WO2025199432A1 - Blood draw device with attached microfluidic device for blood coagulation testing - Google Patents

Abstract

A system for blood sampling and testing includes a catheter assembly having an IV catheter and an access port. A blood draw device is coupled to the access port, with the blood draw device including a catheter tube, a housing that movably receives the catheter tube and has a distal end portion coupleable to the catheter assembly, and an advancement member configured to move relative to the housing to move the catheter tube between first and second positions, to enable a distal end of the catheter tube to be disposed within or past a distal tip of the IV catheter. A coagulation testing device is attached to the blood draw device so as to be positioned proximal to the housing and in fluid communication with the catheter tube, to directly receive a sample of blood from the blood draw device when the catheter tube is in the second position.

Description

Attorney Docket No. 09846-2500934 (P-28838.WO01) BLOOD DRAW DEVICE WITH ATTACHED MICROFLUIDIC DEVICE FOR BLOOD COAGULATION TESTING CROSS-REFERENCE TO RELATED APPLICATION [0001] The present application claims priority to United States Provisional Patent Application No. 63/568,699 entitled “Blood Draw Device with Attached Microfluidic Device for Blood Coagulation Testing” filed March 22, 2024, the disclosure of which is hereby incorporated by reference in its entirety. BACKGROUND OF THE INVENTION Field of the Invention [0002] The present disclosure relates generally to blood draw devices for use with intravenous (IV) catheters and, more specifically, to microfluidic human blood coagulation testing devices attachable to such blood draw devices that provide a point-of-care (POC) testing solution. Background of the Invention [0003] Heparin anticoagulation therapy is a cornerstone of surgical and cardiovascular medicine because of its short half-life, easy reversibility, and low cost. Heparin is used prophylactically in angiography, coronary bypass, cannulation, and extracorporeal membrane oxygenation as well as therapeutically for thromboses, with over 500 million doses given annually worldwide. [0004] One challenge associated with heparin therapy is that heparin has a narrow therapeutic window (e.g., international normalized ratio (2-3 INR) of coagulation time for the blood sample) within which it is safe and effective. The challenge of staying within the therapeutic window during heparin therapy is especially challenging in pediatric patients because of their rapidly changing hemostasis system, therapy guidelines being based on adults, and challenges in collecting sufficient blood volumes. Resulting from these challenges, it is recognized that there is a relatively high occurrence of ICU medication errors associated with heparin therapy. By some estimates, US patients on heparin therapy remain in the therapeutic range only about 64% of the time, while those in developing countries are in the therapeutic range only about 40% of the time (due to less frequent testing). It is recognized that ICU medication errors in heparin therapy and the inability to stay within the desired therapeutic Page 1 of 23 62Q3056.DOCX Attorney Docket No. 09846-2500934 (P-28838.WO01) window may result in overly aggressive anticoagulation (which increases the risk of bleeding) or insufficient coagulation (which increases the risk of ischemic events). [0005] Based on the above, there is a strong thrust on developing microfluidic devices for point-of-care (POC) blood coagulation testing that provide timely information about a patient's hemostasis status during/after heparin therapy. The current industry standard is for such POC blood coagulation testing to be performed by collecting a blood sample via finger prick, with the collected blood then tested by a dedicated readout device that includes an electrochemical sensor-based strip. This method of blood coagulation testing includes several known drawbacks, including: the need to perform a finger prick at every measurement cycle, subjectivity during sample loading onto the electrochemical sensor-based strip, the exposing of the blood sample to the outside environment, and/or the risk of infection to healthcare providers (in hospital settings) and caregivers (in homecare settings) when performing the finger prick. Additionally, most POC devices are assigned to only a single patient and cannot be used for multiple patients, in order to avoid cross-contamination risk. [0006] Other known blood coagulation testing devices and methods include use of a vacutainer (coated with anticoagulant) to collect and store a blood sample, which is then sent to a lab for analysis. At the lab, the anticoagulant treated blood sample may be mixed with Ca2+ ions (to negate the effect of anticoagulant) and then subsequently analyzed to measure clotting parameters. This is recognized as a time-consuming and workflow-heavy process that requires many disposable devices and numerous pre-analytical steps to complete the testing. [0007] Accordingly, there is a need to develop a real-time and minimally-invasive system to frequently monitor anti-coagulation therapy effect, to provide an improved standard of care for a patient. The system would enable the acquisition of a blood sample from an indwelling IV catheter, so as to eliminate the needle for multiple finger pricks for sample acquisition. The blood sample could be provided to an on-site blood coagulation measurement device as part of a closed sample acquisition and testing system, so as to prevent blood exposure during testing. The system would reduce the workflow steps and/or capital equipment costs associated with blood coagulation testing done at pathology labs or with existing dedicated POC readout devices, thereby reducing costs, providing faster turn-around time, and reducing the risk of manual pre-analytical errors. SUMMARY OF THE INVENTION [0008] Provided herein is a system for blood sampling and testing that includes a catheter assembly having an IV catheter and a near patient access port. The system also includes a Page 2 of 23 62Q3056.DOCX Attorney Docket No. 09846-2500934 (P-28838.WO01) blood draw device coupled to the near patient access port, with the blood draw device further including a catheter tube, an introducer housing defining an inner volume configured to movably receive the catheter tube and having a proximal end portion and a distal end portion coupleable to the catheter assembly, and an advancement member configured to move relative to the introducer housing to move the catheter tube between a first position, in which the catheter tube is disposed within the introducer housing, and a second position, in which a distal end portion of the catheter tube is disposed beyond a distal end portion of the introducer housing, such that at least a first portion of the catheter tube may be disposed within the indwelling IV catheter or past a distal tip thereof. The system further includes a coagulation testing device attached to the blood draw device so as to be positioned proximal to the introducer housing and in fluid communication with the catheter tube, to directly receive a sample of blood from the blood draw device when the catheter tube is in the second position. [0009] In some embodiments, the blood draw device includes a secondary catheter coupled to the advancement member and extending out proximally therefrom and out the proximal end portion of the introducer housing, the secondary catheter fluidly connecting the catheter tube and the coagulation testing device, and a