US20230116910A1 - Blood sample optimization system and blood contaminant sequestration device and method - Google Patents

Abstract

Blood sample optimization systems and methods are described that reduce or eliminate contaminates in collected blood samples, which in turn reduces or eliminates false positive readings in blood cultures or other testing of collected blood samples. A blood sample optimization system can include a blood sequestration device located between a patient needle and a sample needle. The blood sequestration device can include a sequestration chamber for sequestering an initial, potentially contaminated aliquot of blood, and may further include a sampling channel that bypasses the sequestration chamber to convey likely uncontaminated blood between the patient needle and the sample needle after the initial aliquot of blood is sequestered in the sequestration chamber.

Description

BACKGROUND
• Bacteraemia is the presence of microorganisms in the blood. Sepsis, on the other hand, is bacteraemia in the presence of clinical symptoms and signs such as fever, tachycardia, tachypnea and hypotension. Bacteraemia and sepsis are associated with a high mortality and an increased incidence and duration of hospital stay and associated costs. Many bacteraemias, sepsis, fungaemias and other pathogens actually occur within a hospital or other healthcare settings with catheters and venipunctures being a source of contamination as potential carriers of these pathogens.
• Blood cultures are the standard test used to detect microbial pathogens related to bacteraemia and sepsis in a patient's blood. The term blood culture refers to a single venipuncture, either from a peripheral site or central or arterial line, with the blood inoculated into one or more blood culture bottles or containers. One bottle is considered a blood culture where two or more are considered a set. Multiple sets may be obtained from multiple venipunctures and are associated with different sites on the patient.
• These methods allow for microbial identification and susceptibility testing to be performed, which is a critical component to managing sepsis, however the lack of rapid results and decreased sensitivity for fastidious pathogens has led to the development of improved systems and adjunctive molecular or proteomic testing.
• Collection of blood samples for conducting blood cultures is a critical component of modern patient care and can either positively affect the patient outcome by providing an accurate diagnosis, or can adversely affect the outcome by prolonging unnecessary antimicrobial therapy, the length of hospital stays, and increasing costs.
• One outcome of collection of blood cultures is contamination. Blood culture contamination can lead to a false positive culture result and/or significant increase in healthcare related costs. Sources of blood culture contamination include improper skin antisepsis, improper collection tube disinfection, and contamination of the initial blood draw which may then skew results.
• Blood culture collection kits generally consist of a “butterfly” set, infusion set, or other type of venipuncture device as offered by companies like BD, Smiths, B. Braun and others, and aerobic and anaerobic blood culture bottles. Various different bottles are also available depending on the test requirements. These bottles are specifically designed to optimize recovery of both aerobic and anaerobic organisms. In conventional kits, a bottle used is known generally as a “Vacutainer,” which is a blood collection tube formed of a sterile glass or plastic tube with a closure that is evacuated to create a vacuum inside the tube to facilitate the draw of a predetermined volume of liquid such as blood.
• False positive blood cultures are typically a result of poor sampling techniques. They cause the use of antibiotics when not needed, increasing hospital costs and patient anxiety. Blood cultures are drawn from a needlestick into the skin, and then a Vacutainer is attached to capture a sample of blood. Contamination may occur from improper or incomplete disinfection of the skin area in and around the puncture site. It may also occur from the coring of the skin by the needle during insertion, with the cored skin cells and any associated contamination being pulled into the sample.
• Blood flow through a hypodermic needle is laminar, and as such, a velocity gradient can be developed over the flow tube as a pressure drop is applied to the hypodermic needle. Either forceful aspiration of blood, or using a very small hypodermic needle, can cause lysis and a release of potassium from the red blood cells, thereby rendering the blood samples abnormal.
• In other instances, some patients have delicate veins that can collapse under a pressure drop or vacuum, particularly as applied by a syringe's plunger that is drawn too quickly for the patient's condition. Since such condition is impossible to know beforehand, such vein collapses are a risk and very difficult to control.
• Various strategies have been implemented to decrease blood culture contamination rates, e.g. training staff with regard to aseptic collection technique, feedback with regard to contamination rates and implementation of blood culture collection kits. Although skin antisepsis can reduce the burden of contamination, 20% or more of skin organisms are located deep within the dermis and are unaffected by antisepsis. Changing needles before bottle inoculation is not advisable as it increases the risk to acquire needle stick injuries without decreasing contamination rates.
• Some conventional systems and techniques for reducing blood culture contamination include discarding the initial aliquot of blood taken from central venous catheters, venipunctures, and other vascular access systems. However, these systems require the user to mechanically manipulate an intravascular device, or require a complex series of steps that are difficult to ensure being followed.
SUMMARY
• This document presents systems and methods for reducing blood culture contamination, lysing of cells, and vein collapse. In some implementations, a system and method can eliminate user variability in disinfection, and also eliminate the risk of skin cells getting into the blood culture sample. The systems and methods disclosed herein do not require a change in existing clinical processes, other than to potentially indicate when a vacutainer or other blood collection device (i.e., syringe) should be attached for drawing contaminant-free blood samples.
• In some implementations of the systems and methods disclosed herein the withdrawal of blood is accomplished passively by use of the patient's own blood pressure, thereby reducing the risk of vein collapse and eliminating any additional user steps over current practice. The systems and methods can be applied to accommodate short-path direct stick or butterfly venipuncture systems. They can also be used with samples drawn through a catheter.
• In one aspect, a blood sequestration device is presented. The blood sequestration device includes an inlet port and an outlet port. The blood sequestration device further includes a sequestration chamber connected with the inlet port, the sequestration chamber having a vent comprising an air permeable blood barrier. The blood sequestration device further includes a sampling channel having a proximal end connected with the inlet port and a distal end connected with the outlet port.
• In another aspect, a blood sequestration device connected with a blood sampling pathway is described. The blood sampling pathway has a patient needle and a sample collection device. The blood sequestration device includes an inlet port connected with the patient needle, and a sequestration chamber connected with the inlet port, the sequestration chamber having a vent comprising an air permeable blood barrier. The blood sequestration device further includes a sampling channel having a proximal end connected with the inlet port, and an outlet port connected with a distal end of the sampling channel and with the sample collection device.
• In yet another aspect, a blood sequestration device connected with a blood sampling system is described. The blood sampling system includes a patient needle for accessing a blood sample from a patient, and a sample needle that is sealed and adapted for receiving an evacuated blood collection tube. The blood sequestration device includes an inlet port connected with the patient needle to receive the blood sample from the patient. The blood sequestration device further includes a sequestration chamber connected with the inlet port and having a vent comprising an air permeable blood barrier, the sequestration chamber for receiving and sequestering a first portion of the blood sample prior to the sample needle being unsealed by the evacuated blood collection tube. The blood sequestration device further includes a sampling channel having a proximal end connected with the inlet port, the sampling channel for conveying a subsequent portion of the blood sample once the sample needle is unsealed by the evacuated blood collection tube. The blood sequestration device further includes an outlet port connected with a distal end of the sampling channel for conveying the subsequent portion of the blood sample to the sample needle.
• In yet another aspect, a blood sample optimization system is disclosed and described. The blood sample optimization system includes a blood sampling system for accessing and acquiring one or more samples of a patient's blood, and a blood sequestration device for receiving and sequestering a first portion of the one or more samples of the patient's blood which might be contaminated by a venipuncture process and which could result in a false positive identification of a pathogen in the patient's blood.
• The blood sampling system includes a patient needle configured for a venipuncture of a patient to access a sample of blood of a patient, a blood sampling pathway connected with the patient needle for conveying the sample of blood, and a sample needle configured for receiving an evacuated blood collection container to collect and contain a subsequent portion of the sample of blood.
• In yet another aspect, a blood sequestration device is disclosed and described. In some implementations, the blood sequestration device can include an inlet port, an outlet port connected with the inlet port, and a sequestration chamber connected with the inlet port. The sequestration chamber can have a vent comprising an air permeable blood barrier.
• The blood sequestration device, in one aspect can include an inlet port, an outlet port, a sequestration chamber connected with the inlet port via a junction, the sequestration chamber having a vent that includes an air permeable blood barrier, the vent being defined by an outer wall that at least partially circumscribes the air permeable blood barrier and includes one or more air vents, the vent further includes a cap that at least partially covers the wall and a one-way seal abutting the air permeable blood barrier that inhibits air from entering the sequestration chamber, and a sampling channel having a proximal end connected with the inlet port via the junction, and a distal end connected with the outlet port. In certain related aspects, the sequestration chamber, the sampling channel and the junction are sized and configured such that a first portion of blood flows into the sequestration chamber toward the air permeable blood barrier for sequestration therein, and a second portion of blood bypasses the sequestration chamber and the first portion of blood sequestered therein and is directed into the sampling channel toward the outlet port.
• In another aspect, the sampling channel and the junction is sized and configured such that a first portion of blood flows into and fills the sequestration chamber to displace air therein through the vent, and such that a second portion of blood bypasses the sequestration chamber and the first portion of blood sequestered therein and is directed into the sampling channel toward the outlet port.
• The blood sequestration and sampling system sequestration device, in certain aspects can include a blood sampling pathway having a patient needle on a proximal end and a sample collection device on a distal end; and a blood sequestration device attached on the blood sampling pathway between the proximal end and distal end of the blood sampling pathway. The blood sequestration device in one aspect can include an inlet port coupled with the blood sampling pathway toward the patient needle, an outlet port coupled with the blood sampling pathway toward the sample collection device, a sequestration chamber connected with the inlet port via a junction, which chamber has a vent that includes an air permeable blood barrier, the vent being defined by an outer wall that at least partially circumscribes the air permeable blood barrier and includes one or more air vents, the vent further including a cap that at least partially covers the wall and a one-way seal abutting the air permeable blood barrier that inhibits air from entering the sequestration chamber; and a sampling channel having a proximal end connected with the inlet port via the junction, and a distal end connected with the outlet port. In a certain related aspect, the sequestration chamber, the sampling channel and the junction can be sized and configured such that a first portion of blood flows into the sequestration chamber toward the air permeable blood barrier for sequestration therein, and a second portion of blood bypasses the sequestration chamber and the first portion of blood sequestered therein and is directed into the sampling channel toward the outlet port.
• The blood sequestration device is connected along the blood sampling pathway between the patient needle and the sample needle, and includes an inlet port for receiving the sample of blood. The blood sequestration device further includes a sequestration chamber connected with the inlet port for receiving a first amount of the sample of blood, the sequestration chamber having a vent comprising an air permeable blood barrier for sequestering at least a first portion of the first amount of the sample of blood. The blood sequestration device may further include a sampling channel having a proximal end connected with the inlet port, the sampling channel conveying a subsequent amount of the sample of blood to the evacuated blood collection container upon the sequestration chamber sequestering at least the first portion of the first amount of the sample of blood. The blood sequestration device further includes an outlet port connected with a distal end of the sampling channel, the outlet port for outputting the subsequent amount of the sample of blood.
• 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.
BRIEF DESCRIPTION OF THE DRAWINGS
