Patent Description:
The present disclosure relates generally to a device for accessing the bloodstream of a patient, and more particularly to a device and a non claimed method for inhibiting potentially contaminated blood from inclusion in a blood culture test sample.

A blood culture is the standard test used to detect microbial infections that may be spreading through a patient's bloodstream. The results from a blood culture are used to verify whether or not an infection is present, and, if so, what type (or types) of microorganisms are responsible for the infection. For example, blood cultures can be used to identify the causative microorganisms in severe pneumonia, puerperal fever, pelvic inflammatory disease, neonatal eppiglottitis, sepsis, and fever of unknown origin.

During a blood culture, a sample of blood (typically at least <NUM>) is with withdrawn from the patient, often via peripheral venipuncture, and stored in one or more blood culture bottles with a specific media for aerobic and anaerobic organisms. Often more than one sample is taken from different areas of the patient's body to form a blood culture set. The proper collection of blood samples is a critical part of conducting a blood culture. An improper collection procedure, for example from improper or incomplete disinfection of the skin area in or around the venipuncture site or coring of skin containing microorganisms by the needle during insertion, can result in a contaminated blood sample.

It is estimated that of the millions of blood culture tests performed on patients each year, roughly one-third of the test results indicate the false presence of microorganisms in the patient's bloodstream (i.e., a false positive). That is, even though microorganisms are found in the patient's blood during the test, those microorganisms were mixed with the blood during the venipuncture procedure. As most caregivers presume that the blood collection procedure was performed correctly, clinicians often treat all positive blood cultures (false or not) with antibiotics. On top of increased patient anxiety and the risks associated with overtreatment, as typical antibiotic treatments range from $<NUM>,<NUM> to $<NUM>,<NUM>, it is estimated that false positive blood cultures significantly add to the cost of healthcare.

<CIT> describes a blood sample device including: a needle assembly, a needle housing, and a biasing mechanism; the needle assembly including: a needle having a sharpened distal tip, and a needle hub, a proximal end of the needle being operably coupled to the needle hub ; the needle hub being slidably coupled to the needle housing for movement between an initial, blood collection position, in which at least a portion of the needle extends beyond the needle housing, and a safe position, in which the sharpened distal tip of the needle is housed within the needle housing; the biasing mechanism being operably coupled between the needle hub and a distal end of the needle housing and configured to bias the needle to the safe position.

Although various strategies and devices have been implemented to decrease blood culture contamination rates, to this day the estimated number of false positive blood cultures remains quite high. Applicants of the present have identified a need for a blood sequestration device to address this concern.

According to the present invention, there is provided a blood sequestration device comprising the features of claim <NUM>. The preferred embodiments of the present invention are defined in the dependent claims.

Embodiments of the present disclosure , which are not according to the present invention, provide a device and method configured to isolate an initial (and potentially contaminated) portion of a blood sample before delivering a balance of the blood sample to an evacuated tube or syringe for use in blood culture testing.

In some embodiments, an initial quantity of at least <NUM> of blood is sequestered in a manner that enables the remaining flow of blood to be diverted to a blood collection device. In some embodiments, the disclosed device passively diverts the remaining flow of blood after the initial quantity of blood has been sequestered with no moving parts. In some embodiments, the disclosed device can be actively shifted between an initial blood sequestration position and a blood collection position. In some embodiments, a sharp distal tip of the disclosed device can be automatically retracted to a safe position to inhibit unwanted needle sticks.

One embodiment of the present disclosure , which is not according to the present invention, provides a blood sequestration device configured to isolate an initial, potentially contaminated portion of blood from a flow of blood from vasculature of a patient, prior to directing the flow of blood to an outlet support where the blood can be accessed. The blood sequestration device can include a body member having an interior wall defining a generally "Y" shaped fluid conduit having a distal portion, a first proximal portion, and a second proximal portion. The first proximal portion can define an inlet port configured to be fluidly coupled to vasculature of the patient. The second proximal portion can define a sequestration chamber configured to isolate an initial portion of blood of a flow of blood, and a vent path configured to enable the escape of gas initially trapped within the sequestration chamber. The first proximal portion can be axially aligned with a longitudinal axis of the distal portion. The second proximal portion can define a fluid path and an outlet port configured to be fluidly coupled to a blood collection device. The second proximal portion can be offset from the longitudinal axis of the distal portion by an oblique angle.

In one embodiment , which is not according to the present invention, axial alignment of the first proximal portion with the distal portion promotes an initial flow of blood into the sequestration chamber. In one embodiment, the vent path includes a gas permeable membrane configured to enable gas initially trapped within the sequestration chamber to vent from the sequestration chamber as blood fills the sequestration chamber. In one embodiment, the outlet port is initially sealed, thereby trapping gas within the second proximal portion, such that a natural pressure of the trapped gas inhibits a flow of blood into the second proximal portion. In one embodiment, the outlet port can include a needle free connector shiftable from a naturally biased closed position to an open position upon the insertion of a Luer taper. In one embodiment, the flow of blood into the second proximal portion is inhibited via a blood collection device. In one embodiment, the outlet port defines a Luer connector. In one embodiment, the oblique angle between the second proximal portion and the distal portion is configured to enable a smooth flow of blood past an opening into the sequestration chamber and into the second proximal portion. In one embodiment, the sequestration chamber has a volume of at least <NUM>. In one embodiment, the device further comprises a portion of flexible tubing in fluid communication with the first proximal portion defining at least a portion of the sequestration chamber.

Another embodiment of the present disclosure , which is not according to the present invention, provides a blood sequestration device configured to isolate an initial portion of blood from a flow of blood of the patient, prior to directing the flow of blood to an outlet port. The blood sequestration device can include a body member having an interior wall defining a fluid conduit having an inlet port, a vented sequestration chamber, a restricted flow path portion positioned between the inlet port and the vented sequestration chamber, and a side outlet port positioned between the inlet port and the restricted flow path portion. The side outlet port can be initially sealed, such that a flow of blood entering the inlet port can follow a path of least resistance to the vented sequestration chamber, where an initial portion of blood can be isolated at least in part by the restricted flow path portion.

In one embodiment, which is not according to the present invention, the restricted flow path portion can be defined by a flow restrictor element positioned within the fluid conduit. In one embodiment the vented sequestration chamber can include a gas permeable membrane configured to enable the gas initially trapped within the vented sequestration chamber to vent from the vented sequestration chamber as the initial portion of blood fills the vented sequestration chamber. In one embodiment, sealing the outlet port can cause a natural pressure of gas trapped in proximity to the outlet port to inhibit a flow of blood into the outlet port. In one embodiment, the outlet port can include a needle free connector shiftable from a naturally biased closed position to an open position upon the insertion of a Luer taper. In one embodiment a flow of blood into the second proximal portion is inhibited via a blood collection device. In one embodiment, the outlet port defines a Luer connector. In one embodiment the vented sequestration chamber has a volume of at least <NUM>.