coupler connected to a proximal end of the secondary catheter, and wherein the coagulation testing device is connected to the secondary catheter via the coupler. [0010] In some embodiments, the blood draw device includes a clamp positioned on the secondary catheter and operable in a closed position and an open position to selectively control a flow of blood through the secondary catheter, from the catheter tube to the coagulation testing device. [0011] In some embodiments, the coagulation testing device includes a housing comprising a first end and a second end and defining an interior housing volume, a microfluidic channel positioned within the interior housing volume, a connector connected to the first end of the housing and configured to mate with the coupler to fluidly connect the microfluidic channel to the secondary catheter, and a pressure control positioned within an opening in the second end of the housing and configured to control an internal pressure within the interior housing volume, wherein the pressure control selectively balances the internal pressure to atmospheric pressure to control an aspiration of blood into the microfluidic channel. [0012] In some embodiments, the connector of the coagulation testing device comprises a venting feature configured to vent air in the coagulation testing device. Page 3 of 23 62Q3056.DOCX Attorney Docket No. 09846-2500934 (P-28838.WO01) [0013] In some embodiments, the pressure control comprises a hydrophobic membrane having a lid positioned thereover, the lid moveable between open and closed positions to control the internal pressure within the interior housing volume. [0014] In some embodiments, the coagulation testing device comprises an analog scale provided on the housing configured to indicate international normalized ratio (INR) representative of a coagulation time of the blood sample. [0015] In some embodiments, the coagulation testing device comprises a digital display attached to the housing, the digital display receiving one or more readings of the blood sample in the microfluidic channel and configured to indicate an international normalized ratio (INR) representative of a coagulation time of the blood sample. [0016] In some embodiments, the digital display receives the one or more readings of the blood sample via a measurement device included in the coagulation testing device, the measurement device comprising one of an optical measurement device, an electrode-based measurement device, or an ultrasonic measurement device. [0017] In some embodiments, the digital display is selectively attachable and removable from the housing, to enable reuse of the digital display and disposal of a remainder of the coagulation testing device. [0018] In some embodiments, the connector of the coagulation testing device comprises a male luer connection and the coupler comprises a female luer connection. [0019] In some embodiments, the distal end portion of the introducer housing comprises a lock configured to couple the introducer housing to the access port. [0020] Also provided is a system for blood sampling and testing that includes a catheter assembly having an IV catheter and a near patient access port. The system also includes a blood draw device coupled to the near patient access port, with the blood draw device further including a catheter tube, an introducer housing defining an inner volume configured to movably receive the catheter tube and having a proximal end portion and a distal end portion coupleable to the catheter assembly, and an advancement member configured to move relative to the introducer housing to move the catheter tube between a first position, in which the catheter tube is disposed within the introducer housing, and a second position, in which a distal end portion of the catheter tube is disposed beyond a distal end portion of the introducer housing, such that at least a first portion of the catheter tube may be disposed within the indwelling IV catheter or past a distal tip thereof. The system further includes a coagulation testing device attached to the blood draw device so as to be positioned proximal to the introducer housing and in fluid communication with the catheter tube, to directly receive a Page 4 of 23 62Q3056.DOCX Attorney Docket No. 09846-2500934 (P-28838.WO01) sample of blood from the blood draw device when the catheter tube is in the second position. The system still further include a dropper attached to the blood draw device so as to be positioned proximal to the introducer housing and in fluid communication with the catheter tube, to directly receive a sample of blood from the blood draw device when the catheter tube is in the second position; wherein the dropper is configured to collect the sample of blood and is actuatable to dispense one or more drops of blood therefrom. [0021] In some embodiments, the dropper includes a housing comprising a first end and a second end and defining an interior housing volume, a capillary tube projection positioned at the first end of the housing and in fluid communication with the interior housing volume, and a deformable bulb positioned at the second end of the housing, the deformable bulb actuatable to force the one or more drops of blood out from the interior housing volume and through the capillary tube projection. [0022] In some embodiments, the blood draw device includes a secondary catheter coupled to the advancement member and extending out proximally therefrom and out the proximal end portion of the introducer housing, the secondary catheter fluidly connecting the catheter tube and the dropper; and a coupler connected to a proximal end of the secondary catheter, and wherein the dropper is connected to the secondary catheter via the coupler. [0023] In some embodiments, the blood draw device comprises a clamp positioned on the secondary catheter and operable in a closed position and an open position to selectively control a flow of blood through the secondary catheter, from the catheter tube to the dropper. [0024] In some embodiments, the dropper further comprises a connector positioned on a sidewall of the housing, between the first and second ends, the connector configured to mate with the coupler to fluidly connect the dropper to the secondary catheter. [0025] In some embodiments, the connector comprises a male luer connection and the coupler comprises a female luer connection. [0026] In some embodiments, the system further includes a point-of-care (POC) diagnostic test cartridge including a test strip, the test strip configured to receive the one or more drops of blood from the dropper. [0027] In some embodiments, the POC diagnostic test cartridge comprises a blood coagulation testing device configured to determine a coagulation parameters of the sample of blood. Page 5 of 23 62Q3056.DOCX Attorney Docket No. 09846-2500934 (P-28838.WO01) BRIEF DESCRIPTION OF THE INVENTION [0028] FIG.1 is a perspective view of a system for improved blood sampling and coagulation testing, in accordance with an aspect of the disclosure; [0029] FIG. 2 is a perspective view of a blood draw device and blood coagulation testing device included in the system of FIG. 1, in accordance with an aspect of the disclosure; [0030] FIG. 3 is an exploded view of the blood draw device and testing device of FIG. 2; [0031] FIG. 4 is a side view of the blood draw device and testing device of FIG. 2, showing the catheter tube in a first, retracted position; [0032] FIG. 5 is a side view of the blood draw device and testing device of FIG. 2, showing the catheter tube in a second, extended position; [0033] FIG. 6 is a