CN213588280U

CN213588280U - Blood isolation device and blood sample optimization system

Info

Publication number: CN213588280U
Application number: CN202020568271.8U
Authority: CN
Inventors: B·E·罗哲斯; G·康; D·K·斯特鲁普; J·D·科克伦; A·德普塔拉; J·德特洛夫; L·波格; B·马科维斯基; K·内森
Original assignee: Core Ltd
Current assignee: Core Ltd
Priority date: 2020-03-13
Filing date: 2020-04-16
Publication date: 2021-07-02
Anticipated expiration: 2030-04-16
Also published as: EP4117521A1

Abstract

The blood isolation device includes an inlet path, an outlet path, an isolation chamber, and a sampling channel. The isolation chamber is connected to the inlet path by a junction and is configured to receive a first portion of blood through the inlet path. The isolation chamber has a vent that allows air to be replaced by the first portion of blood, and the junction is configured to inhibit any first portion of blood received by the isolation chamber from returning to the inlet path. The sampling channel is connected between the inlet path and the outlet path and is configured to convey a subsequent amount of blood between the inlet path and the outlet path after the first amount of blood is received by the isolation chamber.

Description

Blood isolation device and blood sample optimization system

Cross Reference to Related Applications

This application claims the benefit of priority from U.S. non-provisional application 16/819,033 filed 3/13/2020, part of continuation applications of U.S. non-provisional application 15/893,518 filed 2/2018 claiming priority from U.S. patent application 62/467,016 filed 3/2017, and the benefit of U.S. provisional application No. 62/457,764 filed 10/2/2017. Each of these applications is incorporated by reference herein in its entirety.

Background

Bacteremia is the presence of microorganisms in the blood. Sepsis, on the other hand, is bacteremia with clinical symptoms and signs, such as fever, tachycardia, tachypnea, and hypotension. Bacteremia and sepsis are associated with high mortality, increased hospital stays and durations, and associated costs. Indeed, many bacteremia, sepsis, mycoses and other pathogens actually occur in hospitals or other medical facilities, and catheters and venipuncture are potential carriers of these pathogens and are sources of contamination.

Blood culture is a standard test for detecting microbial pathogens associated with bacteremia and sepsis in a patient's blood. The term "blood culture" refers to a single venipuncture from a peripheral site or central or arterial line to inoculate blood into one or more blood culture bottles or containers. One bottle is considered a blood culture, two or more of which are considered a group. Multiple sets may be obtained from multiple venipunctures and associated with different sites of the patient.

These methods allow for microbial identification and drug susceptibility testing, which is a key component in the control of sepsis, but the lack of rapid results and reduced susceptibility to demanding pathogens has led to the development of improved systems as well as ancillary molecular or proteomic tests.

The collection of blood samples for blood culture is a critical component of modern patient care, or can positively affect the outcome of a patient by providing an accurate diagnosis, or can adversely affect the outcome by prolonging unnecessary antimicrobial therapy, length of hospitalization, and increasing costs.

One of the consequences of collecting blood cultures is contamination. Contamination of blood cultures can result in false positive culture results and/or significant increases in healthcare-related costs. Sources of blood culture contamination include improper skin preservation, improper sterilization of the collection tube, and contamination of the initial blood draw, which can lead to distorted results.

Blood culture collection kits typically include a "butterfly" device, an infusion set, or other type of venipuncture device, such as those provided by companies like BD, Smiths, b.braun, etc., as well as aerobic and anaerobic blood culture bottles. Various bottles may also be provided depending on the testing requirements. These bottles are specifically designed to optimize the recovery of aerobic and anaerobic organisms. In conventional kits, the commonly used bottle is called a bottle

It is a blood collection tube formed of a sterile glass or plastic tube with a closure that is evacuated to create a vacuum within the tube to facilitate the withdrawal of a predetermined volume of liquid, such as blood.

False positive blood cultures are often the result of poor sampling techniques. They are used forThis can lead to the use of antibiotics when unnecessary, thereby increasing hospital costs and patient anxiety. Blood cultures are drawn into the skin from the needle and then ligated

To collect a blood sample. Improper or incomplete sterilization of the puncture site and its surrounding skin area may result in contamination. It may also be caused by the needle penetrating the skin during insertion, wherein the cored skin cells and any associated contaminants are pulled into the sample.

The blood flow through the hypodermic needle is laminar, and therefore, when a pressure drop is applied to the hypodermic needle, a velocity gradient can be established across the flow tube. Forced blood aspiration or the use of a small hypodermic needle can cause lysis and release of potassium from the red blood cells, thus rendering the blood sample abnormal.

In other cases, the veins of some patients are fragile and may collapse under pressure drop or vacuum, especially due to the rate of plunger withdrawal of the syringe being too rapid to accommodate the patient's condition. This vein collapse is a risk and difficult to control since the condition is not possible to know in advance.

Various strategies have been implemented to reduce the contamination rate of blood cultures, such as training of employees in sterile collection techniques, feedback on contamination rates, and the implementation of blood culture collection kits. Although skin disinfection can reduce the burden of contamination, 20% or more of skin organisms are located deep in the dermis and are not affected by disinfection. It is not advisable to replace the needle before vial inoculation, as this increases the risk of needle stick injury without reducing the contamination rate.

Some conventional systems and techniques for reducing blood culture contamination include discarding initial aliquots of blood drawn from central venous catheters, venipuncture, and other vascular access systems. However, these systems require the user to mechanically manipulate the endovascular device or require a series of complex steps that are difficult to ensure.

Summary of the utility model

This document presents a system and method for reducing blood culture contamination, cell lysis and vein collapse. In some embodiments, the systems and methods may eliminate variability in user disinfection and also eliminate the risk of skin cells entering the blood culture sample. The systems and methods disclosed herein do not require changes to existing clinical procedures, but rather potentially indicate when a connection should be made

Or other blood collection device (i.e., syringe) to draw a contamination-free blood sample.

In some embodiments of the systems and methods disclosed herein, blood is drawn passively by using the patient's own blood pressure, thereby reducing the risk of vein collapse and eliminating any other user steps in current practice. The system and method may be applied to accommodate short-range direct stick or butterfly venipuncture systems. They may also be used for samples drawn through a catheter.

In some aspects, a blood isolation device includes an inlet pathway, an outlet pathway, and an isolation chamber connected to the inlet pathway by a junction. The isolation chamber is configured to receive a first amount of blood through the inlet path and includes a vent that allows air to be replaced by the first portion of blood, the vent further configured to close when the isolation chamber is filled with the first portion of blood, the junction configured to inhibit the first portion of blood from returning from the isolation chamber. The blood isolation device also includes a sampling channel connected between the inlet path and the outlet path, the sampling channel configured to convey a subsequent quantity of blood between the inlet path and the outlet path after the first portion of blood is received by the isolation chamber.

In other aspects, a blood optimization system includes a housing having an inlet port and an outlet port, the housing containing or housing one or more of an inlet path, an outlet path, an isolation chamber, and a sampling channel. The inlet port may be connected to a patient needle or a catheter. The outlet port may be connected to a blood collection device. Aspects of the present invention allow a first amount of blood to be isolated, at least temporarily, in an isolation chamber, and can be discarded after use.

The details of one or more embodiments are set forth in the accompanying drawings and the description below. Other features and advantages will be apparent from the description and drawings, and from the claims.

Drawings

These and other aspects will now be described in detail with reference to the following drawings.

Fig. 1 shows a blood sample optimization system.

Fig. 2 shows a blood sample optimization system according to an alternative embodiment.

Fig. 3 shows a blood sample optimization system according to another alternative embodiment.

Fig. 4 shows a blood sample optimization system according to another alternative embodiment.

Fig. 5 shows a blood sample optimization system according to another alternative embodiment.

Fig. 6 shows a blood sample optimization system according to an alternative embodiment.

FIG. 7 is a flow chart of a method for optimizing blood culture quality.

Fig. 8A-8E illustrate a blood isolation system for uncontaminated blood sampling according to some embodiments.

Figure 9 shows an access separator for a blood isolation system.

Fig. 10A-10D illustrate a blood isolation system for non-contaminating blood sampling according to an alternative embodiment.

Fig. 11A-11E illustrate a blood isolation system for non-contaminating blood sampling according to other alternative embodiments.

Fig. 12A-12D illustrate a blood sample optimization system including a blood isolation device according to other alternative embodiments.

Fig. 13A-13D illustrate a blood sample optimization system 1300 according to another alternative embodiment.

Fig. 14A-14E illustrate another embodiment of a blood sampling system that isolates contaminants from an initial aliquot or sample to reduce false positives in blood cultures or tests performed on a patient's blood sample.

Figures 15A-15G illustrate a blood isolation device and method of use thereof according to yet another embodiment.

Figures 16A-16D illustrate a blood isolation device according to yet another embodiment.

Fig. 17A-17E illustrate a bottom member of a housing for a blood isolation device.

Fig. 18A-18F illustrate a top member of a housing for a blood isolation device.

Fig. 19A and 19B illustrate a blood isolation device having a top member mated with a bottom member.

Fig. 20 shows a blood sample optimization system including a blood isolation device.

Figure 21 shows a non-vented blood isolation device using a wicking material chamber.

FIGS. 22A and 22B show the material composition of a filter used to isolate blood in an isolation chamber of a blood isolation device.

Fig. 23A-23E illustrate another embodiment of a blood isolation device using vacuum force from a blood collection device.

FIGS. 24A-24D illustrate another embodiment of a blood optimization system and a blood isolation device.

Fig. 25A-25D illustrate another embodiment of a blood optimization system and a blood isolation device.

Fig. 26A-26E illustrate another embodiment of a blood optimization system and a blood isolation device.

Fig. 27A-27D illustrate another embodiment of a blood optimization system and a blood isolation device.

Fig. 28A-28F illustrate another embodiment of a blood optimization system and a blood isolation device.

Fig. 29A-29C illustrate another embodiment of a blood optimization system and a blood isolation device.

Fig. 30A-30G illustrate another embodiment of a blood optimization system and a blood isolation device.

Fig. 31A-31E illustrate another embodiment of a blood optimization system and a blood isolation device.

Figure 32 shows a blood isolation device with a one-way valve.

Figures 33A-33B illustrate an embodiment of a one-way valve for a venting mechanism of an isolation chamber of a blood isolation device.

FIG. 34 shows another embodiment of a blood isolation device having a one-way valve.

Figure 35 shows another embodiment of a one-way valve for a venting mechanism of an isolation chamber of a blood isolation device.

FIGS. 36A-36D illustrate a blood isolation device having a manually actuated closure mechanism.

FIGS. 37A-37E illustrate another embodiment of a blood isolation device having a manually actuated closure mechanism.

FIGS. 38A-38D illustrate yet another embodiment of a blood isolation device having a manually actuated closure mechanism.

39A-39F illustrate other embodiments of blood isolation devices having various configurations for controlling the flow of bodily fluids;

fig. 40A-40D illustrate other embodiments of blood isolation devices having various configurations to control flow and minimize mixing of bodily fluids.

41A-41C illustrate other embodiments of blood isolation devices having various vents for controlling the control or flow of a first portion of a bodily fluid;

42A-42C illustrate various vents and various valves used therein; and is

Fig. 43A-43B illustrate a blood isolation device having a contoured housing for resting or positioning on a limb of a patient.

Like reference symbols in the various drawings indicate like elements.

Detailed description of the invention

This document describes a blood sample optimization system and method for reducing or eliminating contaminants in a collected blood sample, which in turn reduces or eliminates false positive reads in other tests of blood cultures or collected blood samplesAnd (4) counting. In some embodiments, a blood sample optimization system comprises: a patient needle for accessing a patient's blood stream through a blood vessel, a sample needle for accessing a blood collection container (such as an evacuated blood collection container or tube, e.g. a catheter) for collecting blood

Etc.) to provide a blood sample, or other sampling device, and a blood isolation device positioned between the patient needle and the sample needle. The blood isolation device includes an isolation chamber for isolating an initial, possibly contaminated, blood aliquot, and may further include a sampling channel that bypasses the isolation chamber to deliver potentially uncontaminated blood between the patient needle and the sample needle after the initial blood aliquot is isolated in the isolation chamber.

In some embodiments, the blood isolation device includes a shunt junction configured such that flow from the inlet port from the patient needle or tubing leading thereto flows first towards, preferably is directed towards, or is biased towards, the isolation chamber. For example, the shunt junction may be configured or formed such that the first portion of blood follows the path of least resistance toward the isolation chamber. Other types of shunts, junctions, or flow biasing mechanisms may be used with the blood isolation device. The isolation chamber may also include or form a curve or ramp to create a path of least resistance and direct the initial blood flow toward and into the isolation chamber regardless of any positioning or orientation of the blood isolation device.

Fig. 1 illustrates a blood sample optimization system according to some embodiments. The system comprises a patient needle 1 for piercing the skin of a patient to access the vein of the patient and the blood therein. The system further comprises a sample needle (i.e. for

Or the like) 5 that may be contained within and first sealed by a resealable protective cover 10, Luer-actuated valve, or other collection interface or device. Resealable protective cover 10Over-application for drawing blood from a patient

A bottle (not shown) is pushed next to or around the sample needle 5. The system may further comprise a low volume chamber 30 leading to the sample needle 5, but also an orifice or one or more channels 45 leading to an isolation chamber 55 formed by the housing 50.

The isolation chamber 55 is a chamber, channel, passageway, lock or other structure for receiving and holding a first aliquot of the patient's blood, which may be a predetermined or measured amount depending on the volume of the isolation chamber 55. The first blood draw typically contains, or more readily contains, the organisms responsible for bacteremia and sepsis or other pathogens than the subsequent blood draw. The isolation chamber 55 may be a container enclosed in a solid housing, may be formed in or defined by the housing itself, or may be implemented as a tube or lumen. The isolation chamber 55, regardless of how formed and implemented, may have a predetermined volume. In some embodiments, the predetermined volume may be based on the volume of the patient needle, i.e., ranging from less than the volume of the patient needle to any volume up to or greater than 20 times the volume of the patient needle or more. A predetermined volume of isolation chamber 55 may also be established to save or minimize the amount of blood to be isolated and disposed of.

The isolation chamber 55 may be formed, housed or contained within the chamber housing 50, and may be made of plastic, rubber, steel, aluminum, or other suitable material. For example, the isolation chamber 55 may be formed of a flexible tube or other resilient material. The isolation chamber 55 further comprises a breathable blood barrier 20 that allows air to leave the isolation chamber 55. As used herein, the term "breathable blood barrier" refers to a substance, material, or structure that is permeable to air but substantially impermeable to blood. Examples may include hydrophobic membranes and coatings, hydrophilic membranes or coatings in combination with hydrophobic membranes or coatings, screens, filters, mechanical valves, antimicrobial materials, or any other means that allows air to be removed from the isolation chamber 55 when the isolation chamber 55 is filled with blood. In various exemplary embodiments, a breathable blood barrier may be formed from one or more materials that allow air to pass through until contact with liquid, and then such materials are completely or partially sealed to prevent or inhibit the passage of air and/or liquid. In other words, the material forms a gas permeable barrier before coming into contact with the liquid. Upon contact with the liquid, the material substantially or completely prevents further passage of air and/or liquid.

The orifice or channel 45 may have any desired length, cross-sectional shape or size, and/or may be formed to exit the low-volume chamber 30 at any desired angle or orientation. The orifice or passage 45 may also include a one-way flap or valve 60, the one-way flap or valve 60 maintaining an initial aliquot of the blood sample within the isolation chamber 55. In some particular embodiments, the aperture or passage 45 may include a "duck bill" or flapper valve 60 or the like to provide one-way flow of blood from the low volume chamber 30 to the isolation chamber 55. The breathable blood barrier 20 may also be made of a material that allows air to escape but seals when in contact with blood, thereby not allowing outside air to enter the isolation chamber 55. Such a seal would eliminate the need for a valve.

The valve 60 may be any type of valve or closure mechanism. Chamber 30 is designed to contain virtually no residual blood and may be designed to accommodate or allow a particular volume or rate of blood to pass into isolation chamber 55. Likewise, the isolation chamber 55 may also include any type of coating, such as an antimicrobial coating, or a coating that aids in identifying and/or diagnosing the first isolated blood draw component.

