Blood-drawing syringes and systems used for drawing blood

Abstract

This utility model relates to a blood-drawing syringe and a system for performing blood draws. A blood-drawing syringe is provided herein that can be connected to a vascular access device for blood draws. The blood-drawing syringe includes a syringe barrel and a plunger assembly. The plunger assembly includes a plunger rod and a stopper positioned at the distal end of the plunger rod. The plunger assembly is movable within the syringe barrel to move the stopper between a starting position and a stopping position, wherein when the stopper is in the starting position, a first volume is provided in the chamber, and when the stopper is in the stopping position, a second volume is provided in the chamber. The syringe is configured to pre-set the plunger assembly within the syringe barrel before blood draws, wherein the stopper is positioned in the starting position to provide the first volume, which limits the maximum vacuum pressure within the syringe barrel during blood draws.

Description

[0001] Cross-references to related applications

[0002] This application claims priority to U.S. Provisional Patent Application No. 63 / 642,188, filed May 3, 2024, entitled “Blood Draw Syringe for Controlling Vacuum Pressure During Blood Collection,” the disclosure of which is incorporated herein by reference in its entirety. Technical Field

[0003] This disclosure generally relates to syringes for blood collection, and more specifically, to syringes having features thereon that provide a controlled vacuum pressure in the syringe during blood collection to simulate the vacuum pressure in a vacuum blood collection tube. Background Technology

[0004] Catheters are commonly used to infuse and remove fluids (i.e., blood) from the body. In various settings, including hospitals and home care, such fluids are infused into patients or blood is drawn from them via a vascular access device (VAD), which consists of such a catheter inserted into the patient's vascular system. Common VADs consist of plastic catheters inserted into a patient's vein. For example, the length of the catheter varies from a few centimeters when the VAD is a peripheral intravenous catheter (PIVC) to several centimeters when the VAD is a central venous catheter (CVC). VADs can be left in place for short periods (days), medium periods (weeks), or long periods (months to years).

[0005] When a VAD is used for blood collection purposes, a blood collection device or kit can be attached to the VAD (with its catheter left in the patient's body) to collect a blood sample. In some cases, the blood collection device / kit can be configured as a vacuum blood collection tube (e.g., from Becton, Dickinson and Company). The device (or kit) includes a blood collection tube connected to the VAD via a luer-lock access device (LLAD). In other cases, the blood collection device / kit can be configured as a syringe connected to the VAD, which the user actuates to collect a blood sample.

[0006] Vacuum blood collection tubes are advantageous for use with VADs (Vacuum Absorbers) to collect blood samples because they utilize controlled vacuum pressure for blood aspiration, determined by the vacuum pressure generated / set during the tube's manufacture. This controlled vacuum pressure helps control potential hemolysis during blood collection. However, disadvantages associated with using vacuum blood collection tubes include the need to install an LLAD (Limited-Loop Aqueduct) on the VAD and the associated shelf-life limitations.

[0007] Using a blood collection syringe with a vacuum aspiration device (VAD) eliminates the limitations associated with vacuum blood collection tubes regarding the need for a vacuum aspiration device (LLAD) and limited shelf life; however, existing blood collection syringes present a variety of challenges for blood collection. For example, when using a blood collection syringe to collect blood samples, users may find it difficult to control the aspiration rate of the syringe during collection. It should be recognized that excessively high aspiration rates can lead to increased mechanical hemolysis, which may damage the collected blood sample—that is, the vacuum pressure generated in the blood collection syringe may be too high, resulting in increased hemolysis.

[0008] Therefore, there is a need in the art for a blood-drawing syringe that can be used with a Vacuum Aspirator (VAD) to collect blood samples, the syringe being designed (e.g., by limiting the vacuum pressure to the level drawn by the Vacuum Aspirator) to limit / control the vacuum pressure during blood collection. It is also desirable for such a syringe to eliminate the effect of syringe aspiration rate on hemolysis, thereby making the syringe more user-friendly and standardizing the blood collection procedure. Utility Model Content

[0009] This document provides a blood-drawing syringe capable of being connected to a vascular access device for blood draw. The blood-drawing syringe includes a syringe barrel having a distal end and a proximal end, defining a chamber therein, and a fluid connector component located at the distal end of the syringe barrel. The blood-drawing syringe also includes a plunger assembly comprising a plunger rod and a stopper, the plunger rod having a proximal end and a distal end, the stopper being positioned at the distal end of the plunger rod and insertable into the proximal end of the syringe barrel. The plunger assembly is movable within the syringe barrel to move the stopper between a starting position and a stopping position, providing a first volume in a chamber between the stopper and the distal end of the syringe barrel when the stopper is in the starting position, and providing a second volume in a chamber between the stopper and the distal end of the syringe barrel when the stopper is in the stopping position. The second volume is larger than the first volume. The syringe barrel also includes: a first mark provided on the syringe barrel indicating the starting position of the stopper; and a second mark provided on the syringe barrel indicating the stopping position of the stopper. During blood draw, the plunger assembly moves proximally within the syringe barrel to move the plug from the starting position to the stopping position. The size of the first volume limits the vacuum pressure within the syringe barrel during blood draw.

[0010] In some embodiments, the first mark includes: a first sub-mark disposed on the syringe barrel, the first sub-mark indicating a first starting position of the stopper; and a second sub-mark disposed on the syringe barrel, the second sub-mark indicating a second starting position of the stopper.

[0011] In some embodiments, the blood-drawing syringe includes a clamp that is attached to the plunger rod in a position where, when the clamp is against the proximal end of the syringe barrel, the plunger is in a starting position and aligned with a first mark.

[0012] In some embodiments, the clamp is configured to be removed from the plunger rod so that the plunger assembly can be fully advanced distally into the syringe barrel.

[0013] In some embodiments, the blood-drawing syringe includes a stopcock valve disposed within the syringe barrel and positioned at or near a fluid connector component at the distal end of the syringe barrel. The stopcock valve is actuable between an open position and a closed position to control fluid flow into the chamber of the syringe barrel.

[0014] In some embodiments, the first mark and the second mark include one or more of lines, symbols, pictures, icons, letter descriptors, or number descriptors.

[0015] In some embodiments, the longitudinal positioning of a first mark and a second mark on the syringe barrel, which respectively indicate the start and stop positions of the stopper, is selected to set a first volume and a second volume, thereby setting the maximum required vacuum pressure in the syringe barrel during blood draw.

[0016] In some embodiments, the maximum required vacuum pressure is a vacuum pressure that is equal to or less than the vacuum pressure in a vacuum blood collection tube having the same extraction volume as the blood collection syringe.