detailed view of the coagulation testing device of FIG. 2, with an analog read-out, in accordance with an aspect of the disclosure; [0034] FIG. 7 is a detailed view of the coagulation testing device of FIG. 2, with a digital read-out, in accordance with another aspect of the disclosure; [0035] FIG. 8 is a perspective view of a system for improved blood sampling for point-of- care coagulation testing, in accordance with another aspect of the disclosure; [0036] FIG. 9 is a detailed view of a dropper-type blood collection device and point-of-care (POC) testing device included in the system of FIG. 8; and [0037] FIG.10 is a perspective view of a blood draw device and connected blood coagulation testing device, in accordance with another aspect of the disclosure. DESCRIPTION OF THE INVENTION [0038] The following description is provided to enable those skilled in the art to make and use the described embodiments contemplated for carrying out the invention. Various modifications, equivalents, variations, and alternatives, however, will remain readily apparent to those skilled in the art. Any and all such modifications, variations, equivalents, and alternatives are intended to fall within the spirit and scope of the present invention. [0039] As used in this specification, the words "proximal" and "distal" refer to the direction closer to and away from, respectively, a user who would place the device into contact with a patient. Thus, for example, the end of a device first touching the body of the patient would be the distal end, while the opposite end of the device (e.g., the end of the device being manipulated by the user) would be the proximal end of the device. Page 6 of 23 62Q3056.DOCX Attorney Docket No. 09846-2500934 (P-28838.WO01) [0040] Spatial or directional terms, such as “left”, “right”, “inner”, “outer”, “above”, “below”, and the like, are not to be considered as limiting as the invention can assume various alternative orientations. [0041] For purposes of the description hereinafter, the terms “upper”, “lower”, “right”, “left”, “vertical”, “horizontal”, “top”, “bottom”, “lateral”, “longitudinal”, and derivatives thereof shall relate to the invention as it is oriented in the drawing figures. However, it is to be understood that the invention may assume various alternative variations, except where expressly specified to the contrary. It is also to be understood that the specific devices illustrated in the attached drawings, and described in the following specification, are simply exemplary aspects of the invention. [0042] The terms “first”, “second”, and the like are not intended to refer to any particular order or chronology, but refer to different conditions, properties, or elements. [0043] As used herein, “at least one of” is synonymous with “one or more of”. For example, the phrase “at least one of A, B, and C” means any one of A, B, or C, or any combination of any two or more of A, B, or C. For example, “at least one of A, B, and C” includes one or more of A alone; or one or more of B alone; or one or more of C alone; or one or more of A and one or more of B; or one or more of A and one or more of C; or one or more of B and one or more of C; or one or more of all of A, B, and C. [0044] The present invention is directed to a system having a blood draw device (alternatively, “line draw device”) to advance a blood draw catheter tube into an indwelling IV catheter and subsequently draw a blood sample from a patient, with the sample being provide to a microfluidic coagulant testing devices attachable to the blood draw device, so as to provide a closed-system POC testing solution. [0045] Referring to FIG. 1, shown is a non-limiting embodiment of a system 10 for facilitating improved blood sampling and coagulation testing. System 10 may include a catheter assembly 12 having a catheter adapter 14 and associated IV catheter 16. The catheter adapter 14 may include a distal end 18 and a proximal end 20. In some embodiments, the catheter adapter 14 may include an additional adapter port 22 that may disposed between the distal end 18 and the proximal end 20 or disposed at the proximal end 20. The catheter adapter 14 may include a first lumen 24 extending through the distal end 18 and the proximal end 20, and the first lumen 24 may be sealed at proximal end 20 of catheter adapter 14. The IV catheter 16 may be formed of any suitable material and may be of any useful length, as known to those of skill in the art. IV catheter 16 extends from the distal end 18 of catheter adapter 14 and may be configured as an IV catheter (hereafter “IV catheter 16”) that is placed into the vasculature Page 7 of 23 62Q3056.DOCX Attorney Docket No. 09846-2500934 (P-28838.WO01) of the patient, with a distal end or tip 26 of the IV catheter 16 positioned appropriately within a vein 28 to enable a blood draw from the patient. [0046] In some non-limiting embodiments or aspects, the catheter assembly 12 may include a first fluid conduit 30 extending from the port 22. First fluid conduit 30 may be formed of any suitable material known to those of skill in the art and may have a distal end and a proximal end. The distal end of first fluid conduit 30 is coupled to port 22, while the proximal end of first fluid conduit 30 may be coupled to a connector 36. Connector 36 may be a t-connector (e.g., one side port arranged at a 90 degree angle relative to a longitudinal axis of connector 36), a y-connector (e.g., one side port arranged at a 25, a 60, or a 75 degree angle relative to a longitudinal axis of connector 36), or any other type of connector known in the art. The connector 36 includes a second lumen 38 therethrough, having any number of branches suitable for the type of connector. [0047] In some non-limiting embodiments or aspects, catheter assembly 12 may include a needleless access connector 46 coupled to a proximal end of connector 36, with the needleless access connector 46 providing an access port to the catheter assembly 12. The needleless access connector 46 may be configured as a split-septum connector or self-healing septum connector, as examples. In the illustrated embodiment, the access port provided by needleless access connector 46 is a near-patient access port close to the insertion site of the IV catheter 16, but it is recognized that an access port could be provided at other alternative locations close enough to the insertion site that allow for advancement of a blood draw catheter tube into the indwelling IV catheter 16 and out beyond the distal tip thereof. For example, an access port that provides for advancement of a blood draw catheter tube into the indwelling IV catheter 16 could be located on another connector, such as a proximal connector on an extension set (as described below) of the catheter assembly 12. [0048] System 10 further includes a blood draw device 60 (alternatively, “line draw device”) that may be operated to obtain a blood sample from the patient, with such a blood sample enabling coagulation testing of the blood sample, for example. As shown in FIG. 1 and in further detail in FIGS. 2-5, according to a non-limiting embodiment, the blood draw device 60 includes at least an introducer housing 62, a coupling device 64, a catheter tube 66, and an advancement member 68. As will be described in further detail below, the catheter tube 66 is moveable within the introducer housing 62 so as to provide for advancement of a portion of the catheter tube 66 from a first or retracted position inside the introducer housing 62 (FIG. 4) to a second or advanced position outside of the introducer housing 62 (FIG. 5), such that