The housings 50 and 40 may be formed of any suitable material, including plastic, such as Acrylonitrile Butadiene Styrene (ABS) or other thermoplastic or polymeric material, rubber, steel, or aluminum. The breathable blood barrier 20 may include a substance that provides a color or other signaling mechanism that is activated upon contact with blood from an initial draw or upon cessation of evacuation of air or any combination of events occurring with blood in the isolation chamber 55. The breathable barrier may also include an outer layer, such as a hydrophobic film or cover layer, which may inhibit or prevent the filter from being inadvertently or prematurely sealed by external fluid sources, splashes, etc. The compartment 55 may also be translucent or transparent to allow a user to visually confirm that the compartment is full.

Fig. 2 illustrates a blood sample optimization system according to some alternative embodiments. In the embodiment shown in fig. 2, an isolation chamber 55 or waste chamber surrounds the patient needle 1, and an open-ended cuff or housing is connected to the waste chamber and surrounds the bottom of the sample needle housing and the housing. The patient needle 1 and the sample needle 5 are connected together by a protective cap 56, the protective cap 56 forming a continuous blood collection channel therethrough. The protective cover 56 includes a single aperture or passage leading from the blood collection passage to the isolation chamber 55. In other embodiments, the device may include more than a single orifice or channel. Each orifice or channel may include a one-way valve and be sized and adapted for a predetermined amount of blood flow.

The isolation chamber 55 includes a gas permeable blood barrier. The filter may further include a sensor or indicator to sense and/or indicate when a predetermined amount of blood has been collected in the isolation chamber 55, respectively. The indication will alert the user to the fact that the user will be, for example

Is attached to the sample needle 5. The housing of the isolation chamber 55 may be any size or shape and may include any type of material to define an interior space or volume therein. The interior space is initially filled only with air, but may also be coated with reagents or substances, such as detergents, curing agents, etc. Once the evacuated blood collection tube is attached to the sample needle 5, blood will automatically flow into the patient needle 1 through the blood collection channel and the sample needle 5, and into the vial. When no blood collection vial is attached to the sample needle 5 or to the sample needle 5, the sample needle 5 is covered by a resealable protective cover, coating or film that seals the sample needle.

Fig. 3 illustrates a blood sample optimization system according to some alternative embodiments. In the embodiment shown, the sample needle 5 is surrounded by a resealable protective cover or film and is also connected to the patient needle 1. A blood flow channel is formed through the sample needle and the patient needle. The connection between the sample needle and the patient needle includes a "T" or "Y" connector 102 that includes a channel, port or aperture leading from the main blood flow channel to an isolation chamber 104.

The T-or Y-connector 102 may comprise a flap or one-way valve and have an opening sized and adapted for a predetermined blood flow rate. The isolation chamber 104 may be formed by a pipe or by a solid housing and is initially filled with air. The isolation chamber 104 will receive blood that is automatically bled from the patient, i.e., blood that is automatically bled from the patient under pressure from the patient's own blood pressure. The isolation chamber 104 includes a gas permeable blood barrier 106, preferably at the distal end of the tubing forming the isolation chamber 104, and is connected at the proximal end to the T-or Y-connector 102. The T-or Y-connector 102 may be branched at any desired angle to obtain the most efficient flow of blood, and may be formed to minimize the orifice and interface between the channel and the main blood flow channel, thereby minimizing or eliminating mixing of the initial aliquot of blood with the main blood draw sample.

In some alternative embodiments, the sample needle may be secured to tubing of any length, as shown in FIG. 4, with the opposite end of the sample needle connected to a T-or Y-connector 102. The isolation chamber 104 may be any shape or volume so long as it will contain a predetermined amount of blood sample in the initial aliquot. The T-or Y-connector 102 may also include an opening or channel that is parallel to the primary blood flow channel. The breathable blood barrier may also include an indicator 107 or other mechanism to indicate when a predetermined amount of blood has been collected in the isolation chamber, or when the expelled air reaches a certain threshold, i.e., zero. The tubing may also include a clamp 109, and the clamp 109 may be used to clamp and prevent fluid flow therethrough.

Once the gas permeable blood barrier and the main chamber are sealed, an initial aliquot of blood is captured in the isolation chamber 104, and an evacuated blood collection tube (e.g., a blood collection tube) can be introduced

A bottle) is attached to the sample needle 5 to obtain a sample. The blood collection tube can be removed and the sample needle 5 resealed. Any number of subsequent blood collection tubes can then be attached,for further blood sampling or sampling. After all blood draws are completed, the system may be discarded while an initial aliquot of blood is retained in the isolation chamber 104.

Fig. 5 illustrates a blood sample optimization system according to some alternative embodiments. In the embodiment shown, the sample needle 5 is connected to the patient needle by a tubing. A "T" or "Y" connector 120 is added at any desired location along the conduit, and includes an aperture, port or channel leading to the isolation chamber 204, substantially as described above.

Fig. 6 illustrates a blood sample optimization system according to some alternative embodiments, in which an isolation chamber 304 formed as a primary collection channel receives an initial aliquot of blood and is disposed adjacent to a blood sampling channel. The isolation chamber 304 may surround the blood sampling channel, the patient needle 1 and/or the sample needle 5. The primary collection channel may include a T-or Y-connector 120, or other type of aperture or channel. The isolation chamber 304 includes a gas permeable blood barrier, which, as described above, may also include an indicator that is in contact with a fluid, such as blood.

In some embodiments, the patient needle 1 or the sample needle 5 or both may be replaced by a luer lock male or female connector. However, in various embodiments, the connector at the sample needle end of the blood sample optimization system is initially sealed to allow transfer of the initial aliquot of blood to the isolation chamber, which is pressurized at ambient air pressure and includes an air outlet of a gas permeable blood barrier. In this way, the system passively and automatically uses the patient's own blood pressure to overcome the ambient air pressure of the isolation chamber to push air out through the breathable blood barrier and replace the air in the isolation chamber with blood.

FIG. 7 is a flow chart of an exemplary method for optimizing blood culture quality. At 702, a clinician inserts a needle into a vein of a patient. The blood then flows into the isolation chamber, pushing the air in the isolation chamber out of the isolation chamber through the air permeable blood barrier at 704. In some embodiments, the volume of the isolation chamber is less than 0.1 to greater than 5 cubic centimeters (cc's) or more. The isolation chamber is sized for collection of a blood sampleIs more susceptible to contamination than the second and other subsequent portions of the blood sample or subsequent draws. Since the isolation chamber has a breathable blood barrier through which air can be displaced by blood pushed from the patient's vein, such blood will naturally and automatically flow into the isolation chamber and then be drawn into or otherwise enter

Or other bottle for receiving and storing a blood sample.

When the isolation chamber is full, blood will collect at or come into contact with the air permeable blood barrier, which will inhibit or prevent blood from passing therethrough. At 706, when blood contacts the entire inner surface of the breathable blood barrier, then the breathable blood barrier is closed and air is no longer flowing out or in. At 708, an indicator can be provided to the clinician or the entire chamber can be viewed to indicate that an evacuated blood collection tube can be connected, e.g.

The indicator may include visibility into the primary chamber to see if it is full, such as a blood barrier changing color, or other indicator. The filling time of the isolation chamber may be substantially instantaneous and thus, such an indicator may be that the isolation chamber is merely filled, if present.

Prior to connecting the evacuated blood collection tube, communication between the needle, the sampling channel, and the isolation chamber is restricted by the seal of the isolation chamber blood barrier, thereby not allowing air to re-enter the system through the isolation. The sealed communication path may also be achieved by mechanical twisting or other movement, small holes or tortuous paths, thereby eliminating the need for a separate valve or mechanical movement or operation by the clinician. Once the evacuated blood collection tube is removed, the self-sealing membrane closes the sample needle at 710, and an additional subsequent evacuated blood collection tube can be connected at 712. Once the sample is taken, the device is removed from the patient and discarded at 714.

Fig. 8A-8E illustrate an exemplary blood sample optimization system 800 for contamination-free blood sampling, according to some embodiments. The blood sample optimization system 800 includes an inlet port 802 that can be connected to tubing, a patient needle (or both), or other vascular or venous access device, and a pathway separator 804 having a first outlet to an isolation chamber tubing 806 and a second outlet to a sample collection tubing 808. One or both of the isolation chamber tube 806 and the sample collection tube 808 can be formed from tubing. In some embodiments, the isolation chamber tubing 806 is sized to contain a specific volume of the initial blood sample. Once the isolation chamber tubing 806 is filled, the sample collection tubing 808 will receive the blood sample. The sample collection tube 808 may be connected to

A base or housing 810 or other blood sample collection device.

The blood isolation system 800 also includes a blood isolation device 812, as shown in more detail in fig. 8B-8D, the blood isolation device 812 including a housing 818, the housing 818 including a sampling channel 820, the sampling channel 820 defining a passageway for the uncontaminated sample collection tube 808 or being connected at either end to the uncontaminated sample collection tube 808. The sampling channel 820 may be bent through the housing 818 to better secure and stabilize the housing 818 in position along the uncontaminated sample collection tube 808.

The blood isolation device 812 also includes an isolation chamber 822 connected to the isolation chamber tubing 806 or other chamber. The isolation chamber 822 terminates in a breathable blood barrier 824. The breathable blood barrier 824 may also include a colorant that changes to a different color upon full contact with blood as an indication that periodic collection of a blood sample (i.e., an uncontaminated blood sample) may be initiated. Other indicators may be used, such as small lights, sound generating mechanisms, etc. In some embodiments, the breathable blood barrier is positioned at right angles to the direction of isolation chamber 822, but may be positioned at any distance or orientation to save space and material for housing 818. The housing 818 and its housing contents may be formed of any rigid or semi-rigid material or group of materials.

Fig. 9 illustrates a pathway separator 900 for use in a blood isolation system, such as those shown in fig. 8A-8E. Pathway separator 900 includes an inlet port 902, a main line outlet port 904, and an isolation channel outlet port 906. The inlet port 902 may be connected to a main conduit, which in turn is connected to a patient needle system, or directly to a patient needle. Main line outlet port 904 can be connected to a blood sampling system with a main line conduit, e.g.

A base or housing, or directly to such a blood sampling system. The isolation channel outlet port 906 may be connected to an isolation tubing to receive and isolate a first sample of blood until a measurement or predetermined threshold. Alternatively, the isolation channel outlet port 906 may be connected to an isolation chamber. Isolation channel outlet port 906 is preferably at an angle of 20-70 degrees to main line outlet port 904, which main line outlet port 904 is in turn preferably in line with inlet port 902. Once a predetermined amount of the initial blood sample is isolated in the isolation tubing or chamber, a subsequent blood sample will flow into the inlet port 902 and directly out of the main line outlet port 904 without creating impedance according to the mechanisms and techniques described herein.

Fig. 10A-10D illustrate a blood isolation device 1000 according to an alternative embodiment. The blood isolation device 1000 includes an inlet port 1002, a primary outlet port 1004, and an isolation channel port 1006. The inlet port 1002 may be connected to a patient needle or associated tubing. The primary outlet port 1004 may be connected to a blood sample collection device, such as

Associated piping or luer activated valves, etc. Isolation channel port 1006 splits from main outlet port 1004 into isolation chamber 1008. In some embodiments, the isolation chamber 1008 is formed as a helical channel within the housing or other vessel 1001.

The isolation chamber 1008 is distally connected to the breathable blood barrier 1010, substantially as described above. Air in the isolation chamber 1008 is displaced by the gas permeable blood barrier 1010 by an initial aliquot of blood directed into the isolation channel port 1006. Once the isolation chamber 1008 is filled, more blood can be drawn through the primary outlet port 1004 and the samples will not be contaminated.

Fig. 11A-11E illustrate a blood isolation device 1100 according to other alternative embodiments. The blood isolation device 1100 includes an inlet port 1102 (similar to the inlet port described above), a primary outlet port 1104, and an isolation channel port 1106 separate from the primary outlet port 1104 and the inlet port 1102. The isolation channel port is connected to isolation chamber 1108. In the embodiment shown in fig. 11A-11E, the blood isolation device includes a base member 1101 having a channel therein that serves as an isolation chamber 1108. The channel may be formed as a tortuous path through the base member 1101, which in turn is shaped and formed to rest on the limb of the patient.

A portion of the isolation chamber 1108 may protrude from or near the top surface of the base member just prior to exiting the breathable blood barrier 1110 to serve as a blood isolation indicator 1109. The indicator 1109 may be formed of a transparent material or a material that changes color when in contact with blood.

In some embodiments, the blood isolation device 1100 may include a blood sampling device 1120, such as a normally closed needle,

A shield or other collection device. The blood sampling device 1120 may be manufactured and sold with the blood isolation device 1100 for efficiency and convenience so that a first aliquot of blood that may be contaminated by a patient needle insertion procedure may be isolated. Thereafter, blood sampling device 1120 may draw an uncontaminated blood sample to reduce the risk of false positive tests and ensure an uncontaminated sample.

Fig. 12A-12D illustrate a blood sample optimization system 1200 according to other alternative embodiments. System 1200 includes a blood isolation device 1202 for attachment to a blood sampling device 1204, such as

Or other collection and sampling devices. The blood isolation device 1202 is constructed and arranged to be placed in the blood isolation set

The container or vial receives a first aliquot or quantity of blood prior to attachment to the collection needle of the blood sampling device 1204 and isolates the first aliquot or quantity of blood in the isolation channel of the blood isolation device 1202.

In some embodiments, the blood isolation device 1202 can include an inlet port 1212, a primary outlet port, and an isolation channel port. The inlet port 1212 may be connected to a patient needle or associated tubing. The primary outlet port 1214 may be connected to a normally closed needle or device to enable connection with an evacuated blood collection container or other collection device (such as

Associated tubing, luer fittings, syringes, luer activated valves, etc.). The isolation channel port splits from the main outlet port into an isolation chamber 1218.

In some embodiments, isolation chamber 1218 is formed as a passageway within the body of isolation device 1202. The isolation chamber 1218 may be a coiled channel, such as a U-shaped channel, an S-shaped channel, a spiral channel, or any other coiled channel. The isolation device 1202 may include a housing or other containment body and one or more channels formed therein. As shown in fig. 12A and 12B, the isolation device 1202 includes a body 1206 and a cap 1208. The body 1206 is formed with one or more cavities or channels that are also formed with one or more arms 1210 extending from the cap 1208 and that abut the cavities or channels in the body 1206 to form primary collection ports and primary outlet ports.

Fig. 13A-13D illustrate a blood sample optimization system 1300 according to other alternative embodiments. The system 1300 includes a blood isolation device 1302 for attachment to a blood sampling device 1304, such as

Or other body fluid collection and sampling devices. The blood isolation device 1302 is constructed and arranged to be placed in

The container or vial receives the first aliquot or first quantity of blood prior to attachment to the collection needle of the blood sampling device 1304 and isolates the first aliquot or first quantity of blood or other bodily fluid in the isolation channel of the blood isolation device 1302.

The blood isolation device 1302 includes a housing 1301, the housing 1301 having an inlet port 1314, a main outlet port 1312, and an isolation channel port 1316. The inlet port 1314 may be connected to a patient needle or associated tubing. The primary outlet port 1312 may be connected to a normally closed needle or device to enable connection with an evacuated blood collection container or other collection device (such as

Associated tubing, luer fittings, syringes, luer activated valves, etc.). The isolation channel port 1316 splits from the main inlet port 1314 into an isolation chamber 1318.

In the embodiment shown in fig. 13A-13D, isolation chamber 1318 is formed as a cavity or chamber within housing 1301 or is formed by walls defining housing 1301. Isolation chamber 1318 can be a winding channel, such as a U-channel, S-channel, spiral channel, or any other winding channel, defined by the mating and connection of housing 1301 and cap 1307, which cap 1307 can include a protrusion 1305, which protrusion 1305 provides one or more walls or guides for the winding channel in isolation chamber 1318. The projection 1305 from the cap 1307 may be straight or curved and may have various channels, apertures, or grooves embedded therein, and may extend from the cap 1307 at any angle or orientation. When cap 1307 is connected to housing 1301 to complete the formation of isolation chamber 1318, protrusion 1305 forms at least a portion of the winding channel to isolate a first aliquot or first quantity of blood or other bodily fluid in the isolation channel formed in and through isolation chamber 1318.