[0017] This document also provides a blood-drawing syringe capable of being connected to a vascular access device for blood draw. The blood-drawing syringe includes a syringe barrel having a distal end and a proximal end and defining a chamber therein, and a fluid connector component located at the distal end of the syringe barrel. The blood-drawing syringe also includes a plunger assembly including a plunger rod and a stopper, the plunger rod having a proximal end and a distal end, the stopper being positioned at the distal end of the plunger rod and insertable into the proximal end of the syringe barrel. The plunger assembly is movable within the syringe barrel to move the stopper between a starting position and a stopping position, providing a first volume in a chamber between the stopper and the distal end of the syringe barrel when the stopper is in the starting position, and providing a second volume, larger than the first volume, in a chamber between the stopper and the distal end of the syringe barrel when the stopper is in the stopping position. The plunger rod also includes a stop arm fixed at or adjacent to the distal end of the plunger rod. The stop arm includes a proximal end fixed to the plunger rod and a free distal end having a latch formed thereon, the latch being configured to engage with the proximal end of the syringe barrel when the plunger assembly is in an initial position. The stop arm is at an initial angle when engaged with the proximal end of the syringe barrel, and the stop arm is configured to rotate to a second angle when disengaged from the proximal end of the syringe barrel.

[0018] In some embodiments, when the plunger assembly is in the initial position, the stop arm prevents the plunger assembly from being pushed further distally into the syringe barrel.

[0019] In some embodiments, the latch disengages from the proximal end of the syringe barrel as the plunger assembly moves proximally.

[0020] In some embodiments, when the stop arm rotates to the second angle, the plunger assembly can be advanced distally into the syringe barrel until the plug contacts the distal end of the syringe barrel.

[0021] In some embodiments, when the stop arm rotates to the second angle, it rotates toward or away from the plunger rod.

[0022] In some embodiments, during blood draw, the plunger assembly moves proximally within the syringe barrel to move the plug from a starting position to a stopping position, and the size of the first volume limits the vacuum pressure within the syringe barrel during blood draw.

[0023] This document also provides a system for drawing blood. The system includes a vascular access device comprising: a catheter including a distal end and a proximal end; a catheter adapter including a distal adapter and a proximal adapter port, and defining a lumen therein, wherein the proximal end of the catheter is secured to the distal adapter; and an extension kit extending from the catheter adapter and in fluid communication with the catheter through the lumen of the catheter adapter, the extension kit including an extension tube having a distal end coupled to the catheter adapter and a proximal end having a connector thereon. The system also includes a syringe connected to the vascular access device. The syringe includes a syringe barrel having a distal end and a proximal end and defining a chamber therein, and a fluid connector component located at the distal end of the syringe barrel, the fluid connector component being configured to engage with a connector to fluidly connect the syringe to the vascular access device. The syringe also includes a plunger assembly comprising a plunger rod and a stopper. The plunger rod has a proximal end and a distal end, and the stopper is positioned at the distal end of the plunger rod. The stopper is insertable into the proximal end of the syringe barrel. The plunger assembly is movable within the syringe barrel between a starting position and a stopping position. When the stopper is in the starting position, a first volume is provided in a chamber between the stopper and the distal end of the syringe barrel. When the stopper is in the stopping position, a second volume, larger than the first volume, is provided in a chamber between the stopper and the distal end of the syringe barrel. The syringe is configured to pre-set the plunger assembly within the syringe barrel before blood is drawn, wherein the stopper is positioned in the starting position to limit the vacuum pressure within the syringe barrel during blood drawing.

[0024] In some embodiments, the syringe barrel includes: a first mark disposed on the syringe barrel indicating a starting position of the stopper; and a second mark disposed on the syringe barrel indicating a stopping position of the stopper. During blood draw, the plunger assembly moves proximally within the syringe barrel to move the stopper from the starting position to the stopping position, and the size of the first volume limits the vacuum pressure within the syringe barrel during blood draw.

[0025] In some embodiments, the syringe further includes a clip attached to the plunger rod in a position where, when the clip is against the proximal end of the syringe barrel, the plug is in a starting position and aligned with a first mark, and wherein the clip can be removed from the plunger rod to allow the plunger assembly to be fully advanced distally into the syringe barrel.

[0026] In some embodiments, the syringe further includes a stopcock valve disposed within the syringe barrel and positioned at or near a fluid connector component at the distal end of the syringe barrel. The stopcock valve is actuable between an open position and a closed position to control fluid flow into the chamber of the syringe barrel.

[0027] In some embodiments, the plunger rod includes a stop arm fixed at or adjacent to the distal end of the plunger rod. The stop arm includes a proximal end fixed to the plunger rod and a free distal end having a latch formed thereon, the latch being configured to engage with the proximal end of the syringe barrel when the plunger assembly is in an initial position. The stop arm is at an initial angle when engaged with the proximal end of the syringe barrel and is configured to rotate to a second angle when disengaged from the proximal end of the syringe barrel.

[0028] This article also provides a method for drawing blood. The method includes positioning a plunger assembly within a syringe barrel such that the stopper is in a starting position, thereby providing a first volume in a chamber between the stopper and the distal end of the syringe barrel. The method further includes coupling the syringe to a vascular access device by engaging a fluid connector assembly with a connector, and retracting the plunger assembly proximally within the syringe barrel to move the stopper from the starting position to a stop position, thereby aspirating a blood sample into the chamber of the syringe barrel. When the stopper is positioned in the starting position and the first volume is provided before blood drawing begins, the vacuum pressure generated in the syringe barrel during blood drawing is limited.

[0029] In some embodiments, the longitudinal positioning of the start and stop positions of the stopper is selected to set a first volume and a second volume, thereby setting the maximum required vacuum pressure in the syringe barrel during blood draw.

[0030] In some embodiments, the maximum required vacuum pressure is a vacuum pressure that is equal to or less than the vacuum pressure in a vacuum blood collection tube having the same extraction volume as the blood collection syringe.

[0031] This document also provides an adapter-syringe assembly for connection to a vascular access device for blood aspiration. The adapter-syringe assembly includes a blood-drawing syringe and an adapter. The blood-drawing syringe includes a syringe barrel and a plunger assembly having a distal and proximal end and defining a chamber therein, with a fluid connector component located at the distal end of the syringe barrel. The plunger assembly includes a plunger rod having a proximal and distal end and a stopper positioned at the distal end of the plunger rod, the stopper being insertable into the proximal end of the syringe barrel. The plunger assembly is movable within the syringe barrel to move the stopper between a starting position and a stop position, providing a blood aspiration volume in the chamber between the stopper and the distal end of the syringe barrel when the stopper is in the stop position. The adapter connects to the blood-drawing syringe and includes an adapter body defining an internal adapter volume, a distal connector engaging with a vascular access device, and a proximal connector engaging with the fluid connector component at the distal end of the syringe barrel, wherein the size of the internal adapter volume limits the vacuum pressure within the syringe barrel during blood aspiration.

[0032] In some embodiments, the size of the internal adapter volume of the adapter body is selected based on the blood draw volume to set the maximum required vacuum pressure inside the syringe barrel during blood draw.