• These and other aspects will now be described in detail with reference to the following drawings.
• FIG.1 illustrates a blood sample optimization system.
• FIG.2 illustrates a blood sample optimization system in accordance with an alternative implementation.
• FIG.3 illustrates a blood sample optimization system in accordance with another alternative implementation.
• FIG.4 illustrates a blood sample optimization system in accordance with another alternative implementation.
• FIG.5 illustrates a blood sample optimization system in accordance with another alternative implementation.
• FIG.6 illustrates a blood sample optimization system in accordance with an alternative implementation.
• FIG.7 is a flowchart of a method for optimizing a quality of a blood culture.
• FIGS.8A-8E illustrate a blood sequestration system for non-contaminated blood sampling, in accordance with some implementations.
• FIG.9 illustrates a pathway splitter for use in a blood sequestrations system.
• FIGS.10A-10D illustrate a blood sequestration system for non-contaminated blood sampling, in accordance with alternative implementations.
• FIGS.11A-11E illustrate a blood sequestration system for non-contaminated blood sampling, in accordance with other alternative implementations.
• FIGS.12A-12D illustrate a blood sample optimization system including a blood sequestration device in accordance with yet other alternative implementations.
• FIGS.13A-13D illustrate a bloodsample optimization system1300 in accordance with yet another alternative implementations.
• FIGS.14A-14E illustrate yet another implementation of a blood sampling system to sequester contaminates of an initial aliquot or sample to reduce false positives in blood cultures or tests performed on a patient's blood sample.
• FIGS.15A-15G illustrate a blood sequestration device and method of using the same, in accordance with yet another implementation.
• FIGS.16A-16D illustrate a blood sequestration device in accordance with yet another implementation.
• FIGS.17A-17E illustrate a bottom member of a housing for a blood sequestration device.
• FIGS.18A-18F illustrate a top member of a housing for a blood sequestration device.
• FIGS.19A and19B illustrate a blood sequestration device having a top member mated with a bottom member.
• FIG.20 shows a blood sample optimization system including a blood sequestration device.
• FIG.21 illustrates a non-vented blood sequestration device using a wicking material chamber.
• FIGS.22A and22B illustrate a material makeup of a filter for sequestering blood in a sequestration chamber of a blood sequestration device.
• FIGS.23A-23E illustrate another implementation of a blood sequestration device that uses a vacuum force from a blood collection device.
• FIGS.24A-24D illustrate another implementation of a blood optimization system and blood sequestration device.
• FIGS.25A-25D illustrate another implementation of a blood optimization system and blood sequestration device.
• FIGS.26A-26E illustrate another implementation of a blood optimization system and blood sequestration device.
• FIGS.27A-27D illustrate another implementation of a blood optimization system and blood sequestration device.
• FIGS.28A-28F illustrate another implementation of a blood optimization system and blood sequestration device.
• FIGS.29A-29C illustrate another implementation of a blood optimization system and blood sequestration device.
• FIGS.30A-30G illustrate another implementation of a blood optimization system and blood sequestration device.
• Like reference symbols in the various drawings indicate like elements.
DETAILED DESCRIPTION
• This document describes blood sample optimization systems and methods for reducing or eliminating contaminates in collected blood samples, which in turn reduces or eliminates false positive readings in blood cultures or other testing of collected blood samples. In some implementations, a blood sample optimization system includes a patient needle for vascular access to a patient's bloodstream, a sample needle for providing a blood sample to a blood collection container, such as an evacuated blood collection container or tube like a Vacutainer™ or the like, or other sampling device, and a blood sequestration device located between the patient needle and the sample needle. The blood sequestration device includes a sequestration chamber for sequestering an initial, potentially contaminated aliquot of blood, and may further include a sampling channel that bypasses the sequestration chamber to convey likely uncontaminated blood between the patient needle and the sample needle after the initial aliquot of blood is sequestered in the sequestration chamber.
• FIG.1 illustrates a blood sample optimization system in accordance with some implementations. The system includes apatient needle1 to puncture the skin of a patient to access the patient's vein and blood therein. The system further includes a sample needle (i.e., a resealably closed needle for use with Vacutainers™ or the like)5, which may be contained within and initially sealed by aresealable boot10, a Luer activated valve, or another collection interface or device. Theresealable boot10 can be pushed aside or around thesample needle5 by application of a Vacutainer™ bottle (not shown) for drawing the patient's blood. The system can further include alow volume chamber30 that leads to thesample needle5, but also includes an orifice or one ormore channels45 that lead to asequestration chamber55 formed by ahousing50.
• Thesequestration chamber55 is a chamber, channel, pathway, lock, or other structure for receiving and holding a first aliquot of the patient's blood, which may be in a predetermined or measured amount, depending on a volume of thesequestration chamber55. The first draw of blood typically contains or is more susceptible to containing organisms that cause bacteraemia and sepsis or other pathogens than subsequent blood draws. Thesequestration chamber55 can be a vessel encased in a solid housing, formed in or defined by the housing itself, or can be implemented as tubing or a lumen. Thesequestration chamber55, regardless how formed and implemented, may have a predetermined volume. In some implementations, the predetermined volume may be based on a 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 or more of the volume of the patient needle. The predetermined volume of thesequestration chamber55 may also be established to economize or minimize an amount of blood to be sequestered and disposed of.
• Thesequestration chamber55 can be formed, contained or housed in achamber housing50, and can be made of plastic, rubber, steel, aluminum or other suitable material. For example, thesequestration chamber55 could be formed of flexible tubing or other elastomeric materials. Thesequestration chamber55 further includes an airpermeable blood barrier20 that allows air to exit thesequestration chamber55. As used herein the term “air permeable blood barrier” means an air permeable but substantially blood impermeable substance, material, or structure. Examples may include hydrophobic membranes and coatings, a hydrophilic membrane or coating combined with a hydrophobic membrane or coating, mesh, a filter, a mechanical valve, antimicrobial material, or any other means of allowing air to be displaced from thesequestration chamber55 as it is filled with blood. In various exemplary embodiments, an air permeable blood barrier may be formed by one or more materials that allow air to pass through until contacted by a liquid, such material then becomes completely or partially sealed to prevent or inhibit the passage of air and/or liquid. In other words, prior to contact with liquid, the material forms a barrier that is air permeable. After contact with a liquid, the material substantially or completely prevents the further passage of air and/or liquid.
• The orifice orchannel45 can be any desired length, cross-sectional shape or size, and/or can be formed to depart from thelow volume chamber30 at any desired angle or orientation. The orifice orchannel45 may also include a one-way flap orvalve60 that maintains an initial aliquot of blood sample within thesequestration chamber55. In some specific implementations, the orifice orchannel45 can include a “duck bill” orflapper valve60, or the like, for one-way flow of blood fromlow volume chamber30 to thesequestration chamber55. The airpermeable blood barrier20 can also be constructed of a material that allows air to exit but then seals upon contact with blood, thereby not allowing external air to entersequestration chamber55. This sealing would eliminate the need for a valve.
• Valve60 can be any type of valve or closing mechanism.Chamber30 is designed to hold virtually no residual blood, and can be designed to be adapted to hold or allow pass-through of a particular volume or rate of blood intosequestration chamber55. Likewise,sequestration chamber55 may also include any type of coating, such as an antimicrobial coating, or a coating that aids identification and/or diagnosis of components of the first, sequestered blood draw.
• Housing50 and40 can 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 airpermeable blood barrier20 can include a color-providing substance, or other signaling mechanism, that is activated upon contact with blood from the initial blood draw, or when air displacement is stopped, or any combination of events with blood in thesequestration chamber55. The air permeable barrier may also include an outer layer such as a hydrophobic membrane or cover that inhibits or prevents the inadvertent or premature sealing of the filter by an external fluid source, splash etc.Sequestration chamber55 can also be translucent or clear to enable a user to visually confirm the chamber is filled.
• FIG.2 illustrates a blood sample optimization system in accordance with some alternative implementations. In the implementation shown inFIG.2, asequestration chamber55, or waste chamber, surrounds thepatient needle1, with an open-ended cuff or housing connected with the waste chamber and encircling the sample needle housing base and housing. Thepatient needle1 andsample needle5 are connected together by aboot56, which forms a continuous blood draw channel therethrough. Theboot56 includes a single orifice or channel leading from the blood draw channel intosequestration chamber55. The device can include more than one single orifice or channel, in other implementations. Each orifice or channel can include a one-way valve, and can be sized and adapted for predetermined amount of blood flow.
• Thesequestration chamber55 includes an air permeable blood barrier. The filter can further include a sensor or indicator to sense and/or indicate, respectively, when a predetermined volume of blood has been collected in thesequestration chamber55. That indication will alert a user to attach an evacuated blood collection tube or bottle, such as a Vacutainer™ to thesample needle5. The housing for thesequestration chamber55 can be any size or shape, and can include any type of material to define an interior space or volume therein. The interior space is initially filled only with air, but can also be coated with an agent or substance, such as a decontaminate, solidifying agent, or the like. Once evacuated blood collection tube is attached to thesample needle5, blood will flow automatically into thepatient needle1, through the blood draw channel andsample needle5, and into the bottle. Thesample needle5 is covered by a resealable boot, coating or membrane that seals the sample needle when a blood collection bottle is not attached thereon or thereto.
• FIG.3 illustrates a blood sample optimization system in accordance with some alternative implementations. In the implementation shown, asample needle5 is surrounded by a resealable boot or membrane, and is further connected with apatient needle1. A blood flow channel is formed through the sample needle and the patient needle. The connection between the sample needle and patient needle includes a “T” or “Y”connector102, which includes a channel, port or aperture leading out from the main blood flow channel to asequestration chamber104.
• The T orY connector102 may include a flap or one-way valve, and have an opening that is sized and adapted for a predetermined rate of flow of blood. Thesequestration chamber104 can be formed from tubing, or be formed by a solid housing, and is initially filled with air. Thesequestration chamber104 will receive blood that flows out of a patient automatically, i.e. under pressure from the patient's own blood pressure. Thesequestration chamber104 includes an airpermeable blood barrier106, preferably at the distal end of tubing that forms thesequestration chamber104, and which is connected at the proximal end to the T orY connector102. The T orY connector102 can branch off at any desired angle for most efficient blood flow, and can be formed so as to minimize an interface between the aperture and channel and the main blood flow channel, so as to minimize or eliminate mixing of the initial aliquot of blood with main blood draw samples.
• In some alternative implementations, the sample needle may be affixed to a tubing of any length, as shown inFIG.4, connecting at its opposite end to the T orY connector102. Thesequestration chamber104 can be any shape or volume so long as it will contain a predetermined amount of blood sample in the initial aliquot. The T orY connector102 may also include an opening or channel that is parallel to the main blood flow channel. The air permeable blood barrier may further include anindicator107 or other mechanism to indicate when a predetermined amount of blood has been collected in the sequestration chamber, or when air being expelled reaches a certain threshold, i.e. to zero. The tubing can also include aclip109 that can be used to pinch off and prevent fluid flow therethrough.
• Once the air permeable blood barrier and primary chamber are sealed the initial aliquot of blood is trapped in thesequestration chamber104, an evacuated blood collection tube, such as a Vacutainer™ bottle may be attached to thesample needle5 to obtain the sample. The blood collection tube can be removed, and thesample needle5 will be resealed. Any number of follow-on blood collection tubes can then be attached for further blood draws or samples. Upon completion of all blood draws, the system can be discarded, with the initial aliquot of blood remaining trapped in thesequestration chamber104.
• FIG.5 illustrates a blood sample optimization system in accordance with some alternative implementations. In the implementation shown, asample needle5 is connected with a patient needle by tubing. A “T” or “Y”connector120 is added along the tubing at any desired location, and includes an aperture, port or channel leading to asequestration chamber204, substantially as described above.