The isolation chamber 1318 includes a breathable blood barrier 1310 substantially as described above. The air in the isolation chamber 1318 is replaced through the air permeable blood barrier 1310 by providing an initial aliquot of blood in the isolation chamber 1318 with the patient's blood pressure. Once the isolation chamber 1318 is filled and the air in the isolation chamber 1318 is displaced, the patient's blood pressure will be insufficient to drive or provide more blood to the blood isolation device 1302, and particularly the outlet port 1312, until, for example, by a blood sample collection device (such as a blood sample collection device)

) A force, such as a vacuum or other pressure, is provided to withdraw the next aliquot or quantity of blood or body fluid. Further blood withdrawal through the main outlet 1312 may be achieved, wherein these samples will not be contaminated, as any contaminants will be isolated from the first aliquot of blood in the isolation chamber 1318.

Fig. 14A-14E illustrate another embodiment of a blood sampling system 1400 that isolates contaminants from an initial aliquot or sample to reduce false positives in blood cultures or tests performed on a patient's blood sample. The blood sampling system 1400 includes a blood isolation device 1401, which blood isolation device 1401 can be connected between a blood sample collection device 1403 and a patient needle (not shown). The blood sample collection device 1403 may be a Vacutainer or the like. The blood isolation device 1401 includes an inlet port 1402, which inlet port 1402 may be connected to a patient needle inserted into the vascular system of a patient to access and draw a blood sample. The inlet port 1402 may also be connected to tubing or other conduits that in turn are connected to a patient needle.

The inlet port 1402 defines an opening into the blood isolation device 1401 that may have the same cross-sectional dimensions as the tubing or other conduit to which the patient needle or patient needle itself is connected. For example, the opening may be circular with a diameter of about 0.045 inches, but may be between 0.01 inches or less and 0.2 inches or more in diameter. The blood isolation device 1401 also comprises an outlet port 1404, the outlet port 1404 defining an opening out of the blood isolation device 1401 and into the blood sample collection device 1403. The outlet port 1404 may also be connected to tubing or other conduits that in turn connect to the blood isolation device 1403. Outlet port 1404 may also include a connector device, such as a threaded cap, a luer fitting (male or female), an unthreaded interference or glued joint fitting, for attaching various devices, including but not limited to tubing and the like.

The blood isolation device 1401 also includes a sampling channel 1406 between the inlet port 1402 and the outlet port 1404, and once the first aliquot of blood has been separated, the sampling channel 1406 serves as a blood sample pathway. Sampling channel 1406 may be a channel or conduit of any size, shape, or configuration. In some embodiments, the sampling channel 1406 has a substantially similar cross-sectional area to the opening of the inlet port 1402. In other embodiments, sampling channel 1406 may become progressively wider from inlet port 1402 to outlet port 1404.

The blood isolation device 1401 also includes an isolation chamber 1408 that connects to the sampling channel 1406 at any point between the inlet port 1402 and the outlet port 1404 and separates or diverts from the sampling channel 1406, but preferably begins at the proximal end of the sampling channel 1406 near the inlet port 1402. The isolation chamber 1408 is first maintained at atmospheric pressure and includes an air outlet 1412 at or near a distal end of the isolation chamber 1408 opposite the turning point of the sampling channel 1406. The air outlet 1412 includes a breathable blood barrier 1412. As shown in fig. 14B, breathable blood barrier 1412 may be covered with protective cover 1416. Protective cover 1416 may be sized and configured to inhibit a user from touching breathable blood barrier 1412 with their finger or other external instrument, while still allowing air to exit breathable blood barrier 1412 as air is expelled from isolation chamber 1408 as blood is forced into isolation chamber 1408 by the patient's own blood pressure. Additionally, the protective cover 1416 may be configured to inhibit or prevent accidental exposure of the breathable blood barrier to environmental fluids or splashes. This can be accomplished by a variety of mechanical means including, but not limited to, the addition of a hydrophobic membrane on the protective cover.

As shown in fig. 14C and 14D, the sampling channel 1406 may be cylindrical or frustoconical, from a smaller diameter to a larger diameter, to minimize the possibility of lysing red blood cells. Likewise, sampling channel 1406 is formed with minimal or no sharp corners or edges that can also lyse red blood cells. Sampling channel 1406 splits into isolation chamber 1408 near inlet port 1402 via a diversion path 1409. The diverting path 1409 can have any cross-sectional shape or size, but preferably is similar to the cross-sectional shape of at least a portion of the inlet port 1402.

In some embodiments, sampling channel 1406 and isolation chamber 1408 are formed by grooves, channels, locks, or other pathways formed in housing 1414. The housing 1414 may be made of plastic, metal, or other rigid or semi-rigid material. The housing 1414 may have a bottom member in sealing engagement with a top member. One or both of the bottom and top members may include a sampling channel 1406 and an isolation chamber 1408, as well as a turning channel 1409, an inlet port 1402, and an outlet port 1404. In some other embodiments, one or more of the diversion channel 1409, inlet port 1402, and/or outlet port 1404 can be at least partially formed by a cap member attached to either end of the housing 1414. In some embodiments, the top and bottom members and the cap member may be coupled together by laser welding, heat sealing, gluing, snapping, screwing, bolting, ultrasonic welding, or the like. In other embodiments, the housing may be formed of a unitary material. In other embodiments, the housing 1414 may be formed of one or more pieces, where two or more pieces are snapped, connected, welded, or otherwise assembled together to arrange the two or more pieces in the form of the blood isolation device 1401.

In other embodiments, some or all of the interior surfaces of diverted path 1409 and/or isolation chamber 1408 may be coated or loaded with a reagent or substance, such as a detergent, a curing agent, or the like. For example, a solidifying agent may be provided at the diversion path 1409 such that when the isolation chamber 1408 is filled and an initial aliquot of blood is backed up back into the diversion path 1409, the last isolated volume of blood may solidify, forming a barrier between the isolation chamber 1408 and the sampling channel 1406.

Fig. 15A-15G illustrate a blood isolation device 1500. The blood isolation device 1500 may be connected to a normally closed needle or device to enable connection to an evacuated blood collection container or other collection device (e.g., a disposable blood collection container or other collection device)

Associated tubing, luer fittings, syringes, luer activated valves, etc.).

The blood isolation device 1500 includes an inlet port 1502 that is connectable to a patient needle that is inserted into the vascular system of a patient to access and draw a blood sample. The inlet port 1502 may also be connected to tubing or other conduits that in turn are connected to a patient needle. The inlet port 1502 defines an opening into the blood isolation device 1500 that may have the same cross-sectional dimensions as the tubing or other conduit to which the patient needle is connected or the patient needle itself. For example, the opening may be circular with a diameter of about 0.045 inches, but may be between 0.01 inches or less and 0.2 inches or more in diameter.

The inlet port 1502 may also include a sealed or fluid-tight connector or connection, such as a threaded or luer fitting, or the like. In some embodiments, tubing or other conduits associated with the patient needle may be integral with the inlet port 1502, such as by co-molding, gluing, laser welding, or heat bonding the components together. In this manner, the blood isolation device 1500 may be manufactured and sold with the patient needle as a single unit, thereby eliminating the need to connect the patient needle to the blood isolation device 1500 when drawing blood or sampling.

The blood isolation device 1500 also includes an outlet port 1504 that defines an opening out of the blood isolation device 1500 and into the blood sample collection device. The outlet port 1504 may also be connected to tubing or other conduits that in turn connect to a blood isolation device, and may also include a sealed or fluid-tight connector or connection, such as a threaded or luer fitting, or the like. Thus, as described above, the blood isolation device 1500 may be manufactured and sold as a single unit with the patient needle and/or tubing and the blood sample collection device, thereby eliminating the need to connect the patient needle and blood sample collection device to the blood isolation device 1500 when drawing blood or sampling.

Blood isolation device 1500 also includes a sampling channel 1506 between inlet port 1502 and outlet port 1504, the sampling channel 1506 serving as a blood sample channel once the first aliquot of blood is isolated. The sampling channel 1506 may be any size, shape, or configuration of channel or conduit. In some embodiments, the sampling channel 1506 has a substantially similar cross-sectional area to the opening of the inlet port 1502. In other implementations, the sampling channel 1506 may gradually widen from the inlet port 1502 to the outlet port 1504.

Blood isolation apparatus 1500 also includes an isolation chamber 1508, the isolation chamber 1508 being connected to the sampling channel 1506 at any location between the inlet port 1502 and the outlet port 1504 (but preferably, near the proximal end of the inlet port 1502 from the sampling channel 1506) and separating or diverting from the sampling channel 1506. In some embodiments, the steering comprises a Y-joint. The isolation chamber 1508 is preferably maintained at atmospheric pressure and includes a vent 1510 at or near the distal end of the isolation chamber 1508. The vent 1510 includes a breathable blood barrier 1512. Fig. 15C shows the blood isolation device 1500 with the isolation chamber 1508 filled with a first aliquot or sample of blood from the patient.

The breathable blood barrier 1512 may be covered with a protective cover 1516. The protective cover 1516 may be sized and configured to inhibit a user from touching the breathable blood barrier 1512 with their finger or other external instrument, while still allowing air to escape from the breathable blood barrier 1512 as air is expelled from the isolation chamber 1508 due to the patient's own pressure being forced into the isolation chamber 1508. The protective cover 1516 may be configured to inhibit or prevent accidental exposure of the filter to environmental fluids or splashes. This can be accomplished by a variety of mechanical means including, but not limited to, the addition of a hydrophobic membrane on the protective cover.

Fig. 15B is a perspective view of the blood isolation device 1500 from the outlet port 1504 of the blood isolation device 1500 including the vent port 1510 and the top side of the housing 1501, and illustrates the initial aliquot of blood filling the isolation chamber 1508 when the sampling channel 1506 is empty prior to activation of the sample collection device. Fig. 15G is a perspective view of the blood isolation device 1500 from the outlet port 1504 of the blood isolation device 1500 and the bottom side of the housing 1501, and illustrates an initial aliquot of blood filling the isolation chamber 1508 when the sampling channel 1506 is empty prior to activation of the sample collection device. Fig. 15C is another perspective view of the blood isolation device 1500 from the inlet port 1502 of the blood isolation device 1500 including the vent 1510 and the top side of the housing 1501, and illustrates the withdrawal of blood through the sampling channel 1506 while isolated blood remains substantially in the isolation chamber 1508.

Fig. 15D is a cross section of a blood isolation device 1500 showing a housing 1501 defining a sampling channel 1506 and an isolation chamber 1508, according to some embodiments. Fig. 15E and 15F illustrate various form factors for a housing of a blood isolation device according to one or more embodiments described herein.

The isolation chamber 1508 may have a larger cross-sectional area than the sampling channel 1506, and the cross-sectional area and length may be configured for a predetermined or specific volume of blood to be isolated or locked. The sampling channel 1506 may be sized to be compatible with tubing used for one or both of a patient needle tubing or a blood collection set tubing.

The housing 1501 may be formed of multiple portions or a single integral portion. In some embodiments, as shown in fig. 15D, the housing 1501 includes a top member 1520 and a bottom member 1522 that are mated together, one or both of which have a groove, channel, lock, conduit, or other passageway pre-formed therein, such as by an injection molding process or by etching, cutting, drilling, or the like. The top member 1520 may be connected to the bottom member 1522 by any mating or connecting mechanism, such as by laser welding, thermal bonding, ultrasonic welding, gluing, using screws, rivets, bolts, etc., or by other mating mechanisms, such as latches, grooves, tongues, pins, flanges, etc.

In some embodiments, such as shown in fig. 15D, the top member 1520 may include a groove, channel, lock, conduit, or other passageway, while the bottom member 1522 may include a protrusion 1524, the protrusion 1524 sized and adapted to at least one of the groove, channel, lock, or other passageway of the top member 1520. The protrusion 1524 may provide a surface feature, such as a partial groove or channel, to complete the formation of the sampling channel 1506 and/or the isolation chamber 1508. In some embodiments, the protrusion 1524 may be formed with one or more angled sides or surfaces to more closely fit within a corresponding groove, channel, lock, or other passageway. In other embodiments, both the top member 1520 and the bottom member can include grooves, channels, locks, or other passageways, as well as one or more protrusions 1524.

In some embodiments, the sampling channel 1506 and the isolation chamber 1508 are formed by grooves, channels, locks, or other passageways formed in the housing 1501. The housing 1501 may be made of any suitable material, including rubber, plastic, metal, or other material. The case 1501 may be formed of a transparent or translucent material, or an opaque or non-translucent material. In other embodiments, the housing 1501 may be substantially opaque or non-translucent, while the surface of the housing immediately adjacent the sampling channel 1506 and/or the isolation chamber 1508 is transparent or translucent, thereby providing a visual cue or indicia to the practitioner that the isolation first fills the chamber 1508 to the necessary or desired degree, and/or a visual cue or indicia that then keeps the isolated blood isolated while a clean blood sample is drawn through the sampling channel 1506. Other visual cues or indicia of isolation may include, but are not limited to: the breathable blood barrier 1512 becomes a different color when in contact with blood, saturated or partially saturated; a color-coded label or indicator at any point along or adjacent to the isolation chamber; an audible signal; a vibration signal; or other signals.

Following venipuncture by a patient's patient needle (not shown), which may collect multiple pathogens from the patient's skin, a first amount of patient blood with these pathogens as the patient's own blood pressure overcomes the atmospheric pressure in the isolation chamber 1508 to displace the air therein through the air permeable blood barrier 1512Fluid will enter the inlet port 1502 of the blood isolation device 1500 and flow into the isolation chamber 1508 by following the path of least resistance. The patient's blood pressure is insufficient to overcome the pressure build-up in the sealed sampling channel 1506. Eventually, the isolation chamber 1508, which has a predetermined volume, fills with blood that displaces air through the air permeable blood barrier 1512. Once the blood impinges on the breathable blood barrier 1512, the blood interacts with the breathable blood barrier 1512 material to completely or partially seal the vent 1510. May provide a signal or indication that the practitioner is now available

The capsule or other blood sample collection device collects the next batch of patient blood for sampling. The blood in the isolation chamber 1508 is now effectively isolated in the isolation chamber.

After filling the blood isolation path 1508 but in use

Or other blood sample collection device, the patient's blood pressure may drive the compression of air in the sampling channel 1506, possibly causing a small amount of blood to move through the shunt point to the isolation chamber 1508 and into the sampling channel 1506, queuing the uncontaminated blood for drawing through the sampling channel 1506.

In some instances, as shown in fig. 15G, inlet port 1532 may include a male luer for connection to a removable patient needle, while outlet port 11534 may include a female luer for connection to a syringe. Such embodiments of inlet and outlet ports may be used with any of the devices described herein to avoid

The tendency of the device to collapse the patient's vein. In this embodiment, the clinician may use the syringe in a modulated manner to obtain the blood sample. In operation, a syringe is attached to the outlet port 1004 and a needle is attached to the inlet port 1002. Venipuncture with a needle, withoutThe clinician is required to pull the syringe. An initial aliquot of blood fills the isolation chamber, and a syringe can then be used to draw a sample of blood through the collection channel, bypassing the isolated blood in the isolation chamber.

Fig. 16-19 illustrate yet another embodiment of a blood isolation device. Figures 16A-16D illustrate a blood isolation device 1600 that can be attached to a blood sample collection device 1600 (such as, for example, a blood isolation device 1600)

An evacuated blood collection container (not shown)) with a patient needle (not shown) and/or associated tubing. Fig. 17 shows a bottom member of a blood isolation device, and fig. 18 shows a top member of a blood isolation device that can be mated together to form an inlet port, an outlet port, an isolation chamber, and a sampling channel, as explained more fully below. Fig. 19A and 19B show the top and bottom members mated together. It should be understood that fig. 16-19 illustrate one exemplary manner of constructing a blood isolation device as described herein, and that other forms of construction are possible.