[0033] In some embodiments, the maximum required vacuum pressure is a vacuum pressure that is equal to or less than the vacuum pressure in a vacuum blood collection tube having the same blood collection volume as the blood collection syringe.

[0034] In some embodiments, the adapter body includes a scalable or extendable adapter body that can be configured in a shortened configuration and an extended configuration, wherein the internal adapter volume includes a first internal adapter volume when the scalable adapter body is in a shortened configuration and a second internal adapter volume when the scalable adapter body is in an extended configuration.

[0035] In some embodiments, the adapter further includes a stopcock valve disposed in the adapter body, the stopcock valve being actuated between an open position and a closed position to control the flow of fluid through the adapter and into the syringe barrel.

[0036] This document also provides an adapter for connecting to a vascular access device and a syringe for blood draw. The adapter includes an adapter body defining an internal adapter volume, a distal connector engaging with the vascular access device, and a proximal connector engaging with the syringe, wherein the size of the internal adapter volume limits the vacuum pressure in the syringe during blood draw.

[0037] In some embodiments, the size of the internal adapter volume of the adapter body is selected based on the blood draw volume to set the maximum required vacuum pressure in the syringe during blood draw.

[0038] In some embodiments, the maximum required vacuum pressure is a vacuum pressure that is equal to or less than the vacuum pressure in a vacuum blood collection tube having the same blood collection volume as the syringe.

[0039] In some embodiments, the adapter body includes a scalable or extendable adapter body that can be configured in a shortened configuration and an extended configuration, wherein the internal adapter volume includes a first internal adapter volume when the scalable adapter body is in a shortened configuration and a second internal adapter volume when the scalable adapter body is in an extended configuration.

[0040] In some embodiments, the adapter further includes a stopcock valve disposed in the adapter body, the stopcock valve being actuated between an open position and a closed position to control the flow of fluid through the adapter and into the syringe.

[0041] This document also provides a system for performing blood draws. The system includes a vascular access device comprising a catheter including a distal end and a proximal end; a catheter adapter including a distal adapter and a proximal adapter port, and defining a lumen therein, wherein the proximal end of the catheter is secured to the distal adapter; and an extension kit extending from the catheter adapter and in fluid communication with the catheter through the lumen of the catheter adapter, the extension kit including an extension tube having a distal end coupled to the catheter adapter and a proximal end having a needle kit thereon, the needle kit including a retainer and a needle. The system also includes an adapter-syringe assembly connected to the vascular access device. The adapter-syringe assembly includes a syringe and an adapter. The syringe includes a syringe barrel and a plunger assembly. The syringe barrel has a distal end and a proximal end and defines a chamber therein. The plunger assembly includes a plunger rod having a proximal end and a distal end, and a stopper positioned at the distal end of the plunger rod. The stopper is insertable into the proximal end of the syringe barrel. The plunger assembly is movable within the syringe barrel to move the stopper between a starting position and a stopping position. When the stopper is in the stopping position, a blood-drawing volume is provided in the chamber between the stopper and the distal end of the syringe barrel. The adapter is coupled to a blood-drawing syringe and includes an adapter body, a proximal end, and a distal end. The adapter body defines an internal adapter volume. The proximal end includes a proximal connector that engages with the distal end of the syringe barrel. The distal end includes a rubber stopper that seals the distal end. The distal end is configured to be received within a retainer, through which a needle punctures the rubber stopper. When the adapter is coupled to the blood-drawing syringe, a plunger assembly can retract to move the stopper to a stop position, thereby creating a vacuum pressure within the chambers of the adapter and syringe barrel. This vacuum pressure draws blood into the chambers when the needle punctures the rubber stopper.

[0042] In some embodiments, the vacuum pressure is a vacuum pressure that is equal to or less than the vacuum pressure in a vacuum blood collection tube having the same extraction volume as the blood collection syringe.

[0043] In some embodiments, the adapter-syringe assembly further includes a clip attached to the plunger rod that holds the plunger assembly in a retracted position, wherein the plug is in a stopped position, and the clip is configured to be removable from the plunger rod to allow the plunger assembly to be fully advanced distally into the syringe barrel.

[0044] This document also provides a blood-drawing syringe that can be connected to a vascular access device for blood draw. The blood-drawing syringe includes a syringe barrel having a distal and a proximal end and defining a chamber therein, and a fluid connector component located at the distal end of the syringe barrel. The blood-drawing syringe also includes a plunger assembly including a plunger rod and a stopper, the plunger rod having a proximal and a distal end, the stopper being positioned on the plunger rod and capable of being inserted into the proximal end of the syringe barrel, wherein the plunger assembly is movable within the syringe barrel to move the stopper between a starting position and a stopping position, providing a first volume in a chamber between the stopper and the distal end of the syringe barrel when the stopper is in the starting position, and providing a second volume, larger than the first volume, in a chamber between the stopper and the distal end of the syringe barrel when the stopper is in the stopping position. The plunger assembly also includes an air chamber or cavitation defined at least partially by at least one of the plunger rod and the stopper, wherein the air chamber or cavitation forms part of the first volume. During blood draw, the plunger assembly moves proximally within the syringe barrel to move the plug from the starting position to the stopping position, and the size of the first volume limits the vacuum pressure within the syringe barrel during blood draw.

[0045] In some embodiments, the air chamber or cavitation includes an air chamber defined by the distal end of the plunger rod, and wherein the plug includes a channel formed therethrough aligned with the air chamber, such that the air chamber is fluidly connected to a chamber of the syringe barrel.

[0046] In some embodiments, the air chamber or cavitation includes an air chamber defined by a stopper, wherein the stopper includes a hollow protrusion extending proximally from the remainder of the stopper, the protrusion defining the air chamber, wherein the protrusion is received in another chamber formed in the distal end of the plunger rod, and wherein the air chamber of the stopper is fluidly connected to a chamber of the syringe barrel.

[0047] In some embodiments, the blood-drawing syringe further includes a vent plug positioned on a stopper and separating the chamber of the syringe barrel from the air chamber, wherein the vent plug is configured to be permeable to air but impermeable to fluid.

[0048] In some embodiments, the air chamber or cavitation includes a cavitation, wherein the stopper includes an elongated stopper including a proximal rib and a distal rib separated by an interrib gap, the proximal rib being configured to form a tight seal with the syringe barrel, the distal rib including a plurality of channels arranged circumferentially therearound, and wherein a cavitation is formed in a volume defined between the syringe barrel and the interrib gap region of the stopper, the cavitation being fluidly connected to a chamber of the syringe barrel through channels formed in the distal rib.

