outlet without physically and / or mechanically isolating (or isolating) the isolation chamber or portion. When such a control device is in the second state, one or more features and / or geometries of the control device may cause bodily fluids to flow preferentially from the inlet to the outlet, and the initial volume of bodily fluids may be retained in the isolation chamber or section without physical and / or mechanical isolation or separation of the isolation chamber or section.

[0187] While the flow limiter 219 has been described above as modulating and / or controlling the magnitude of the negative pressure applied on or through at least a portion of device 200 (e.g., within isolation chamber 230 and / or otherwise on flow controller 240), in other embodiments, the control device may include any suitable features, mechanisms, and / or means configured to modulate, generate, and / or otherwise control one or more pressure differentials through at least a portion of the control device. For example, in some embodiments, a user may rotate an actuator and / or actuate an actuator to change (e.g., decrease or increase) the size of one or more portions of the fluid flow path or fluid flow interface within a portion of the control device to manually modulate and / or otherwise control the amount or magnitude of the negative pressure within one or more portions of the control device.

[0188] Although not shown, any of the devices described herein may include an opening, port, connector, diaphragm, Luer-Lok, gasket, valve, threaded connector, standard fluid interface, etc. (referred to as a "port" for simplicity) in fluid communication with an isolation chamber. In some such embodiments, the port may be configured to connect to any suitable device, reservoir, pressure source, etc. For example, in some embodiments, the port may be configured to connect to a reservoir, which in turn allows a larger volume of body fluid to be diverted and / or transferred to the isolation chamber. In other embodiments, the port may be connected to a negative pressure source, such as a vacuum container, pump, syringe, and / or the like, to collect a portion or all of the volume of body fluid in the isolation chamber, channel, reservoir, etc., and the volume of body fluid (e.g., pre-sample volume) may be used for additional clinical and / or in vitro diagnostic testing purposes. In other embodiments, the port may be configured to receive probes, sampling tools, testing devices, and / or the like, which may be used to perform one or more tests (e.g., tests insensitive to potential contamination) on the initial volume while it is being set up or isolated in the isolation chamber. In other embodiments, the port can be connected to any suitable pressure source or infusion device configured to infuse an initial volume of body fluid isolated in the isolation chamber back into the patient and / or a source of body fluid (e.g., for pediatric patients, severely ill patients, patients with low blood volume, and / or similar patients). In other embodiments, the isolation passage, chamber, and / or reservoir can be configured to include additional diagnostic testing components (e.g., paper tests) integrated into the chamber, such that the initial body fluid is used for the test.

[0189] In other embodiments, isolation chambers, channels, and / or reservoirs may be designed, sized, and configured to allow for the removal of testing equipment and compatibility with and / or specific access to other types of body fluid tests typically performed on patients with suspected conditions. For example, patients with suspected 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 (e.g., after receiving an initial volume of body fluid), and the body fluid contained therein can be used for these additional testing purposes before or after collecting subsequent samples for microbiological testing.

[0190] Although not shown, in some embodiments, the fluid control device may include one or more cavities, channels, flow paths, etc., configured to selectively allow “bypass” flow for bodily fluids, wherein an initial amount or volume of bodily fluid may flow from an inlet through the cavity, channel, flow path, etc., to bypass an isolation chamber and flow into a collection device. In some embodiments, the fluid control device may include an actuator having, for example, at least three states: a first state, a second state, and a third state, in which bodily fluid may flow from an inlet to an isolation portion; in the second state, after an initial volume has been isolated in an isolation chamber, bodily fluid may flow from an inlet to an outlet; and in the third state, bodily fluid may flow from an inlet through a bypass fluid path to an outlet. In other embodiments, the control device may include a first actuator configured to switch the device between a first state and a second state, as described in detail above with reference to specific embodiments, and the control device may include a second actuator configured to switch the device to a bypass configuration or a similar configuration. In some other embodiments, the control device may include any suitable means, features, components, mechanisms, actuators, controllers, etc., configured to selectively place the fluid control device in a bypass configuration or state.

[0191] In some embodiments, a method of using a fluid control device such as those described herein may include a series of steps establishing fluid communication between a source of bodily fluid (e.g., a patient's vein or the like) and an inlet of the fluid control device. The outlet of the fluid control device is then positioned in fluid communication with and / or otherwise engaged with a negative pressure source. This negative pressure source may be a sample reservoir, syringe, vacuum container, intermediate transfer device, and / or the like. When the outlet is connected to the negative pressure source, the fluid control device may be in a first state or operating mode, and thus, a negative pressure differential is applied through the fluid control device, which aspirates an initial volume of bodily fluid into the isolation chamber of the fluid control device. For example, negative pressure within a sample reservoir may be operable to aspirate an initial volume of bodily fluid from a patient into the isolation chamber. Once the initial volume of bodily fluid is placed in the isolation chamber, the fluid control device automatically or via user intervention transitions from the first state or operating mode to a second state or operating mode, such that (1) the initial volume is isolated in the isolation chamber and (2) fluid communication is established between the inlet and outlet. The initial volume isolation allows contaminants carried during the initial flow to also be isolated within the isolation chamber. With the initial volume of body fluid isolated within the isolation chamber and fluid communication established between the inlet and outlet, subsequent volumes of body fluid, essentially free of contaminants, can be collected in one or more sample reservoirs.