Another embodiment of the present disclosure , which is not according to the present invention, provides a blood sequestration device configured to isolate an initial portion of blood from a flow of blood of a patient, prior to directing the flow of blood to an outlet port. The blood sequestration device can include a body member and an elastomeric blood control valve. The body member can have an inlet port, a vented sequestration chamber, and an outlet port. The vented sequestration chamber can be configured to isolate an initial portion of blood from the flow of blood while enabling the escape of gas trapped within the vented sequestration chamber. The elastomeric blood control valve can be positioned between the inlet port and the outlet port and can be movable between an initial, closed position, where the elastomeric blood control valve inhibits a flow of blood from the inlet port to the output port, and an open position, where the elastomeric blood control valve permits the flow of blood from the inlet port to the outlet port.

In one embodiment, which is not according to the present invention, the vented sequestration chamber includes a gas permeable membrane configured to enable gas initially trapped within the vented sequestration chamber to vent from the vented sequestration chamber as the initial portion of blood fills the vented sequestration chamber. In one embodiment, the vented sequestration chamber is operably coupled to a side port positioned between the inlet port and the outlet port of the body member. In one embodiment, sealing the outlet port causes a natural pressure of gas trapped in proximity to the outlet port to inhibit a flow of blood into the outlet port. In one embodiment, the outlet port defines a Luer connector. In one embodiment the vented sequestration chamber has a volume of at least <NUM>.

Another embodiment of the present disclosure , which is not according to the present invention, provides a blood sequestration device configured to automatically retract and safely house a sharpened distal tip of the needle following the isolation of an initial portion of blood and collection of a subsequent sample of blood from a flow of blood of the patient. The blood sequestration device can include a needle, a sequestration body, a needle housing, and a biasing mechanism. The needle can have a sharpened distal tip, a proximal end, and a wall defining a lumen therebetween. The sequestration body can have an inlet port operably coupled to the proximal end of the needle, a vented sequestration chamber in fluid communication with the lumen of the needle and configured to isolate an initial portion of blood from a flow of blood while enabling escape of gas trapped within the sequestration chamber, and an outlet port configured to be fluidly coupled to a blood collection device for the collection of a subsequent sample of blood from the flow of blood. The needle housing can be configured to selectively house the sharpened distal tip of the needle in a safe position. The biasing mechanism can be positioned between the sequestration body and the needle housing, and can be configured to bias the needle from an initial, blood collection position to the safe position, in which the sharpened distal tip of the needle is housed within the needle housing.

In one embodiment, which is not according to the present invention, the sequestration body can include one or more wings. In one embodiment the sequestration body can include a guide lock, and the needle housing can define a channel in which the guide lock is configured to traverse. In one embodiment, the guide lock is configured to selectively lock the sequestration body relative to the needle housing against the bias of the biasing mechanism in the blood collection position. In one embodiment, rotation of the sequestration body relative to the needle housing enables automatic withdrawal of the sharpened distal tip of the needle into the needle housing.

Another embodiment of the present disclosure , which is not according to the present invention, provides a blood sequestration device configured to automatically retract and safely house a sharpened distal tip of the needle following the isolation of an initial portion of blood and collection of a subsequent sample of blood from a flow of blood of a patient. The blood sequestration device can include a housing, needle, needle biasing mechanism, and movable element. The needle can be operably coupled to the housing, and can include a sharpened distal tip, proximal end, and wall defining a lumen therebetween. The needle biasing mechanism can be operably coupled to the proximal end of the needle and can be configured to bias the needle from an initial position, in which the sharpened distal tip of the needle protrudes from the housing, to a safe position, in which the sharpened distal tip of the needle is housed within the housing. The movable element can be shiftable within the housing between an initial blood sequestration position, a blood collection position, and a needle retraction position. The movable element can define a sequestration chamber, a fluid conduit for blood collection, and a chamber configured to retain the needle in the safe position.

In one embodiment, which is not according to the present invention, the movable element can define one or more push tabs configured to protrude from the housing to enable user manipulation of the movable element relative to the housing between the initial blood sequestration position, blood collection position, and needle retraction position. In one embodiment, user manipulation of the one or more push tabs in the first direction can cause the movable element to shift from the initial blood sequestration position to the blood collection position. In one embodiment, further user manipulation of the one or more push tabs in the first direction can cause the movable element to shift from the blood collection position to the needle retraction position. In one embodiment, the movable element can define a first push tab and a second push tab configured to protrude from the housing to enable user manipulation of the movable element relative to the housing between the initial blood sequestration position, blood collection position, and needle retraction position. In one embodiment, user manipulation of the first push tab in a first direction causes the movable element to shift from the initial blood sequestration position to the blood collection position. In one embodiment, user manipulation of the second push tab in a second direction causes the movable element to shift from the blood collection position to the needle retraction position. In one embodiment, the sequestration chamber includes a gas permeable membrane configured to enable the gas initially trapped within the sequestration chamber to vent from the sequestration chamber as the initial portion of blood of the flow of blood fills the sequestration chamber. In one embodiment, the fluid conduit for blood collection is operably coupled to a length of flexible tubing configured to be operably coupled to a blood collection device. In one embodiment the fluid conduit for blood collection is occluded upon shifting the movable element to the needle retracted position. In one embodiment, in the needle retracted position, the entire movable element is housed within the housing to inhibit user manipulation of the movable element relative to the housing. In one embodiment, the device further includes a catheter operably coupled to the housing and configured to coaxially ride over the needle for positioning within vasculature of the patient.

Another embodiment of the present disclosure , which is not according to the present invention, provides a blood sequestration device configured to automatically retract and safely house a sharpened distal tip of a needle following the isolation of an initial portion of blood from a flow of blood from vasculature of the patient. The blood sequestration device can include a housing, needle, needle biasing mechanism, catheter, and movable element. The needle can be operably coupled to the housing, and can include a sharpened distal tip, proximal end, and wall defining a lumen therebetween. The needle biasing mechanism can be operably coupled to the proximal end of the needle and can be configured to bias the needle from an initial position, in which the sharpened distal tip of the needle protrudes from the housing, to a safe position, in which the sharpened distal tip of the needle is housed within the housing. The catheter can be operably coupled to the housing and can be configured to coaxially ride over the needle for positioning within the vasculature of the patient. The movable element can be shiftable within the housing between an initial blood sequestration position and a blood collection position. The movable element can define a sequestration chamber and a chamber configured to retain the needle in the safe position.