[0049] In some embodiments, the air chamber or cavitation includes a cavitation, wherein the plug includes a proximal plug, and the plunger assembly further includes a distal plug that is longitudinally spaced from the proximal plug and attached to the distal end of the plunger rod, the distal plug including one or more annular ribs thereon, each annular rib including a plurality of channels arranged circumferentially thereon, and wherein the cavitation is defined by the syringe barrel and the volume between the proximal and distal plugs, the cavitation being in fluid communication with the chamber of the syringe barrel through channels formed in one or more annular ribs of the distal plug. Attached Figure Description

[0050] Figure 1 This is a perspective view of a vascular access device and a blood-drawing syringe for drawing blood according to an embodiment of the present disclosure;

[0051] Figure 2 yes Figure 1 An exploded view of the syringe;

[0052] Figures 3A to 3C According to the embodiments of this disclosure, Figure 1 A side perspective view of a syringe in various operating states;

[0053] Figure 4 According to another embodiment of this disclosure, Figure 1 A three-dimensional view of the side of the syringe;

[0054] Figures 5A to 5C According to another embodiment of this disclosure, Figure 1 A side perspective view of a syringe in various operating states;

[0055] Figures 6A to 6C According to another embodiment of this disclosure, Figure 1 A side perspective view of a syringe in various operating states;

[0056] Figures 7A to 7C According to another embodiment of this disclosure, Figure 1 A side perspective view of a syringe in various operating states;

[0057] Figures 8A to 8C According to another embodiment of this disclosure, Figure 1A side perspective view of a syringe in various operating states;

[0058] Figures 9A to 9C It is based on the embodiments of this disclosure and is compatible with Figure 1 A side perspective view of an adapter-syringe assembly used with a vascular access device, showing the adapter-syringe assembly in various operating states;

[0059] Figure 10A and Figure 10B This is a side perspective view of an adapter having an extendable / expandable adapter body according to an embodiment of the present disclosure;

[0060] Figures 11A to 11C According to another embodiment, it is compatible with Figure 1 A side perspective view of an adapter-syringe assembly used with a vascular access device, showing the adapter-syringe assembly in various operating states;

[0061] Figure 12 This is a perspective view of a vascular access device and adapter-syringe assembly for drawing blood, according to another embodiment of the present disclosure.

[0062] Figures 13A to 13C According to another embodiment of this disclosure, Figure 12 The adapter-syringe assembly shown is in various operating states.

[0063] Figure 14 According to another embodiment of this disclosure, it is compatible with Figure 2 A side cross-sectional view of the plunger assembly used with the syringe;

[0064] Figure 15 According to another embodiment of this disclosure, it is compatible with Figure 2 A side cross-sectional view of the plunger assembly used with the syringe;

[0065] Figure 16 According to another embodiment of this disclosure, it is compatible with Figure 2 A side cross-sectional view of the plunger assembly used with the syringe;

[0066] Figure 17 yes Figure 16 The cross-section of the plunger assembly taken along line 17-17;

[0067] Figure 18 According to another embodiment of this disclosure, it is compatible with Figure 2 A side cross-sectional view of the plunger assembly used with the syringe; and

[0068] Figure 19 yes Figure 18The cross-section of the plunger assembly taken along line 19-19. Detailed Implementation

[0069] The following description is provided to enable those skilled in the art to manufacture and use the aspects contemplated for implementing this invention. However, various modifications, equivalents, variations, and substitutions will be apparent to those skilled in the art. Any and all such modifications, variations, equivalents, and substitutions are intended to fall within the spirit and scope of this disclosure.

[0070] In the following description, for descriptive purposes, the terms “upper,” “lower,” “right,” “left,” “vertical,” “horizontal,” “top,” “bottom,” “lateral,” “longitudinal,” and their derivatives shall relate to the orientation of the present invention as shown in the accompanying drawings. However, it should be understood that the present invention may take various alternative variations unless explicitly stated to the contrary. It should also be understood that the specific devices shown in the accompanying drawings and described in the following specification are merely exemplary aspects of the present invention. Therefore, specific dimensions and other physical characteristics relating to the aspects disclosed herein should not be considered limiting.

[0071] In this disclosure, the distal end of a component or device refers to the end furthest from the user's hand when the component or device is in the use position, i.e., when the user is preparing to use or holding the blood-drawing device during use. The proximal end refers to the end closest to the user's hand when the component or device is in the use position, i.e., when the user is preparing to use or holding the blood-drawing device during use. Similarly, in this application, the terms "in the distal direction" and "towards the distal" refer to the direction toward the passage connector portion of the fluid transfer device, and the terms "in the proximal direction" and "towards the proximal" refer to the direction opposite to the direction of the connector.

[0072] refer to Figure 1 This illustrates a non-limiting embodiment of a vascular access device 10 that facilitates blood draws from a patient. Figure 1 As shown, VAD 10 is configured as catheter assembly 12, which provides access to the patient's vascular system. According to embodiments of this disclosure, VAD 10 can have any of a variety of suitable configurations, including being configured / arranged as an integrated catheter assembly or a non-integrated catheter assembly, wherein a non-limiting example includes BD Nexiva. TM Closed intravenous (IV) catheter system, BD Intima TM Catheter systems or other suitable vascular access devices.

[0073] like Figure 1As shown, VAD 10 includes a catheter assembly 12, which includes a catheter adapter 14 and an associated 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, which may be disposed between the distal end 18 and the proximal end 20 or 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 lumen 24 may be sealed at the proximal end 20 of the catheter adapter 14, for example, by a split-septum connector or a self-healing septum connector (not shown). The catheter 16 extends from the distal end 18 of the catheter adapter 14 and may be configured as a PIVC placed into a patient's vein, wherein the distal end or tip of the catheter 16 is suitably positioned within the vein to enable blood draw from the patient. As known to those skilled in the art, the catheter 16 may be formed of any suitable material and may have any useful length.

[0074] In some non-limiting embodiments or aspects, for example, a needle assembly 28 may be disposed as a catheter-over-needle at the proximal end 20 of the catheter adapter 14, wherein the needle assembly 28 includes a needle 30 extending through the catheter adapter 14 (i.e., through its lumen 24) and into the catheter 16. The needle assembly 28 may include the needle 30 and a housing 32. The housing 32 may engage with the proximal end 20 of the catheter adapter 14 and may be configured (including during insertion of the needle 30 into the patient's vascular system and during subsequent withdrawal of the needle 30 from the catheter 16 and through the catheter adapter 12) to control the movement of the needle 30 relative to the catheter 16 and / or the catheter adapter 14.

[0075] In some non-limiting embodiments or aspects, the catheter assembly 12 may include an extension kit 34 coupled to port 22. The extension kit 34 may be used to provide a fluid path from VAD 10 for blood aspiration. The extension kit 34 may include an extension tube 36 having a distal end 38 and a proximal end 40. The distal end 38 of the extension tube 36 may be coupled to port 22, while the proximal end 40 of the extension tube 36 may include an adapter or connector 42. In some embodiments, the connector 42 may include a Luer connector or other needleless access connector. In some embodiments, a clamp 44 may be disposed on the extension tube 36, between the distal end 38 and the proximal end 40 of the extension tube 36, the clamp 44 being selectively actuated to block fluid flow from one end of the extension tube 36 to the other.