a distal end thereof may be routed into the catheter assembly 12. Once a portion of the catheter Page 8 of 23 62Q3056.DOCX Attorney Docket No. 09846-2500934 (P-28838.WO01) tube 66 has been routed into the catheter assembly 12 and adjacent to or out past the distal tip 26 of indwelling IV catheter 16, the catheter tube 66 may enable collection of a blood sample. [0049] According to embodiments, the catheter tube 66 is sized to enable introduction thereof into the fluid path (i.e., into a lumen of IV catheter 16, lumen 24 of catheter adapter 14, and first fluid conduit 30) of catheter assembly 12 and for advancement therethrough. Accordingly, the catheter tube 66 can have an outer diameter (e.g., between a 10-gauge and a 30-gauge) that is smaller than the smallest lumen of the catheter assembly fluid path. The catheter tube 66 can have a length that is sufficient to place a distal end 70 of the catheter tube 66 in a desired position within the fluid path of the system 10. Thus, in one embodiment, the catheter tube 66 may have a length sufficient to provide for advancement of the distal end 70 thereof out from the introducer housing 62 and through the catheter assembly (i.e., through connector 36, fluid conduit 30, catheter adapter 14 and IV catheter 16), and all the way out past the distal tip 26 of IV catheter 16. [0050] In some embodiments, and in order to accommodate positioning of the catheter tube 66 within IV catheter 16 and advancement thereof out past the distal tip 26 of IV catheter 16, the distal end 26 of the IV catheter 16 may include fenestrations formed therein. The fenestrations at the distal end 26 of the IV catheter 16 serve to maintain fluid continuity from the vein and through the IV catheter 16 - i.e., the fenestrations prevent catheter tube 66 from occluding the IV catheter 16 at the distal tip 26 thereof. [0051] As shown in FIGS.2-5, the introducer housing 62 of blood draw device 60 can be an elongate member having a proximal end 72 and a distal end 74 and defining an inner volume 76. In some embodiments, the introducer housing 62 may be formed of a pair of housing portions that are coupled together to define the inner volume 76. The introducer housing 62 may include one or more features or surface finishes on an outer surface thereof that can be arranged to increase the ergonomics of the blood draw device 60, which in some instances can allow a user to manipulate the blood draw device 60 with one hand (i.e., single-handed use). [0052] The coupling device 64 of blood draw device 60 is provided at the distal end 74 of the introducer housing 62, with the coupling device 64 providing for reversible coupling of the blood draw device 60 to catheter assembly 12, such as via needleless access connector 46 as shown in FIG.1. In some embodiments, the coupling device 64 is configured as a lock 80 that includes a blunted cannula 82 and locking arms 84 for coupling to the needleless access connector 46 of catheter assembly 12, with the blunted cannula 82 and locking arms 84 forming three points of contact therewith. However, those of skill will appreciate that any connection Page 9 of 23 62Q3056.DOCX Attorney Docket No. 09846-2500934 (P-28838.WO01) or coupling, for example a luer, can be used, so long as the distal end 70 of catheter tube 66 may pass through the coupling device 64 to catheter assembly 12. [0053] The advancement member 68 of blood draw device 60 includes a first portion 86 and a second portion 88. The first portion 86 is movably disposed along an upper surface 90 of the introducer housing 62 and the second portion 88 is movably disposed within the inner volume 76 of the introducer housing 62. The arrangement of the advancement member 68 and the introducer housing 62 is such that a connecting portion (not shown) of the advancement member 68 that joins the first and second portions 86, 88 is seated within a slot 92 formed in the upper surface 90 of the introducer housing 62 – the slot 92 generally extending between the proximal and distal ends 72, 74 of the introducer housing 62. As the first and second portions 86, 88 are joined together, movement of the first portion 86 along the upper surface 90 of the introducer housing 62 results in a corresponding movement of the second portion 88 within the inner volume 76. [0054] As shown in FIGS. 2-5, the first portion 86 of the advancement member 68 may be configured as a tab or tab having a contact surface 94a engageable by a user and an underside 94b that is in contact with the outer surface 90 of the introducer housing 62. In such embodiments, the upper surface 90 of the introducer housing 62 can include a track 96, for example, a set of ribs, ridges, bumps, grooves, and/or the like along which the underside 94b of tab or protrusion advances when the advancement member 68 is engaged by a user. In this manner, a user can engage the first portion 86 of the advancement member 68 and can move the advancement member 68 relative to the introducer housing 62. [0055] As shown in FIGS. 2-5, the second portion 88 includes an opening 98 extending therethrough that is configured to grip or retain a portion of the catheter tube 66. Due to a portion of the catheter tube 66 being retained within the opening 98 of second portion, 94, movement of the advancement member 68 relative to introducer housing 62 causes a corresponding movement of the catheter tube 66 relative to the introducer housing 62. In this manner, the distal end 70 of the catheter tube 66 can be selectively moved out of or back into the inner volume 76 of the introducer housing 62 as desired, such as advancing the distal end 70 of the catheter tube 66 out of the introducer housing 62 when the blood draw device 60 has been coupled to the catheter assembly 12 and collection of an arterial blood sample is to be performed. [0056] As further shown in FIGS. 2-5, blood collection device 60 includes a secondary catheter 102 provided at the proximal end 72 of the introducer housing 62. The secondary catheter 102 has a proximal end portion 104 and a distal end portion 106 and defines a lumen Page 10 of 23 62Q3056.DOCX Attorney Docket No. 09846-2500934 (P-28838.WO01) 108. A portion of the secondary catheter 102 is disposed within and extends through an opening 110 formed in the proximal end 72 of introducer housing 62. As such, the proximal end portion 104 is at least partially disposed outside of the introducer housing 62 and the distal end portion 106 is at least partially disposed within the introducer housing 62, with the distal end portion 106 coupled to the second portion 88 of the advancement member 68. In some embodiments, the secondary catheter 102 can have a larger diameter than the catheter tube 66, which can function to limit, reduce, and/or substantially prevent hemolysis of a volume of blood as the volume of blood flows through the catheter 66 and the secondary catheter 102. [0057] According to embodiments of the disclosure, a clamp 112 is positioned on the secondary catheter 102 that is operable to selectively enable blood flow along a length of the secondary catheter 102 from the distal end portion 106 to the proximal end portion 104. That is, the clamp 112 may be actuatable between a closed position in which the clamp 112 stops blood flow through the clamped portion of the secondary catheter 102 and an open position in which the clamp 112 allows blood flow through the clamped portion of the secondary catheter 102. In some embodiments, the clamp 112 may be configured such that the default position thereof is the closed position. [0058] According to embodiments of the disclosure, the