Referring to fig. 16A-16D, a blood isolation device 1600 includes an inlet port 1602 that is connectable to a patient needle that is inserted into the vascular system of a patient to access and draw a blood sample. The inlet port 1602 may also be connected to tubing or other conduits that in turn are connected to a patient needle. The inlet port 1602 defines an opening into the blood isolation device 1600, which may have the same cross-sectional dimensions as a tubing or other catheter connected to a patient needle or the patient needle itself. For example, the opening may be circular with a diameter of about 0.045 inches, but may be between 0.01 inches or less and 0.2 inches or more in diameter.

Inlet port 1602 may also include a sealed or fluid-tight connector or connection, such as a thread or luer fitting, or the like. In some embodiments, a tube or other conduit associated with the patient needle may be integral with the inlet port 1602, such as by co-molding, gluing, laser welding, or heat bonding the components together. In this manner, the blood isolation device 1600 may be manufactured and sold as a single unit with the patient needle and/or tubing, thereby eliminating the need to connect the patient needle to the blood isolation device 1600 when drawing blood or sampling.

The blood isolation device 1600 also includes an outlet port 1604 that defines an opening out of the blood isolation device 1600 and into the blood sample collection device. Outlet port 1604 may also be connected to tubing or other conduits that in turn connect to a blood isolation device, and may also include a sealed or fluid-tight connector or connection, such as a thread or luer fitting, or the like. Thus, as described above, the blood isolation device 1600 can be manufactured and sold as a single unit with the patient needle and/or tubing and the blood sample collection device, thereby eliminating the need to connect the patient needle and blood sample collection device with the blood isolation device 1600 when drawing blood or sampling.

The blood isolation device 1600 also includes a sampling channel 1606 between the inlet port 1602 and the outlet port 1604, and an isolation chamber 1608 connected to or separated or diverted from the sampling channel 1606 at any point between the inlet port 1602 and the outlet port 1604. Once the first aliquot of blood is isolated in the isolation chamber 1608, the sampling channel 1606 serves as a blood sampling path. Sampling channel 1606 can be any size, shape, or configuration of channel or conduit. In some embodiments, the sampling channel 1606 has a substantially similar cross-sectional area to the opening of the inlet port 1602. In other embodiments, sampling channel 1606 can gradually widen from inlet port 1602 to outlet port 1604. The isolation chamber 1608 may have a larger cross-section to form a large reservoir toward the isolation channel path so that blood will first want to enter the reservoir rather than a smaller diameter portion on the sampling channel 1606, as more fully shown in fig. 17 and 19.

In some exemplary embodiments, the transfer between the sampling channel 1606 and the isolation chamber 1608 is via a shunt junction 1607. The shunt junction 1607 may be generally Y-shaped, T-shaped, or U-shaped. In some preferred exemplary embodiments, and as shown in fig. 17A-17B, flow splitter junction 1607 is configured such that flow exiting inlet port 1602 is preferably directed toward isolation chamber 1608. The isolation chamber 1608 may also include or form a curve or ramp to direct the initial flow of blood toward and into the isolation chamber 1608.

Preferably, the isolation chamber 1608 is maintained at atmospheric pressure and includes a vent 1610 at or near a distal end of the isolation chamber 1608. The vent 1610 may include a breathable blood barrier 1612 as described above.

The blood isolation device 1600 may include a housing 1601, which may be formed of multiple parts or a single integral part. In some embodiments, as shown in fig. 17A-17E and 18A-18F, the housing 1601 includes a top member 1620 and a bottom member 1622 that fit together. The blood isolation device 1600 may also include a gasket or other sealing member (not shown) such that when the top member 1620 is mechanically attached to the bottom member 1622, the interface therebetween is sealed by the gasket or sealing member. Fig. 17A-17E illustrate a bottom member 1622 of a housing for a blood isolation device 1600. Base member 1622 may include grooves, channels, locks, conduits, or other passageways preformed therein, e.g., by an injection molding process or by etching, cutting, drilling, etc., to form sampling channel 1606, isolation chamber 1608, and shunt junction 1607.

The isolation chamber 1608 may have a larger cross-section than the sampling channel 1606 such that blood will preferentially enter the isolation chamber rather than a smaller diameter portion on the sampling channel 1606.

Fig. 18A-18F illustrate top member 1620, which may be connected to bottom member 1622 by any mating or connecting mechanism, such as by laser welding, thermal bonding, gluing, using screws, rivets, bolts, etc., or by other mating mechanisms, such as latches, grooves, tongues, pins, flanges, etc. Top component 1620 may include some or all of grooves, channels, locks, conduits, or other passageways to form sampling channel 1606, isolation chamber 1608, and shunt junction 1607. In other embodiments, both top member 1620 and bottom member 1622 may include grooves, channels, locks, or other passageways.

In some embodiments, sampling channel 1606 and isolation chamber 1608 are formed by grooves, channels, locks, or other passageways formed in housing 1601. The housing 1601 may be made of rubber, plastic, metal, or any other suitable material. The housing 1601 may be formed of a transparent or translucent material or formed of an opaque or non-translucent material. In other embodiments, the housing 1601 may be substantially opaque or non-translucent, while the housing surface immediately adjacent the sampling channel 1606 and/or the isolation chamber 1608 may be transparent or translucent, thereby providing a visual cue or indicia to the practitioner that the isolation chamber 1608 is first filled to the necessary or desired extent, and/or a subsequent visual cue or indicia that isolated blood is still isolated when a clean blood sample is drawn through the sampling channel 1606. Other visual cues or indicia of isolation may include, but are not limited to: the breathable blood barrier 1612 changes to a different color when in contact with blood, saturated or partially saturated; a color-coded label or indicator at any point along or adjacent to the isolation chamber; an audible signal; a vibration signal; or other signals.

As shown in fig. 18A-18F, the breathable blood barrier 1612 may be covered by a protective member 1616 or surrounded by a protective member 1616. The protective member 1616 may be sized and configured to inhibit a user from contacting the breathable blood barrier 1612 with their fingers or other external instruments, while still allowing air to exit the breathable blood barrier 1612 as the air is removed from the isolation chamber 1608. In some embodiments, the protective member 1616 comprises a protrusion extending upward from the top surface of the top member 1620 and around the breathable blood barrier 1612. The protective member 1616 is configured to inhibit or prevent accidental exposure of the filter to environmental fluids or splashes. This can be accomplished by a variety of mechanical means including, but not limited to, the addition of a hydrophobic membrane on the protective cover.

In use, the blood isolation device 1600 includes a sampling channel 1606 and an isolation chamber 1608. Both passageways are initially filled with air at atmospheric pressure, but the sampling channel 1606 is directed to be filled

Or other such sealed blood sampling device, initially sealed at an outlet port 1604 and an isolation chamber 1608 terminates at a vent 1610 to atmosphere, the vent 1610 including a gas permeable blood barrier 1612.

After venipuncture by a patient's patient needle (not shown), which may collect many pathogens from the patient's skin, a first amount of patient blood with these pathogens will pass through the inlet port 1602 of the blood isolation device 1600. By finding the path of least resistance, the initial amount of potentially contaminated blood will preferentially flow into the isolation chamber 1608. The patient's own blood pressure overcomes the atmospheric pressure in the vented isolation chamber 1608 to displace the air therein through the air permeable blood barrier 1612, but not enough to overcome the pressure build up in the sealed sampling channel 1606. In various exemplary embodiments, the isolation chamber 1608 and the sampling channel 1606 may be configured such that the force generated by the patient's blood pressure is sufficient to overcome any effects of gravity, regardless of the orientation of the blood isolation device.

Eventually, the isolation chamber 1608 fills with blood, which displaces air through the air permeable blood barrier 1612. Once blood contacts the breathable blood barrier, the blood interacts with the breathable blood barrier 1612 to completely or partially seal the vent 1610. May provide a signal or indication that the practitioner is now available

Or other blood sampling device.

After filling the blood isolation passage 1608 but in use

Or other blood sample collection device, the patient's blood pressure may drive compression of air in the sampling channel 1606, which may cause a small amount of blood to move across the shunt point into the sampling channel 1606, queuing uncontaminated blood for withdrawal through the sampling channel 1606.

Figure 19A is a side view of blood isolation device 1600 and figure 19B is a cross-sectional view of blood isolation device 1600 showing top member 1620 mated with bottom member 1622.

Fig. 20 illustrates a blood sample optimization system 2000 that includes a patient needle 2002 for accessing a patient's bloodstream through a blood vessel, a blood sample collection device 2004 for facilitating collection of one or more blood samples, and a catheter 2006 that provides a fluid connection between the patient needle 2002 and the blood sample collection device 2004. In some embodiments, the blood sample collection device 2004 includes a protective cap that includes a sealed collection needle over which is placed a sealed vacuum-loaded container that, once punctured by the collection needle, draws a blood sample from the patient needle 2002 through the conduit 2006 under vacuum pressure or force.

The blood sample optimization system 2000 further includes a blood isolation device 2008, the blood isolation device 2008 being located at any point on the conduit 2006 between the patient needle 2002 and the blood sample collection device 2004 as described herein.

Fig. 21 shows a non-vented blood isolation device 2100 using a wicking material chamber. The blood isolation device 2100 includes a housing 2101 with a sampling channel 2104, the sampling channel 2104 at least partially surrounded or adjoined by an isolation chamber 2102 filled with a wicking material. An initial aliquot of blood is drawn from the patient needle into the sampling channel 2104 where it is immediately wicked into the wicking material of the isolation chamber 2102. The wicking material and/or isolation chamber 2102 is sized and adapted to receive and hold a predetermined amount of blood such that blood subsequently or later withdrawn passes through the wicking material and flows directly through the sampling channel 2104 to a sampling device, e.g., a blood collection device

The wicking material may include substances such as curing agents, soil release agents, or other additives.

As described herein, a variety of different structures and materials may be used to form the breathable blood barrier. As shown in fig. 22A and 22B, the gas permeable blood barrier 2202 of the blood isolation device 2200 can include a matrix 2204 of polymeric beads, at least some of which are treated to make them hydrophilic. The breathable blood barrier 2202 also includes a self-sealing material 2206, such as carboxymethyl cellulose (CMC) or cellulose gum, or other sealing material. The breathable blood barrier 2202 may also include voids 2208, the voids 2208 allowing air to flow prior to or during partial contact with a fluid, such as blood. As shown in fig. 22B, contact with the fluid causes the self-sealing material 2206 to expand and close the void 2208, thereby blocking air flow through the void 2208 and forming a full or partial seal.

Fig. 23A and 23B illustrate yet another embodiment of a blood isolation device 2300 having an inlet port 2302 connected to a patient needle, an outlet port 2304 connected to a blood sample collection device, an isolation chamber 2306 and a sampling channel 2308, which sampling channel 2308 bypasses the isolation chamber 2306 once the isolation chamber is filled with an initial aliquot of potentially contaminated blood to be isolated. The isolation chamber 2306 includes a hydrophobic plug 2312 at a distal end of the isolation chamber 2306 distal to the inlet port 2302. Vacuum or other pulling force applied from outlet port 2304, e.g. from

Etc., drawing blood into the inlet port 2302 and directly into the isolation chamber 2306, the initial aliquot of blood at the isolation chamber 2306 will contact the hydrophobic plug 2312 and return the initial aliquot of blood to the isolation chamber 2306 where it is isolated. A small amount of blood may enter the sampling channel 2308, which is initially closed by the valve 2308. Upon release of the valve 2308, a subsequent amount of blood, under vacuum or other force, will flow into the inlet port 2302, bypassing the isolation chamber 2306, and into and through the sampling channel 2308 toward the outlet port 2304 and to the collection device.

The sampling channel 2308 may have any suitable geometry and may be formed of a plastic tube or any other suitable material. The valve 2308 may be a clamp or other closure device to pinch, shunt, bend, or otherwise close the sampling channel 2308 before isolating the initial aliquot of blood in the isolation chamber 2306. For example, the valve 2308 may also be formed as a baffle, door, or closable window or barrier within the sampling channel 2308.

23C-23E illustrate an alternative embodiment of a blood isolation device 2300' in which an isolation chamber 2320 is provided at the inlet port 2316 for connection to a patient needle and with a blood sample collection device (e.g., such as a blood sample collection device)

Syringe, etc.) to be connected from the main collection channel 2322. The isolation chamber 2320 includes a gas-permeable, blood-impermeable blood barrier 2324, such as a plug of hydrophobic material or a filter formed from one or more layers. The valve 2324 closes and opens the collection channel 2322, and the device 2300' may be used similarly as described above.

Fig. 24A-24D illustrate a blood sample optimization system 2400 that includes: a patient needle 2402 for accessing a blood vessel into the bloodstream of a patient, a blood sample collection device 2404 for facilitating collection of one or more blood samples for blood testing or blood culture, and a catheter 2406 providing a fluid connection between the patient needle 2402 and the blood sample collection device 2404. In some embodiments, the blood sample collection device 2404 includes a protective covering that includes a sealed collection needle over which is placed a sealed vacuum-loaded container that, once punctured by the collection needle, draws a blood sample from the patient needle 2402 through the conduit 2006 under the vacuum pressure or force.

Blood sample optimization system 2400 also includes a blood isolation device 2408, which blood isolation device 2408 is located at any point on catheter 2406 between patient needle 2402 and blood sample collection device 2404. The position of the blood isolation device 2408 may be based on the length of the catheter between the blood isolation device 2408 and the patient needle 2402 and the associated volume provided by that length.

The blood isolation device 2408 includes: an inlet port 2412 for connection to a catheter 2406 towards the patient needle 2402; and an outlet port 2414 for connection to the catheter 2406 towards the blood sample collection device 2404; and the housing 2416 may be any shape, although the housing shown in fig. 24A-24D is substantially cylindrical and includes an inlet port 2412 and an outlet port 2414, although shown as being located at opposite ends of the housing 2416, the inlet port 2412 and the outlet port 2414 may be located anywhere on the housing.

The blood isolation device 2408 also includes a blood isolation chamber 2418 connected to the inlet port 2412. The blood isolation chamber 2418 is defined by an inner chamber housing 2419 that is movable from a first position to receive and isolate a first aliquot of blood to a second position in which one or more apertures 2424 are exposed at the proximal end of the inner chamber housing 2419 to allow blood to flow around and/or around the inner chamber housing 2419 and through a blood sample passage 2422 defined by an outer surface of the inner chamber housing 2419 and an inner surface of the housing 2416. The blood isolation chamber 2418 includes a gas permeable blood barrier 2420 at the distal end of the blood isolation chamber 2418.

In operation, the inner chamber housing 2419 is in a first position toward the inlet port 2412 such that the one or more apertures 2424 are closed and the blood isolation chamber 2418 is in a direct path of entry from the patient needle. After venipuncture of the patient and by means of a syringe or

Or other blood collection device 2404, an initial aliquot of blood flows into blood isolation chamber 2418. As the initial aliquot of blood flows into the blood isolation chamber, it displaces air therein and eventually causes the blood to contact the blood barrier 2420, forcing the inner chamber housing to the second position. The inner chamber housing 2419 and/or housing 2416 can include a locking mechanism of one or more tabs, grooves, detents, ridges, etc. to hold the inner chamber housing 2419 in the first position until the blood isolation chamber 2418 is filled to provide a force to overcome the locking mechanism to move the inner chamber housing 2419 to the second position. Once in the second position, the initial aliquot of blood is isolated in the blood isolation chamber 2418 and the one or more orifices 2424 are opened to create a pathway from the inlet port 2412 to the blood sampling channel 2422, bypass the blood isolation chamber 2418 and/or flow around the blood isolation chamber 2418.

As described above, the housing 2416 and/or the inner chamber housing 2419 may be formed cylindrically and concentrically, but may have any shape, such as square, rectangular, elliptical, oval, or other cross-sectional shape. The outer surface of the distal end of the inner chamber housing 2419 may have one or more outwardly projecting tangs 2421 with gaps therebetween. The tangs 2421 contact the inner surface of the housing 2416 to help define the blood sampling channel 2422 therebetween and to help stop the inner chamber housing 2419 in the second position. The gap between tangs 2421 enables blood to flow through blood sampling channel 2422 and toward outlet port 2414. When the inner chamber housing 2419 is in the second position and the blood isolation chamber 2418 is filled with the first aliquot of blood, additional blood sample will automatically flow through the inlet port 2412, through the one or more orifices 2424, through the blood sampling channel 2422, through the gaps between the tangs 2421, and finally through the outlet port 2414 for collection by the blood sampling device 2404.