• FIG.6 illustrates a blood sample optimization system in accordance with some alternative implementations, in which asequestration chamber304, formed as a primary collection channel, receives an initial aliquot of blood, and is provided adjacent to the blood sampling channel. Thesequestration chamber304 can encircle the blood sampling channel, thepatient needle1, and/or thesample needle5. The primary collection channel can include a T orY connector120, or other type of aperture or channel. Thesequestration chamber304 includes an air permeable blood barrier, which can also include an indicator of being contacted by a fluid such as blood, as described above.
• In some implementations, either thepatient needle1 or thesample needle5, or both, can be replaced by a Luer lock male or female connector. However, in various implementations, the connector at a sample needle end of the blood sample optimization system is initially sealed to permit the diversion of the initial aliquot of blood to the sequestration chamber, which is pressured at ambient air pressure and includes the air outlet of the air permeable blood barrier. In this way, the system passively and automatically uses a patient's own blood pressure to overcome the ambient air pressure of the sequestration chamber to push out air through the air permeable blood barrier and displace air in the sequestration chamber with blood.
• FIG.7 is a flowchart of an exemplary method for optimizing the quality of a blood culture. At702, a clinician places a needle into a patient's vein. At704, blood then flows into a sequestration chamber, pushing the air in the sequestration chamber out of the sequestration chamber through an air permeable blood barrier. In some implementations, the volume of the sequestration chamber is less than 0.1 to more than 5 cubic centimeters (cc's), or more. The sequestration chamber is sized and adapted to collect a first portion of a blood sample, which is more prone to contamination than secondary and other subsequent portion of the blood sample or subsequent draws. Since the sequestration chamber has an air-permeable 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 sequestration chamber before it is drawn into or otherwise enters into a Vacutainer or other bottle for receiving and storing a blood sample.
• When the sequestration chamber fills, the blood will gather at or otherwise make contact with the air permeable blood barrier, which will inhibit or prevent blood from passing therethrough. At706, when the blood comes into contact with the entire internal surface area of the air permeable blood barrier, the air permeable blood barrier is then closed and air no longer flows out or in. At708, the clinician may be provided an indictor or can see the full chamber, to indicate the evacuated blood collection tube, such as a Vacutainer™ can be attached. The indicator can include visibility into the primary chamber to see whether it is full, the blood barrier changing color, for example, or other indicator. The fill time of the sequestration chamber may be substantially instantaneous, so such indicator, if present, may be only that the sequestration chamber is filled.
• Prior to an evacuated blood collection tube being attached, communication between the needle, sampling channel, and the sequestration chamber is restricted by the sealing of the sequestration chamber blood barrier thereby not permitting air to reenter the system through the sequestration. Sealing the communication path could also be accomplished with a mechanical twist or other movement, a small orifice or tortuous pathway, eliminating the need for a separate valve or mechanical movement or operation by the clinician. At710, once the evacuated blood collection tube is removed, the self-sealing membrane closes the sample needle, and at712, additional subsequent evacuated blood collection tubes may be attached. Once samples have been taken, at714 the device is removed from the patient and discarded.
• FIGS.8A-8E illustrate an exemplary bloodsample optimization system800 for non-contaminated blood sampling, in accordance with some implementations. The bloodsample optimization system800 includes aninlet port802 that can be connected to tubing, a patient needle (or both), or other vascular or venous access device, and apathway splitter804 having a first outlet to asequestration chamber tubing806 and a second outlet to samplecollection tubing808. One or both of thesequestration chamber tubing806 and thesample collection tubing808 can be formed of tubing. In some implementations, thesequestration chamber tubing806 is sized so as to contain a particular volume of initial blood sample. Thesample collection tubing808 will receive a blood sample once thesequestration chamber tubing806 is filled. Thesample collection tubing808 can be connected to a Vacutainer™ base orhousing810, or other blood sample collection device.
• Theblood sequestration system800 further includes ablood sequestration device812 which, as shown in more detail inFIGS.8B-8D, includes ahousing818 that includes asampling channel820 defining a pathway for the non-contaminatedsample collection tubing808 or connected at either end to the non-contaminatedsample collection tubing808. Thesampling channel820 can be curved through thehousing818 so as to better affix and stabilize thehousing818 at a location along the non-contaminatedsample collection tubing808.
• Theblood sequestration device812 further includes asequestration chamber822 connected with thesequestration chamber tubing806 or other chamber. Thesequestration chamber822 terminates at an airpermeable blood barrier824. The airpermeable blood barrier824 can also include a coloring agent that turns a different color upon full contact with blood, as an indicator that the regular collection of blood samples (i.e. the non-contaminated blood samples) can be initiated. Other indicators may be used, such as a small light, a sound generation mechanism, or the like. In some implementations, the air permeable blood barrier is positioned at a right angle from the direction ofsequestration chamber822, but can be positioned at any distance or orientation in order to conserve space and materials used for thehousing818. Thehousing818 and its contents can be formed of any rigid or semi-rigid material or set of materials.
• FIG.9 illustrates apathway splitter900 for use in a blood sequestrations system, such as those shown inFIGS.8A-8E, for example. Thepathway splitter900 includes aninlet port902, a mainline outlet port904, and a sequestrationchannel outlet port906. Theinlet port902 can be connected to main tubing that is in turn connected to a patient needle system, or directly to a patient needle. The mainline outlet port904 can be connected to main line tubing to a blood sampling system, such as a vacutainer base or housing, or directly to such blood sampling system. The sequestrationchannel outlet port906 can be connected to sequestration tubing for receiving and sequestering a first sample of blood, up to a measured amount or predetermined threshold. Alternatively, the sequestrationchannel outlet port906 can be connected to a sequestration chamber. The sequestrationchannel outlet port906 is preferably 20-70 degrees angled from the mainline outlet port904, which in turn is preferably in-line with theinlet port902. Once the predetermined amount of initial blood sample is sequestered in the sequestration tubing or chamber, in accordance with mechanisms and techniques described herein, follow-on blood samples will flow into theinlet port902 and directly out the mainline outlet port904, without impedance.
• FIGS.10A-10D illustrate ablood sequestration device1000 in accordance with alternative implementations. Theblood sequestration device1000 includes aninlet port1002, amain outlet port1004, and asequestration channel port1006. Theinlet port1002 can be connected to a patient needle or related tubing. Themain outlet port1004 can be connected to a blood sample collection device such as a Vacutainer, associated tubing, or a Luer activated valve, or the like. Thesequestration channel port1006 splits off from themain outlet port1004 to asequestration chamber1008. In some implementations, thesequestration chamber1008 is formed as a helical channel within a housing orother container1001.
• Thesequestration chamber1008 is connected at the distal end to an airpermeable blood barrier1010, substantially as described above. Air in thesequestration chamber1008 is displaced through the airpermeable blood barrier1010 by an initial aliquot of blood that is guided into thesequestration channel port1006. Once thesequestration chamber1008 is filled, further blood draws through themain outlet port1004 can be accomplished, where these samples will be non-contaminated.
• FIGS.11A-11E illustrate ablood sequestration device1100 in accordance with other alternative implementations. Theblood sequestration device1100 includes aninlet port1102, similar to the inlet ports described above, amain outlet port1104, and asequestration channel port1106 that splits off from themain outlet port1104 andinlet port1102. The sequestration channel port is connected to asequestration chamber1108. In the implementation shown inFIGS.11A-11E, the blood sequestration device includes abase member1101 having a channel therein, which functions as thesequestration chamber1108. The channel can be formed as a tortuous path through thebase member1101, which is in turn shaped and formed to rest on a limb of a patient.
• A portion of thesequestration chamber1108 can protrude from the base member or near a top surface of the base member, just before exiting to an airpermeable blood barrier1110, to serve as ablood sequestration indicator1109. Theindicator1109 can be formed of a clear material, or a material that changes color when in contact with blood.
• In some implementations, theblood sequestration device1100 can include ablood sampling device1120 such as a normally closed needle, Vacutainer™ shield or other collection device. Theblood sampling device1120 can be manufactured and sold with theblood sequestration device1100 for efficiency and convenience, so that a first aliquot of blood that may be contaminated by a patient needle insertion process can be sequestered. Thereafter, theblood sampling device1120 can draw non-contaminated blood samples to reduce the risk of false positive testing and ensure a non-contaminated sample.
• FIGS.12A-12D illustrate a bloodsample optimization system1200 in accordance with yet other alternative implementations. Thesystem1200 includes ablood sequestration device1202 for attaching to ablood sampling device1204, such as a Vacutainer™ or other collection and sampling device. Theblood sequestration device1202 is configured and arranged to receive, prior to a Vacutainer™ container or vial being attached to a collection needle of theblood sampling device1204, a first aliquot or amount of blood, and sequester that first aliquot or amount in a sequestration channel of theblood sequestration device1202.
• In some implementations, theblood sequestration device1202 can include aninlet port1212, a main outlet port, and a sequestration channel port. Theinlet port1212 can be connected to a patient needle or related tubing. The main outlet port1214 can be connected to a normally closed needle or device to enable connection with an evacuated blood collection container or other collection device such as a Vacutainer™, associated tubing, luer connectors, syringe, a Luer activated valve, or the like. The sequestration channel port splits off from the main outlet port to asequestration chamber1218.
• In some implementations, thesequestration chamber1218 is formed as a channel within the body of asequestration device1202. Thesequestration chamber1218 can be a winding channel, such as a U-shaped channel, an S-shaped channel, a helical channel, or any other winding channel. Thesequestration device1202 can include a housing or other containing body, and one or more channels formed therein. As shown inFIGS.12A and12B, thesequestration device1202 includes amain body1206 and acap1208. Themain body1206 is formed with one or more cavities or channels, which are further formed with one ormore arms1210 that extend from thecap1208, and which abut the cavities or channels in themain body1206 to form the primary collection port and main outlet port.
• FIGS.13A-13D illustrate a bloodsample optimization system1300 in accordance with yet other alternative implementations. Thesystem1300 includes ablood sequestration device1302 for attaching to ablood sampling device1304, such as a Vacutainer or other bodily fluid collection and sampling device. Theblood sequestration device1302 is configured and arranged to receive, prior to a Vacutainer container or vial being attached to a collection needle of theblood sampling device1304, a first aliquot or amount of blood, and to sequester that first aliquot or amount of blood or other bodily fluid in a sequestration channel of theblood sequestration device1302.
• Theblood sequestration device1302 includes ahousing1301 having aninlet port1314, amain outlet port1312, and asequestration channel port1316. Theinlet port1314 can be connected to a patient needle or associated tubing. Themain outlet port1312 can be connected to a normally closed needle or device to enable connection with an evacuated blood collection container or other collection device such as a Vacutainer™ associated tubing, luer connectors, syringe, a Luer activated valve, or the like. Thesequestration channel port1316 splits off from themain inlet port1314 to asequestration chamber1318.
• In the implementation shown inFIGS.13A-D, thesequestration chamber1318 is formed as a cavity or chamber withinhousing1301 or formed by walls that definehousing1301. Thesequestration chamber1318 can be a winding channel, such as a U-shaped channel, an S-shaped channel, a helical channel, or any other winding channel, that is defined by the cooperation and connection ofhousing1301 withcap1307 which cap1307 can include aprotrusion1305 that provides one or more walls or directors for the winding channel in thesequestration chamber1318. Theprotrusion1305 from thecap1307 can be straight or curved, and may have various channels, apertures or grooves embedded therein, and can extend from thecap1307 any angle or orientation. When thecap1307 is connected with thehousing1301 to complete the formation of thesequestration chamber1318, theprotrusion1305 forms at least part of the winding channel to sequester a first aliquot or amount of blood or other bodily fluid in a sequestration channel formed in thesequestration chamber1318 and by the winding channel.