In one embodiment, which is not according to the present invention, the chamber configured to retain the needle in the safe position can further define a fluid conduit for blood collection. In one embodiment, the fluid conduit for blood collection is operably coupled to a length of flexible tubing configured to be operably coupled to a blood collection device. In one embodiment, the movable element can define one or more push tabs configured to protrude from the housing to enable user manipulation of the movable element relative to the housing between the initial blood sequestration position and the blood collection position. In one embodiment, user manipulation of the one or more push tabs cause the movable element to shift from the initial blood sequestration position to the blood collection position, wherein the needle is retracted into the safe position. In one embodiment, the sequestration chamber includes a gas permeable membrane configured to enable gas initially trapped within the sequestration chamber to vent from the sequestration chamber as the initial portion of blood of the flow of blood fills the sequestration chamber. In one embodiment, in the blood collection position the entire movable element is housed within the housing to inhibit user manipulation of the movable element relative to the housing.

The summary above is not intended to describe each illustrated embodiment or every implementation of the present disclosure. The figures and the detailed description that follow more particularly exemplify these embodiments.

The disclosure can be more completely understood in consideration of the following detailed description of various embodiments of the disclosure, in connection with the accompanying drawings, in which:.

Various blood sequestration devices are described herein for use in accessing the vein of a subject. It is to be appreciated, however, that the example embodiments described herein can alternatively be used to assess the vasculature of a subject at locations other than a vein, including but not limited to the artery of a subject. It is additionally to be appreciated that the term "caregiver," "clinician," or "user" refers to any individual that can collect a blood sample for blood culture analysis with any of the example embodiments described herein or alternative combinations thereof. Similarly, the term "patient" or "subject," as used herein is to be understood to refer to an individual or object in which the blood sequestration device is utilized, whether human, animal, or inanimate. Various descriptions are made herein, for the sake of convenience, with respect to the procedures being performed by a clinician to access the vein of the subject, while the disclosure is not limited in this respect.

It is also to be appreciated that the term "distal," as used herein refers to the direction along a longitudinal axis of the blood sequestration device that is closest to the subject during the collection of a blood sample. Conversely, the term "proximal," as used herein, refers to the direction lying along the longitudinal axis of the blood sequestration device that is further away from the subject during the collection of a blood sample, opposite to the distal direction.

Referring to <FIG>, a plan view of a blood sequestration device <NUM> is depicted in accordance with a first embodiment of the disclosure. In one embodiment, the blood sequestration device <NUM> can include a body member <NUM> having an interior wall <NUM> defining a generally "Y" shaped fluid conduit <NUM>. The fluid conduit <NUM> can include a distal portion <NUM>, a first proximal portion <NUM>, and a second proximal portion <NUM>.

The distal portion <NUM> can include an inlet port <NUM> configured to be fluidly coupled to vasculature of a patient. For example, in one embodiment, the inlet port <NUM> can be in fluid communication with a catheter assembly <NUM>. The catheter assembly <NUM> can include a catheter hub <NUM> and a catheter tube <NUM>. In one embodiment, the catheter tube <NUM> can extend from a tapered distal end to a proximal end, where the catheter tube <NUM> can be operably coupled to the catheter hub <NUM>. The catheter tube <NUM> can define a lumen configured to provide a fluid pathway between a vein of the subject and the catheter hub <NUM>. In one embodiment, the catheter tube <NUM> can include a barium radiopaque line to ease in the identification of the catheter tube <NUM> during radiology procedures. In an alternative embodiment, the catheter tube <NUM> can include a metallic radiopaque line, or any other suitable radiopaque material. The catheter hub <NUM> can include a catheter hub body having a distal end, a proximal end and an internal wall defining an interior cavity therebetween. The interior cavity can include a proximal portion extending from an open proximal end, and a distal portion in proximity to the distal end. In one embodiment, the distal end of the catheter hub body is operably coupled to the proximal end of the catheter tube <NUM>, such that the lumen of the catheter tube is in fluid communication with the proximal portion of the interior cavity.

In some embodiments, the catheter assembly <NUM> can further include an extension tube <NUM> operably coupling the catheter assembly <NUM> to the blood sequestration device <NUM>. In other embodiments, the blood sequestration device <NUM> can be directly coupled to the catheter assembly <NUM> and/or the blood sequestration device <NUM> and the catheter assembly <NUM> can be formed as a unitary member. Some embodiments of the catheter assembly <NUM> can further include a wing assembly <NUM> configured to aid a clinician in gripping, maneuvering and/or securing of the catheter assembly <NUM> to the patient during the collection of a blood sample.

The first proximal portion <NUM> can define a sequestration chamber <NUM> configured to isolate an initial quantity of blood during the collection of a blood sample for blood culture analysis. For example, in one embodiment, blood from the vasculature of the patient under normal pressure can flow into and fill the sequestration chamber <NUM>, thereby displacing a quantity of gas initially trapped within the sequestration chamber <NUM>.

The first proximal portion <NUM> can include a vent path <NUM> configured to enable the escape of the gas initially trapped within the sequestration chamber <NUM>, while inhibiting the escape of blood. For example, in one embodiment, the vent path <NUM> can be sealed at one end by a plug <NUM>. The plug <NUM> can be made out of an air permeable, hydrophilic material that enables the passage of air, but inhibits the passage of liquid. For example, in one embodiment, the plug <NUM> can include a plurality of pores shaped and sized to enable the passage of low-pressure gas, but inhibit the passage of low-pressure fluid, such that the pores of the plug <NUM> become effectively sealed upon contact with the low-pressure fluid. Air that resides within the sequestration chamber <NUM> is therefore pushed through the plug <NUM> by the incoming blood, until the blood reaches the plug <NUM> or is otherwise stopped.

In one embodiment, the plug <NUM> can be inserted into the vent path <NUM> (as depicted in <FIG>). For example, in one embodiment, the vent path <NUM> can define a Luer connector configured to accept a portion of the plug <NUM>. In another embodiment, the vent plug <NUM> can be adhered to the body member <NUM>, so as to occlude the vent path <NUM> (as depicted in <FIG>). Alternatively, the vent plug <NUM> can be shaped and sized to fit within the first proximal portion <NUM> of the fluid conduit <NUM> at a proximal end of the sequestration chamber <NUM>. In yet another embodiment, the plug <NUM> can be operably coupled to an extension tube <NUM>, which can be operably coupled to the distal end of the first proximal portion, (as depicted in <FIG>) such that an interior volume of the extension tubing defines at least a portion of the sequestration chamber, thereby enabling the increase of the internal capacity of the sequestration chamber <NUM>. In one embodiment, the sequestration chamber <NUM> has a volume of at least <NUM>, although other volumes of the sequestration chamber <NUM> are also contemplated.