proximal end portion 104 of the secondary catheter 102 is coupled to and/or otherwise includes a coupler 114 configured to mate with a coagulation testing device 116 that is useable with (or is considered part of) the blood draw device 60 to perform a coagulation test on the blood sample. That is, the coagulation testing device 116 may determine and indicate a prothrombin time (PT) international normalized ratio (INR) or “PT/INR” – hereafter, simply “INR” - representative of a coagulation time of the blood sample. According to some embodiments, the coupler 114 may be configured as a luer connection (i.e., a female luer connection) configured to mate with a corresponding luer connection (i.e., a male luer connection) of the testing device 116, to physically and fluidically couple the secondary catheter 102 to the testing device 116, which as described further here below, may be a number of suitable point-of-care (POC) blood coagulation testing devices 116. [0059] As shown in more detail in FIGS. 2 and 6, in accordance with one aspect of the disclosure, the coagulation testing device 116 connected to blood draw device 60 (via coupler 114) is configured as an analog testing device that requires no processing and/or power components. The coagulation testing device 116 includes a housing 118, a connector 120 provided on the housing 118, a microfluidic channel 122 positioned within an interior volume of the housing 118, and a pressure control 124 positioned on the housing 118. Page 11 of 23 62Q3056.DOCX Attorney Docket No. 09846-2500934 (P-28838.WO01) [0060] According to some embodiments, the housing 118 may be configured as a rectangular housing that includes opposing first and second ends 126, 128 and side surfaces 130 provided between the first and second ends 126, 128, with the housing 118 defining an interior housing volume 132. The first end 126 includes the connector 120 thereon, with the connector 120 configured to mechanically and fluidly connect the testing device 116 to the blood draw device 60. In some embodiments, the connector 120 comprises a male luer connection (including a rotatable collar and tapered stem) that mates with the coupler 114, which may comprise a female luer connection. In some embodiments, the connector 120 may also include a venting feature 134 formed thereon (e.g., a hydrophobic membrane positioned over an opening) that is configured to vent the coagulation testing device 116 prior to transmission/delivery of a blood sample thereto. In some embodiments, the connector 120 is coated internally with a pro-coagulant agent (e.g., thromboplastin) to facilitate coagulation, when blood fills-in to the region of the connector 120 and is retained there prior to being allowed to flow into housing 118, as described below. [0061] The second end 128 of housing 118 includes the pressure control 124 thereon, which functions to selectively control an internal pressure within the interior housing volume 132 once a sample of blood has been collected proximal to the clamp 112 (i.e., within secondary catheter 102, between the clamp 112 and the testing device 116). The pressure control 124 may include a hydrophobic membrane 136 positioned over an opening 138 formed in the second end 128, along with a lid 140 positioned over the hydrophobic membrane 136 that is moveable between open and closed positions. With the lid 140 movable between open and closed positions, the hydrophobic membrane 136 may be selectively exposed to the ambient surrounding to control the internal pressure within the interior housing volume 132. That is, via the hydrophobic membrane 136, the internal pressure within the interior housing volume 132 may be brought to atmospheric pressure to control an aspiration of blood into the microfluidic channel 122. [0062] The microfluidic channel 122 is provided within the interior housing volume 132 and may be visible through the housing 118 (which may be formed of a transparent rigid polymeric material, for example). The microfluidic channel 122 may be formed by a length of capillary tubing 142 that is arranged in a serpentine pattern within the interior housing volume 132. The capillary tubing 142 is connected at a first end thereof to the connector 120, such that the microfluidic channel 122 is placed in fluid communication with the secondary catheter 102 (through mating of the coupler 114 and connector 120). The capillary tubing 142 then proceeds from its first end along a serpentine path to its second end, which is fluidly connected to the Page 12 of 23 62Q3056.DOCX Attorney Docket No. 09846-2500934 (P-28838.WO01) opening 138 in the second end of housing 118 adjacent the hydrophobic membrane 136. With the second end of capillary tubing 142 in fluid communication with the opening 138 and hydrophobic membrane 136, opening of the lid 140 of pressure member causes a change in pressure within the microfluidic channel 122 – thereby causing at least a portion of a blood sample to be aspirated into the microfluidic channel 122. As understood in the art, the distance that the blood travels through the microfluidic channel 122 is dependent (at least in part) on the coagulation properties of the blood. [0063] In accordance with one aspect of the disclosure, and as shown in FIG. 6, the side surface 130 of the housing 118 includes markings and numbering thereon that provide an analog scale 144 by which the coagulation testing device can measure the coagulation properties of the blood. The analog scale 144 is aligned with the path of the microfluidic channel 122, such as with numbering increasing along the side surface of the housing 118 from the first end 126 to the second end 128. The analog scale 144 provided on the housing 118 is configured to indicate an international normalized ratio (INR) representative of a coagulation time/property of the blood sample, with the distance that the blood travels through the microfluidic channel 122 corresponding to a specified INR value. [0064] In accordance with another aspect of the disclosure, and as shown in FIG. 7, the coagulation testing device 116 may further include a digital display 146 in addition to or in substitute of the analog scale 144. The digital display 146 may be attached to the side surface 130 of the housing 118, such as in an area that does not cover the path of the microfluidic channel 122 and/or the markings and numbering on housing 118. The digital display 146 is configured to indicate the INR value representative of a coagulation time/property of the blood sample. The digital display 146 may receive and process one or more readings of the blood sample in the microfluidic channel 122. According to embodiments, the digital display 146 may receive the readings of the blood sample via a measurement device 148 included in the coagulation testing device, with the measurement device 148 comprising one of an optical measurement device, an electrode-based measurement device, an electrode-based measurement device, or an ultrasonic measurement device, as non-limiting examples. [0065] An optical measurement device may illuminate the microfluidic channel 122 and capture/process an image of blood fill in the capillary tubing 142 – with the optical measurement device determining the amount of blood fill in the capillary tubing 142 based on a color difference between the blood-filled portion and the air-filled portion in the microfluidic channel 122, so as to enable determination of the INR value. Page 13 of 23 62Q3056.DOCX Attorney Docket No. 09846-2500934 (P-28838.WO01) [0066] An electrode-based measurement device may operate to measure changes in