• Thesequestration chamber1318 includes an airpermeable blood barrier1310, substantially as described above. Air in thesequestration chamber1318 is displaced through the airpermeable blood barrier1310 by an initial aliquot of blood that is provided into thesequestration chamber1318 by the blood pressure of the patient. Once thesequestration chamber1318 is filled and the air in thesequestration chamber1318 displaced, the blood pressure of the patient will be insufficient to drive or provide further blood into theblood sequestration device1302, and in particular theoutlet port1312, until a force such as a vacuum or other pressure, such as provided by the blood sample collection device like Vacutainer is provided to draw out a next aliquot or amount of blood or bodily fluid. Further blood draws through themain outlet port1312 can be accomplished, where these samples will be non-contaminated since any contaminants would be sequestered in thesequestration chamber1318 with the first aliquot of blood.
• FIGS.14A-14E illustrate yet another implementation of ablood sampling system1400 to sequester contaminates of an initial aliquot or sample to reduce false positives in blood cultures or tests performed on a patient's blood sample. Theblood sampling system1400 includes ablood sequestration device1401 that can be connected between a bloodsample collection device1403 and a patient needle (not shown). The bloodsample collection device1403 can be a Vacutainer or the like. Theblood sequestration device1401 includes aninlet port1402 that can be connected with a patient needle that is inserted into a patient's vascular system for access to and withdrawing of a blood sample. Theinlet port1402 may also be connected with tubing or other conduit that is in turn connected with the patient needle.
• Theinlet port1402 defines an opening into theblood sequestration device1401, which opening can be the same cross sectional dimensions as tubing or other conduit connected with the patient needle or the patient needle itself. For instance, the opening can be circular with a diameter of approximately 0.045 inches, but can have a diameter of between 0.01 inches or less to 0.2 inches or more. Theblood sequestration device1401 further includes an outlet port1404, which defines an opening out of theblood sequestration device1401 and to the bloodsample collection device1403. The outlet port1404 may also be connected with tubing or other conduit that is in turn connected with theblood sequestration device1403. The outlet port1404 can further include a connector device such as a threaded cap, a Luer connector (male or female), a non threaded interference or glue joint fitting for attachment of various devices including but not limited to tubing, or the like.
• Theblood sequestration device1401 further includes asampling channel1406 between theinlet port1402 and the outlet port1404, and which functions as a blood sample pathway once a first aliquot of blood has been sequestered. Thesampling channel1406 can be any sized, shaped or configured channel, or conduit. In some implementations, thesampling channel1406 has a substantially similar cross sectional area as the opening of theinlet port1402. In other implementations, thesampling channel1406 can gradually widen from theinlet port1402 to the outlet port1404.
• Theblood sequestration device1401 further includes asequestration chamber1408 that is connected to and split off or diverted from thesampling channel1406 at any point between theinlet port1402 and the outlet port1404, but preferably from a proximal end of thesampling channel1406 near theinlet port1402. Thesequestration chamber1408 is at first maintained at atmospheric pressure, and includes anair outlet1412 at or near a distal end of thesequestration chamber1408 opposite the diversion point from thesampling channel1406. Theair outlet1412 includes an airpermeable blood barrier1412. As shown inFIG.14B, the airpermeable blood barrier1412 can be overlaid with aprotective cover1416. Theprotective cover1416 can be sized and configured to inhibit a user from touching the airpermeable blood barrier1412 with their finger or other external implement, while still allowing air to exit the airpermeable blood barrier1412 as the air is displaced from thesequestration chamber1408 by blood being forced into thesequestration chamber1408 by a patient's own blood pressure. In addition theprotective cover1416 can be constructed to inhibit or prevent accidental exposure of the air permeable blood barrier to environmental fluids or splashes. This can be accomplished in a variety of mechanical ways including but not limited to the addition of a hydrophobic membrane to the protective cover.
• As shown inFIGS.14C and14D, thesampling channel1406 can be cylindrical or frusto-conical in shape, going from a smaller diameter to a larger diameter, to minimize a potential to lyse red blood cells. Likewise, thesampling channel1406 is formed with a minimal amount of or no sharp turns or edges, which can also lyse red blood cells. Thesampling channel1406 splits off to thesequestration chamber1408 near theinlet port1402 via adiversion pathway1409. Thediversion pathway1409 can have any cross-sectional shape or size, but is preferably similar to the cross-sectional shape of at least part of theinlet port1402.
• In some implementations, thesampling channel1406 and thesequestration chamber1408 are formed by grooves, channels, locks or other pathways formed inhousing1414. Thehousing1414 can be made of plastic, metal or other rigid or semi-rigid material. Thehousing1414 can have a bottom member that sealably mates with a top member. One or both of the bottom member and the top member can include thesampling channel1406 and thesequestration chamber1408, as well as thediversion pathway1409, theinlet port1402, and the outlet port1404. In some other implementations, one or more of thediversion pathway1409, theinlet port1402, and/or the outlet port1404 can be at least partially formed by a cap member that is connected to either end of thehousing1414. In some implementations, the top member and the bottom member, as well as the cap member(s), can be coupled together by laser welding, heat sealing, gluing, snapping, screwing, bolting, or the like. In other implementations, some or all of the interior surface of thediversion pathway1409 and/orsequestration chamber1408 can be coated or loaded with an agent or substance, such as a decontaminate, solidifying agent, or the like. For instance, a solidifying agent can be provided at thediversion pathway1409 such that when thesequestration chamber1408 is filled and the initial aliquot of blood backs up to thediversion pathway1409, that last amount of sequestered blood could solidify, creating a barrier between thesequestration chamber1408 and thesampling channel1406.
• FIGS.15A-15G illustrate ablood sequestration device1500. Theblood sequestration device1500 can be connected to a normally closed needle or device to enable connection with an evacuated blood collection container or other collection device such as a Vacutainer™, associated tubing, luer connectors, syringe, a Luer activated valve, or the like.
• Theblood sequestration device1500 includes aninlet port1502 that can be connected with a patient needle that is inserted into a patient's vascular system for access to and withdrawing of a blood sample. Theinlet port1502 may also be connected with tubing or other conduit that is in turn connected with the patient needle. Theinlet port1502 defines an opening into theblood sequestration device1500, which opening may be the same cross sectional dimensions as tubing or other conduit connected with the patient needle or the patient needle itself. For instance, the opening can be circular with a diameter of approximately 0.045 inches, but can have a diameter of between 0.01 inches or less to 0.2 inches or more.
• Theinlet port1502 can also include a sealing or fluid-tight connector or connection, such as threading or Luer fitting, or the like. In some implementations, tubing or other conduit associated with the patient needle can be integral with theinlet port1502, such as by co-molding, gluing, laser weld, or thermally bonding the parts together. In this manner, theblood sequestration device1500 can be fabricated and sold with the patient needle as a single unit, eliminating the need for connecting the patient needle to theblood sequestration device1500 at the time of blood draw or sampling.
• Theblood sequestration device1500 further includes anoutlet port1504, which defines an opening out of theblood sequestration device1500 and to the blood sample collection device. Theoutlet port1504 may also be connected with tubing or other conduit that is in turn connected with the blood sequestration device, and may also include a sealing or fluid-tight connector or connection, such as threading or Luer fitting, or the like. Accordingly, as discussed above, theblood sequestration device1500 can be fabricated and sold with the patient needle and/or tubing and the blood sample collection device as a single unit, eliminating the need for connecting the patient needle and the blood sample collection device to theblood sequestration device1500 at the time of blood draw or sampling.
• Theblood sequestration device1500 further includes asampling channel1506 between theinlet port1502 and theoutlet port1504, and which functions as a blood sample pathway once a first aliquot of blood has been sequestered. Thesampling channel1506 can be any sized, shaped or configured channel or conduit. In some implementations, thesampling channel1506 has a substantially similar cross sectional area as the opening of theinlet port1502. In other implementations, thesampling channel1506 can gradually widen from theinlet port1502 to theoutlet port1504.
• Theblood sequestration device1500 further includes asequestration chamber1508 that is connected to and split off or diverted from thesampling channel1506 at any point between theinlet port1502 and theoutlet port1504, but preferably from a proximal end of thesampling channel1506 near theinlet port1502. In some implementations, the diversion includes a Y-shaped junction. Thesequestration chamber1508 is preferably maintained at atmospheric pressure, and includes avent1510 at or near a distal end of thesequestration chamber1508. Thevent1510 includes an airpermeable blood barrier1512.FIG.15C illustrates theblood sequestration device1500 with thesequestration chamber1508 filled with a first aliquot or sample of blood from the patient.
• The airpermeable blood barrier1512 can be covered with aprotective cover1516. Theprotective cover1516 can be sized and configured to inhibit a user from touching the airpermeable blood barrier1512 with their finger or other external implement, while still allowing air to exit the airpermeable blood barrier1512 as the air is displaced from thesequestration chamber1508 by blood being forced into thesequestration chamber1508 by a patient's own blood pressure. Theprotective cover1516 can be constructed to inhibit or prevent accidental exposure of the filter to environmental fluids or splashes. This can be accomplished in a variety of mechanical ways including but not limited to the addition of a hydrophobic membrane to the protective cover.
• FIG.15B is a perspective view of theblood sequestration device1500 from theoutlet port1504 and top side of ahousing1501 of theblood sequestration device1500 that includes thevent1510, and illustrating an initial aliquot of blood fillingsequestration chamber1508 while thesampling channel1506 is empty, before a sample collection device is activated.FIG.15G is a perspective view of theblood sequestration device1500 from theoutlet port1504 and bottom side of thehousing1501 of theblood sequestration device1500, and illustrating the initial aliquot of blood fillingsequestration chamber1508 while thesampling channel1506 is empty, before the sample collection device is activated.FIG.15C is another perspective view of theblood sequestration device1500 from theinlet port1502 and top side of ahousing1501 of theblood sequestration device1500 that includes thevent1510, and illustrating blood now being drawn throughsampling channel1506 while the sequestered blood remains substantially in thesequestration chamber1508.
• FIG.15D is a cross section of theblood sequestration device1500 in accordance with some implementations, showing thehousing1501 that defines thesampling channel1506 and thesequestration chamber1508.FIGS.15E and15F illustrate various form factors of a housing for a blood sequestration device, in accordance with one or more implementations described herein.
• Thesequestration chamber1508 can have a larger cross-sectional area than thesampling channel1506, and the cross-sectional area and length can be configured for a predetermined or specific volume of blood to be sequestered or locked. Thesampling channel1506 can be sized to be compatible with tubing for either or both of the patient needle tubing or the blood collection device tubing.
• Thehousing1501 can be formed of multiple parts or a single, unitary part. In some implementations, and as illustrated inFIG.15D, thehousing1501 includes atop member1520 and abottom member1522 that are mated together, one or both of which having grooves, channels, locks, conduits or other pathways pre-formed therein, such as by an injection molding process or by etching, cutting, drilling, etc. Thetop member1520 can be connected with thebottom member1522 by any mating or connection mechanism, such as by laser welding, thermal bonding, ultrasonic welding, gluing, using screws, rivets, bolts, or the like, or by other mating mechanisms such as latches, grooves, tongues, pins, flanges, or the like.
• In some implementations, such as shown inFIG.15D, thetop member1520 can include the grooves, channels, locks, conduits or other pathways, while thebottom member1522 can include aprotrusion1524 that is sized and adapted to fit into at least one of the grooves, channels, locks or other pathways of thetop member1520. Theprotrusion1524 can provide a surface feature, such as a partial groove or channel, for instance, to complete the formation of either thesampling channel1506 and/or thesequestration chamber1508. In some implementations, theprotrusion1524 can be formed with one or more angled sides or surfaces for a tighter fit within the corresponding groove, channel, lock or other pathway. In yet other implementations, both thetop member1520 and the bottom member can include grooves, channels, locks or other pathways, as well as one ormore protrusions1524.