In some embodiments, a longitudinal axis of the first proximal portion <NUM> of the fluid conduit <NUM> can be axially aligned with a longitudinal axis of the distal portion <NUM> of the fluid conduit <NUM>. In this manner, the axial alignment of the first proximal portion <NUM> with the distal portion <NUM> can promote an initial flow of blood into the sequestration chamber <NUM>.

In some embodiments, the body member <NUM> of the blood sequestration device <NUM> can be constructed of a clear or translucent material configured to enable a clinician to view the presence of blood within the sequestration chamber <NUM>. In this respect, the clinician can monitor the proper isolation of an initial portion of blood during the collection of a blood sample for blood culture analysis.

The second proximal portion <NUM> can define a fluid path and an outlet port <NUM> configured to be fluidly coupled to a blood collection device <NUM>. For example, in one embodiment, the outlet port <NUM> can define a Luer connector configured to accept a portion of the blood collection device <NUM>. In other embodiments, the outlet port <NUM> can define a threaded portion configured to be threadably coupled to a portion of the blood collection device <NUM>.

In some embodiments, the blood collection device <NUM> can be a vial or syringe <NUM> fluidly coupled to the outlet port <NUM> by an extension tube <NUM>. In some embodiments, the flow of blood into the second proximal portion <NUM> can be inhibited by the blood collection device <NUM>. For example, in one embodiment, the blood collection device <NUM> can include a clamp <NUM> configured to occlude the extension tube <NUM> and/or inhibit the venting of an initial quantity of gas present in the second proximal portion <NUM> and portions of the blood collection device <NUM>, such that a natural pressure of the trapped gas within the second proximal portion <NUM> inhibits a flow of blood into the second proximal portion <NUM>.

In some embodiments, a longitudinal axis of the second proximal portion <NUM> of the fluid conduit <NUM> can be at an oblique angle to a longitudinal axis of the distal portion <NUM> of the fluid conduit <NUM>. In this manner, the oblique angle of the second proximal portion <NUM> can enable a smooth flow of blood past an opening into the sequestration chamber <NUM> and into the second proximal portion <NUM>, once the sequestration chamber <NUM> has been filled with the initial quantity of blood for isolation.

Referring to <FIG>, a blood sequestration device <NUM> is depicted in accordance with a second embodiment of the disclosure. The blood sequestration device <NUM> can include a body member <NUM> having an interior wall <NUM> defining a fluid conduit <NUM>. The fluid conduit <NUM> can define an inlet port <NUM>, a vented sequestration chamber <NUM>, and an outlet port <NUM>.

The inlet port <NUM> can be configured to be fluidly coupled to vasculature of a patient. For example, in one embodiment, the inlet port <NUM> can be in fluid communication with a catheter assembly <NUM>. In some embodiments, the blood sequestration device <NUM> can be operably coupled to the catheter assembly <NUM> by an extension tube <NUM>. In other embodiments, the blood sequestration device <NUM> can be directly coupled to the catheter assembly <NUM> and/or the blood sequestration device <NUM> and the catheter assembly <NUM> can be formed as a unitary member. Some embodiments of the catheter assembly <NUM> can further include a wing assembly configured to aid a clinician and gripping, maneuvering, and/or securing of the catheter assembly to the patient during the collection of a blood sample.

The vented sequestration chamber <NUM> can be configured to isolate an initial quantity of blood during the collection of a blood sample. For example, in one embodiment, blood from the vasculature of the patient under normal pressure can flow into and fill the vented sequestration chamber <NUM>, thereby displacing a quantity of gas initially trapped within the sequestration chamber <NUM>. The vented sequestration chamber <NUM> can include a vent path <NUM> sealed by an air permeable, hydrophilic material plug <NUM> configured to enable the passage of air, but inhibit the passage of liquid. Accordingly, air that resides within the vented sequestration chamber <NUM> can be pushed through the plug <NUM> by the incoming blood, until the blood reaches the plug <NUM> or is otherwise stopped.

The outlet port <NUM> can be positioned between the inlet port <NUM> and the vented sequestration chamber <NUM>. In one embodiment, the outlet port <NUM> can be positioned on a side wall of the body member <NUM>, substantially orthogonal to a longitudinal axis of the inlet port <NUM> and/or the sequestration chamber <NUM>.

In some embodiments, the interior wall <NUM> of the fluid conduit <NUM> can define a restricted flow path portion <NUM> configured to aid in the isolation of an initial quantity of blood within the vented sequestration chamber <NUM>. In some embodiments, the restricted flow path portion <NUM> is defined by contours of the interior wall <NUM> of the fluid conduit. In other embodiments, the restricted flow path portion <NUM> is defined by a separate flow restrictor element <NUM> positioned within the fluid conduit <NUM> (as depicted in <FIG>).

In some embodiments, the outlet port <NUM> can be initially sealed during the collection of a sample of blood, such that a flow of blood entering the inlet port <NUM> naturally follows a path of least resistance into the vented sequestration chamber <NUM>, where an initial quantity of blood can be isolated. Accordingly, in one embodiment, sealing of the outlet port <NUM> causes a natural pressure of gas trapped in proximity to the outlet port <NUM> to inhibit a flow of blood into the outlet port <NUM>. In one embodiment, the outlet port <NUM> can define a Luer connector configured to accept a portion of a blood collection device <NUM>. The blood collection device <NUM> can be configured to occlude the outlet port <NUM>, so as to inhibit the flow of blood into the outlet port <NUM> and encourage the natural flow of an initial quantity of blood into the vented sequestration chamber <NUM>. In one embodiment, the outlet port <NUM> can include a needle free connector <NUM> shiftable from a naturally biased close position to an open position upon the insertion of a Luer taper (as depicted in <FIG>).

Referring to <FIG>, a blood sequestration device <NUM> is depicted in accordance with a third embodiment of the disclosure. The blood sequestration device <NUM> can include a body member <NUM> and an elastomeric blood control valve <NUM>. The body member <NUM> can include an interior wall <NUM> defining a fluid conduit <NUM> having an inlet port <NUM>, a vented sequestration chamber <NUM>, and an outlet port <NUM>.

The inlet port <NUM> can be configured to be fluidly coupled to a vein of a patient, so as to enable a flow of blood from vasculature of the patient to flow into the fluid conduit <NUM> of the blood sequestration device <NUM>. For example, in one embodiment, the inlet port <NUM> can be fluidly coupled to a catheter assembly <NUM>.