Fig. 25A-25D illustrate a blood optimization system 2500 and a blood isolation device 2502 formed substantially as described in fig. 15, 16, 17, 18, and 19, but formed to inhibit a user or other object from contacting or blocking the venting mechanism of the blood isolation chamber 2520. The initial air in the blood isolation chamber 2520 is replaced by the initial aliquot of blood at the time of venipuncture, and the patient's blood pressure overcomes the ambient air pressure in the blood isolation chamber 2520. The venting mechanism includes a gas permeable blood barrier 2506, such as a porous material or group of materials that allow air to escape but block blood from exiting the blood isolation chamber 2520.

The exhaust mechanism includes: an inner wall 2516 at least partially circumscribing or surrounding the breathable blood barrier 2506; and an outer wall 2504 spaced apart from the inner wall 2516. The outer wall 2504 may have one or more exhaust ports 2514 formed therein. The outer wall 2504 extends higher up than the inner wall 2516 so that a cover 2510, such as a cap, plug, cap, etc., may be attached to the outer wall 2504 and may be moved a small distance away from the top of the inner wall 2516. A seal 2508 in the form of a silicon wafer or other resilient material is fitted within the outer wall 2504 to cover the gas permeable blood barrier 2506 and abut the top of the inner wall 2516. The seal 2508 covers and seals the air permeable blood barrier 2506 and prevents air from entering the blood isolation chamber 2520 through the air permeable blood barrier 2506. A fulcrum 2512 on the underside of the lid 2510 allows the seal 2508 to flexibly disconnect from the top of the inner wall 2516 when pushed by air vented from the blood isolation chamber 2520, allowing air to vent from the breathable blood barrier 2506 and through one or more vents 2514 in the outer wall 2504.

Fig. 26A-26E illustrate a blood sample optimization system 2600 that includes a patient needle 2602 for vascular access to a patient blood stream, a blood sample collection device 2604 that facilitates collection of one or more blood samples for blood testing or blood culture, and a catheter 2606 that provides a fluid connection between the patient needle 2602 and the blood sample collection device 2604. The conduit 2606 may comprise a flexible tube. In a preferred embodiment, the blood sample collection device 2604 includes a protective shield 2605 that includes a sealed collection needle on which is placed a sealed vacuum-loaded container that, once pierced by the collection needle, draws a blood sample from the patient needle 2602 through the conduit 2006 under vacuum pressure or force.

Blood sample optimization system 2600 also includes a blood isolation device 2608, the blood isolation device 2608 being located at any point on catheter 2606 between patient needle 2602 and blood sample collection device 2604. The position of the blood isolation device 2608 may be based on the length of the catheter between the blood isolation device 2608 and the patient needle 2602 and the associated volume provided by that length.

The blood isolation device 2608 comprises: an inlet port 2612 for connection with the catheter 2606 towards the patient needle 2602; and an outlet port 2614 for connection with the catheter 2606 towards the blood sample collection device 2604. The blood isolation device 2608 includes an outer housing 2616 and an inner housing 2617, both having a cylindrical shape and connected concentrically. The outer housing 2616 includes an outer wall 2618 and an inner conduit 2620, the inner conduit 2620 defining a blood sampling channel 2622 to transport blood through the conduit 2606 to the blood sampling device 2604. The inner housing 2617 fits tightly between the inner conduit 2620 and the outer wall 2618 of the outer housing and is able to rotate relative to the outer housing 2616. The fit between the outer housing 2616 and the inner housing 2617 may be a friction fit to hold the housings in a particular position. The inner housing 2617 defines a blood isolation chamber 2624, preferably a spiral or open-spiral channel around the outer surface of the inner conduit 2620 of the outer housing 2616, and terminates in a vent 2628 having a gas permeable blood barrier, as shown in fig. 26E.

When the blood isolation device is in the first state, as shown in fig. 26C, the blood isolation chamber 2624 is connected to the blood sampling channel 2622 via a shunt junction 2624 formed in the inner conduit 2620. At 26 ℃. The protective shield 2606 on the collection needle 2604 provides a barrier for air or blood so that an initial aliquot of blood is transferred into the blood isolation chamber 2624 when the patient's blood pressure overcomes the ambient air pressure in the blood isolation passageway 2624 to expel air therefrom through the vent 2628.

As shown in fig. 26D, when the inner housing 2617 is rotated relative to the outer housing 2616 to a second state, and vice versa, the blood isolation chamber 2624 is severed from the shunt junction 2624, thereby enabling a direct path from the patient needle through the catheter 2606 to the collection needle 2604 via the blood sampling channel 2622. The outer housing 2616 and/or the inner housing 2617 may include ridges or grooves formed in a portion of its surface to facilitate relative rotation from the first state to the second state.

Fig. 27A-27D illustrate a blood optimization system 2700 and a blood isolation device 2702 formed substantially as described with reference to at least fig. 15, 16, 17, 18, 19, and 25, but formed to inhibit a user or other object from contacting or blocking an exhaust mechanism from a blood isolation chamber 2720. The air initially in the blood isolation chamber 2720 is replaced by an initial aliquot of blood at the time of venipuncture, where the patient's blood pressure overcomes the ambient air pressure in the blood isolation chamber 2720. The venting mechanism includes a gas permeable blood barrier 2706, such as a porous material or set of materials that allow air to escape but prevent blood from leaving the blood isolation chamber 2720.

The exhaust mechanism includes: an inner wall 2716 at least partially circumscribing or surrounding the breathable blood barrier 2706; and an outer wall 2704 spaced apart from the inner wall 2716. A cap 2722 is positioned on the exhaust mechanism, preferably by having a lower cap wall 2728, which lower cap wall 2728 fits between the inner wall 2716 and the outer wall 2704 of the exhaust mechanism and frictionally abuts the inner wall 2716 or the outer wall 2704 or both. The cap 2722 also includes one or more vents 2724 or slits, apertures, openings, etc. that extend through an upper surface of the cap 2722 around a downwardly extending stopper 2726. The stopper 2726 is sized and adapted to fit tightly within the space defined by the inner wall 2716.

In the first position, as shown in fig. 27C, the cap 2722 extends from the venting mechanism to allow air from the blood isolation chamber 2720 to vent through the air permeable blood barrier 2706 and the one or more vent holes 2724. Once the air from the blood isolation chamber 2720 has been replaced, i.e., when the blood isolation chamber 2720 is filled with a first aliquot of potentially contaminated blood from the patient, the cap 2722 may be pushed down to a second position on the venting mechanism, as shown in fig. 27D, so that the stopper 2726 fits within the inner wall 2716 above the gas permeable blood barrier 2706 to seal the venting mechanism. In either the first or second position, the cap 2722 protects the breathable blood barrier 2706 from outside air or from being touched by a user.

Fig. 28A-28F illustrate a blood optimization system 2800 and a blood isolation device 2802 formed substantially as described with reference to at least fig. 15, 16, 17, 18, 19, 25, and 26, but using a multi-layered filter, in certain implementations, a filter with a captured reactive material to achieve a gas permeable blood barrier. As shown in fig. 28C and 28D, the breathable blood barrier 2803 includes a first layer 2804 of breathable but blood impermeable material and a second layer 2806 comprising a reactive material, such as a hydrophilic material, for repelling blood while still allowing air to pass through the two layers. As shown in fig. 28E and 28F, the breathable blood barrier 2803 may include any number of layers, such as a third layer 2808 formed of the same breathable, but blood impermeable material as the first layer 2804, while the second layer 2806 includes a blood reactive material that is trapped or embedded.

Fig. 29A-29C illustrate a blood optimization system 2900 and a blood isolation device 2902, substantially as described with reference to at least fig. 15, 16, 17, 18, 19, 25And 26, but wherein blood isolation chamber 2904 is at least partially filled with a blood-drawing material 2906. The blood-wicking material 2906 may be used as a wicking material for use when puncturing a patient's vein and for use in applications such as

Or a blood drawing device such as a syringe, further draws blood to be isolated.

Fig. 30A-30G illustrate a blood optimization system 2999 and a blood isolation device 3000 formed substantially as described with reference to at least fig. 15, 16, 17, 18, 19, 25, and 26. The blood isolation device 3000 includes an inlet port 3002 that is connectable to a patient needle inserted into the vascular system of a patient to access and draw a blood sample. Inlet port 3002 may also be connected to tubing or other conduits that in turn are connected to a patient needle. The inlet port 3002 defines an opening into the blood isolation device 3000 that may have the same cross-sectional dimensions as the tubing or other conduit to which the patient needle is connected or the patient needle itself. For example, the opening may be circular with a diameter of about 0.045 inches, but may be between 0.01 inches or less and 0.2 inches or more in diameter.

Inlet port 3002 may also include a sealed or fluid-tight connector or connection, such as a thread or luer fitting, or the like. In some embodiments, a tube or other conduit associated with the patient needle may be integral with the inlet port 3002, for example, by co-molding, gluing, laser welding, or heat bonding the components together. In this manner, the blood isolation device 3000 may be manufactured and sold with the patient needle and/or tubing as a single unit, thereby eliminating the need to connect the patient needle with the blood isolation device 3000 when drawing blood or sampling.

The blood isolation device 3000 also includes an outlet port 3004, the outlet port 3004 defining an opening out of the blood isolation device 3000 and into the blood sample collection device. Outlet port 3004 may also be connected to tubing or other conduits that in turn are connected to a blood isolation device, and may also include a sealed or fluid-tight connector or connection, such as a thread or luer fitting, or the like. Thus, as described above, the blood isolation device 3000 may be manufactured and sold as a single unit with the patient needle and/or tubing and the blood sample collection device, thereby eliminating the need to connect the patient needle and blood sample collection device to the blood isolation device 3000 when drawing blood or sampling.

The blood isolation device 3000 also includes a sampling channel 3006 between the inlet port 3002 and the outlet port 3004, and an isolation chamber 3008 connected to or disconnected or diverted from the sampling channel 3006 at any point between the inlet port 3002 and the outlet port 3004. Once the first aliquot of blood has been isolated in the isolation chamber 3008, the sampling channel 3006 serves as a blood sampling pathway. The sampling channel 3006 can be any size, shape, or configuration of channel or conduit. In some embodiments, sampling channel 3006 has a substantially similar cross-sectional area as the opening of inlet port 3002. In other embodiments, sampling channel 3006 can gradually widen from inlet port 3002 to outlet port 3004. The isolation chamber 3008 may have a larger cross-section to create a larger reservoir toward the isolation channel path so that blood will enter the reservoir first rather than a smaller diameter portion on the sampling channel 3006.

In some exemplary embodiments, the transfer between the sampling channel 3006 and the isolation chamber 3008 is through the shunt junction 3007. The shunt interface 3007 can be generally Y-shaped, T-shaped, or U-shaped. In some preferred exemplary embodiments, and as shown in fig. 17A-17B, the diverter interface 3007 is configured such that flow exiting the inlet port 3002 is preferably directed toward the isolation chamber 3008. The isolation chamber 3008 can also include or form a curve or bevel to direct the initial flow of blood to and into the isolation chamber 3008.

Preferably, the isolation chamber 3008 is maintained at atmospheric pressure and includes a vent 3010 at or near the distal end of the isolation chamber 3008. Vent 3010 may include a breathable blood barrier 3012 as described above.

The blood isolation device 3000 may include a housing 3001, which housing 3001 may be formed of multiple parts or a single integral part. In some embodiments, and as shown in fig. 30F, the housing 3001 includes a top member 3020 and a bottom member 3022 that fit together. The blood isolation device 3000 may also include a gasket or other sealing member (not shown) such that when the top member 3020 and the bottom member 3022 are mechanically attached, the interface therebetween is sealed by the gasket or sealing member. The base member 3022 may include grooves, channels, locks, conduits, or other passageways preformed therein, for example, by an injection molding process or by etching, cutting, drilling, or the like, to form the sampling channel 3006, the isolation chamber 3008, and the shunt junction 3007.

The isolation chamber 3008 can be larger in cross-section than the sampling channel 3006, such that blood preferentially enters the sampling chamber 3006, rather than a smaller diameter portion of the sampling channel 3006.

In some embodiments, the sampling channel 3006 and the isolation chamber 3008 are formed by grooves, channels, locks, or other passageways formed in the housing 3001. The housing 3001 may be made of rubber, plastic, metal, or any other suitable material. The housing 3001 may be formed of a transparent or translucent material, or an opaque or non-translucent material. In other embodiments, the housing 3001 may be substantially opaque or non-translucent, while the surface of the housing immediately adjacent the sampling channel 3006 and/or the isolation chamber 3008 may be transparent or translucent, thereby providing a visual cue or indicia to the practitioner that the isolation chamber 3008 is first filled to the necessary or desired extent, and/or then that isolated blood is still isolated when a clean blood sample is drawn through the sampling channel 3006. Other isolated visual cues or markers may include, but are not limited to: the breathable blood barrier 3012 becomes a different color when contacted, saturated, or partially saturated with blood; a color-coded label or indicator at any point along or adjacent to the isolation chamber; an audible signal; a vibration signal; or other signals.

The breathable blood barrier 3012 may be covered by or surrounded by a cap 3032. The cap 3032 may be sized and configured to inhibit a user from contacting the breathable blood barrier 3012 with their fingers or other external instruments, while still allowing air to exit the breathable blood barrier 3012 as the air is vented from the isolation chamber 3008. The cap 3032 can be configured to inhibit or prevent accidental exposure of the filter to environmental fluids or splashes. This can be accomplished by a variety of mechanical means including, but not limited to, the addition of a hydrophobic membrane on the protective cover.

The venting mechanism includes a wall 3030, the wall 3030 at least partially circumscribing or surrounding the breathable blood barrier 3012. The wall 3030 may have one or more exhaust ports formed therein. A cap 3032 covers the wall 3030 and may be snapped, glued, or otherwise attached in place. A seal 3017 in the form of a silicon wafer or other elastomeric material is fitted within the wall 3030 to cover the breathable blood barrier 3012 and abut the top of the wall 3030. The seal 3017 covers and seals the air permeable blood barrier 3012 and inhibits air from entering the blood isolation chamber 3008 through the air permeable blood barrier 3012. The fulcrum 3012 on the underside of the cap 3032 allows the seal 3008 to flexibly disconnect from the top of the inner wall 3016 when pushed by air expelled from the blood isolation chamber 3008 to allow air to be expelled from the gas permeable blood barrier 3012 and through one or more vents in the wall 3030 and/or the cap 3032.

In use, the blood isolation device 3000 includes a sampling channel 3006 and an isolation chamber 3008. Both channels are initially filled with air at atmospheric pressure, but the sampling channel 3006 is directed to be filled

Or other such sealed blood sampling device, the initially sealed outlet port 3004 isolates the chamber 3008, and the isolated chamber 3008 terminates at a vent 3010 to atmosphere, the vent 3010 comprising a gas permeable blood barrier 3012.

After venipuncture by a patient's patient needle (not shown), which may collect multiple pathogens from the patient's skin, a first amount of patient blood having these pathogens will pass through the inlet port 3002 of the blood isolation device 3000. By finding the path of least resistance, this initial amount of potentially contaminated blood will preferentially flow into the isolation chamber 3008. The patient's own blood pressure overcomes the atmospheric pressure in the isolated chamber 3008 after venting to displace the air therein through the air permeable blood barrier 3012, but is not sufficient to overcome the pressure build up in the sealed sampling channel 3006. The isolation chamber 3008 and sampling channel 3006 can be configured such that the force generated by the patient's blood pressure is sufficient to overcome any effects of gravity, regardless of the orientation of the blood isolation device.

Eventually, the isolation chamber 3008 fills with blood, which displaces air through the air permeable blood barrier 3012. Once blood contacts the breathable blood barrier, the blood interacts with the breathable blood barrier 3012 to completely or partially seal the vent 3010. May provide a signal or indication that the practitioner is now available

Or other blood sampling device.

After filling the blood isolation path 3008 but in use

Or other blood sample collection device, the patient's blood pressure may drive the compression of air in the sampling channel 3006, which may cause a small amount of blood to move through the shunt point into the sampling channel 3006, queuing uncontaminated blood for drawing through the sampling channel 3006.