voltage/current of the microfluidic channel 122 based on variation in resistance between the blood-filled portion and the air-filled portion in the microfluidic channel 122. [0067] A capacitance-based measurement device may operate to measure changes in capacitance of the microfluidic channel 122 based on variation in the dielectric constant between the blood-filled portion and the air-filled portion in the microfluidic channel 122. [0068] In some embodiments, the digital display 146 is selectively attachable and removable from the housing 118. For example, the digital display 146 may be applied to the side surface 130 of housing 118 via an adhesive or may be secured to the housing 118 via a clip-in type attachment. With the digital display 146 being selectively attachable and removable from the housing 118, the digital display 146 may be removed from the housing 118 prior to disposal of the coagulation testing device (after completion of a coagulation test), such that the digital display 146 may be retained for future use with another coagulation testing device. [0069] Referring still to FIGS. 1-7, operation of the system 10 for purposes of acquiring a blood sample and performing coagulation testing thereon is now described in further detail. [0070] In an initial step, the blood draw device 60 is connected to a vascular access device 12 that has previously been placed within the vasculature of a patient. In some embodiments, a distal connector 46 of the blood draw device 60 that includes a blunted cannula 82 and locking arms 84 is connected to a catheter connector 36 (with, for example, a needle-free connector 46) of the vascular access device 12 to mechanically and fluidly connect the blood draw device 60 to the vascular access device 12. [0071] Upon connection of the blood draw device 60 to the vascular access device 12, the advancement member 48 may be actuated distally to push the catheter tube 66 distally out from the blood draw device 60 and into the IV catheter 16. The advancement member 68 is advanced until the catheter tube 66 has reached the second position, such that the distal end 70 of the catheter tube 66 is positioned adjacent or out past the distal end of the IV catheter 16. [0072] With the catheter tube 66 advanced to the desired second position, the coagulation testing device 116 is then connected to the coupler 114 of blood draw device 60. After attachment of the coagulation testing device 116, the clamp 112 on secondary catheter 102 may be actuated from its closed position to its open position, to allow for a flow of blood through the secondary catheter 102 to the coupler 114 and the connector 120 of coagulation testing device 116. The clamp 112 is then actuated back from its open position to its closed position, preventing a flow of additional blood to the coagulation testing device 116 – thereby providing Page 14 of 23 62Q3056.DOCX Attorney Docket No. 09846-2500934 (P-28838.WO01) a limited “blood sample” proximal to clamp 112 that is to be tested by coagulation testing device 116. [0073] With the desired blood sample provided proximal to clamp 112, the lid 140 of coagulation testing device 116 that is positioned over the hydrophilic membrane 136 is then opened. Upon opening of the lid 140, at least a portion of the blood sample is caused to flow/aspirate into the microfluidic channel 122 of the coagulation testing device 116 as the internal pressure of the coagulation testing device 116 is balanced to atmospheric pressure. Blood thus enters the microfluidic channel 122 and travels a certain distance through the microfluidic channel 122 based on the coagulation properties of the blood. The analog scale 144 on the coagulation testing device 116 (i.e., the markings and numerical indicators on the housing 118 that are provided along the path of the microfluidic channel 122) indicates a INR value for the blood sample based on the travel distance of the blood through the microfluidic channel 122, thereby providing a visual output to a healthcare provider of the coagulation testing. [0074] Beneficially, as the blood sample tested by coagulation testing device 116 is obtained directly from the blood draw device 60 in a closed system arrangement, exposure of the blood sample to the outside/ambient environment is prevented/eliminated, so as to minimize the risk of contaminates negatively affecting testing of the blood. [0075] Referring now to FIGS. 8 and 9, a system 150 for facilitating improved blood sampling and coagulation testing is shown in accordance with another aspect of the disclosure. In system 150, the structure of blood draw device 60 is identical to that of system 10 shown in FIGS. 1-7 (and the blood draw device 60 may be connected to vascular access device 12 in the same manner), and thus like members are labeled identically in system 150. However, as provided in detail here below, the coagulation testing device 116 of system 10 is replaced by a dropper-type blood collection device 152 (hereafter “dropper 152”) in system 150. The dropper 152 is operable to collect a sample of blood from blood draw device 60 and provide for a controlled dispensing of the blood sample to a separate testing device, such as a point-of-care (POC) diagnostic test cartridge, as a non-limiting example. [0076] As shown in FIG. 8, the dropper 152 is attached to the blood draw device 60 so as to be positioned proximal to the introducer housing 62 and in fluid communication with the catheter tube 66 (via secondary catheter 102). The dropper 152 is thus able to directly receive a sample of blood from the blood draw device 60 when the catheter tube 66 is in the second position, with the dropper 152 configured to collect the sample of blood and being actuatable to dispense one or more drops of blood therefrom. The dropper 152 includes a housing 154, a Page 15 of 23 62Q3056.DOCX Attorney Docket No. 09846-2500934 (P-28838.WO01) connector 156 provided on the housing 154, a capillary tube projection 158 positioned extending out from one end of the housing 154, and a deformable bulb 160 positioned at the opposite end of the housing 154. [0077] According to some embodiments, the housing 154 may be configured as a generally cylindrical shaped housing 154 that includes opposing first and second ends 162, 164 and a side surface 166 provided between the first and second ends 162, 164, with the housing 154 defining an interior housing volume 168. The side surface 166 includes the connector 156 thereon, with the connector 156 configured to mechanically and fluidly connect the dropper 152 to the blood draw device 60. In some embodiments, the connector 156 comprises a male luer connection (including a rotatable collar and tapered stem) that mates with the coupler 114, which may comprise a female luer connection. [0078] The first end 162 of the housing 154 includes the capillary tube projection 158 thereon, with the capillary tube projection 158 extending outwardly from the first end 162. The capillary tube projection 158 is in fluid communication with the interior volume of housing 154 via an opening provided in the first end 162. Accordingly, the capillary tube projection 158 is able to receive blood from within the interior volume of housing 154 – with the capillary tube projection 158 providing for a controlled dispensing of drops of blood from the dropper 152 via actuation of the deformable bulb 160. [0079] The second end 164 of housing 154 includes the deformable bulb 160 thereon, which functions to selectively control dispensing of drops of blood from the dropper 152. The deformable bulb 160 may be formed of an elastomeric