[0076] Further as Figure 1As shown, a blood-drawing syringe 100 (hereinafter "syringe 100") can be provided, which can be coupled to a VAD 10 to perform blood drawing—wherein the VAD and syringe 100 together provide a system 50 for blood collection. The syringe can be connected to an extension kit via a connector 42 (e.g., via the mating of connector 42 and a corresponding Luer connector of syringe 100), as explained in further detail below. With syringe 100 coupled to VAD 10, the user can then actuate syringe 100 to draw blood into syringe 100 to collect a blood sample.

[0077] refer to Figure 2 The syringe 100 according to a non-limiting embodiment is shown in more detail. The syringe 100 generally includes a syringe barrel 102 and a plunger assembly 104. For example, the plunger assembly 104 can be axially moved within the syringe barrel 102 from an advance position to a retracted position to facilitate blood draw from a patient.

[0078] The syringe barrel 102 is formed by a generally cylindrical outer wall 106 and an end wall 108, which together define a chamber 110 for retaining fluid therein. The syringe barrel 102 includes an open proximal end 112 and a distal end 114, the proximal end 112 being configured to receive a plunger assembly 104 therein, and the end wall 108 being positioned at the distal end 114. The proximal end 112 of the syringe barrel 102 may include a flange 116 to facilitate manipulation and positioning of the syringe 100 and to maintain the relative position of the syringe barrel 102 with respect to the plunger assembly 104 during drug administration. At the distal end 114, an end portion 118 extends distally and outwardly from the end wall 108 and defines an inner cavity 120 in fluid communication with the chamber 110. A fluid connector component 122 is disposed on the end portion 118, which is connectable to a corresponding connector (e.g., connector 42) with which the syringe 100 will engage for blood aspiration. In some embodiments, the fluid connector component 122 is configured as a Luer adapter, which is configured to engage with a corresponding Luer connector on the connector 42 on the VAD 10.

[0079] The plunger assembly 104 of the syringe 100 is formed by an elongated plunger rod 124 and a plunger head or stopper 126. The plunger rod 124 may include a body 128 extending between a proximal plunger end 130 and a distal plunger end 132. In some embodiments, the body 128 may include a plurality of elongated blades or walls 134 extending axially along the length of the body between the proximal plunger end 130 and the distal plunger end 132. A thumb press 136 is positioned at the proximal plunger end 130, which can be engaged by a user's thumb (or other finger) to apply a distally directed force to the plunger assembly 104, thereby moving the plunger rod 124 relative to the syringe barrel 102. In some embodiments, a flange extension 138 (e.g., a disc-shaped flange) is positioned at the distal plunger end 132, the flange extension 138 being configured to engage with the stopper 126.

[0080] A plug 126 of the plunger assembly 104 is positioned at the distal end 132 of the plunger so as to be movable together with the plunger rod 124 within the chamber 110 of the syringe barrel 102. The plug 126 may be made of a different material than the plunger rod 124, and the plug 126 is capable of forming a tight seal with the syringe barrel 102 as the plunger rod 124 moves from one end of the syringe barrel 102 to the other. In some embodiments, the plug 126 includes a receiver (not shown) formed therein, the receiver being sized and configured to receive a flange extension 138 of the plunger rod 124, wherein the flange extension 138 is engaged with the receiver by, for example, a press-fit connection to secure the plug 126 to the plunger rod 124; however, it will be understood that the plug 126 and the distal end 132 of the plunger can be secured by other techniques known in the art. The plug 126 may also include a pair of spaced-apart annular flanges 140 (i.e., O-rings) formed thereon, which form a tight seal with the cylindrical outer wall 106 of the syringe barrel 102.

[0081] According to embodiments of this disclosure, syringe 100 is configured to collect blood samples in a controlled manner to reduce mechanical hemolysis during blood collection and achieve faster blood filling time when acquiring samples. Specifically, before initiating the blood collection sequence, syringe 100 may be pre-set / pre-configured with a stopper 126 at a desired position within syringe barrel 102. The pre-positioning of the stopper 126 is used to control the vacuum pressure within syringe 100 during blood collection. That is, it is recognized that the initial and final positions of the stopper 126 within syringe 100 correspond to the initial volume (V1) at the start of blood collection and the final volume (V2) at the end of blood collection, determined by the position of the stopper 126 of syringe 100; therefore, V2-V1 is the desired blood collection volume. According to the ideal gas law, the vacuum pressure of each volume within syringe 100 depends on the size / dimension of the volume, and the product of the pressure and volume at the initial volume is equal to the product of the pressure and volume at the final volume, according to the following:

[0082] P2*V2=P1*V1,

[0083] Wherein, P2 is the second pressure within the syringe 100 when it is in the stopped position and the volume is the final volume V2, and P1 is the first pressure (e.g., ambient pressure) within the syringe 100 when it is in the starting position and the volume is the initial volume V1. Therefore, knowing the relationship between pressure and volume, pre-setting the initial volume V1 in the syringe 100 ensures that the maximum vacuum pressure within the syringe 100 is controlled at the desired level during blood collection. In some embodiments, the maximum vacuum pressure P2 can be controlled such that it matches the maximum vacuum pressure set / provided in a vacuum blood collection tube (i.e., a vacuumtainer) with a similar extraction volume, as explained in further detail below.

[0084] Figures 3A to 8C Various embodiments of syringes 100 for implementing controlled collection of blood samples according to various aspects of this disclosure are provided. As described above, each of these syringes 100 is configured to be pre-set / pre-constructed to a desired collection volume before the start of the blood draw sequence, the pre-set volume being used to control the vacuum pressure within the syringe 100 during blood draw.

[0085] Now for reference Figures 3A to 3C And continue to refer to Figure 2 This illustration shows a syringe 100 according to one embodiment of the present disclosure. To pre-set / pre-configure the syringe 100 to the desired collection volume and the maximum vacuum pressure required during blood draw, the syringe barrel 102 of the syringe 100 includes a plurality of markings thereon. (See figure) Figure 3AAs shown, a first mark 142 is provided on the syringe barrel 102, which indicates the starting position of the plunger assembly 104 (i.e., the starting position of the plug 126); as Figure 3B As shown, a second mark 144 is provided on the syringe barrel 102, which indicates the stopping position of the plunger assembly 104 (i.e., the stopping position of the stopper 126) after blood draw is completed. According to various embodiments, marks 142, 144 may be considered / defined as including one or more of the following: lines, symbols, pictures, icons, letter descriptors, number descriptors, or other suitable indicator marks. In some embodiments, marks 142, 144 may be embossed, embossed, laser-drilled, marked, scribbled, or produced in other suitable ways.