In another aspect, the blood isolation chamber and/or blood sampling channel or other components of any of the embodiments described herein may provide a visually discernable warning or result in a component adapted to be in operative fluid communication with a flash chamber of an introducer used to insert an intravenous catheter into a blood vessel of a patient. The device and method provide a visually discernable alert when blood from a patient is communicated to a test component reactive to the communicated plasma to undergo a visual change. The reaction with blood or plasma is performed depending on one or more reagents placed therein, which are configured to test for high or low levels of blood content, substances, or thresholds thereof, to visually change appearance depending on the results.

In other aspects, the blood isolation chamber and/or the blood sampling channel can be sized and adapted to provide a particular volume of blood flow during the isolation procedure and/or the sampling procedure.

Fig. 31A illustrates yet another embodiment of a blood isolation device 3099 of the blood optimization system 3100, wherein the blood isolation device 3099 is attached to a sampling tube, typically comprising a resealable sampling or patient needle, between the patient needle 3103 and the sampling device 3105. Referring also to fig. 31B-D, the blood isolation device 3099 includes an inlet port 3102, which inlet port 3102 may be connected to a patient needle inserted into the vascular system of a patient to access and draw a blood sample. The inlet port 3102 may also be connected to tubing or other conduits that in turn are connected to a patient needle. The inlet port 3102 defines an opening into the blood isolation device 3100, which may have the same cross-sectional dimensions as the tubing or other conduit to which the patient needle is connected or the patient needle itself. For example, the opening may be circular with a diameter of about 0.045 inches, but may be between 0.01 inches or less and 0.2 inches or more in diameter.

Inlet port 3102 may also include a sealed or fluid-tight connector or connection, such as a thread or luer fitting, or the like. In some embodiments, tubing or other conduits associated with the patient needle may be integral with the inlet port 3102, for example by co-molding, gluing, laser welding or heat bonding the components together. In this manner, the blood isolation device 3099 can be manufactured and sold with the patient needle and/or tubing as a single unit, thereby eliminating the need to connect the patient needle with the blood isolation device 3099 when drawing blood or sampling.

The blood isolation device 3099 also includes an outlet port 3104, which outlet port 3104 defines an opening out of the blood isolation device 3099 and into the blood sample collection device. Outlet port 3104 may also be connected to tubing or other conduits that in turn connect to a blood isolation device, and may also include a sealed or fluid-tight connector or connection, such as a thread or luer fitting, or the like. Thus, as described above, the blood isolation device 3099 can be manufactured and sold as a single unit with the patient needle and/or tubing and the blood sample collection device, thereby eliminating the need to connect the patient needle and blood sample collection device with the blood isolation device 3099 when drawing blood or sampling.

The blood isolation device 3099 also includes a sampling channel 3106 between the inlet port 3102 and the outlet port 3104, and an isolation chamber 3108 connected to or disconnected or diverted from the sampling channel 3106 at any point between the inlet port 3102 and the outlet port 3104. Once the first aliquot of blood is isolated in isolation chamber 3108, sampling channel 3106 serves as a blood sampling pathway. Sampling channel 3106 may be a channel or conduit of any size, shape, or configuration. In some embodiments, sampling channel 3106 has a substantially similar cross-sectional area as the opening of inlet port 3102. In other embodiments, sampling channel 3106 may gradually widen from inlet port 3102 to outlet port 3104. The isolation chamber 3108 may have a larger cross-section to create a large reservoir toward the isolation channel path so that blood will enter the reservoir first, rather than a smaller diameter portion on the sampling channel 3106.

In some exemplary embodiments, the transfer between sampling channel 3106 and isolation chamber 3108 is via a shunt junction 3167. The diverter junction 3167 may be a generally Y-shaped, T-shaped, or U-shaped junction. In some preferred exemplary embodiments, and as shown in fig. 17A-17B, the diverter junction 3167 is configured such that fluid flowing into and out of the inlet port 3102 is preferably directed to the isolation chamber 3108. This preferred direction may be assisted by the isolation chamber 3108 initially being filled with air at or near atmospheric pressure, which may be displaced by an incoming fluid such as blood. Isolation chamber 3108 may also include or form a curve or ramp to direct the initial blood flow toward and into isolation chamber 3108. Further, the isolation chamber 3108 may have a larger cross-section than the sampling channel 3106, such that blood will preferentially enter the isolation chamber first, rather than a smaller diameter portion on the sampling channel 3106.

The blood isolation device 3099 may include a housing 3101, which housing 3101 may be formed of multiple parts or a single integral part. In some embodiments, and as shown in fig. 32, housing 3101 includes a top member 3120 and a bottom member 3122 that fit together. The blood isolation device 3099 may also include a gasket or other sealing member (not shown) such that when the top member 3120 and the bottom member 3122 are mechanically attached, the interface therebetween is sealed by the gasket or sealing member. Base member 3122 may include grooves, channels, locks, conduits, or other passageways preformed therein, e.g., by an injection molding process or by etching, cutting, drilling, etc., to form sampling channel 3106, isolation chamber 3108, and shunt junction 3167.

In some embodiments, sampling channel 3106 and isolation chamber 3108 are formed by grooves, channels, locks, or other passageways formed in housing 3101, for example by corresponding grooves, channels, locks, or other passageways formed in one or both of top member 3120 or bottom member 3122 of housing 3101. The housing 3101 may be made of rubber, plastic, metal, or any other suitable material. The housing 3101 may be formed of a transparent or translucent material, or an opaque or non-translucent material. In other embodiments, housing 3101 may be substantially opaque or non-translucent, while the surface of the housing immediately adjacent sampling channel 3106 and/or isolation chamber 3108 may be transparent or translucent, thereby providing a visual cue or indicia to the practitioner that isolation chamber 3108 is first filled to the necessary or desired extent, and/or then that isolated blood is still isolated when a clean blood sample is drawn through sampling channel 3106. Other isolated visual cues or markers may include, but are not limited to: the breathable blood barrier 3112 becomes a different color when contacted, saturated or partially saturated with blood; a color-coded label or indicator at any point along or adjacent to the isolation chamber; an audible signal; a vibration signal; or other signals.

Preferably, the isolation chamber 3108 is maintained at or near atmospheric pressure and includes a venting mechanism 3110 at or near the distal end of the isolation chamber 3108. Venting mechanism 3110 may include a gas permeable blood barrier 3112, such as a porous plug that automatically seals to blood or other liquid when in contact with the blood or other liquid. The venting mechanism 3110 also includes one or more vents, holes, apertures, slits, openings, etc. to allow air to escape or be forced out of the isolation chamber 3108.

As best shown in fig. 32, the breathable blood barrier 3012 may be covered by or surrounded by a cap 3032. The cap 3032 may be sized and configured to inhibit a user from contacting the breathable blood barrier 3012 with their fingers or other external instruments, while still allowing air to exit the breathable blood barrier 3012 as the air is vented from the isolation chamber 3008. The cap 3032 may be configured to inhibit or prevent accidental exposure of the filter to environmental fluids or splashes. This can be accomplished by a variety of mechanical means including, but not limited to, the addition of a hydrophobic membrane on the protective cover.

As shown in fig. 31E, 32, the venting mechanism 3110 includes a valve 3140, the valve 3140 surrounding any outlet, aperture, or vent of the venting mechanism, but allowing air to escape the isolation chamber 3108 as shown. Valve 3140 is preferably a one-way valve, such as an umbrella valve as shown in fig. 33A-33B, which may be placed in front of a gas permeable blood barrier or plug at the vent of device 3099. The umbrella valve includes a central stem that fits into an opening 3144 or receptacle in the top housing 3122, and a circular valve member that flexibly opens under fluid pressure, such as from air or blood, and then recloses to prevent reverse flow of air, blood, or other fluid. Alternatively, the valve 3140 may be a duckbill valve as shown in fig. 34 and 35.

Venting mechanism includes a wall 3131, the wall 3131 at least partially circumscribing or surrounding the breathable blood barrier 3112. Wall 3131 may have one or more vents formed therein. Cap 3032 may be inserted on wall 3130 (as in fig. 34) or within wall 3130 (as in fig. 32), and may be snapped, glued, or otherwise attached in place.

In use, the blood isolation device 3100 includes a sampling channel 3106 and an isolation chamber 3108. Both passageways are initially filled with air at atmospheric pressure, but the sampling channel 3106 is directed to be filled with air

Or other such sealed blood sampling deviceThe port 3104 is open, and the isolation chamber 3108 terminates at a vent to atmosphere 3110, which includes a breathable blood barrier 3112.

After venipuncture by a patient's patient needle (not shown), which may collect many pathogens from the patient's skin, a first amount of patient blood with these pathogens will pass through the inlet port 3102 of the blood isolation device 3100. By finding the path of least resistance, this initial amount of potentially contaminated blood will preferentially flow into the isolation chamber 3108. The patient's own blood pressure overcomes the atmospheric pressure in the isolated chamber 3108 after deflation to displace the air therein through the air permeable blood barrier 3112, but not enough to overcome the pressure build up in the sealed sampling channel 3106. In various exemplary embodiments, isolation chamber 3108 and sampling channel 3106 may be configured such that the force generated by the patient's blood pressure is sufficient to overcome any effects of gravity, regardless of the orientation of the isolation device.

Eventually, the isolation chamber 3108 fills with blood, which displaces air through the air permeable blood barrier 3112. Once blood contacts the breathable blood barrier, the blood interacts with the breathable blood barrier 3112 material to completely or partially seal the vent 3110. May provide a signal or indication that the practitioner is now available

Or other blood sampling device.

After filling the blood isolation passageway 3108 but in use

Or other blood sample collection device, the patient's blood pressure may drive the compression of air in sampling channel 3106, which may cause a small amount of blood to move past the shunt point into sampling channel 3106, queuing uncontaminated blood for drawing through sampling channel 3106.

Fig. 36A-36D illustrate a blood optimization system 3600 and a blood isolation device 3602 that are formed substantially as described above, but with a manually actuated closure mechanism near a breathable blood barrier and/or drain. The blood isolation device 3602 includes an inlet port that may be connected with a patient needle device 3604 via a portion of tubing 3608 for insertion of a needle into the vascular system of a patient to access and draw a blood sample. The patient needle device 3604 may have a protective cover, a retractable needle and opposing "wings" for manipulating the retractable needle and providing anchoring to the patient's skin at a location near the venipuncture site.

The inlet port may also be connected to tubing 3608 or other conduit, which tubing 3608 or other conduit is in turn connected to the patient needle device 3604. The inlet port defines an opening into the blood isolation device 3602 that may be the same cross-sectional size as the tubing or other conduit to which the patient needle is connected or the patient needle itself. The inlet port may also include a sealed or fluid-tight connector or connection, such as a thread or luer fitting, or the like.

The blood isolation device 3602 also includes an outlet port that defines an opening out of the blood isolation device 3602 and into the blood sample collection device 3606. The blood sample collection device 3606 generally includes a sampling needle that is sealed by a thin pierceable membrane or the like and upon which a needle, such as a needle, may be placed

To provide vacuum-forced blood sample collection. The outlet port may be connected to a pipe or other conduit, and may also include a sealed or fluid-tight connector or connection, such as a thread or luer, etc. Thus, as described above, the blood isolation device 3602 may be manufactured and sold together with the patient needle device 3604 and/or tubing and/or the blood sample collection device 3606 as a single unit, thereby eliminating the need to connect the patient needle and blood sample collection device with the blood isolation device 3602 at the time of blood draw or sampling.

As described with reference to various embodiments herein, the blood isolation device 3602 also includes a sampling channel between the inlet port and the outlet port, and an isolation chamber connected to, or separated or diverted from, the sampling channel at any point between the inlet port and the outlet port. Once the first aliquot of blood has been isolated in the isolation chamber, the sampling channel serves as a blood sampling path. The sampling channel may be any size, shape or configuration of channel or conduit. In some embodiments, the sampling channel has a cross-sectional area substantially similar to the opening of the inlet port. In other embodiments, the sampling channel may gradually widen from the inlet port to the outlet port. The isolation chamber may have a larger cross-section to form a large reservoir towards the isolation channel path so that blood will enter the reservoir first rather than a smaller diameter portion on the sampling channel.

In some exemplary embodiments, the transfer between the sampling channel and the isolation chamber is through a shunt junction. The shunt junction may be generally Y-shaped, T-shaped, U-shaped, or the like. In some embodiments, and as shown in fig. 17A-17B, the diverter junction is configured such that flow exiting from the inlet port is preferably directed or biased toward the isolation chamber. Other types of shunts, junctions, or flow biasing mechanisms may be used with blood isolation device 3602. The isolation chamber may also include or form a curve or ramp to direct the initial blood flow toward and into the isolation chamber.

The blood isolation device 3602 may include a housing that may be formed of multiple parts or a single integral part. In some embodiments, the housing includes a top member and a bottom member that mate together. The blood isolation device may also include a gasket or other sealing member (not shown) such that when the top member and the bottom member are mechanically attached, the interface therebetween is sealed by the gasket or sealing member. The base member may include grooves, channels, locks, conduits or other passageways preformed therein, such as by an injection molding process or by etching, cutting, drilling, etc., to form the sampling channels, isolation chambers and diverter junctions.

In some embodiments, the sampling channel and the isolation chamber are formed by grooves, channels, locks, or other passageways formed in the housing. The housing may be made of rubber, plastic, metal, or any other suitable material. The housing may be formed of a transparent or translucent material or an opaque or non-translucent material. In other embodiments, the housing may be largely opaque or non-translucent, while the surface of the housing immediately adjacent the sampling channel and/or the isolation chamber may be transparent or translucent, thereby providing a visual cue or indicia to the practitioner that the isolation chamber is first filled to the necessary or desired extent, and/or that isolated blood is still isolated when a clean blood sample is drawn through the sampling channel. Other isolated visual cues or markers may include, but are not limited to: the breathable blood barrier changes to a different color when contacted, saturated or partially saturated with blood; a color-coded label or indicator at any point along or adjacent to the isolation chamber; an audible signal; a vibration signal; or other signals.

The isolation chamber is preferably maintained at atmospheric pressure and includes a vent 3609 at or near the distal end of the isolation chamber. Vent 3609 may include a breathable blood barrier as described above. Vent 3609 is preferably located on the top surface of the housing of blood isolation device 3602. The vent 3609 and/or the breathable blood barrier may be defined by a wall or other separation mechanism.

As shown in fig. 36B-36D, blood isolation device 3602 may include a cover 3610, the cover 3610 adapted to cover and close or otherwise seal vent 3609 once an initial aliquot of blood has filled the isolation chamber and air has been expelled through vent 3609. Cover 3610 may have an initial configuration or open mode removed from vent 3609 to allow air to escape from blood isolation device 3602, particularly the blood isolation chamber. Lid 3610 may also have a second configuration or closed mode in which a second portion of lid 3610 covers and at least partially seals vent 3609, at least to the extent that blood does not leak out of lid 3610 in its closed mode or second configuration.

In some embodiments, cover 3610 may comprise an adhesive label, at least a portion of which is initially adhered to a surface of the housing of blood isolation device 3602 proximate vent 3609, and a second portion of the adhesive label seals vent 3609. The cover 3610 may be actuated from an initial configuration to a second configuration, or from an open mode to a closed mode, through the use of a release mechanism 3612. In some embodiments, the release mechanism 3612 may include a sleeve, a first portion of which lines or bears against an underside of a second portion of the adhesive label, the second portion of the sleeve extending outwardly to form a tab that can be grasped by a user's fingers and progressively pulled away from the second portion of the adhesive label, laying down the second portion of the adhesive label and adhering to the housing of the blood isolation device 3602 around the through port 3609.

Thus, for the exemplary embodiment in use, blood isolation device 3602 includes a sampling channel and an isolation chamber. Both of these passageways are initially filled with air at atmospheric pressure, but the sampling channel is directed to an outlet port that will initially be filled with air

Or other such sealed blood sampling device, and the isolation chamber terminates in a vent to atmosphere that includes a gas permeable blood barrier. After venipuncture of a patient's patient needle (not shown), which may collect multiple pathogens from the patient's skin, a first amount of patient blood with these pathogens will pass through the inlet port of the blood isolation device. An initial amount of potentially contaminated blood will preferentially flow into the isolation chamber by finding the path of least resistance. The patient's own blood pressure overcomes the atmospheric pressure in the isolated chamber after venting, displacing air therein through the air permeable blood barrier, but not enough to overcome the pressure build up in the sealed sampling channel. In various exemplary embodiments, the isolation chamber and the sampling channel may be configured such that the force generated by the patient's blood pressure is sufficient to overcome any effects of gravity, regardless of the orientation of the isolation device.