material, for example, that may be depressed between the fingers of a healthcare provider. The depression/actuation of the deformable bulb 160 causes a change of volume within the interior volume of housing 154, thereby generating a pressure within the interior volume that forces a quantity of blood out through the opening at the first end 162 of housing 154 and out through the capillary tube projection 158. In some embodiments, blood may be dispensed out through the capillary tube projection 158 in a drop by drop manner, or via another controlled dispensing technique. [0080] As shown in FIG. 9, according to embodiments the controlled dispensing of blood out from dropper 152 may be provided to a POC testing device 170, such as a diagnostic test cartridge (e.g., an iStat test cartridge from Abbott Laboratories) configured to measure coagulation parameters of the blood or other physiological parameters or human body analytes (e.g., disease biomarkers). One or more drops of blood may be dispensed onto a test strip 172 of the POC testing device 170, for example, to provide for such testing. Beneficially, as the blood sample dispensed from dropper 152 is obtained directly from the blood draw device 60 Page 16 of 23 62Q3056.DOCX Attorney Docket No. 09846-2500934 (P-28838.WO01) in a closed system arrangement, the blood sample will be free of contaminates that may negatively affect testing of the blood. [0081] It is recognized that aspects of the disclosure are not limited to the specific blood draw device 60 shown and described in FIGS. 1-9, and that blood draw devices with other suitable constructions may also incorporate aspects of the disclosure. Referring now to FIG. 10, a system 180 is shown that includes a blood draw device 182 according to another embodiment of the disclosure. The blood draw device 182 includes a housing 184 having a proximal end 186 and a distal end 188, and an advancement member 190 slideably received within housing 184 (i.e., within an inner volume 192 of housing 184). In the illustrated embodiment, the advancement member 190 is provided as one or more telescopic cylinders 190a that are provided in a telescoping relationship with housing 184, such that advancement member 190 may be slideably received entirely, or almost entirely, within the inner volume 192 of housing 184. Advancement member 190 also includes a proximal end 194 and a distal end 196 and, in non-limiting embodiments, advancement member 190 may have a variable diameter along its length. As one example, the distal end 196 of advancement member 190 may have a larger diameter than other portions of advancement member 190 such that, as advancement member 190 is retracted, one or more features on housing 184 may interact with the enlarged portion of advancement member 190 to prevent pulling advancement member 190 completely out of housing 184. As another example, the distal end 196 of advancement member 190 may have a smaller diameter than other portions of advancement member 190, to keep the advancement member 190 in position at a blood draw forward condition, so that a hand of the operator is freed up to manipulate additional components (e.g., a vacutainer tube). [0082] Blood draw device 182 further includes a catheter tube 198 having a proximal end 200 and a distal end 202. Catheter tube 198 is received within the inner volume 192 of housing 184, and may be advanced and/or retracted relative to housing 184 by displacement of the advancement member 190 relative to the housing 184. In some embodiments, the catheter tube 198 may be joined to advancement member 190 via a fitting 204 provided at the distal end 196 of advancement member 190, such that displacement of the advancement member 190 relative to the housing 184 causes a corresponding displacement of catheter tube 198. In non-limiting embodiments, catheter tube 198 may be advanced from a first position in which distal end 202 of catheter tube 198 is within housing 184, to a second position in which a distal end 202 of catheter tube 198 is positioned distally of housing 184 (and also positioned distally of IV catheter 16), as previously described regarding blood draw device 60 and operation thereof. Page 17 of 23 62Q3056.DOCX Attorney Docket No. 09846-2500934 (P-28838.WO01) [0083] Blood draw device 182 also includes a coupling device 206 thereon which may be identical to the coupling device shown and described in the blood draw device of FIGS. 1-7. That is, coupling device 206 is configured as a lock 80 that includes a blunted cannula 82 and locking arms 84 for coupling to the needleless access connector 46 of catheter assembly 12, with the blunted cannula 82 and locking arms 84 forming three points of contact therewith. However, it is appreciated that alternative embodiments of blood draw device 182 may include a coupling device 206 of another type to secure blood draw device 182 to catheter assembly 12, including luer connections, clips, blunt plastic cannulae, blunt metal cannulae, hybrid luers (e.g., with a cannula) friction fits, and the like. [0084] According to aspects of the disclosure, a secondary catheter 208 may be routed through the telescopic cylinder 190a of advancement member 190, with the secondary catheter 208 providing a fluid connection between the catheter tube 198 and a coupler 210 provided at the proximal end portion of the secondary catheter 208. In some embodiments, and as shown in FIG. 10, the coupler 210 may mate with a coagulation testing device 116 (such as shown described in FIGS. 1-7) to provide a system 180 for facilitating improved blood sampling and coagulation testing. In other embodiments, the coupler 210 may mate with a dropper-type blood collection device 152 (such as shown described in FIGS. 8 and 9) to provide a system 180 for facilitating improved blood sampling and coagulation testing. [0085] Beneficially, embodiments of the disclosure thus provide a system for blood sampling and testing. The system enables the acquisition of a blood sample from an indwelling IV catheter, as to eliminate the needle for multiple finger pricks for sample acquisition. The blood sample is provided to an on-site blood coagulation measurement device as part of a closed sample acquisition and testing system, so as to prevent blood exposure during testing and provide for real-time (or near real-time) monitoring of anti-coagulation therapy effect, to provide an improved standard of care for a patient. [0086] Although the present disclosure has been described in detail for the purpose of illustration based on what is currently considered to be the most practical and preferred embodiments or aspects, it is to be understood that such detail is solely for that purpose and that the present disclosure is not limited to the disclosed embodiments or aspects, but, on the contrary, is intended to cover modifications and equivalent arrangements that are within the spirit and scope of the appended claims. For example, it is to be understood that the present disclosure contemplates that, to the extent possible, one or more features of any embodiment may be combined with one or more features of any other embodiment. Page 18 of 23 62Q3056.DOCX

Claims