The vented sequestration chamber <NUM> can be configured to isolate an initial quantity of blood during the collection of a blood sample. For example, in one embodiment, blood from the vasculature of the patient under normal pressure can flow into and fill the vented sequestration chamber <NUM>, thereby displacing a quantity of gas initially trapped within the sequestration chamber <NUM>. The vented sequestration chamber <NUM> can include a vent path <NUM> sealed by an air permeable, hydrophilic material plug <NUM> configured to enable the passage of air, but inhibit the passage of liquid.

In one embodiment, the vented sequestration chamber <NUM> can be positioned between the inlet port <NUM> and the outlet port <NUM>. In one embodiment, the vented sequestration chamber <NUM> can extend from a side wall of the body member <NUM> at an oblique angle relative to a longitudinal axis of the inlet port <NUM> and/or the outlet port <NUM>. In another embodiment, the vented sequestration chamber <NUM> can extend from the side wall of the body member <NUM> substantially orthogonal to a longitudinal axis of the inlet port <NUM> and/or outlet port <NUM>. In some embodiments, a portion of the vented sequestration chamber <NUM> can be defined by a length of flexible hollow tubing <NUM>. In some embodiments, the vented sequestration chamber has a volume of at least <NUM>, although other volumes of the vented sequestration chamber <NUM> are also contemplated.

The elastomeric blood control valve <NUM> can be positioned between the inlet port <NUM> and the outlet port <NUM>. The elastomeric blood control valve <NUM> can be configured to move from an initial, closed position (as depicted in <FIG>) to inhibit a flow of blood from the inlet port <NUM> to the outlet port <NUM>, to an open position (as depicted in <FIG>) where the elastomeric blood control valve <NUM> permits the flow of blood from the inlet port <NUM> to the outlet port <NUM>. In the initial, closed position a natural pressure of gas trapped in proximity to the outlet port <NUM> inhibits a flow of blood into the outlet port, such that blood naturally flows into the vented sequestration chamber <NUM>. Upon shifting the blood control valve <NUM> to the open position, the blood flow will follow the path of least resistance to exit the blood sequestration device <NUM> at the outlet port <NUM>, to which a blood collection device can be operably coupled. Further, when the blood control valve <NUM> is in the open position, the blood control valve <NUM> is arranged such that the vented sequestration chamber <NUM> is sealed from fluid communication with the fluid conduit <NUM>.

In one embodiment, the elastomeric blood control valve <NUM> can include an actuator <NUM> secured to the interior wall <NUM> of the body member <NUM>, so as to extend axially within the fluid conduit <NUM>. The actuator <NUM> can be a rigid, hollow member configured to enable fluid to pass therethrough. The elastomeric blood control valve <NUM> can further include a seal member <NUM> secured within the fluid conduit <NUM> of the body member <NUM> with the aid of the actuator <NUM>, such that the seal member <NUM> is axially shiftable relative to the actuator <NUM> between the closed position in which flow of fluid through the blood control valve <NUM> is inhibited or restricted, and the open position, in which the seal member <NUM> is shifted relative to the actuator <NUM>, thereby enabling the flow of fluid from the inlet port <NUM>, through the elastomeric blood control valve <NUM>, and out through the outlet port <NUM>. One example of such a blood control valve is disclosed in <CIT>, the contents of which are incorporated by reference herein.

Referring to <FIG>, a blood sequestration device <NUM> is depicted in accordance with an embodiment of the present invention.

The blood sequestration device <NUM> can be configured to automatically retract and safely house a sharpened distal tip of the needle following the isolation of an initial quantity of blood during the collection of a blood sample. The blood sequestration device <NUM> can include a needle <NUM>, a sequestration body <NUM>, a needle housing <NUM>, and a biasing mechanism <NUM>.

The needle <NUM> can include an elongate cylindrically shaped metal structure defining a lumen that extends between a sharpened distal tip <NUM> and a proximal end <NUM>. The sharpened distal tip <NUM> can be constructed and arranged to pierce the skin of the subject during needle insertion. For example, in one embodiment, the sharp distal tip <NUM> can include a V-point designed to reduce the penetration force used to penetrate the needle <NUM> and a portion of the sequestration body <NUM> through the skin, tissue, and vein wall of a subject. In one embodiment, the length of the needle <NUM> can be extended to aid in accessing vasculature of obese patients.

The proximal end <NUM> of the needle <NUM> can be operably coupled to a needle hub <NUM>. In some embodiments, the needle <NUM> and needle hub <NUM> can be collectively referred to as a needle assembly. In one embodiment, the needle hub <NUM> can be constructed to provide a visual indication of a flashback when the sharpened distal tip <NUM> of the needle <NUM> enters the vein of the subject. For example, in one embodiment, the needle hub <NUM> can define a flash chamber in communication with the lumen of the needle <NUM>.

The sequestration body <NUM> can coaxially ride over at least a portion of the needle <NUM>. In one embodiment, the sequestration body <NUM> can include a catheter portion <NUM> and a sequestration chamber <NUM>. The catheter portion <NUM> can include a catheter hub <NUM> and a catheter tube <NUM>. The catheter tube can extend from a distal taper end to a proximal end, where the catheter tube <NUM> can be operably coupled to the catheter hub <NUM>. The catheter tube <NUM> can define a lumen configured to provide a fluid pathway between a vein of the subject and the catheter hub <NUM>. In one embodiment, the catheter tube <NUM> can include a barium radiopaque line to ease in the identification of the catheter tube <NUM> during radiology procedures.

The catheter hub <NUM> can include a catheter hub body having a distal end, a proximal end, and an internal wall defining an interior cavity therebetween. The interior cavity can include a proximal portion extending from an open proximal end, and a distal portion in proximity to the distal end. In one embodiment, the distal end of the catheter hub body can be operably coupled to the proximal end of the catheter tube <NUM>, such that the lumen of the catheter tube is in fluid communication with the proximal portion of the interior cavity.

In some embodiments, the catheter portion <NUM> can further comprise a closed catheter assembly, including an extension tube <NUM>, an extension tube clamp <NUM>, and a needleless connector <NUM>. Alternatively, the interior wall defining the interior cavity of the catheter hub <NUM> can further define a side port (not depicted) configured to enable an alternative fluid communication path with the interior cavity of the catheter hub <NUM>. In one embodiment, the side port can be positioned substantially orthogonal to a longitudinal axis of the catheter hub <NUM>. The side port can be selectively sealed by a flexible sealing member position within the interior cavity of the catheter hub <NUM>. Some embodiments can further include a wing assembly <NUM> configured to aid a clinician and gripping, maneuvering and/or securing the sequestration body <NUM> to the subject during the collection of a blood sample.