[0086] When the stopper 126 is located at the first mark 142, a first volume V1 is defined within the syringe barrel 102 between the distal end 114 of the syringe barrel 102 and the stopper 126 (see [link]). Figure 3A When the stopper 126 is located at the second mark 144, a second volume V2 is defined within the syringe barrel 102 between the distal end 114 of the syringe barrel 102 and the stopper 126 (see...). Figure 3B Therefore, the required extraction volume of syringe 100 is defined as the second volume V2 minus the first volume V1 (V_extraction = V2 - V1). As an example, if the extraction volume of syringe 100 is 7 ml (mL), then V1 can be chosen to be 0.6 mL, and V2 = 7 + 0.6 = 7.6 mL.

[0087] As previously mentioned, the maximum vacuum pressure provided in the syringe 100 during blood draw can be set / controlled by positioning the stopper 126 in the desired initial position (i.e., setting the initial volume V1). According to the ideal gas law, the maximum pressure during blood draw can be defined as:

[0088] P2 = P1 * V1 / V2.

[0089] Once the desired P2 value is known, an initial volume V1 can be selected to ensure that P2 is set to the desired value, wherein the first mark 142 allows the plunger assembly 104 (and the stopper 126) to be easily positioned within the syringe barrel 102 to provide the initial volume. In some embodiments, a maximum pressure P2 can be selected such that the syringe 100 has the same extraction volume as... The maximum vacuum pressure inside is the same as the maximum vacuum pressure to ensure that hemolysis during blood collection is similar to that during Vacutainer blood collection. Therefore, for the example above, where V1 is chosen to be 0.6 mL and V2 = 7 + 0.6 = 7.6 mL, P2 can be set at the following level: P2 = 101 kPa (assuming P1 is the ambient pressure at sea level) × 0.6(V1) / 7.6(V2) = 8 kPa (absolute value), which matches the maximum vacuum pressure of a 7 mL extraction volume inside a 13 × 100 size Vacutainer tube.

[0090] Therefore, for such Figures 3A to 3C The syringe 100 shown, when used for blood drawing, may include the following steps: (1) pulling the plunger assembly 104 proximally to set the stopper 126 in the initial position (first mark 142), as shown. Figure 3A As shown; (2) Connect syringe 100 to VAD 10; (3) Pull plunger assembly 104 proximally to the stop position (second mark 144) to collect a blood sample, as shown. Figure 3B As shown; and (4) at the desired time, pushing the plunger assembly 104 distally to the distal end 114 of the syringe barrel 102 to dispense the blood sample into the sample container, as shown. Figure 3C As shown.

[0091] Now for reference Figure 4 According to another embodiment of this disclosure, Figures 3A to 3C The syringe 100 can be modified to include additional markings thereon. Specifically, a pair of first markings 142a and 142b (i.e., first sub-marker 142a and second sub-marker 142b) can be provided on the syringe barrel 102 to enable the syringe 100 to be used for different blood draw volumes. For example, if it is desired to achieve draw volumes of 7 mL and 4 mL with the syringe 100, a first sub-marker 142a can be provided on the syringe barrel 102 indicating the starting position of the plunger assembly 104 relative to the stop position of 7 mL draw (i.e., the starting position of the stopper 126), and a second sub-marker 142b can be provided on the syringe barrel 102 indicating the starting position of the plunger assembly 104 relative to the stop position of 4 mL draw (i.e., the starting position of the stopper 126). Each of the starting positions at the first sub-marker 142a and the second sub-marker 142b can be selected to provide an initial volume V1 that sets the maximum vacuum pressure P2 in the syringe 100 at the desired level, as described in detail above.

[0092] Now for reference Figures 5A to 5C And continue to refer to Figure 2This illustrates a syringe 100 according to another embodiment of the present disclosure. The syringe 100 and... Figures 3A to 3C The syringe (with a syringe barrel 102 including a first mark 142 and a second mark 144) is the same as the one used in this study, except that the syringe 100 is provided with a removable clamp 146 to ensure that the plunger assembly 104 is held in the starting position before blood is drawn using the syringe 100. The removable clamp 146 is attached to the plunger rod 124 such that when the clamp 146 is in place, the foremost position of the plunger assembly 104 corresponds to the starting position. The inclusion of a removable clip 146 eliminates a step in the blood-drawing process—the end user no longer needs to pull the plunger assembly 104 proximally to the starting position, as this can be done during manufacturing. The clip 146 is secured to the plunger rod 124 at a location where, as the plunger assembly 104 is pushed distally into the syringe barrel 102 during assembly, the clip 146 engages with the proximal end 112 of the syringe barrel 102 when the plunger assembly 104 is positioned in the desired starting position. The clip 146 limits the amount / length of the plunger assembly 104 that can be inserted into the syringe barrel 102 and defines the starting position of the plunger assembly 104 (and the stopper 126). Then, after blood collection, the clip 146 can be removed from the plunger rod 124 to allow the plunger assembly 104 to be advanced distally the full distance within the syringe barrel 102 to dispense the collected blood into the sample container.

[0093] Therefore, for such Figures 5A to 5C The syringe 100 shown can be used to draw blood, and the blood collection may include the following steps: (1) connecting the syringe 100 to the VAD 10 and prepositioning the plunger assembly 104 at the first mark 142 (starting position), as shown in Figure 5A; (2) pulling the plunger assembly 104 proximally to the second mark 144 (stop position) to collect a blood sample, as shown in Figure 5A. Figure 5B As shown; and (3) at the desired time, removing the clamp 146 from the plunger rod 124 and pushing the plunger assembly 104 distally to the distal end 114 of the syringe barrel 102 to dispense the blood sample into the sample container, as shown. Figure 5C As shown.

[0094] Now for reference Figures 6A to 6C And continue to refer to Figure 2A syringe 100 according to another embodiment of the present disclosure is shown. In the syringe 100, a first mark 142 and a second mark 144 corresponding to the start and stop positions of the plunger assembly 104 may be provided again on the syringe barrel 102. Furthermore, in the illustrated embodiment, the syringe 100 also includes a stopcock valve 148 integrated therein, which is actuable between an open position and a closed position—wherein the stopcock valve is located at / adjacent to the distal end 114 of the syringe barrel 102, for example, within / on the end 118. During manufacture of the syringe 100, the stopcock valve 148 may be in the open position, thereby allowing the plunger assembly 104 to be pulled back to the start position, during which the initial volume V1 is set to the desired amount. Once the syringe 100 is attached to the VAD 10, but before the plunger assembly 104 is pulled to the stop position, the stopcock valve 148 may be actuated to the closed position. Actuating the stopcock valve 148 to the closed position before pulling the plunger assembly 104 back to the stop position will allow the syringe 100 to reach the maximum possible vacuum pressure before any blood flows into the syringe 100, which will reduce the maximum vacuum in the syringe 100 as blood is drawn into the syringe barrel 102.