• In some implementations, thesampling channel1506 and thesequestration chamber1508 are formed by grooves, channels, locks or other pathways formed inhousing1501. Thehousing1501 can be made of any suitable material, including rubber, plastic, metal or other material. Thehousing1501 can be formed of a clear or translucent material, or of an opaque or non-translucent material. In other implementations, thehousing1501 can be mostly opaque or non-translucent, while the housing surface directly adjacent to thesampling channel1506 and/or thesequestration chamber1508 is clear or translucent, giving a practitioner a visual cue or sign that thesequestration chamber1508 is first filled to the extent necessary or desired, and/or then a visual cue or sign that the sequestered blood remains sequestered while a clean sample of blood is drawn through thesampling channel1506. Other visual cues or signs of the sequestration can include, without limitation: the airpermeable blood barrier1512 turning a different color upon contact, saturation, or partial saturation with blood; a color-coded tab or indicator at any point along or adjacent to the sequestration chamber; an audible signal; a vibratory signal; or other signal.
• After a venipuncture by a patient needle of a patient (not shown), which could gather a number of pathogens from the patient's skin, a first amount of the patient's blood with those pathogens will make its way into theinlet port1502blood sequestration device1500 and flow into thesequestration chamber1508 by following the path of least resistance, as the patient's own blood pressure overcomes the atmospheric pressure in thesequestration chamber1508 to displace air therein through the airpermeable blood barrier1512. The patient's blood pressure will not be sufficient to overcome the air pressure that builds up in the sealedsampling channel1506. Eventually, thesequestration chamber1508, which has a predetermined volume, is filled with blood that displaces air through the airpermeable blood barrier1512. Once the blood hits the air permeable blood barrier, the blood interacts with the airpermeable blood barrier1512 material to completely or partially seal thevent1510. A signal or indication may be provided that the practitioner can now utilize the Vacutainer capsule or other blood sample collection device to acquire a next amount of the patient's blood for sampling. The blood in thesequestration chamber1508 is now effectively sequestered in the sequestration chamber.
• Upon filling theblood sequestration pathway1508 but prior to use of the Vacutainer or other blood sample collection device, the patient's blood pressure may drive compression of the air in thesampling channel1506, possibly resulting in a small amount of blood moving past the diversion point to thesequestration chamber1508 and into thesampling channel1506, queuing up the uncontaminated blood to be drawn through thesampling channel1506.
• In some instances, as shown inFIG.15H, an inlet port1532 can include a male luer connector for connecting to a removable patient needle, and an outlet port11534 can include a female luer connector for connecting with a syringe. This implementation of the inlet port and outlet port can be used with any device described herein, for avoiding a propensity of a Vacutainer-type device collapsing a patient's vein. In this implementation, a clinician can use the syringe in a modulated fashion to obtain a blood sample. In operation, the syringe is attached to theoutlet port1004, and the needle is attached to theinlet port1002. A venipuncture is performed with the needle, and without the clinician pulling on the syringe. An initial aliquot of blood fills a sequestration chamber, and then the syringe can be used to draw a sample of blood through the collection channel, bypassing the sequestered blood in the sequestration chamber.
• FIGS.16-19 illustrate yet another implementation of a blood sequestration device.FIGS.16A-16D illustrate a blood sequestration device1600 that can be connected between a blood sample collection device, such as an evacuated blood collection container like a Vacutainer™ (not shown), and a patient needle (not shown) and/or associated tubing.FIG.17 illustrates a bottom member of the blood sequestration device, andFIG.18 illustrates a top member of the blood sequestration device, which top member and bottom member can be mated together to form an inlet port, and outlet port, a sequestration chamber and a sampling channel, as explained more fully below.FIGS.19A and B show the top member and bottom member mated together. It should be understood thatFIGS.16-19 illustrate one exemplary manner of constructing a blood sequestration device as described herein, and other forms of construction are possible.
• Referring toFIGS.16A-D, the blood sequestration device1600 includes aninlet port1602 that can be connected with a patient needle that is inserted into a patient's vascular system for access to and withdrawing of a blood sample. Theinlet port1602 may also be connected with tubing or other conduit that is in turn connected with the patient needle. Theinlet port1602 defines an opening into the blood sequestration device1600, which opening can be the same cross sectional dimensions as tubing or other conduit connected with the patient needle or the patient needle itself. For instance, the opening can be circular with a diameter of approximately 0.045 inches, but can have a diameter of between 0.01 inches or less to 0.2 inches or more.
• Theinlet port1602 can also include a sealing or fluid-tight connector or connection, such as threading or Luer fitting, or the like. In some implementations, tubing or other conduit associated with the patient needle can be integral with theinlet port1602, such as by co-molding, gluing, laser weld, or thermally bonding the parts together. In this manner, the blood sequestration device1600 can be fabricated and sold with the patient needle and/or tubing as a single unit, eliminating the need for connecting the patient needle to the blood sequestration device1600 at the time of blood draw or sampling.
• The blood sequestration device1600 further includes anoutlet port1604, which defines an opening out of the blood sequestration device1600 and to the blood sample collection device. Theoutlet port1604 may also be connected with tubing or other conduit that is in turn connected with the blood sequestration device, and may also include a sealing or fluid-tight connector or connection, such as threading or Luer fitting, or the like. Accordingly, as discussed above, the blood sequestration device1600 can be fabricated and sold with the patient needle and/or tubing and the blood sample collection device as a single unit, eliminating the need for connecting the patient needle and the blood sample collection device to the blood sequestration device1600 at the time of blood draw or sampling.
• The blood sequestration device1600 further includes asampling channel1606 between theinlet port1602 and theoutlet port1604, and asequestration chamber1608 that is connected to and split off or diverted from thesampling channel1606 at any point between theinlet port1602 and theoutlet port1604. Thesampling channel1606 functions as a blood sampling pathway once a first aliquot of blood has been sequestered in thesequestration chamber1608. Thesampling channel1606 can be any sized, shaped or configured channel, or conduit. In some implementations, thesampling channel1606 has a substantially similar cross sectional area as the opening of theinlet port1602. In other implementations, thesampling channel1606 can gradually widen from theinlet port1602 to theoutlet port1604. Thesequestration chamber1608 may have a larger cross section to form a big reservoir toward the sequestration channel path so that the blood will want to enter the reservoir first versus entering a smaller diameter on thesampling channel1606, as is shown more fully inFIGS.17 and19.
• In some exemplary implementations, the diversion between thesampling channel1606 and thesequestration chamber1608 is bydiverter junction1607.Diverter junction1607 may be a substantially Y-shaped, T-shaped, or U-shaped. In some preferred exemplary implementations, and as shown inFIG.17A-17B, thediverter junction1607 is configured such that the flow out of theinlet port1602 is preferentially directed toward thesequestration chamber1608. Thesequestration chamber1608 may also include or form a curve or ramp to direct the initial blood flow toward and into thesequestration chamber1608.
• Thesequestration chamber1608 is preferably maintained at atmospheric pressure, and includes a vent1610 at or near a distal end of thesequestration chamber1608. The vent1610 may include an airpermeable blood barrier1612 as described above.
• The blood sequestration device1600 can include ahousing1601 that can be formed of multiple parts or a single, unitary part. In some implementations, and as illustrated inFIGS.17A-17E andFIGS.18A-18F, thehousing1601 includes atop member1620 and abottom member1622 that are mated together. The blood sequestration device1600 can also include a gasket or other sealing member (not shown) so that when thetop member1620 is mechanically attached with thebottom member1622, the interface between the two is sealed by the gasket or sealing member. TheFIGS.17A-17E illustrate abottom member1622 of a housing for a blood sequestration device1600. Thebottom member1622 can include grooves, channels, locks, conduits or other pathways pre-formed therein, such as by an injection molding process or by etching, cutting, drilling, etc., to form thesampling channel1606, thesequestration chamber1608, anddiverter junction1607.
• Thesequestration chamber1608 may have a larger cross section than thesampling channel1606 so that the blood will preferentially move into the sequestration chamber first versus entering a smaller diameter on thesampling channel1606.
• FIGS.18A-18F illustrate thetop member1620, which can be connected with thebottom member1622 by any mating or connection mechanism, such as by laser welding, thermal bonding, gluing, using screws, rivets, bolts, or the like, or by other mating mechanisms such as latches, grooves, tongues, pins, flanges, or the like. Thetop member1620 can include some or all of the grooves, channels, locks, conduits or other pathways to form thesampling channel1606, thesequestration chamber1608, and thediverter junction1607. In yet other implementations, both thetop member1620 and thebottom member1622 can include the grooves, channels, locks or other pathways.
• In some implementations, thesampling channel1606 and thesequestration chamber1608 are formed by grooves, channels, locks or other pathways formed inhousing1601. Thehousing1601 can be made of rubber, plastic, metal or any other suitable material. Thehousing1601 can be formed of a clear or translucent material, or of an opaque or non-translucent material. In other implementations, thehousing1601 can be mostly opaque or non-translucent, while the housing surface directly adjacent to thesampling channel1606 and/or thesequestration chamber1608 may be clear or translucent, giving a practitioner a visual cue or sign that thesequestration chamber1608 is first filled to the extent necessary or desired, and/or then a visual cue or sign that the sequestered blood remains sequestered while a clean sample of blood is drawn through thesampling channel1606. Other visual cues or signs of the sequestration can include, without limitation: the airpermeable blood barrier1612 turning a different color upon contact, saturation, or partial saturation with blood; a color-coded tab or indicator at any point along or adjacent to the sequestration chamber; an audible signal; a vibratory signal; or other signal.
• As shown inFIGS.18A-18F, the airpermeable blood barrier1612 can be covered with, or surrounded by, aprotective member1616. Theprotective member1616 can be sized and configured to inhibit a user from touching the airpermeable blood barrier1612 with their finger or other external implement, while still allowing air to exit the airpermeable blood barrier1612 as the air is displaced from thesequestration chamber1608. In some implementations, theprotective member1616 includes a protrusion that extends up from a top surface of thetop member1620 and around the airpermeable blood barrier1612. Theprotective member1616 can be constructed to inhibit or prevent accidental exposure of the filter to environmental fluids or splashes. This can be accomplished in a variety of mechanical ways including but not limited to the addition of a hydrophobic membrane to the protective cover.
• In use, the blood sequestration device1600 includes asampling channel1606 and asequestration chamber1608. Both pathways are initially air-filled at atmospheric pressure, but thesampling channel1606 is directed to anoutlet port1604 that will be initially sealed by a Vacutainer or other such sealed blood sampling device, and thesequestration chamber1608 terminates at a vent1610 to atmosphere that includes an airpermeable blood barrier1612.
• After a venipuncture by a patient needle of a patient (not shown), which could gather a number of pathogens from the patient's skin, a first amount of the patient's blood with those pathogens will pass throughinlet port1602 of blood sequestration device1600. This initial volume of potentially contaminated blood will preferentially flow into thesequestration chamber1608 by finding the path of least resistance. The patient's own blood pressure overcomes the atmospheric pressure in the ventedsequestration chamber1608 to displace air therein through the airpermeable blood barrier1612, but is not sufficient to overcome the air pressure that builds up in the sealedsampling channel1606. In various exemplary embodiments, thesequestration chamber1608 andsampling channel1606 can be configured such that the force generated by the patient's blood pressure is sufficient to overcome any effect of gravity, regardless of the blood sequestration device's orientation.
• Eventually, thesequestration chamber1608 fills with blood that displaces air through the airpermeable blood barrier1612. Once the blood contacts the air permeable blood barrier, the blood interacts with the airpermeable blood barrier1612 material to completely or partially seal the vent1610. A signal or indication may be provided that the practitioner can now utilize the Vacutainer or other blood sampling device.
• Upon filling theblood sequestration pathway1608 but prior to use of the Vacutainer or other blood sample collection device, the patient's blood pressure may drive compression of the air in thesampling channel1606, possibly resulting in a small amount of blood moving past the diversion point into thesampling channel1606, queuing up the uncontaminated blood to be drawn through thesampling channel1606.
• FIG.19A is a side view, andFIG.19B is a cross-sectional view, of the blood sequestration device1600, illustrating thetop member1620 mated with thebottom member1622.
• FIG.20 shows a bloodsample optimization system2000 that includes apatient needle2002 for vascular access to a patient's bloodstream, a bloodsample collection device2004 to facilitate the collecting of one or more blood samples, and aconduit2006 providing a fluid connection between thepatient needle2002 and the bloodsample collection device2004. In some implementations, the bloodsample collection device2004 includes a protective shield that includes a sealed collection needle on which a sealed vacuum-loaded container is placed, which, once pierced by the collection needle, draws in a blood sample under vacuum pressure or force through theconduit2006 from thepatient needle2002.