The sequestration chamber <NUM> can be configured to isolate an initial quantity of blood during the collection of a blood sample. In one embodiment, the sequestration chamber <NUM> can have a distal end, a proximal end, and an internal wall defining an interior cavity therebetween. The distal end of the sequestration chamber <NUM> can be operably coupled to the proximal and the catheter hub <NUM>, such that interior cavities of the catheter hub <NUM> and sequestration chamber <NUM> are in fluid communication.

The proximal end of the sequestration chamber <NUM> can define a vent path <NUM> configured to enable the escape of gas initially trapped within the sequestration chamber <NUM>, while inhibiting the escape of blood. For example, in one embodiment, the vent path <NUM> can be sealed at one end by a valve or septum <NUM>. In one embodiment, the septum <NUM> can be configured to enable at least a portion of the needle <NUM> to pass therethrough during insertion of the catheter tube <NUM> into the vein of the subject. The septum <NUM> can be configured to seal upon withdrawal of the needle <NUM> through the septum <NUM>, thereby inhibiting the leakage of blood after the needle <NUM> has been withdrawn. In one embodiment, the septum can further be made out of an air permeable, hydrophilic material configured to enable the passage of air, but inhibit the passage of liquid, thereby enabling air that resides within the sequestration chamber <NUM> to be evacuated through the septum <NUM> by the incoming initial quantity of blood to be sequestered.

The needle housing <NUM> can have a distal end, a proximal end, and a housing wall <NUM> defining a needle housing cavity therebetween. The needle housing cavity can be shaped and sized to accommodate at least a portion of the needle hub <NUM> there within. The needle hub <NUM> can be slidably coupled to the needle housing <NUM> between an initial, blood collection position (as depicted in <FIG>), in which at least a portion of the needle <NUM> extends beyond the needle housing <NUM>, and a safe position, in which the sharpened distal tip <NUM> of the needle <NUM> is housed within the needle housing <NUM>.

The biasing mechanism <NUM> can be operably coupled between the needle hub <NUM> and the distal end of the needle housing <NUM>, and can be configured to naturally bias the needle hub <NUM> to the safe position. In one embodiment, the biasing mechanism <NUM> can be a coil spring, although other biasing mechanisms are also contemplated. The needle housing wall <NUM> can further define a channel <NUM> including a blood collection position notch <NUM>, into which a guide lock <NUM> of the needle hub <NUM> can extend. In some embodiments, rotation of the needle hub <NUM> relative to the needle housing <NUM> about its longitudinal axis can cause the guide lock <NUM> to rotate out of the blood collection position notch <NUM>, such that the natural bias of the biasing mechanism <NUM> can shift the needle hub <NUM> to the safe position, wherein the needle hub <NUM> is guided by the guide lock <NUM> of the needle hub <NUM> to traverse along a length of the channel <NUM>.

Referring to <FIG>, a blood sequestration device <NUM> is depicted in accordance with a fifth embodiment of the disclosure. The blood sequestration device <NUM> can be configured to automatically retract and safely house a sharpened distal tip of the needle following the isolation of an initial quantity of blood during the collection of a blood sample. The blood sequestration device <NUM> can include a housing <NUM>, needle <NUM>, needle biasing mechanism <NUM>, and movable element <NUM>.

The housing <NUM> can have a distal end <NUM>, proximal end <NUM> and housing wall <NUM> defining a cavity <NUM>. As depicted in <FIG>, in one embodiment, the housing <NUM> can generally be formed in the shape of a truncated sector, wherein the interior surface of the housing wall <NUM> along the distal end <NUM> forms an arc in which points along the interior surface of the housing wall <NUM> along the distal end <NUM> are generally equidistant from a point <NUM> located in proximity to the proximal end <NUM> of the housing <NUM>.

The movable element <NUM> can reside at least partially within the cavity <NUM> of the housing <NUM>, and can be pivotably coupled to the housing <NUM> about point <NUM>, such that the movable element <NUM> is configured to rotate or shift relative to the housing <NUM> between an initial blood sequestration position (as depicted in <FIG>), a blood collection position (as depicted in <FIG>), and a needle retraction position (as depicted in <FIG>).

In one embodiment, the movable element <NUM> can define one or more chambers and/or fluid pathways. For example, in one embodiment, the movable element <NUM> can define a sequestration chamber <NUM>, a blood collection pathway <NUM>, and a chamber <NUM> configured to house at least a portion of the needle <NUM> upon retraction. In one embodiment, the movable element <NUM> can further define one or more push tabs <NUM> configured to protrude from the housing <NUM> to enable a clinician to manipulate the movable element <NUM> relative to the housing <NUM> between the initial blood sequestration position, blood collection position, and needle retraction position.

The needle <NUM> can include an elongate cylindrical shaped metal structure defining a lumen that extends between a sharpened distal tip <NUM> and a proximal end <NUM>. The sharpened distal tip <NUM> can be constructed and arranged to pierce the skin of the subject during needle insertion. The proximal end <NUM> of the needle <NUM> can be operably coupled to a needle hub <NUM>. In some embodiments, the needle <NUM> and the needle hub <NUM> can be collectively referred to as a needle assembly.

The needle hub <NUM> can be slidably coupled to the housing <NUM> between an initial position (as depicted in <FIG>), in which at least a portion of the needle <NUM> extends beyond the housing <NUM>, and a safe position (as depicted in <FIG>), in which the sharpened distal tip <NUM> of the needle <NUM> is housed within the housing <NUM>. The biasing mechanism <NUM> can be operably coupled between the needle hub <NUM> and the distal end of the housing <NUM>, and can be configured to naturally bias the needle hub <NUM> to the safe position.

In one embodiment, the blood sequestration device <NUM> can be provided in the initial blood sequestration position, with the needle <NUM> extending outwardly from the distal end <NUM> of the housing <NUM>. Upon insertion of the needle <NUM> into the vein of a subject, blood flows through the lumen of the needle <NUM>, and into the sequestration chamber <NUM> defined in the movable element <NUM>.

The sequestration chamber <NUM> can include a vent path <NUM> configured to enable the escape of gas initially trapped within the sequestration chamber <NUM>, while inhibiting the escape of blood. For example, in one embodiment, the vent path <NUM> can be sealed by a plug <NUM>, constructed of an air permeable, hydrophilic material that enables the passage of air, but inhibits the passage of liquid. Air that resides within the sequestration chamber <NUM> is therefore pushed through the plug <NUM> by the incoming blood, until the blood reaches the plug <NUM> or is otherwise stopped. In one embodiment, the sequestration chamber <NUM> has a volume of at least <NUM>, although other volumes of the sequestration chamber <NUM> are also contemplated.