[0095] Therefore, for such Figures 6A to 6C The syringe 100 shown, the blood draw performed may include the following steps: (1) pulling the plunger assembly 104 proximally to position the stopper 126 at the starting position (first mark 142), as shown. Figure 6A As shown; (2) Connect syringe 100 to VAD 10; (3) Once syringe 100 is connected to VAD 10, actuate stopcock valve 148 to the closed position; (4) Pull plunger assembly 104 proximally to the stop position (second mark 144), as shown. Figure 6B As shown; (5) actuate the stopcock valve 148 to the open position to collect a blood sample; and (6) at the desired time, push the plunger assembly 104 distally to the distal end 114 of the syringe barrel 102 to dispense the blood sample into the sample container, as shown. Figure 6C As shown.

[0096] Now for reference Figures 7A to 7C and Figures 8A to 8C And continue to refer to Figure 2The image shows a syringe 100 according to an additional embodiment of the present disclosure. To pre-set / pre-configure the syringe 100 to a desired collection volume and a desired maximum vacuum pressure during blood draw, the plunger assembly 104 of the syringe 100 includes a limiter 150 thereon, which enables the plunger assembly 104 (and its stopper 126) to be positioned in an initial position that sets the initial volume to the desired amount. According to some embodiments, the limiter 150 is configured as a rotatable stop arm (hereinafter “stop arm 150”) secured near the proximal end 130 of the plunger rod 124. The stop arm 150 includes a proximal end 152 and a distal end 154, wherein the proximal end 152 of the stop arm 150 is secured to the plunger rod 124, and the distal end 154 of the stop arm 150 includes a hook or latch 156 configured to engage with the proximal end 112 of the syringe barrel 102. In some embodiments, the proximal end 152 of the stop arm 150 is fixed to the plunger rod 124 toward its proximal end 130 and between adjacent blades / walls 134, so as to be positioned between adjacent blades / walls.

[0097] The stop arm 150 may be integrally formed as part of the plunger rod 124 (i.e., as part of the same molded component) or may be fixed to the plunger rod 124 by a suitable fastening method. When integrally formed as part of the plunger rod 124, the stop arm 150 may form an (initial) angle relative to the plunger rod 124, wherein the stop arm 150 may bend to an angular position greater than or less than the initial angle. When configured as a separate component fixed to the plunger rod 124, the stop arm 150 may be biased, for example by a spring or other suitable biasing member, to an angular position relative to the plunger rod 124.

[0098] During the manufacture and pre-configuration / pre-construction of the syringe 100, the stop arm 150 may initially be angled relative to the plunger rod 124 to align with the proximal end of the cylindrical outer wall 106 of the syringe barrel 102, such that the latch 156 of the stop arm 150 can engage with the syringe barrel 102. Therefore, the syringe 100 can be initially assembled by pushing the plunger assembly 104 distally into the syringe barrel 102 until the latch 156 of the stop arm 150 engages with the proximal end 112 of the syringe barrel 102, wherein the stop arm 150 limits the amount / length of the plunger assembly 104 that can be inserted into the syringe barrel 102 and defines the initial position of the plunger assembly 104 (and the stopper 126). The stop arm 150 may be formed on the plunger rod 124, and the dimensions of the stop arm 150 are designed to allow the plunger rod 124 to move to the desired initial position, thereby setting the initial volume V1 to the desired amount.

[0099] During subsequent blood draw using syringe 102, as the plunger assembly 104 is withdrawn proximally within syringe 102, the latch 156 of stop arm 150 disengages from the proximal end 112 of syringe 102. When stop arm 150 disengages from syringe 102, the biasing force on stop arm 150 causes it to rotate from its initial angle to a second angle, which may be greater than or less than the initial angle.

[0100] In one embodiment, and as Figures 7A to 7C As shown in the embodiment, the biasing of the stop arm 150 causes the stop arm 150 to rotate toward the plunger rod 124 so that it lies substantially flat on the plunger rod 124, such that (during the dispensing of the collected blood sample) when the plunger assembly 104 is pushed distally back into the syringe barrel 102, the stop arm 150 remains out of contact with the syringe barrel 102.

[0101] In another embodiment, and as Figures 8A to 8C As shown in the embodiment, the biasing of the stop arm 150 causes the stop arm 150 to rotate outward, thereby moving away from the plunger rod 124, so that (during the dispensing of the collected blood sample) when the plunger assembly 104 is pushed distally back into the syringe barrel 102, the stop arm 150 remains out of contact with the syringe barrel 102.

[0102] Therefore, for such Figures 7A to 7C and Figures 8A to 8C The syringe 100 shown, the blood draw performed may include the following steps: (1) connecting the syringe 100 to the VAD 10, with the plunger assembly 104 pre-positioned at the first mark 142 and in the initial position (restrained by the stop arm 150 and engaged with the proximal end 112 of the syringe barrel 102) (as shown). Figure 7A and Figure 8A (as shown); (2) Pull the plunger assembly 104 proximally to the second mark 144 and pull it to the stop position (as shown). Figure 7B and Figure 8B (as shown), wherein the latch 156 of the stop arm 150 disengages from the syringe barrel 102 and rotates inward / outward from its initial angle to collect a blood sample; and (3) at the desired time, the plunger assembly 104 is pushed distally to the distal end 114 of the syringe barrel 102 to dispense the blood sample into a sample container (as shown). Figure 7C and Figure 8C As shown), the stop arm 150 is positioned to allow the plunger assembly 104 to be pushed to the distal side.

[0103] According to an additional embodiment of this disclosure, the blood-drawing syringe itself is not configured to achieve controlled collection of blood samples to ensure that the maximum vacuum pressure within the syringe is controlled at a desired level during blood draw (e.g., such that the maximum vacuum pressure is similar to Vacutainer pressure). Instead, a separate adapter can be provided for the syringe to provide similar control. That is, instead of the blood-drawing syringe 100 including features thereon capable of pre-positioning a stopper within the syringe barrel 102 to provide an initial volume V1 required compared to the final volume V2 (as described in detail above), a separate adapter can instead be used to provide such an initial volume V1.

[0104] refer to Figures 9A to 9C The illustration shows an adapter-syringe assembly 158 according to one aspect of the present disclosure, which includes an adapter 160 connected to a blood-drawing syringe 100. The adapter 160 can be generally characterized as including an adapter body 162, a distal connector 164 located at the distal end of the adapter body 162, and a proximal connector 166 located at the proximal end of the adapter body 162. In some embodiments, the distal connector 164 of the adapter 160 may include a male Luer connector that can be coupled / mated with a (female) Luer connector of connector 42 of VAD 10, while the proximal connector 166 of the adapter 160 may include a female Luer connector that can be coupled / mated with a fluid connector component 122 (i.e., a male Luer connector) of the blood-drawing syringe 100.