• The bloodsample optimization system2000 further includes ablood sequestration device2008, located at any point on theconduit2006 between thepatient needle2002 and the bloodsample collection device2004 as described herein.
• FIG.21 illustrates a non-ventedblood sequestration device2100 using a wicking material chamber. Theblood sequestration device2100 includes ahousing2101 that has asampling channel2104 that is at least partially surrounded or abutted by asequestration chamber2102 that is filled with a wicking material. An initial aliquot of blood is drawn in from the patient needle into thesampling channel2104 where it is immediately wicked into the wicking material of thesequestration chamber2102. The wicking material and/orsequestration chamber2102 is sized and adapted to receive and hold a predetermined amount of blood, such that follow-on or later blood draws pass by the wicking material and flow straight through thesampling channel2104 to a sampling device such as a Vacutainer. The wicking material can include a substance such as a solidifier, a decontaminate, or other additive.
• As described herein, an air permeable blood barrier may be created using a wide variety of different structures and materials. As shown inFIGS.22A and B, an airpermeable blood barrier2202 of ablood sequestration device2200 can include apolymer bead matrix2204, in which at least some beads are treated to make them hydrophilic. The airpermeable blood barrier2202 further includes a self-sealingmaterial2206, such as carboxymethyl cellulose (CMC) or cellulose gum, or other sealing material. The airpermeable blood barrier2202 can further includevoids2208 that permit air flow before contact or during partial contact with a fluid such as blood. As shown inFIG.22B, contact with a fluid causes the self-sealingmaterial2206 to swell and close off thevoids2208, occluding air flow through thevoids2208 and creating a complete or partial seal.
• FIGS.23A and B illustrate yet another implementation of ablood sequestration device2300, having aninlet port2302 to connect with a patient needle, anoutlet port2304 to connect with a blood sample collection device, asequestration chamber2306, and asampling channel2308 that bypasses thesequestration chamber2306 once the sequestration chamber is filled to an initial aliquot of potentially contaminated blood to be sequestered. Thesequestration chamber2306 includes ahydrophobic plug2312 at a distal end of thesequestration chamber2306 that is farthest from theinlet port2302. A vacuum or other drawing force applied from theoutlet port2304, such as from a Vacutainer or the like, draws in blood into theinlet port2302 and directly into thesequestration chamber2306, where the initial aliquot of blood will contact thehydrophobic plug2312 and cause the initial aliquot of blood to back up into thesequestration chamber2306 and be sequestered there. A small amount of blood may make its way into thesampling channel2308, which is initially closed off byvalve2308. Upon release of thevalve2308, and under further force of the vacuum or other force, follow-on amounts of blood will flow intoinlet port2302, bypass thesequestration chamber2306, and flow into and throughsampling channel2308 toward theoutlet port2304 and to the collection device.
• Thesampling channel2308 can have any suitable geometry and can be formed of plastic tubing or any other suitable material.Valve2308 can be a clip or other enclosing device to pinch, shunt, bend or otherwise close off thesampling channel2308 before the initial aliquot of blood is sequestered in thesequestration chamber2306. For instance,valve2308 can also be formed as a flap, door or closable window or barrier within thesampling channel2308.
• FIGS.23C-23E illustrate an alternative implementation of theblood sequestration device2300′, in which asequestration chamber2320 branches off from amain collection channel2322 between aninlet port2316 to connect with a patient needle and anoutlet port2318 to connect with a blood sample collection device, such as a Vacutainer, a syringe, or the like. Thesequestration chamber2320 includes an air-permeable, bloodimpermeable blood barrier2324, such as a hydrophobic plug of material, or a filter formed of one or more layers, for example. Avalve2324 closes off and opens thecollection channel2322, and thedevice2300′ can be used similarly as described above.
• FIG.24A-24D illustrate a bloodsample optimization system2400 that includes apatient needle2402 for vascular access to a patient's bloodstream, a bloodsample collection device2404 to facilitate the collecting of one or more blood samples for blood testing or blood cultures, and aconduit2406 providing a fluid connection between thepatient needle2402 and the bloodsample collection device2404. In some implementations, the bloodsample collection device2404 includes a protective shield that includes a sealed collection needle on which a sealed vacuum-loaded container is placed, which, once pierced by the collection needle, draws in a blood sample under vacuum pressure or force through theconduit2006 from thepatient needle2402.
• The bloodsample optimization system2400 further includes ablood sequestration device2408, located at any point on theconduit2406 between thepatient needle2402 and the bloodsample collection device2404. The location of theblood sequestration device2408 can be based on a length of the conduit between theblood sequestration device2408 and thepatient needle2402, and the associated volume that length provides.
• Theblood sequestration device2408 includes aninlet port2412 for being connected to theconduit2406 toward thepatient needle2402, and anoutlet port2414 for being connected to theconduit2406 toward the bloodsample collection device2404, and ahousing2416. Thehousing2416 can be any shape, although it is shown inFIGS.24A-D as being substantially cylindrical, and includes theinlet port2412 andoutlet port2414, which can be located anywhere on the housing although shown as being located on opposite ends of thehousing2416.
• Theblood sequestration device2408 further includes ablood sequestration chamber2418 connected with theinlet port2412. Theblood sequestration chamber2418 is defined by aninner chamber housing2419 that is movable from a first position to receive and sequester a first aliquot of blood, to a second position to expose one ormore apertures2424 at a proximal end of theinner chamber housing2419 to allow blood to bypass and/or flow around theinner chamber housing2419 and through ablood sample channel2422 defined by the outer surface of theinner chamber housing2419 and the inner surface of thehousing2416. Theblood sequestration chamber2418 includes an airpermeable blood barrier2420 at a distal end of theblood sequestration chamber2418.
• In operation, theinner chamber housing2419 is in the first position toward theinlet port2412, such that the one ormore apertures2424 are closed, and theblood sequestration chamber2418 is in a direct path from the patient needle. Upon venipuncture of a patient, and drawing of blood by way of a syringe or Vacutainer, or otherblood collection device2404, the initial aliquot of blood flows into theblood sequestration chamber2418. As the initial aliquot of blood flows into the blood sequestration chamber, it displaces air therein and eventually the blood contacts theblood barrier2420, forcing the inner chamber housing to the second position. Theinner chamber housing2419 and/orhousing2416 can include a locking mechanism of one or more small tabs, grooves, detents, bumps, ridges, or the like, to maintain theinner chamber housing2419 in the first position until theblood sequestration chamber2418 is filled, providing force to overcome the locking mechanism to enable movement of theinner chamber housing2419 to the second position. Once in the second position, the initial aliquot of blood is sequestered in theblood sequestration chamber2418 and the one ormore apertures2424 are opened to create a pathway from theinlet port2412 to theblood sampling channel2422, bypassing and/or flowing around theblood sequestration chamber2418.
• As described above, thehousing2416 and/orinner chamber housing2419 can be formed as cylindrical and concentric, but can be any shape, such as squared, rectangular, elliptical, oval, or other cross-sectional shape. The outer surface of the distal end of theinner chamber housing2419 can have one or more outwardly projectingtangs2421 with gaps therebetween. Thetangs2421 contact the inner surface of thehousing2416 to help define theblood sampling channel2422 therebetween, and to help stop theinner chamber housing2419 in the second position. The gaps between thetangs2421 enable blood to flow through theblood sampling channel2422 and to theoutlet port2414. When theinner chamber housing2419 is in the second position and theblood sequestration chamber2418 is filled with the first aliquot of blood, further blood samples will automatically flow through theinlet port2412, through the one ormore apertures2424, through theblood sampling channel2422, through the gaps between thetangs2421, and ultimately through theoutlet port2414 to be collected by ablood sampling device2404.
• FIGS.25A-D show ablood optimization system2500 andblood sequestration device2502, formed substantially as described inFIGS.15,16,17,18 and19, but being formed to inhibit a user or other object from touching or blocking an air venting mechanism from ablood sequestration chamber2520. Air initially in theblood sequestration chamber2520 is displaced by an initial aliquot of blood upon venipuncture, where a patient's blood pressure overcomes the ambient air pressure in theblood sequestration chamber2520. The air venting mechanism includes an airpermeable blood barrier2506, such as a porous material or set of materials that allows air to escape but blocks blood from leaving theblood sequestration chamber2520.
• The air venting mechanism includes aninner wall2516 that at least partially circumscribes or surrounds the airpermeable blood barrier2506, and anouter wall2504 spaced apart from theinner wall2516. Theouter wall2504 can have one ormore air vents2514 formed therein. Theouter wall2504 extends higher upward than theinner wall2516, such that alid2510, such as a cap, plug, cover, etc., can be attached to theouter wall2504 and be displaced by a small distance from the top of theinner wall2516. Aseal2508 in the form of a silicone wafer, or other elastomeric material, fits within theouter wall2504 to cover the airpermeable blood barrier2506 and abut the top of theinner wall2516. Theseal2508 covers and seals the airpermeable blood barrier2506 and inhibits air from entering theblood sequestration chamber2520 through the airpermeable blood barrier2506. Afulcrum2512 on an underside of thelid2510 allows theseal2508 to flexibly disconnect from the top of theinner wall2516 when pushed by air displaced from theblood sequestration chamber2520, to allow air to vent from the airpermeable blood barrier2506 and through the one ormore air vents2514 in theouter wall2504.
• FIG.26A-E illustrate a bloodsample optimization system2600 that includes apatient needle2602 for vascular access to a patient's bloodstream, a bloodsample collection device2604 to facilitate the collecting of one or more blood samples for blood testing or blood cultures, and aconduit2606 providing a fluid connection between thepatient needle2602 and the bloodsample collection device2604. Theconduit2606 can include flexible tubing. In preferred implementations, the bloodsample collection device2604 includes aprotective shield2605 that includes a sealed collection needle on which a sealed vacuum-loaded container is placed, which, once pierced by the collection needle, draws in a blood sample under vacuum pressure or force through theconduit2006 from thepatient needle2602.
• The bloodsample optimization system2600 further includes ablood sequestration device2608, located at any point on theconduit2606 between thepatient needle2602 and the bloodsample collection device2604. The location of theblood sequestration device2608 can be based on a length of the conduit between theblood sequestration device2608 and thepatient needle2602, and the associated volume that length provides.
• Theblood sequestration device2608 includes aninlet port2612 for being connected to theconduit2606 toward thepatient needle2602, and anoutlet port2614 for being connected to theconduit2606 toward the bloodsample collection device2604. Theblood sequestration device2608 includes anouter housing2616 and aninner housing2617, both having a cylindrical form, and being connected concentrically. Theouter housing2616 includes anouter wall2618 and aninner conduit2620 that defines ablood sampling channel2622 to convey blood through theconduit2606 to theblood sampling device2604. Theinner housing2617 fits snugly between theinner conduit2620 and theouter wall2618 of the outer housing, and is rotatable in relation to theouter housing2616. The fit between theouter housing2616 and theinner housing2617 can be a friction fit that maintains the housings in a particular position. Theinner housing2617 defines ablood sequestration chamber2624, preferably a helical or corkscrew channel around the outer surface ofinner conduit2620 of theouter housing2616, and which terminates at anair vent2628 having an air permeable blood barrier, as shown inFIG.26E.
• Theblood sequestration chamber2624 is connected with theblood sampling channel2622 viadiversion junction2624 formed in theinner conduit2620, when the blood sequestration device in a first state, illustrated inFIG.26C. Theprotective shield2606 on thecollection needle2604 provides a block for air or blood, enabling a diversion of an initial aliquot of blood into theblood sequestration chamber2624 as the patient's blood pressure overcomes the ambient air pressure in theblood sequestration channel2624 to displace air therefrom throughair vent2628.
• When theinner housing2617 is rotated relative to theouter housing2616, or vice versa, to a second state, as illustrated inFIG.26D, theblood sequestration chamber2624 is shut off fromdiversion junction2624, enabling a direct path from the patient needle through theconduit2606 to thecollection needle2604, viablood sampling channel2622. Theouter housing2616 and/orinner housing2617 can include ridges or grooves formed within a portion of their surfaces, to facilitate relative rotation from the first state to the second state.