Once an initial quantity of blood has been sequestered within the sequestration chamber <NUM>, a clinician can manipulate the one or more push tabs <NUM> to cause the movable element <NUM> to shift from the initial blood sequestration position to the blood collection position. In the blood collection position, blood can flow from the vein of the subject through the lumen of the needle <NUM>, through the blood collection pathway <NUM> defined within the movable element <NUM>, and out of the housing <NUM> through an outlet port <NUM>, which can be operably coupled to a blood collection device via an extension tube <NUM>.

Once a satisfactory quantity of blood has been collected, a clinician can manipulate the one or more push tabs <NUM> to cause the movable element <NUM> to shift from the blood sequestration position to the needle retraction position. Prior to movement of the movable element <NUM> to the needle retraction position, a distal surface of the movable element <NUM> can inhibit retraction of the needle <NUM> into the cavity <NUM> of the housing <NUM>. By contrast, the chamber <NUM> configured to house at least a portion of the needle <NUM> upon retraction can include structure defining an opening <NUM> shaped and sized to enable the needle hub <NUM> to pass therethrough, thereby enabling the needle <NUM> to be retracted within the chamber <NUM> under the natural bias of the needle biasing mechanism <NUM> to the safe position. In the safe position, the sharpened distal tip <NUM> of the needle <NUM> is housed within the chamber <NUM> to reduce the risk of unintended needle sticks.

In some embodiments, movement of the movable element <NUM> to the needle retraction position can cause the one or more push tabs to be shifted into the cavity <NUM> of the housing <NUM>, thereby inhibiting a clinician from further movement of the movable element <NUM>. In one embodiment, movement of the movable element to the needle retraction position can cause a portion of the movable element <NUM> and/or housing <NUM> to crimp the extension tube <NUM>, thereby inhibiting leakage of fluid from an attached blood collection device.

In embodiments, the shift between the initial sequestration position (as depicted in <FIG>) and the blood collection position (as depicted in <FIG>), and the shift from the blood collection position (as depicted in <FIG>) to the needle retraction position (as depicted in <FIG>) can occur as one fluid motion. In alternative embodiments, an interference protrusion may be introduced within the distal end <NUM>, and within the rotation path of the movable element <NUM>, such that the clinician is aware, via tactile feedback, that the movable element <NUM> is in the blood collection position and a pause is warranted. In yet other embodiments, a ratchet mechanism can be introduced into pivoting point <NUM> such that the movable element <NUM> ceases movement in the blood collection position and the clinician must manipulate the one or more push tabs <NUM> again to move the movable element <NUM> from the blood collection position to the needle retraction position.

Referring to <FIG>, in some embodiments, the blood sequestration device <NUM>' can include a first push tab 526A and a second push tab 526B configured to protrude from the housing <NUM> to enable a clinician to manipulate the movable element <NUM> relative to the housing <NUM> between the initial blood sequestration position, blood collection position, and needle retraction position. In one embodiment, manipulation of the first push tab 526A in a first direction causes the movable element <NUM> to shift from the initial blood sequestration position to the blood collection position. Manipulation of the second push tab 526B in a second direction causes the movable element <NUM> to shift from the blood collection position to the needle retraction position. Other configurations of push tabs <NUM> defined by the movable element <NUM> are also contemplated.

In embodiments, the shift between the initial sequestration position (as depicted in <FIG>) and the blood collection position (as depicted in <FIG>), and the shift from the blood collection position (as depicted in <FIG>) to the needle retraction position (as depicted in <FIG>) can occur separately as fluid motions. In alternative embodiments, an interference protrusion may be introduced within the distal end, and within the rotation path of the movable element <NUM>, such that the clinician is aware, via tactile feedback, that the movable element <NUM> is in the blood collection position and a pause is warranted. In yet other embodiments, a ratchet mechanism can be introduced into the pivoting point such that the movable element <NUM> ceases movement in the blood collection position and the clinician must manipulate the one or more push tabs 526A again to move the movable element <NUM> from the blood collection position to the needle retraction position, but bypassing the initial sequestration position.

In some embodiments, the blood sequestration device can further include a catheter assembly to aid in the collection of a blood sample. Referring to <FIG>, a blood sequestration device <NUM> is depicted in accordance with a sixth embodiment of the disclosure. The blood sequestration device <NUM> can be configured to automatically retract and safely house a sharpened distal tip of a needle following the insertion of a catheter assembly for the collection of a blood sample. The blood sequestration device <NUM> can include a housing <NUM>, needle <NUM>, needle biasing mechanism <NUM>, movable element <NUM>, and catheter assembly <NUM>.

The housing <NUM> can have a distal end <NUM>, a proximal end <NUM> and a housing wall <NUM> defining a cavity <NUM>. As depicted in <FIG>, in one embodiment, the housing <NUM> can generally be formed in the shape of a truncated sector, wherein the interior surface of the housing wall <NUM> along the distal end <NUM> forms an arc in which points along the interior surface of the housing wall <NUM> along the distal end <NUM> are generally equidistant from a point <NUM> located in proximity to the proximal end <NUM> of the housing <NUM>.

The movable element <NUM> can reside at least partially within the cavity <NUM> of the housing <NUM>, and can be pivotably coupled to the housing <NUM> about a point <NUM>, such that the movable element <NUM> is configured to rotate or shift relative to the housing <NUM> between an initial blood sequestration position (as depicted in <FIG>), a needle retraction position (as depicted in <FIG>), and a blood collection position (as depicted in <FIG>).

In one embodiment, the movable element <NUM> can define one or more chambers and/or fluid pathways. For example, in one embodiment, the movable element <NUM> can define a sequestration chamber <NUM>, a blood collection pathway <NUM>, and a chamber <NUM> configured to house at least a portion of the needle <NUM> upon retraction. In one embodiment, the movable element <NUM> can further define one or more push tabs <NUM> configured to protrude from the housing <NUM> to enable a clinician to manipulate the movable element <NUM> relative to the housing <NUM> between the initial blood sequestration position, needle retraction position, and blood collection position.

The needle <NUM> can include an elongate cylindrical shaped metal structure defining a lumen that extends between a sharpened distal tip <NUM> and a proximal end <NUM>. The sharpened distal tip <NUM> can be constructed and arranged to pierce the skin of the subject during needle insertion. The proximal end <NUM> of the needle <NUM> can be operably coupled to a needle hub <NUM>. In some embodiments, the needle <NUM> and needle hub <NUM> can be collectively referred to as a needle assembly.