[0192] Although the method using the fluid control device is explicitly described as including the enumerated ordered steps, in other embodiments, the ordering of certain events and / or procedures in any method or process described herein may be modified, and such modifications are variations of the invention. Additionally, certain events and / or procedures may be performed concurrently in parallel processes and sequentially as described above, where possible. Certain steps may be performed partially or omitted before proceeding to subsequent steps. For example, although the device is described herein as transitioning from a first state to a second state in discrete or similar operations, it should be understood that the device described herein can be configured to transition from the first state to the second state automatically and / or passively, and such transition may occur over a period of time. In other words, in some cases, the transition from the first state to the second state may be relatively gradual, such that the control device begins to transition from the first state to the second state as the last portion of the initial volume of bodily fluid is transferred to the isolation chamber. In some cases, the rate of change during the transition from the first state to the second state may be selectively controlled to achieve one or more desired characteristics associated with that transition. Furthermore, in some such cases, the inflow of the last portion of the initial volume can limit and / or substantially prevent the leakage of bodily fluids already contained in the isolation section. Thus, although the transition from the first state to the second state can occur over a given amount of time, the isolation section can still isolate the volume of bodily fluid contained therein.

Claims

1. An apparatus for obtaining a body fluid sample with reduced contaminants, the apparatus comprising: A housing forming an isolation chamber, the housing having an inlet configured to be fluidly connected to a source of bodily fluids and an outlet configured to be fluidly connected to a fluid collection device; A flow controller installed in the isolation chamber and defining a portion of the isolation chamber; as well as An actuator coupled to the housing, the actuator having a first configuration and a second configuration, wherein in the first configuration the inlet is in fluid communication with the isolation chamber, and in the second configuration the inlet is in fluid communication with the outlet, the actuator defining a portion of a first fluid flow path through the housing between the inlet and a first side of the flow controller and a portion of a second fluid flow path through the housing between the outlet and a second side of the flow controller in the first configuration. The flow controller is configured to transition from a first state to a second state, in which the portion of the isolation chamber has a first volume, and in the second state, the portion of the isolation chamber has a second volume larger than the first volume. The flow controller transitions in response to suction applied at the outlet. When the flow controller transitions from the first state to the second state, it allows a negative pressure differential to be generated between the isolation chamber and the inlet, the negative pressure differential being operable to aspirate an initial volume of body fluid into the isolation chamber. The actuator is configured to switch to the second configuration after the initial volume of body fluid is aspirated into the isolation chamber, so as to fluidly connect a portion of the first fluid flow path to a portion of the second fluid flow path and to allow subsequent volumes of body fluid to flow from the inlet to the outlet in response to the suction, while isolating the isolation chamber from the portion of the first fluid flow path.

2. The device according to claim 1, wherein, The flow controller is a diaphragm configured to deform in response to the suction force to transition the flow controller from the first state to the second state.

3. The device according to claim 1, wherein, The actuator includes at least one seal configured to form a substantially fluid-impermeable seal with the inner surface of the housing to prevent bodily fluids from flowing through the at least one seal.

4. The device according to claim 3, wherein, In the first configuration, the actuator positions the at least one seal between the inlet and the outlet to prevent bodily fluids from flowing between the inlet and the outlet.

5. The device according to claim 1, wherein, Changing the actuator from the first configuration to the second configuration includes moving the actuator from a first position relative to the housing to a second position relative to the housing to fluidly connect the portion of the first fluid flow path to the portion of the second fluid flow path.

6. The device according to claim 1, wherein, The actuator is configured to automatically switch between the first configuration and the second configuration.

7. The device according to claim 1, wherein, The rate at which the flow controller transitions from the first state to the second state at least partially controls the negative pressure difference between the isolation chamber and the inlet.

8. The device according to claim 1, wherein, The portion of the isolation chamber is a first portion, and the flow controller separates the first portion of the isolation chamber from the second portion of the isolation chamber.

9. The device according to claim 8, wherein, The housing includes a first port and a second port, and In the first configuration, the actuator causes the first port to place the inlet in fluid communication with the first portion of the isolation chamber and the second port to place the outlet in fluid communication with the second portion of the isolation chamber.

10. The device according to claim 1, wherein, The fluid collection device is fluidly connected to be operable to generate the suction at the outlet.