• FIGS.27A-D illustrate ablood optimization system2700 andblood sequestration device2702, formed substantially as described with reference to at leastFIGS.15,16,17,18,19, and25, but being formed to inhibit a user or other object from touching or blocking an air venting mechanism from ablood sequestration chamber2720. Air initially in theblood sequestration chamber2720 is displaced by an initial aliquot of blood upon venipuncture, where a patient's blood pressure overcomes the ambient air pressure in theblood sequestration chamber2720. The air venting mechanism includes an airpermeable blood barrier2706, such as a porous material or set of materials that allows air to escape but blocks blood from leaving theblood sequestration chamber2720.
• The air venting mechanism includes aninner wall2716 that at least partially circumscribes or surrounds the airpermeable blood barrier2706, and an outer wall2704 spaced apart from theinner wall2716. A cap2722 is positioned on the air venting mechanism, preferably by having alower cap wall2728 that fits between theinner wall2716 and the outer wall2704 of the air venting mechanism, and frictionally abutting either theinner wall2716 or the outer wall2704 or both. The cap2722 further includes one ormore vent holes2724 or slits, apertures, openings, or the like, which extend through an upper surface of the cap2722 around a downwardly extendingplug2726. Theplug2726 is sized and adapted to fit snugly within the space defined byinner wall2716.
• In a first position, as illustrated inFIG.27C, the cap2722 is extended from the air venting mechanism to allow air from theblood sequestration chamber2720 to exit through the airpermeable blood barrier2706 and through the one or more vent holes2724. Once the air from theblood sequestration chamber2720 has been displaced, i.e., when theblood sequestration chamber2720 is filled with the first aliquot of potentially tainted blood from the patient, then the cap2722 can be pushed down on the air venting mechanism in a second position as shown inFIG.27D, so that theplug2726 fits within theinner wall2716 over the airpermeable blood barrier2706 to seal the air venting mechanism. In either the first position or the second position, the cap2722 protects the airpermeable blood barrier2706 from outside air or from being touched by a user.
• FIGS.28A-F illustrate ablood optimization system2800 andblood sequestration device2802, formed substantially as described with reference to at leastFIGS.15,16,17,18,19,25 and26, but utilizing a multi-layered filter, and in some implementations, a filter with trapped reactive material, for an air permeable blood barrier. As shown inFIGS.28C and D, an airpermeable blood barrier2803 includes afirst layer2804 of an air permeable but blood impermeable material, and asecond layer2806 that includes a reactive material, such as a hydrophobic material, for repelling blood while still allowing air to pass through both layers. As shown inFIGS.28E and F, the airpermeable blood barrier2803 can include any number of layers, such as athird layer2808 formed of the same air permeable but blood impermeable material asfirst layer2804, while asecond layer2806 includes trapped or embedded blood reactive material.
• FIGS.29A-C illustrate ablood optimization system2900 andblood sequestration device2902, formed substantially as described with reference to at leastFIGS.15,16,17,18,19,25 and26, but in which ablood sequestration chamber2904 is at least partially filled with a blood-absorptive material2906. The blood-absorptive material2906 can act as a wicking material to further draw in blood to be sequestered upon venipuncture of the patient, and prior to use of a blood drawing device such as a Vacutainer™ or a syringe, or the like.
• FIGS.30A-G illustrate a blood optimization system3000 andblood sequestration device3002, formed substantially as described with reference to at leastFIGS.15,16,17,18,19,25 and26. The blood sequestration device3000 includes aninlet port3002 that can be connected with a patient needle that is inserted into a patient's vascular system for access to and withdrawing of a blood sample. Theinlet port3002 may also be connected with tubing or other conduit that is in turn connected with the patient needle. Theinlet port3002 defines an opening into the blood sequestration device3000, which opening can be the same cross sectional dimensions as tubing or other conduit connected with the patient needle or the patient needle itself. For instance, the opening can be circular with a diameter of approximately 0.045 inches, but can have a diameter of between 0.01 inches or less to 0.2 inches or more.
• Theinlet port3002 can also include a sealing or fluid-tight connector or connection, such as threading or Luer fitting, or the like. In some implementations, tubing or other conduit associated with the patient needle can be integral with theinlet port3002, such as by co-molding, gluing, laser weld, or thermally bonding the parts together. In this manner, the blood sequestration device3000 can be fabricated and sold with the patient needle and/or tubing as a single unit, eliminating the need for connecting the patient needle to the blood sequestration device3000 at the time of blood draw or sampling.
• The blood sequestration device3000 further includes anoutlet port3004, which defines an opening out of the blood sequestration device3000 and to the blood sample collection device. Theoutlet port3004 may also be connected with tubing or other conduit that is in turn connected with the blood sequestration device, and may also include a sealing or fluid-tight connector or connection, such as threading or Luer fitting, or the like. Accordingly, as discussed above, the blood sequestration device3000 can be fabricated and sold with the patient needle and/or tubing and the blood sample collection device as a single unit, eliminating the need for connecting the patient needle and the blood sample collection device to the blood sequestration device3000 at the time of blood draw or sampling.
• The blood sequestration device3000 further includes asampling channel3006 between theinlet port3002 and theoutlet port3004, and asequestration chamber3008 that is connected to and split off or diverted from thesampling channel3006 at any point between theinlet port3002 and theoutlet port3004. Thesampling channel3006 functions as a blood sampling pathway once a first aliquot of blood has been sequestered in thesequestration chamber3008. Thesampling channel3006 can be any sized, shaped or configured channel, or conduit. In some implementations, thesampling channel3006 has a substantially similar cross sectional area as the opening of theinlet port3002. In other implementations, thesampling channel3006 can gradually widen from theinlet port3002 to theoutlet port3004. Thesequestration chamber3008 may have a larger cross section to form a big reservoir toward the sequestration channel path so that the blood will want to enter the reservoir first versus entering a smaller diameter on thesampling channel3006.
• In some exemplary implementations, the diversion between thesampling channel3006 and thesequestration chamber3008 is by diverter junction3007. Diverter junction3007 may be a substantially Y-shaped, T-shaped, or U-shaped. In some preferred exemplary implementations, and as shown inFIG.17A-17B, the diverter junction3007 is configured such that the flow out of theinlet port3002 is preferentially directed toward thesequestration chamber3008. Thesequestration chamber3008 may also include or form a curve or ramp to direct the initial blood flow toward and into thesequestration chamber3008.
• Thesequestration chamber3008 is preferably maintained at atmospheric pressure, and includes a vent3010 at or near a distal end of thesequestration chamber3008. The vent3010 may include an airpermeable blood barrier3012 as described above.
• The blood sequestration device3000 can include ahousing3001 that can be formed of multiple parts or a single, unitary part. In some implementations, and as illustratedFIG.30F, thehousing3001 includes atop member3020 and abottom member3022 that are mated together. The blood sequestration device3000 can also include a gasket or other sealing member (not shown) so that when thetop member3020 is mechanically attached with thebottom member3022, the interface between the two is sealed by the gasket or sealing member. Thebottom member3022 can include grooves, channels, locks, conduits or other pathways pre-formed therein, such as by an injection molding process or by etching, cutting, drilling, etc., to form thesampling channel3006, thesequestration chamber3008, and diverter junction3007.
• Thesequestration chamber3008 may have a larger cross section than thesampling channel3006 so that the blood will preferentially move into the sequestration chamber first versus entering a smaller diameter on thesampling channel3006.
• In some implementations, thesampling channel3006 and thesequestration chamber3008 are formed by grooves, channels, locks or other pathways formed inhousing3001. Thehousing3001 can be made of rubber, plastic, metal or any other suitable material. Thehousing3001 can be formed of a clear or translucent material, or of an opaque or non-translucent material. In other implementations, thehousing3001 can be mostly opaque or non-translucent, while the housing surface directly adjacent to thesampling channel3006 and/or thesequestration chamber3008 may be clear or translucent, giving a practitioner a visual cue or sign that thesequestration chamber3008 is first filled to the extent necessary or desired, and/or then a visual cue or sign that the sequestered blood remains sequestered while a clean sample of blood is drawn through thesampling channel3006. Other visual cues or signs of the sequestration can include, without limitation: the airpermeable blood barrier3012 turning a different color upon contact, saturation, or partial saturation with blood; a color-coded tab or indicator at any point along or adjacent to the sequestration chamber; an audible signal; a vibratory signal; or other signal.
• The airpermeable blood barrier3012 can be covered with, or surrounded by, acap3032. Thecap3032 can be sized and configured to inhibit a user from touching the airpermeable blood barrier3012 with their finger or other external implement, while still allowing air to exit the airpermeable blood barrier3012 as the air is displaced from thesequestration chamber3008. Thecap3032 can be constructed to inhibit or prevent accidental exposure of the filter to environmental fluids or splashes. This can be accomplished in a variety of mechanical ways including but not limited to the addition of a hydrophobic membrane to the protective cover.
• The air venting mechanism includes awall3030 that at least partially circumscribes or surrounds the airpermeable blood barrier3012. Thewall3030 can have one or more air vents formed therein. Thecap3032 coverswall3030 and can be snapped, glued, or otherwise attached in place. Aseal3017 in the form of a silicone wafer, or other elastomeric material, fits within thewall3030 to cover the airpermeable blood barrier3012 and abut the top of thewall3030. Theseal3017 covers and seals the airpermeable blood barrier3012 and inhibits air from entering theblood sequestration chamber3008 through the airpermeable blood barrier3012. Afulcrum3012 on an underside of thecap3032 allows theseal3008 to flexibly disconnect from the top of the inner wall3016 when pushed by air displaced from theblood sequestration chamber3008, to allow air to vent from the airpermeable blood barrier3012 and through the one or more air vents in thewall3030 and/orcap3032.
• In use, the blood sequestration device3000 includes asampling channel3006 and asequestration chamber3008. Both pathways are initially air-filled at atmospheric pressure, but thesampling channel3006 is directed to anoutlet port3004 that will be initially sealed by a Vacutainer or other such sealed blood sampling device, and thesequestration chamber3008 terminates at a vent3010 to atmosphere that includes an airpermeable blood barrier3012.
• After a venipuncture by a patient needle of a patient (not shown), which could gather a number of pathogens from the patient's skin, a first amount of the patient's blood with those pathogens will pass throughinlet port3002 of blood sequestration device3000. This initial volume of potentially contaminated blood will preferentially flow into thesequestration chamber3008 by finding the path of least resistance. The patient's own blood pressure overcomes the atmospheric pressure in the ventedsequestration chamber3008 to displace air therein through the airpermeable blood barrier3012, but is not sufficient to overcome the air pressure that builds up in the sealedsampling channel3006. In various exemplary embodiments, thesequestration chamber3008 andsampling channel3006 can be configured such that the force generated by the patient's blood pressure is sufficient to overcome any effect of gravity, regardless of the blood sequestration device's orientation.
• Eventually, thesequestration chamber3008 fills with blood that displaces air through the airpermeable blood barrier3012. Once the blood contacts the air permeable blood barrier, the blood interacts with the airpermeable blood barrier3012 material to completely or partially seal the vent3010. A signal or indication may be provided that the practitioner can now utilize the Vacutainer or other blood sampling device.
• Upon filling theblood sequestration pathway3008 but prior to use of the Vacutainer or other blood sample collection device, the patient's blood pressure may drive compression of the air in thesampling channel3006, possibly resulting in a small amount of blood moving past the diversion point into thesampling channel3006, queuing up the uncontaminated blood to be drawn through thesampling channel3006.
• In yet another aspect, the blood sequestration chamber and/or blood sampling channel, or other component, of any of the implementations described herein, can provide a visually discernable warning or result in a component adapted for operative fluid communication with the flash chamber of an introducer for an intravenous catheter into a blood vessel of a patient. The device and method provides a visually discernable alert when blood from the patient communicates with a test component reactive to communicated blood plasma, to visually change. The reaction with the blood or the plasma occurs depending on one or a plurality of reagents positioned therein configured to test for blood contents, substances or threshold high or low levels thereof, to visually change in appearance upon a result.
• In yet other aspects, the blood sequestration chamber and/or blood sampling channel can be sized and adapted to provide a particular volumetric flow of blood, either during the sequestration process and/or the sampling process.
• Although a variety of embodiments have been described in detail above, other modifications are possible. Other embodiments may be within the scope of the following claims.