Eventually, the isolation chamber fills with blood, which displaces air through the air permeable blood barrier. Once blood contacts the breathable blood barrier, the blood interacts with the breathable blood barrier material to completely or partially seal the vent. To enhance this seal or self-seal, the user may grasp the distal end of the release liner and pull it away from the underside of the second portion of the adhesive label until the second portion of the adhesive label exposes the adhesive to the top surface of the housing proximate the vent and/or breathable blood barrier. Once so adhered, as shown in fig. 36D, vent 3609 will not allow air to re-enter the blood isolation chamber and the user can now collect more blood using blood collection device 3606, which bypasses the isolation chamber of blood isolation device 3602.

Other manually actuated closure mechanisms may be used. For example, fig. 37A-37E illustrate a blood optimization system 3700 and a blood isolation device 3702 that are formed substantially as described above, but with a manually actuated closure mechanism near the breathable blood barrier and/or vent. The blood isolation device 3702 includes an inlet port connectable to a patient needle device 3704 for inserting a needle into the vascular system of a patient to access and draw a blood sample. The patient needle device 3704 may have a protective shield, a retractable needle, and opposing "wings" for manipulating the retractable needle and providing anchoring to the patient's skin at a location near the venipuncture site.

The inlet port may also be connected to a tubing 3708 or other conduit, which tubing 3708 or other conduit is in turn connected to a patient needle device 3704. The inlet port defines an opening in the blood isolation device 3702 that may be the same cross-sectional size as the tubing or other conduit to which the patient needle is connected or the patient needle itself. The inlet port may also include a sealed or fluid-tight connector or connection, such as a thread or luer fitting, or the like.

The blood isolation device 3702 also includes an outlet port that defines an opening that exits the blood isolation device 3702 and enters the blood sample collection device 3706. The blood sample collection device 3706 typically includes a sampling needle that is sealed by a thin pierceable membrane or the like and upon which a sample such as a blood sample collection needle may be placed

To provide vacuum-forced blood sample collection. The outlet port may be connected to a pipe or other conduit, and may also include a seal or be impermeableA fluid connector or connection, such as a thread or luer fitting, or the like. Thus, as described above, the blood isolation device 3702 may be manufactured and sold as a single unit with the patient needle device 3704 and/or the tubing and/or blood sample collection device 3706, thereby eliminating the need to connect the patient needle and blood sample collection device to the blood isolation device 3702 during blood draw or sampling.

As described with reference to various embodiments herein, the blood isolation device 3702 also includes a sampling channel between the inlet and outlet ports, and an isolation chamber connected to or separated or diverted from the sampling channel at any point between the inlet and outlet ports. Once the first aliquot of blood has been isolated in the isolation chamber, the sampling channel serves as a blood sampling path. The sampling channel may be any size, shape or configuration of channel or conduit. In some embodiments, the sampling channel has a cross-sectional area substantially similar to the opening of the inlet port. In other embodiments, the sampling channel may gradually widen from the inlet port to the outlet port. The isolation chamber may have a larger cross-section to form a large reservoir towards the isolation channel path so that blood will enter the reservoir first rather than a smaller diameter portion on the sampling channel. The isolation chamber may be linear, curvilinear or any other shape.

In some exemplary embodiments, the transfer between the sampling channel and the isolation chamber is through a shunt junction. The shunt junction may be generally Y-shaped, T-shaped, U-shaped, or the like. In some embodiments, and as shown in fig. 17A-17B, the diverter junction is configured such that flow exiting from the inlet port is preferably directed or biased toward the isolation chamber. The blood isolation device 3702 may use other types of diverters, junctions, or flow deflecting mechanisms. The isolation chamber may also include or form a curve or ramp to direct the initial blood flow toward and into the isolation chamber.

The blood isolation device 3702 can include a housing that can be formed of multiple parts or a single integral part. In some embodiments, the housing includes a top member and a bottom member that mate together. The blood isolation device may also include a gasket or other sealing member (not shown) such that when the top member and the bottom member are mechanically attached, the interface therebetween is sealed by the gasket or sealing member. The base member may include grooves, channels, locks, conduits or other passageways preformed therein, such as by an injection molding process or by etching, cutting, drilling, etc., to form the sampling channels, isolation chambers and diverter junctions.

In some embodiments, the sampling channel and the isolation chamber are formed by grooves, channels, locks, or other passageways formed in the housing. The housing may be made of rubber, plastic, metal, or any other suitable material. The housing may be formed of a transparent or translucent material or an opaque or non-translucent material. In other embodiments, the housing may be largely opaque or non-translucent, while the surface of the housing immediately adjacent the sampling channel and/or the isolation chamber may be transparent or translucent, thereby providing a visual cue or indicia to the practitioner that the isolation chamber is first filled to the necessary or desired extent, and/or that isolated blood is still isolated when a clean blood sample is drawn through the sampling channel. Other isolated visual cues or markers may include, but are not limited to: the breathable blood barrier changes to a different color when in contact with blood, saturated or partially saturated; a color-coded label or indicator at any point along or adjacent to the isolation chamber; an audible signal; a vibration signal; or other signals.

The isolation chamber is preferably maintained at atmospheric pressure and includes a vent 3709 at or near the distal end of the isolation chamber. Vent 3709 can include a breathable blood barrier as described above. Vent 3709 is preferably located on the top surface of the housing of blood isolation device 3702. Vent 3709 and/or a breathable blood barrier can be defined by a wall or other separation mechanism. As shown in fig. 37B and 37C, vent 3709 can include a closure mechanism 3710. In some embodiments, the closure mechanism 3710 is a raised portion that protrudes from an outer surface of the housing. Raised portion 3710 may include a wall surrounding vent 3709 and/or the breathable blood barrier therein. The wall may have one or more vents therein. The raised portion may also include a top surface that is oriented, curved, and/or adapted to receive a portion of a person's finger or other appendage to seal the opening formed or included in vent 3709.

As shown in fig. 37C-37E, closure mechanism 3710 of vent 3709 may be configured to accept a portion of a person's finger or other appendage, preferably to close and/or seal vent 3709 once the isolation chamber is filled with a first desired aliquot of potentially contaminated blood. In some configurations, the closure mechanism 3710. In some embodiments, the closure mechanism simply defines a surface that interfaces with another object, such as a person's fingertip, a cotton swab, a piece of tape, or any other object, to seal any vent, aperture, opening, hole, etc., including vent hole 3709.

Thus, for the exemplary embodiment of the blood isolation device 3702 in use, the sampling channel and isolation chamber are first air-filled at atmospheric pressure, but the sampling channel is directed to the outlet port that will initially be air-filled

Or other such sealed blood sampling device, the isolation chamber terminates in a vent to atmosphere that includes a breathable blood barrier. After venipuncture of a patient's patient needle (not shown), which may collect multiple pathogens from the patient's skin, a first amount of patient blood with these pathogens will pass through the inlet port of the blood isolation device. This initial amount of potentially contaminated blood will preferentially flow into the isolation chamber by finding the path of least resistance. The patient's own blood pressure overcomes the atmospheric pressure in the isolation chamber after venting, displacing air therein through the air permeable blood barrier, but not enough to overcome the pressure build up in the sealed sampling channel. In various exemplary embodiments, the isolation chamber and the sampling channel may be configured such that the force generated by the patient's blood pressure is sufficient to overcome any effects of gravity, regardless of the orientation of the isolation device.

Eventually, the isolation chamber fills with blood that displaces air through a gas permeable blood barrier, which may or may not be a complete barrier or a sealed blood. Once blood contacts the breathable blood barrier, the blood interacts with the breathable blood barrier material to at least partially seal the vent. To enhance this seal or seal itself, the user may place another object, such as a human fingertip, a cotton swab, a piece of tape, or any other object, to seal any vent, the opening, hole, etc., including vent 3709. Once so placed, vent 3709 will not allow air to re-enter the blood isolation chamber, the initial aliquot of blood will be isolated, and the user can now collect more blood using blood collection device 3706, which bypasses the isolation chamber of blood isolation device 3702.

Other manually actuated closure mechanisms may also be used. For example, fig. 38A-38D illustrate a blood optimization system 3800 and a blood isolation device 3802 formed substantially as described above, but with a manually-actuated closure mechanism in the form of a cap 3180 to close and/or seal the breathable blood barrier and/or the vent. The blood isolation device 3802 includes an inlet port connectable with the patient needle device 3804 for inserting a needle into the vascular system of a patient to access and draw a blood sample. Patient needle device 3804 may have a protective shield, a retractable needle, and opposing "wings" for manipulating the retractable needle and providing anchoring to the skin of the patient at a location proximate to the venipuncture site.

The inlet port may also be connected to tubing 3808 or other conduit connected to the patient needle device 3804. The inlet port defines an opening in the blood isolation device 3802 that may have the same cross-sectional dimensions as the tubing or other conduit to which the patient needle is connected or the patient needle itself. The inlet port may also include a sealed or fluid-tight connector or connection, such as a thread or luer fitting, or the like.

The blood isolation device 3802 also includes an outlet port that defines an opening out of the blood isolation device 3802 and into the blood sample collection device 3806. Blood sample collection device 3806 generally includes a sampling needle sealed by a thin pierceable membrane or the like and may be used during samplingOn which is placed a

To provide vacuum-forced blood sample collection. The outlet port may be connected to a pipe or other conduit, and may also include a sealed or fluid-tight connector or connection, such as a thread or luer, etc. Thus, as described above, the blood isolation device 3802 may be manufactured and sold with the patient needle device 3804 and/or tubing and/or the blood sample collection device 3806 as a single unit, thereby eliminating the need to connect a patient needle and blood sample collection device with the blood isolation device 3802 at the time of blood draw or sampling.

As described with reference to various embodiments herein, the blood isolation device 3802 further includes a sampling channel between the inlet port and the outlet port, and an isolation chamber connected to, or separate from, or diverted from the sampling channel at any point between the inlet port and the outlet port. Once the first aliquot of blood has been isolated in the isolation chamber, the sampling channel serves as a blood sampling path. The sampling channel may be any size, shape or configuration of channel or conduit. In some embodiments, the sampling channel has a cross-sectional area substantially similar to the opening of the inlet port. In other embodiments, the sampling channel may gradually widen from the inlet port to the outlet port. The isolation chamber may have a larger cross-section to form a large reservoir towards the isolation channel path so that blood will enter the reservoir first rather than a smaller diameter portion on the sampling channel. The isolation chamber may be linear, curvilinear or any other shape.

In some exemplary embodiments, the transfer between the sampling channel and the isolation chamber is through a shunt junction. The shunt junction may be generally Y-shaped, T-shaped, U-shaped, or the like. In some embodiments, and as shown in fig. 17A-17B, the diverter junction is configured such that the flow from the inlet flows first, preferably toward or toward the isolation chamber. For example, the shunt junction of any of the blood isolation device embodiments described or illustrated herein may be configured or formed such that the first portion of blood follows the path of least resistance toward the isolation chamber. The blood isolation device 3802 may use other types of shunts, junctions, or flow biasing mechanisms. The isolation chamber may also include or form a curve or bevel to create a path of least resistance and direct the initial blood flow toward and into the isolation chamber regardless of any positioning or orientation of the blood isolation device.

The blood isolation device 3802 may include a housing that may be formed of multiple components or a single unitary component. In some embodiments, the housing includes a top member and a bottom member that mate together. The blood isolation device may also include a gasket or other sealing member (not shown) such that when the top member and the bottom member are mechanically attached, the interface therebetween is sealed by the gasket or sealing member. The base member may include grooves, channels, locks, conduits or other passageways preformed therein, such as by an injection molding process or by etching, cutting, drilling, etc., to form the sampling channels, isolation chambers and diverter junctions.

The isolation chamber is preferably maintained at atmospheric pressure and includes a vent 3809 at or near the distal end of the isolation chamber. Vent 3809 may include a breathable blood barrier as described above. Vent 3809 is preferably located on the top surface of the housing of blood isolation device 3802. Vent 3809 and/or the breathable blood barrier may be defined by a wall or other separation mechanism. Vent 3809 may include a cap 3810 as a closure mechanism.

In the devices and systems disclosed herein, a first portion of the bodily fluid is received in the isolation chamber, while a subsequent amount of the bodily fluid substantially bypasses the isolation chamber and is conveyed from the input end to the output end through the sampling channel. However, given that there is no physical barrier, geometry, switch or gate between the isolation chamber and the sampling channel, it is not possible to redirect the flow or isolate the body fluid in the isolation chamber, and therefore some mixing occurs between the first portion of body fluid and the subsequent portion of body fluid. Thus, the bodily fluid isolation device may include passive structures (i.e., non-movable, non-mechanically operable, or non-electrically operable structures) and/or configurations associated with the interface and/or isolation chamber and/or sampling channel and/or input path that inhibit or minimize such mixing of the first portion of bodily fluid from the isolation chamber or into the sampling channel.

39A-39F and 40A-40D illustrate various embodiments of a bodily fluid isolation device 3900 for isolating a first portion of a bodily fluid, such as blood, from a patient. Each bodily fluid isolation device 3900 includes an inlet path 3908, the inlet path 3908 being connectable to a bodily fluid sample source (not shown) from a patient, such as a patient needle for venipuncture from a patient, a catheter inserted into a patient, and the like. Each body fluid isolation device 3900 further includes an outlet path 3910, the outlet path 3910 may be connected to a body fluid collection device (not shown), such as a vacuum bottle-type collection device, a syringe, or the like. Each bodily fluid isolation device 3900 further includes an isolation chamber 3912 and a sampling channel 3914. Isolation chamber 3912 is coupled to inlet path 3908 via junction 3911, as shown in fig. 39A-39F, and is configured to receive a first portion of bodily fluid from a bodily fluid sample source through inlet path 3908. For example, during venipuncture, at least a portion of the first portion of bodily fluid, such as the initial splash, may include skin microorganisms, particularly microorganisms of the subcutaneous layer of skin, and these microorganisms may be isolated in isolation chamber 3912 and discarded after use of bodily fluid isolation device 3900.

Isolation chamber 3912 may include a vent 3920 having a gas permeable bodily fluid barrier, vent 3920 allowing air to be displaced by the first portion of bodily fluid. In some cases, vent 3920 includes a material or mechanism configured to allow air to move out of isolation chamber 3912 through the first portion of bodily fluid, but to close or close upon contact with some of the first portion of bodily fluid. Sampling channel 3914 is connected between the inlet path and the outlet path and is configured to transport a subsequent amount of bodily fluid between inlet path 3908 and outlet path 3910 after a first amount of bodily fluid is accepted by isolation chamber 3912.

Isolation chamber 3912 may be formed as a curved fluid path, such as a U-shaped, S-shaped, or other shaped curved path, to physically space and functionally isolate a first portion of the first portion of bodily fluid from inlet path 3908, regardless of whether a last portion of the first portion of bodily fluid proximate to inlet path 3908 is mixed with each subsequent amount of bodily fluid. Isolation chamber 3912 may be formed to have a predetermined volume to correspond to a desired volume or amount of the first portion of bodily fluid.

In most cases, sampling channel 3914 and outlet 3906 can be coupled to a bodily fluid collection device that includes a sealing needle or other seal to external ambient pressure. When isolation chamber 3912 includes vent 3920, isolation chamber 3912 is in contact with an external ambient pressure that is less than the pressure of the patient's internal bodily fluids. Thus, based on the pressure differential between the patient's bodily fluid pressure and each of the sampling channel 3914 (which has a sealed distal end, i.e., terminates in a sealed needle or other sealed member) and the isolation chamber 3912 (which is open to atmospheric pressure through the vent 3920), a first portion of blood is naturally directed into the isolation chamber 3912 to displace air therein and through the vent 3920 when venipuncture is performed using a needle connected to the inlet port. If isolation chamber 3912 does not include a vent, andthe body fluid collecting device is a closed system after venipuncture, the pressure and passage of the body fluid of the patient, such as

Such vacuum sealed collection vials will drive the flow of the first portion and subsequent volume of bodily fluid from the patient to the collection device by the pressure differential between the vacuum applied from the collection device or, for example, from a syringe.