The needle hub <NUM> can be slidably coupled to the housing <NUM> between an initial position (as depicted in <FIG>), in which a least a portion of the needle <NUM> extends beyond the housing <NUM>, and a safe position (as depicted in <FIG>), in which the sharpened distal tip <NUM> of the needle <NUM> is housed within the housing <NUM>. The biasing mechanism <NUM> can be operably coupled between the needle hub <NUM> and the distal end of the housing <NUM>, and can be configured to naturally bias the needle hub <NUM> to the safe position.

The catheter assembly <NUM> can include a catheter tube <NUM> and a catheter hub <NUM>. The catheter assembly <NUM> can be configured to coaxially ride over at least a portion of the needle <NUM> and/or needle assembly. In one embodiment, the catheter hub <NUM> can be operably coupled to the distal end <NUM> of the housing <NUM>.

In one embodiment, the blood sequestration device <NUM> can be provided in the initial blood sequestration position, with the needle <NUM> and catheter assembly <NUM> extending outwardly from the distal end <NUM> of the housing <NUM>. Upon insertion of the needle <NUM> and catheter tube <NUM> into the vein of the subject, blood flows through the lumen of the needle <NUM>, and into the sequestration chamber <NUM> defined within the movable element <NUM>.

Once an initial quantity of blood has been sequestered within the sequestration chamber <NUM>, a clinician can manipulate the one or more push tabs <NUM> to cause the movable element <NUM> to shift from the initial blood sequestration position to the needle retraction position. Prior to movement of the movable element <NUM> to the needle retraction position, a distal surface of the movable element <NUM> can inhibit retraction of the needle <NUM> into the cavity <NUM> of the housing <NUM>. By contrast, the chamber <NUM>, configured to house at least a portion of the needle <NUM> upon retraction, can include structure defining an opening <NUM> shaped and sized to enable the needle hub <NUM> to pass therethrough, thereby enabling the needle <NUM> to be retracted within the chamber <NUM> under the natural bias of the needle biasing mechanism <NUM> to the safe position. In the safe position, the sharpened distal tip <NUM> of the needle <NUM> is housed within the chamber <NUM> to reduce the risk of unintended needle sticks, while leaving the catheter assembly <NUM> in place within the subject's vein.

Once the needle <NUM> has been safely retracted, a clinician can manipulate the one or more push tabs <NUM> to cause the movable element <NUM> to shift from the needle retraction position to the blood collection position. In the blood collection position, blood can flow from the vein of the subject through the catheter assembly <NUM>, through the blood collection pathway <NUM> defined within the movable element <NUM>, and out of the housing <NUM> through an outlet port <NUM>, which can be operably coupled to a blood collection device via an extension tube <NUM>. Once a satisfactory quantity of blood has been collected, a clinician can remove the catheter assembly <NUM> from the patient's vein.

In embodiments, the shift between the initial sequestration position (as depicted in <FIG>) and the needle retraction position (as depicted in <FIG>), and the shift from the needle retraction position (as depicted in <FIG>) and the blood collection position (as depicted in <FIG>) can occur as one fluid motion. In other words, after the initial blood flow is sequestered in the initial sequestration position, the clinician can manipulate the one or more push tabs <NUM> such that the movable element <NUM> rotates to the blood collection position, thereby rotating through the needle retraction position. In alternative embodiments, an interference protrusion may be introduced within the distal end, and within the rotation path of the movable element <NUM>, such that the clinician is aware, via tactile feedback, that the movable element <NUM> is in the needle retraction position and a pause is warranted. In yet other embodiments, a ratchet mechanism can be introduced into pivoting point <NUM> such that the movable element <NUM> ceases movement in the needle retraction position and the clinician must manipulate the one or more push tabs <NUM> again to move the movable element from the needle retraction position to the blood collection position.

Referring to <FIG>, in some embodiments, the blood collection pathway <NUM> and chamber <NUM> defined within the movable element <NUM> can be combined. In this embodiment, once an initial quantity of blood has been sequestered within the sequestration chamber <NUM>, a clinician can manipulate the one or more push tabs <NUM> to move the movable element <NUM> to shift from the initial blood sequestration position to the blood collection position, which enables both retraction of the needle <NUM> within the chamber <NUM> under the natural bias of the needle biasing mechanism <NUM> to the safe position, as well as a flow of blood from the vein of the subject through the catheter assembly <NUM>, through the blood collection pathway <NUM> defined within the movable element <NUM>, and out of the housing <NUM> through an outlet port <NUM>, which can be operably coupled to a blood collection device. Other configurations of chambers and/or fluid pathways within the movable element <NUM> are also contemplated.

Claim 1:
A blood sequestration device (<NUM>) configured to isolate an initial, potentially contaminated portion of blood from a flow of blood from vasculature of a patient during collection of a blood sample, the blood sequestration device (<NUM>) including:
a needle assembly (<NUM>, <NUM>),
a sequestration body (<NUM>),
a needle housing (<NUM>), and
a biasing mechanism (<NUM>);
the needle assembly including:
a needle (<NUM>) having a sharpened distal tip (<NUM>), and
a needle hub (<NUM>), a proximal end of the needle (<NUM>) being operably coupled to the needle hub (<NUM>);
the sequestration body (<NUM>) being configured to coaxially ride over at least a portion of the needle (<NUM>), the sequestration body (<NUM>) including:
a vented sequestration chamber (<NUM>),
an outlet port, and
a catheter portion (<NUM>), the catheter portion (<NUM>) including a catheter hub (<NUM>) and a catheter tube (<NUM>);
the sequestration chamber (<NUM>) being configured to isolate an initial portion of blood from a flow of blood;
a proximal end of the sequestration chamber (<NUM>) defining a vent path (<NUM>) configured to enable the escape of gas initially trapped within the sequestration chamber (<NUM>), the vent path (<NUM>) being sealed at one end by a septum (<NUM>);
the septum (<NUM>) being configured to enable at least a portion of the needle (<NUM>) to pass through the septum (<NUM>) during insertion of the catheter tube (<NUM>) into a vein of the patient;
the needle hub (<NUM>) being slidably coupled to the needle housing (<NUM>) for movement between an initial, blood collection position, in which at least a portion of the needle (<NUM>) extends beyond the needle housing (<NUM>), and a safe position, in which the sharpened distal tip (<NUM>) of the needle (<NUM>) is housed within the needle housing (<NUM>);
the biasing mechanism (<NUM>) being operably coupled between the needle hub (<NUM>) and a distal end of the needle housing (<NUM>) and configured to bias the needle (<NUM>) to the safe position.