Claims (20)

1. A blood sequestration device comprising;

an inlet port;

an outlet port;

a sequestration chamber connected with the inlet port via a junction, the sequestration chamber having a vent that includes an air permeable blood barrier, the vent being defined by an outer wall that at least partially circumscribes the air permeable blood barrier and includes one or more air vents, the vent further including a cap that at least partially covers the wall and a one-way seal abutting the air permeable blood barrier that inhibits air from entering the sequestration chamber; and

a sampling channel having a proximal end connected with the inlet port via the junction, and a distal end connected with the outlet port;

the sequestration chamber, the sampling channel and the junction being sized and configured such that a first portion of blood flows into the sequestration chamber toward the air permeable blood barrier for sequestration therein, and a second portion of blood bypasses the sequestration chamber and the first portion of blood sequestered therein and is directed into the sampling channel toward the outlet port.

2. The blood sequestration device in accordance withclaim 1, further comprising a housing that houses and defines the inlet port, the outlet port, the sequestration chamber, and the sampling channel.

3. The blood sequestration device in accordance withclaim 1, wherein

the vent further includes an inner wall within the outer wall and that contains the air permeable blood barrier.

4. The blood sequestration device in accordance withclaim 1, wherein

the one-way seal is positioned over the inner wall and within the outer wall of the vent.

5. The blood sequestration device in accordance withclaim 4, wherein

the cap includes an inner surface that faces the air permeable blood barrier, the inner surface of the cap including a fulcrum against which the seal can flexibly unseal from the air permeable blood barrier to allow air to escape the sequestration chamber.

6. The blood sequestration device in accordance withclaim 1, wherein

the air permeable blood barrier includes a sealing material that seals the vent upon contact with blood.

7. The blood sequestration device in accordance withclaim 1, wherein

the air permeable blood barrier includes a filter having a first layer and a second layer, the second layer of the filter having a hydrophobic material to repel blood.

8. A blood sequestration and sampling system comprising;

a blood sampling pathway having a patient needle on a proximal end and a sample collection device on a distal end; and

a blood sequestration device attached on the blood sampling pathway between the proximal end and distal end of the blood sampling pathway, the blood sequestration device comprising:

an inlet port coupled with the blood sampling pathway toward the patient needle;

an outlet port coupled with the blood sampling pathway toward the sample collection device;

a sequestration chamber connected with the inlet port via a junction, the sequestration chamber having a vent that includes an air permeable blood barrier, the vent being defined by an outer wall that at least partially circumscribes the air permeable blood barrier and includes one or more air vents, the vent further including a cap that at least partially covers the wall and a one-way seal abutting the air permeable blood barrier that inhibits air from entering the sequestration chamber; and

a sampling channel having a proximal end connected with the inlet port via the junction, and a distal end connected with the outlet port;

the sequestration chamber, the sampling channel and the junction being sized and configured such that a first portion of blood flows into the sequestration chamber toward the air permeable blood barrier for sequestration therein, and a second portion of blood bypasses the sequestration chamber and the first portion of blood sequestered therein and is directed into the sampling channel toward the outlet port.

9. The blood sequestration system in accordance withclaim 8, wherein the blood sequestration device further comprises a housing that houses and defines the inlet port, the outlet port, the sequestration chamber, and the sampling channel.

10. The blood sequestration system in accordance withclaim 8, wherein the vent of the blood sequestration device further includes an inner wall within the outer wall and that contains the air permeable blood barrier.

11. The blood sequestration system in accordance withclaim 8, wherein the one-way seal of the vent is positioned over the inner wall and within the outer wall of the vent.

12. The blood sequestration system in accordance withclaim 11, wherein the cap includes an inner surface that faces the air permeable blood barrier, the inner surface of the cap including a fulcrum against which the seal can flexibly unseal from the air permeable blood barrier to allow air to escape the sequestration chamber.

13. The blood sequestration system in accordance withclaim 8, wherein the air permeable blood barrier of the blood sequestration device includes a sealing material that seals the vent upon contact with blood.

14. The blood sequestration system in accordance withclaim 8, wherein the air permeable blood barrier of the blood sequestration device includes a filter having a first layer and a second layer, the second layer of the filter having a hydrophobic material to repel blood.

15. A blood sequestration device comprising;

an inlet port;

an outlet port;

a sequestration chamber connected with the inlet port via a junction, the sequestration chamber having a vent that includes an air permeable blood barrier, the vent being defined by an outer wall that at least partially circumscribes the air permeable blood barrier and includes one or more air vents, the vent further including a cap that at least partially covers the wall and a one-way seal abutting the air permeable blood barrier that inhibits air from entering the sequestration chamber; and

a sampling channel having a proximal end connected with the inlet port via the junction, and a distal end connected with the outlet port;

the sequestration chamber, the sampling channel and the junction being sized and configured such that a first portion of blood flows into and fills the sequestration chamber to displace air therein through the vent, and such that a second portion of blood bypasses the sequestration chamber and the first portion of blood sequestered therein and is directed into the sampling channel toward the outlet port.

16. The blood sequestration device in accordance withclaim 15, further comprising a housing that houses and defines the inlet port, the outlet port, the sequestration chamber, and the sampling channel.

17. The blood sequestration device in accordance withclaim 15, wherein the vent further includes an inner wall within the outer wall and that contains the air permeable blood barrier.

18. The blood sequestration device in accordance withclaim 15, wherein the one-way seal is positioned over the inner wall and within the outer wall of the vent.

19. The blood sequestration device in accordance withclaim 18, wherein the cap includes an inner surface that faces the air permeable blood barrier, the inner surface of the cap including a fulcrum against which the seal can flexibly unseal from the air permeable blood barrier to allow air to escape the sequestration chamber.

20. The blood sequestration device in accordance withclaim 15, wherein the air permeable blood barrier includes a sealing material that seals the vent upon contact with blood.

Images