The shape and/or configuration of inlet pathway 3908 and/or outlet pathway 3910 and/or isolation chamber 3912 and/or sampling channel 3914 and/or the junction may be designed to limit or inhibit hemolysis if the bodily fluid is blood.

In some embodiments, blood isolation device 3900 includes a housing 3902 to house or define an inlet pathway 3908, an outlet pathway 3910, an isolation chamber 3912, and/or a sampling channel 3914. Housing 3902 may be formed from any number of components, such as a top portion that mates with a bottom portion, such as described herein. Housing 3902 may include an inlet port 3904 configured to connect inlet path 3908 with a blood sample source, and an outlet port 3906 configured to connect outlet path 3910 with a blood collection device. Each of the inlet port 3904 and the outlet port 3906 may be configured to mate with or be secured to an external device, such as a tube, syringe, needle, or any other mating mechanism. For example, inlet port 3904 and/or outlet port 3906 may extend into housing 3902 or outwardly from housing 3902 in the form of a luer fitting or as a threaded connector having external or internal threads or other type of connector. The access port 3904 may be connected, for example, to a patient needle or needle system, as well as any interventional tubes connected thereto. The outlet port 3906 may be connected to a blood sample collection device, such as a syringe,

A device or any other blood sample collection device.

The access path 3908 can provide an interface, e.g., defined by a cross-sectional dimension, that corresponds to a cross-sectional dimension of the access port 3904, or to a cross-sectional dimension of a conduit or other device connected to the access port 3904. The outlet pathway 3910 may provide an interface, for example defined by a cross-sectional dimension, that corresponds to a cross-sectional dimension of the outlet port 3906 or a tube, syringe, fluid sampling system, blood collection device, or other device connected to the outlet port 3906. As described above, the interface provided by the inlet pathway 3908 and/or the outlet pathway 3910 may also include other physical features, such as threads, friction fits, locks, connectors, flanges, ridges, snaps, or other features.

Consistent with the embodiments described herein, each junction 3911A-3911F has no additional moving parts to actively control the flow of the first portion of blood into or out of isolation chamber 3912 or actively divert flow, and thus junctions 3911A-3911F may define a mixing region where a subsequent amount of blood may mix with at least a small portion of the first portion of blood in isolation chamber 3912. Thus, junctions 3911A-3911F illustrate, but are not limited to, various sizes, shapes, and/or configurations to allow a first portion of blood to enter and substantially fill isolation chamber 3912 and to inhibit any first portion of blood received by isolation chamber 3912 from returning to inlet path 3908 and/or sampling channel 3914.

As shown in fig. 39A-39F, each junction 3911 may have various shapes and configurations, such as angles, curves, cross-sections, etc., to push, direct, deflect, or assist the first portion of blood toward isolation chamber 3912 and into isolation chamber 3912. As the first portion of blood is received or otherwise directed into isolation chamber 3912 and into isolation chamber 3912, junction 3911 may define a mixing region where subsequent amounts of blood or fluid may mix with at least a portion (i.e., the last portion) of the first portion of blood received by isolation chamber 3912. Thus, junction 3911 may be configured to inhibit or control blood mixing between isolation chamber 3912 and inlet path 3908. Configurations and features may be employed to alter the flow rate and/or direction of the first portion of blood through junction 3911.

As shown in fig. 39A, a flow path for the first portion of blood may be formed by the bias of junction 3911 from inlet path 3908 in a direction toward isolation chamber 3912 such that the first portion of blood is directed away from sampling channel 3914 and initially avoids sampling channel 3914. As shown in fig. 39A, inlet path 3908 can curve toward isolation chamber 3912. Alternatively, as shown in fig. 39B, the inlet path 3908 may connect substantially equally in the direction between the isolation chamber 3912 and the sampling channel 3914, with access to ambient (atmospheric) pressure via vent 3920 allowing a first portion of blood (typically under the patient's blood pressure) to enter and fill the isolation chamber 3912 to displace air therein.

In still other embodiments, as shown in fig. 39C, the connection from inlet path 3908 may be biased toward sampling channel 3914 to reduce or minimize the mixing area provided by junction 3911 while still allowing the first portion of blood to enter and at least partially fill isolation chamber 3912. In some cases, as shown in fig. 39D, the interface between the inlet pathway 3908 and the junction 3911 and/or isolation chamber 3912 and/or sampling channel 3914 may be larger in volume or other dimensions than the cross-section of the inlet pathway 3908. This larger cross-sectional area may slow the flow of blood into isolation chamber 3912. The cross-sectional area may be configured to the desired metered blood flow velocity, particularly if the cross-sectional area is associated with the inlet 3904 and/or the inlet path 3908 and/or even the sampling channel 3914.

However, as shown in fig. 39E, the cross-section of the inlet path 3908 may coincide with the sampling channel 3914, but be smaller than the junction 3911 to the isolation chamber 3912, so that the different larger area of the junction 3911 relative to the sampling channel 3914 may help bias the first portion of blood to enter and fill the isolation chamber 3912 and will affect the mixing characteristics. Still further, as shown in fig. 39F, the junction 3911 may include a constricted region 3913, i.e., a region having a smaller cross-sectional area, as a separation between the isolation chamber 3912 and the sampling channel 3914. Thus, unless and until a force such as a vacuum is applied to sampling channel 3914 via outlet path 3910, a first portion of blood will flow through the constriction region into isolation chamber 3912, as described herein.

Fig. 40A-40D illustrate, but are not limited to, various features, structures, compositions, and/or configurations that enable a first portion of blood to enter and substantially fill isolation chamber 3912, but that also inhibit at least a portion of the first portion of blood received by isolation chamber 3912 from returning to inlet path 3908 and/or sampling channel 3914. Junction 3911 may include one or more baffles, restrictors, regulators, dividers, guides, screens, orifices, nozzles, or other passive structural components to control, prevent, direct, or otherwise manage blood flow through blood isolation device 3900. For example, as shown in fig. 40A, the joint 3911 may include one or more tapered baffles 4002, i.e., baffles having a tapered shape, preferably with the tapered end pointing toward the isolation chamber 3912. Thus, the first portion of blood may be directed, even accelerated, via the tapered baffles from inlet path 3908 to isolation chamber 3912. Two or more staggered baffles 4004 may act in junction 3911 as a mechanism to disrupt, control, or alter the laminar flow of the first portion of blood from inlet path 3908 to isolation chamber 3912, particularly to alter the mixing of the first portion of bodily fluid in the isolation chamber with the bodily fluid that subsequently flows through sampling channel 3914. One or more baffles, limiters, regulators, dividers, guides, screens, orifices, nozzles, or other passive structural components may be integral with or extend from housing 3902 or components thereof, or may be included in an insertable component or a separate component.

As shown in fig. 40C, the joint 3911 can include one or more spacers 4006 formed in the joint 3911, the spacers 4006 being formed to at least partially separate the cross-sectional area of the joint. In some embodiments, each divider 4006 can extend all the way through the cross-section of the junction 3911, e.g., from a central region of the cross-section, or only partially. In other embodiments, one or more spacers 4006 can be formed by ridges extending from the inner surface of the junction 3911, and can be straight, curved, or spiraled, such as rifling. As shown in fig. 40D, the junction 3911 can also include one or more guides 4008, such as walls, barriers, barricades, occlusions, obstacles, or other structural fluid guides. Each guide 4008 may be formed and secured to optimize the flow of fluid into isolation chamber 3912 or to alter the mixing of a first portion of the bodily fluid in the isolation chamber with the bodily fluid that subsequently flows through sampling channel 3914.

The tapered baffles 4002, staggered baffles 4004, dividers 4006 and/or guides 4008 can be used in a blood isolation device, alone or in an arrangement or combination of one or more of the foregoing structures. Each of tapered baffles 4002, staggered baffles 4004, dividers 4006, and/or guides 4008 may be formed by a mold of housing 3902, e.g., made of the same material as housing 3902. The tapered baffles 4002, staggered baffles 4004, dividers 4006 and/or guides 4008 can be formed from straight or angled members, curved and/or rounded projections, and the like.

Consistent with some embodiments described herein, and again as shown in fig. 41A, blood isolation device 4100 may include a vent 4102 from an isolation chamber (not shown). Vent 4102 may be implemented as an aperture that may be elevated or extended from the housing and may include a gas permeable, blood impermeable material or other structure that may be configured to close or seal upon contact with blood or other liquid. Vent 4102 may have a particular cross-sectional ventilation area, i.e., the area through which air from the isolation chamber may flow, and may increase, i.e., have a larger diameter or cross-sectional dimension, as shown by vent 4104 of blood isolation device 4100.

Furthermore, as shown in fig. 41A, a single small vent 4102 is well suited for most uses, and may fail if the isolation chamber is covered or blocked before the entire first portion of blood is received. Thus, a vent may be formed by two or more vents 4106, the total cross-section of which may be tailored to a particular or predetermined air flow. The number of vents 4106 can be selected based on the probability or likelihood that one or more vents 4106 will fail to function for some reason (e.g., due to being blocked, covered, etc. by, for example, a practitioner's finger, a patient's arm, clothing, or the like).

The vent of the blood isolation device may also employ a one-way valve or other mechanism that is passively actuated within vent 4200, for example, by replacement of air in the isolation chamber by the first portion of blood. The valve may be an umbrella valve, as described herein. However, umbrella valves are subject to a cracking pressure that can activate, i.e., move, release or deflect, at least a portion of the periphery of the valve to allow air to vent from the isolation chamber. According to some embodiments, as shown in fig. 42A, the preload of umbrella valve 4202 in the exhaust structure may be reduced to reduce the cracking pressure. The preload is defined by the downward bias of the umbrella valve 4202, and in particular, the peripheral end of the umbrella valve. The preload may be reduced by, for example, reducing the amount of downward bias, particularly at the peripheral end of the umbrella valve. In other embodiments, as shown in fig. 42B, the outer circumference of umbrella valve 4204 can be formed thin to reduce cracking pressure, and the thinness can be adjusted for a particular cracking pressure to activate umbrella valve 4204. In yet another embodiment, the material used for the umbrella valve 4204 may be selected to achieve a particular cracking pressure.

In still other embodiments, as shown in fig. 42C, the valve used in the vent 4200 may be a flapper valve 4206, the flapper valve 4206 being cut out of a sheet material and having a particular desired cracking pressure or range of cracking pressures. In some embodiments, the flapper valve 4206 may be a cut out from the material forming the housing of the blood isolation device. The thickness of the material at the valve 4206 and the type and extent of the cut around the valve 4206 may be configured for a particular cracking pressure or range.

Although embodiments of the blood optimization system and blood isolation device have been described in detail herein, in most cases, the blood isolation device in use will likely rest on the arm of the patient. Thus, in some embodiments, as shown in the cross-sectional representations of fig. 43A and 43B, the housing of the blood isolation device 4300 may include a bottom portion 4302 mated with a top portion 4304, wherein the bottom portion 4302 includes a concave or curved bottom surface 4305. In this configuration, the blood isolation device 4300 may be placed on the arm of a patient in a particular orientation or position in order for the blood isolation device 4300 to function optimally, while allowing a practitioner or clinician a clear line of sight to the operability of the blood isolation device 4300. The curved bottom surface 4305 is preferably opposite the vent 4307 provided on the top 4304 of the blood isolation device 4300. The bottom surface 4305 of the bottom 4302 may also include an adhesive or other friction forming mechanism to further stabilize the blood isolation device 4300 on the patient's arm or other limb.

Although some embodiments have been described in detail above, other modifications are possible. Other embodiments may be within the scope of the following claims.

Claims

1. A blood isolation device comprising:

an entry path;

an exit path;

a separation chamber connected to the inlet pathway by a junction and configured to receive a first portion of blood through the inlet pathway, the separation chamber having a vent that allows air to be displaced by the first portion of blood, the junction configured to inhibit any of the first portion of blood received by the separation chamber from returning to the inlet pathway; and

a sampling channel is connected between the inlet path and the outlet path, the sampling channel configured to convey a subsequent quantity of blood between the inlet path and the outlet path after the first quantity of blood is received by the isolation chamber.

2. The blood isolation device of claim 1 wherein the junction is angled from the inlet pathway toward the isolation chamber.

3. The blood isolation device of claim 1, wherein the junction has a cross-sectional area that is less than a cross-sectional area of the inlet pathway.

4. The blood isolation device of claim 1, wherein the junction has a cross-sectional area greater than a cross-sectional area of the inlet pathway.

5. The blood isolation device of claim 1, wherein the junction comprises one or more passive structures configured to inhibit any of the first portion of blood received by the isolation chamber from returning to the inlet path.

6. The blood isolation device of claim 5 wherein the one or more passive structures comprise a tapered baffle having a tapered end directed toward the isolation chamber.

7. The blood isolation device of claim 5, wherein the one or more passive structures comprise two or more staggered baffles extending from an inner surface of the junction.

8. The blood isolation device of claim 5, wherein the one or more passive structures comprise a dividing wall extending across a cross-section of the junction.

9. The blood isolation device of claim 5, wherein the one or more passive structures comprise a flow director extending from an inner surface of the junction, the flow director configured to control the flow of blood.

10. The blood isolation device of claim 1 wherein the vent comprises two or more vent holes.

11. A blood isolation device comprising:

a housing having an inlet port and an outlet port, the housing comprising:

an ingress path connected to the ingress port;

an outlet path connected to the outlet port;

a separation chamber connected to the inlet pathway by a junction and configured to receive a first amount of blood through the inlet pathway, the separation chamber having a vent that allows air to be replaced by a first portion of blood, the vent further configured to close when the separation chamber is filled with the first portion of blood, the junction configured to inhibit the first portion of blood from returning from the separation chamber; and

a sampling channel is connected between the inlet path and the outlet path, the sampling channel configured to convey a subsequent amount of blood between the inlet path and the outlet path after a first portion of blood is received by the isolation chamber.

12. The blood isolation device of claim 11 wherein the vent further comprises a closing mechanism that prevents air from re-entering the isolation chamber after the air is replaced.

13. The blood isolation device of claim 11, wherein the junction comprises one or more passive structures configured to inhibit any first portion of blood received by the isolation chamber from returning to the inlet path.

14. The blood isolation device of claim 13 wherein the one or more passive structures comprise a tapered baffle having a tapered end directed toward the isolation chamber.

15. The blood isolation device of claim 13, wherein the one or more passive structures comprise two or more staggered baffles extending from an inner surface of the junction.

16. The blood isolation device of claim 13, wherein the one or more passive structures comprise a dividing wall extending across a cross-section of the junction.

17. The blood isolation device of claim 13, wherein the one or more passive structures comprise a flow director extending from an inner surface of the junction, the flow director configured to control the flow of blood.

18. A blood sample optimization system, comprising:

a blood sampling system comprising:

a venipuncture apparatus configured to venipuncture a patient to obtain a blood sample of the patient;

a blood sampling path connected to the venipuncture apparatus for transporting the blood sample; and

a reservoir configured to receive an evacuated blood collection tube to collect and contain a subsequent portion of the blood sample; and

a blood isolation device connected along a blood sampling path between a patient needle and a sample needle, the blood isolation device comprising:

an access path connected to a patient needle;

an outlet path connected to the sample needle;

a separation chamber connected to the inlet pathway by a junction and configured to receive a first portion of blood through the inlet pathway, the separation chamber having a vent that allows air to be displaced by the first portion of blood, the junction configured to inhibit any first portion of blood received by the separation chamber from returning to the inlet pathway; and

a sampling channel is connected between the inlet path and the outlet path, the sampling channel configured to convey a subsequent quantity of blood between the inlet path and the outlet path after a first quantity of blood is received by the isolation chamber.

19. The blood sample optimization system of claim 18, wherein the interface of the blood isolation device includes one or more passive structures configured to inhibit any first portion of blood received by the isolation chamber from returning to the inlet path.

20. The blood sample optimization system of claim 19, wherein the one or more passive structures include a wall extending from an inner surface of the junction to control the flow of the first portion of blood.