Attorney Docket No. 09846-2500934 (P-28838.WO01) THE INVENTION CLAIMED IS 1. A system for blood sampling and testing, the system comprising: a catheter assembly comprising an intravenous (IV) catheter and an access port; a blood draw device coupled to the access port and in fluid communication with the IV catheter via the catheter assembly, the blood draw device comprising: a catheter tube; a housing having a proximal end portion and a distal end portion, the distal end portion coupleable to the access port, the housing defining an inner volume configured to movably receive the catheter tube; and an advancement member configured to move relative to the housing to move the catheter tube between a first position, in which the catheter tube is disposed within the housing, and a second position in which a distal end of the catheter tube is disposed beyond the distal end portion of the housing and within the IV catheter or past a distal tip of the IV catheter; and a coagulation testing device attached to the blood draw device so as to be positioned proximal to the housing and in fluid communication with the catheter tube, to directly receive a sample of blood from the blood draw device when the catheter tube is in the second position. 2. The system of claim 1, wherein the blood draw device comprises: a secondary catheter coupled to the advancement member and extending out proximally therefrom and out the proximal end portion of the housing, the secondary catheter fluidly connecting the catheter tube and the coagulation testing device; and a coupler connected to a proximal end of the secondary catheter, and wherein the coagulation testing device is connected to the secondary catheter via the coupler. 3. The system of claim 2, wherein the blood draw device comprises a clamp positioned on the secondary catheter and operable in a closed position and an open position to selectively control a flow of blood through the secondary catheter, from the catheter tube to the coagulation testing device. Page 19 of 23 62Q3056.DOCX Attorney Docket No. 09846-2500934 (P-28838.WO01) 4. The system of claim 3, wherein the coagulation testing device comprises: a housing comprising a first end and a second end and defining an interior housing volume; a microfluidic channel positioned within the interior housing volume; a connector connected to the first end of the housing and configured to mate with the coupler to fluidly connect the microfluidic channel to the secondary catheter; and a pressure control positioned within an opening in the second end of the housing and configured to control an internal pressure within the interior housing volume; wherein the pressure control selectively balances the internal pressure to atmospheric pressure to control an aspiration of blood into the microfluidic channel. 5. The system of claim 4, wherein the connector of the coagulation testing device comprises a venting feature configured to vent air in the coagulation testing device. 6. The system of claim 4, wherein the pressure control comprises a hydrophobic membrane having a lid positioned thereover, the lid moveable between open and closed positions to control the internal pressure within the interior housing volume. 7. The system of claim 4, wherein the coagulation testing device comprises an analog scale provided on the housing configured to indicate an international normalized ratio (INR) representative of a coagulation time of the blood sample. 8. The system of claim 4, wherein the coagulation testing device comprises a digital display attached to the housing, the digital display receiving one or more readings of the blood sample in the microfluidic channel and configured to indicate an international normalized ratio (INR) representative of a coagulation time of the blood sample. 9. The system of claim 8, wherein the digital display receives the one or more readings of the blood sample via a measurement device included in the coagulation testing device, the measurement device comprising one of an optical measurement device, an electrode-based measurement device, or an ultrasonic measurement device. Page 20 of 23 62Q3056.DOCX Attorney Docket No. 09846-2500934 (P-28838.WO01) 10. The system of claim 8, wherein the digital display is selectively attachable and removable from the housing, to enable reuse of the digital display and disposal of a remainder of the coagulation testing device. 11. The system of claim 4, wherein the connector comprises a male luer connection and the coupler comprises a female luer connection. 12. The system of claim 1, wherein the distal end portion of the housing comprises a lock configured to couple the housing to the access port. 13. A system for blood sampling and testing, the system comprising: a catheter assembly comprising an intravenous (IV) catheter and an access port; a blood draw device coupled to the access port and in fluid communication with the IV catheter via the catheter assembly, the blood draw device comprising: a catheter tube; a housing having a proximal end portion and a distal end portion, the distal end portion coupleable to the access port, the housing defining an inner volume configured to movably receive the catheter tube; and an advancement member configured to move relative to the housing to move the catheter tube between a first position, in which the catheter tube is disposed within the housing, and a second position in which a distal end of the catheter tube is disposed beyond the distal end portion of the housing and past a distal tip of the IV catheter; and a dropper attached to the blood draw device so as to be positioned proximal to the housing and in fluid communication with the catheter tube, to directly receive a sample of blood from the blood draw device when the catheter tube is in the second position; wherein the dropper is configured to collect the sample of blood and is actuatable to dispense one or more drops of blood therefrom. 14. The system of claim 13, wherein the dropper comprises: a housing comprising a first end and a second end and defining an interior housing volume; a capillary tube projection positioned at the first end of the housing and in fluid communication with the interior housing volume; and Page 21 of 23 62Q3056.DOCX Attorney Docket No. 09846-2500934 (P-28838.WO01) a deformable bulb positioned at the second end of the housing, the deformable bulb actuatable to force the one or more drops of blood out from the interior housing volume and through the capillary tube projection. 15. The system of claim 14, wherein the blood draw device comprises: a secondary catheter coupled to the advancement member and extending out proximally therefrom and out the proximal end portion of the housing, the secondary catheter fluidly connecting the catheter tube and the dropper; and a coupler connected to a proximal end of the secondary catheter, and wherein the dropper is connected to the secondary catheter via the coupler. 16. The system of claim 15, wherein the blood draw device comprises a clamp positioned on the secondary catheter and operable in a closed position and an open position to selectively control a flow of blood through the secondary catheter, from the catheter tube to the dropper. 17. The system of claim 15, wherein the dropper further comprises a connector positioned on a sidewall of the housing, between the first and second ends, the connector configured to mate with the coupler to fluidly connect the dropper to the secondary catheter. 18. The system of claim 17, wherein the connector comprises a male luer connection and the coupler comprises a female luer connection. 19. The system of claim 13, further comprising a point-of-care (POC) diagnostic test cartridge including a test strip, the test strip configured to receive the one or more drops of blood from the dropper. 20. The system of claim 19, wherein the POC diagnostic test cartridge comprises a blood coagulation testing device configured to determine coagulation parameters of the sample of blood. Page 22 of 23 62Q3056.DOCX