11. An apparatus for obtaining a body fluid sample with reduced contaminants, the apparatus comprising: A housing forming an isolation chamber, the housing having an inlet configured to be fluidly connected to a source of bodily fluids and an outlet configured to be fluidly connected to a fluid collection device; An actuator disposed in the housing, in a first configuration, allows fluid communication between the inlet and a first portion of the isolation chamber via a first fluid flow path through the housing and allows fluid communication between the outlet and a second portion of the isolation chamber via a second fluid flow path through the housing, and in a second configuration, the actuator fluidly connects a portion of the first fluid flow path and a portion of the second fluid flow path to position the inlet in fluid communication with the outlet; as well as A flow controller disposed within the isolation chamber and defining a first portion of the isolation chamber, the flow controller transitioning from a first state to a second state, in which the first portion of the isolation chamber has a first volume, and in the second state, the first portion of the isolation chamber has a second volume larger than the first volume. When the outlet is fluidly connected to the fluid collection device, the flow controller transitions in response to suction applied through a second fluid flow path and the second portion of the isolation chamber. During the transition from the first state to the second state, the flow controller allows a negative pressure differential to be generated between the first portion of the isolation chamber and the inlet, the negative pressure differential being operable to draw an initial volume of bodily fluid into the first portion of the isolation chamber via the first fluid flow path. The actuator is configured to switch from the first configuration to the second configuration after the initial volume of body fluid is in the first portion of the isolation chamber, so as to allow subsequent volumes of body fluid to flow from the inlet to the outlet in response to the suction, while isolating the isolation chamber from the portion of the first fluid flow path.

12. The device according to claim 11, wherein, The housing includes a first port and a second port, and In the first configuration, the actuator causes the first port to place the inlet in fluid communication with the first portion of the isolation chamber and the second port to place the outlet in fluid communication with the second portion of the isolation chamber.

13. The device according to claim 12, wherein, In the second configuration, the actuator isolates the first port from the inlet and the second port from the outlet.

14. The device according to claim 11, wherein, The flow controller is a diaphragm configured to deform in response to the suction force to transition the flow controller from the first state to the second state.

15. The device according to claim 11, wherein, The first side of the flow controller partially defines the first portion of the isolation chamber, and the second side of the flow controller partially defines the second portion of the isolation chamber.

16. The device according to claim 11, wherein, The volume of the second part of the isolation chamber is configured to decrease as the flow controller changes from the first configuration to the second configuration.

17. The device according to claim 15, wherein, In the second state, the flow controller causes the first part of the isolation chamber to have a third volume and the second part of the isolation chamber to have a fourth volume smaller than the third volume.

18. A system for obtaining a body fluid sample with reduced contaminants, the system comprising: Fluid control device, the fluid control device comprising: A shell forming an isolation chamber, the shell having an outlet and an inlet configured to be fluidly connected to a source of bodily fluids; A flow controller disposed within the isolation chamber and defining a portion thereof; and An actuator coupled to the housing, the actuator having a first configuration and a second configuration, wherein in the first configuration the inlet is in fluid communication with the isolation chamber, and in the second configuration the inlet is in fluid communication with the outlet, the actuator defining, in the first configuration, a portion of a first fluid flow path through the housing between the inlet and a first side of the flow controller and a portion of a second fluid flow path through the housing between the outlet and a second side of the flow controller; and A fluid collection device, fluidly connectable to the outlet of the fluid control device, the fluid collection device being configured to apply suction through a second fluid flow path when fluidly connected to the outlet. The flow controller is configured to transition from a first state to a second state, in which the portion of the isolation chamber has a first volume, and in the second state, the portion of the isolation chamber has a second volume larger than the first volume. The flow controller is configured to transition in response to suction applied through the second fluid flow path. When the flow controller transitions from the first state to the second state, the flow controller allows a negative pressure differential to be generated between the isolation chamber and the inlet, the negative pressure differential being operable to draw an initial volume of body fluid into the isolation chamber. The actuator is configured to switch to the second configuration after the initial volume of body fluid is aspirated into the isolation chamber, so as to fluidly connect a portion of the first fluid flow path to a portion of the second fluid flow path and to allow subsequent volumes of body fluid to flow from the inlet to the outlet in response to the suction, while isolating the isolation chamber from the portion of the first fluid flow path.

19. The system according to claim 18, wherein, The flow controller is a diaphragm configured to deform in response to the suction force to transition the flow controller from the first state to the second state.

20. The system according to claim 18, wherein, The actuator includes at least one seal configured to form a substantially fluid-impermeable seal with the inner surface of the housing. In the first configuration, the actuator causes the at least one seal to separate the portion of the first fluid flow path from the portion of the second fluid flow path to prevent bodily fluid from flowing from the inlet to the outlet.

21. The system according to claim 20, wherein, In the second configuration, the actuator causes the at least one seal to allow fluid communication between the portion of the first fluid flow path and the portion of the second fluid flow path.

22. The system according to claim 18, wherein, The actuator is configured to automatically switch between the first state and the second configuration.

23. The system according to claim 18, wherein, The rate at which the flow controller transitions from the first state to the second state at least partially controls the negative pressure difference between the isolation chamber and the inlet.

24. The system according to claim 18, wherein, The portion of the isolation chamber is a first portion, and the flow controller separates the first portion of the isolation chamber from the second portion of the isolation chamber.

25. The system according to claim 24, wherein, The housing includes a first port and a second port, and In the first state, the actuator causes the first port to place the inlet in fluid communication with the first portion of the isolation chamber and the second port to place the outlet in fluid communication with the second portion of the isolation chamber.

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