[0105] The adapter body 162 surrounds the internal volume 168 of the adapter 160. The adapter body 162 may be specifically configured such that its internal volume 168 is set to an (adapter) volume V1, which functions the same as the initial volume V1 described in the previous embodiments, wherein the adapter volume V1 is selected to match the air volume within the Vacutainer to obtain a target extraction volume (i.e., the final volume V2). Thus, as a non-limiting example, when used for 7 mL extraction, the adapter volume V1 may include 0.6 ml, while when used for 4 mL extraction, the adapter volume V1 may include 3.6 ml.

[0106] Therefore, for such Figures 9A to 9C The blood draw performed using the syringe 100 and adapter 160 shown may include the following steps: (1) connecting the adapter 160 to the blood-drawing syringe 100 by mating the proximal Luer connector 166 of the adapter 160 with the Luer connector 122 of the syringe, as shown. Figure 9AAs shown; (2) Connect the adapter 160 and syringe 100 to the VAD (not shown) by mating the distal Luer connector 164 of the adapter 160 with the connector 42; (3) Pull the plunger assembly 104 from the starting position (at the distal end 114 of the syringe barrel 102) to the stop position to collect a blood sample, as shown. Figure 9B As shown; and (4) at the desired time, pushing the plunger assembly 104 distally to the distal end 114 of the syringe barrel 102 to dispense the blood sample into the sample container, as shown. Figure 9C As shown.

[0107] In some embodiments, and as Figure 10A and Figure 10B As shown, the adapter 160 can be configured as an adjustable adapter 160, wherein the internal volume 168 within the adapter body 162 can be varied, allowing the adapter 160 to achieve different extraction volumes via a syringe. That is, as described above, the adapter volume V1 can be selected to match the air volume within the vacuum to obtain a target extraction volume; for example, when used for 7 mL extraction, the adapter volume V1 is set to 0.6 ml, while when used for 4 mL extraction, the adapter volume V1 is set to 3.6 ml. To provide such multiple adapter volumes V1, the adapter body 162 may include an extendable or expandable tube that can be shortened and / or lengthened to change the internal adapter volume V1. Thus, for example, as... Figure 10A As shown, when adapter 160 is used with a syringe to draw 7 mL of blood, adapter body 162 can be used in a shortened configuration, wherein the internal adapter volume V1 is 0.6 mL. For example, as Figure 10B As shown, when the adapter 160 is used with a syringe to draw 4 mL of blood, the adapter body 162 can be actuated to its elongated configuration, wherein the internal adapter volume V1 increases to 3.6 mL.

[0108] In some embodiments, and as Figures 11A to 11C As shown, adapter 160 may also include a stopcock valve 170 integrated therein, which is actuable between an open position and a closed position. When adapter 160 is initially connected to each of syringe 100 and VAD 10, stopcock valve 170 may be in the closed position. When stopcock valve 170 is in the closed position, plunger assembly 104 of syringe 100 can be pulled distally from an initial position (at the distal end 114 of syringe barrel 102) to a stop position, thereby creating / maintaining the maximum possible vacuum pressure within syringe 100 before any blood flows into syringe 100, which will reduce the maximum vacuum within syringe 100 as blood is drawn into syringe barrel 102.

[0109] Therefore, for such Figures 11A to 11C The blood draw performed using the syringe 100 and adapter 160 shown may include the following steps: (1) connecting the adapter 160 to the blood-drawing syringe 100, wherein the stopcock valve 170 is in the closed position, as shown. Figure 11A As shown; (2) Connect adapter 160 and syringe 100 to VAD (not shown), with stopcock valve 170 in the closed position; (3) Pull plunger assembly 104 from the starting position (at the distal end 114 of syringe barrel 102) proximally to the stop position, with stopcock valve 170 in the closed position, and then actuate stopcock valve 170 to the open position to draw blood into syringe 100 to collect a blood sample, such as Figure 11B As shown; and (4) at the desired time, pushing the plunger assembly 104 distally to the distal end 114 of the syringe barrel 102 to dispense the blood sample into the sample container, as shown. Figure 11C As shown.

[0110] Now for reference Figure 12 and Figures 13A to 13C Additional embodiments of this disclosure provide an adapter and blood-drawing syringe assembly 172, which will be used with a blood collection kit configured to house a Vacutainer device. That is, as... Figure 12 As shown, a VAD 174 can be provided, which is similar in construction / arrangement to... Figure 1 It is roughly similar to VAD10; however, Figure 12 The VAD 174 of the embodiment does not include a Luer connector at the proximal end of the extension kit in the VAD 10, but may instead include a needle kit 176 at the proximal end of the extension kit 178. The needle kit 176 may include a retainer 178 and a pointed needle 180, the retainer 178 having a hollow internal volume within which the pointed needle 180 is housed. The needle kit 176 is configured to receive a standard vacuum blood collection tube (i.e., a Vacutainer), but as described below, the needle kit 176 may also receive an adapter-syringe assembly 172.

[0111] like Figures 13A to 13C As shown, an adapter 182 may be provided, which enables the blood-drawing syringe 100 to be connected to... Figure 12 The VAD 174 and pin kit 176 are used together. The adapter 182 may include an adapter body 184, which is constructed similar to... Figures 9A to 9CThe adapter body 162 shown, and the adapter 182 thereon, do not include a distal male Luer connector. Instead, the adapter 182 may include a rubber stopper or plug 186 operable with the needle kit 176 of the VAD. The plug 186 is located at the distal end of the adapter body 184 to seal the distal end of the adapter body 184, and when the adapter 182 is connected to the blood-drawing syringe 100, the plug 186 enables the syringe 100 to be used as a vacuum blood collection tube. That is, when the adapter 182 is connected to the blood-drawing syringe 100, the plunger assembly 104 can retract distally from a starting position (at the distal end 114 of the syringe barrel 102) to a stop position corresponding to the desired aspiration volume, wherein the retraction of the plunger assembly 104 creates a vacuum within the syringe barrel 102, which is maintained until the plug 186 is punctured (by the needle 180 of the needle kit 176). In some embodiments, (e.g., in conjunction with) Figures 5A to 5C (As shown and described in detail) A clamp 188 can be set on the syringe 100 to ensure that the plunger assembly 104 remains in the stop position after retraction.

[0112] Therefore, for such Figures 13A to 13C The syringe 100 shown, the blood draw performed may include the following steps: (1) connecting the adapter 182 to the blood-drawing syringe 100, as shown Figure 13A As shown; (2) Pull the plunger assembly 104 from the starting position (at the distal end 114 of the syringe barrel 102) to the proximal position to obtain the desired extraction volume, as shown. Figure 13B As shown; (3) inserting the adapter 182 and a portion of the syringe 100 into the retainer 178 (not shown) of the needle assembly 176, and piercing the plug 186 with the needle 180 to draw blood into the syringe 100 through the vacuum within the syringe barrel 102 to collect a blood sample; and (4) at the desired time, pushing the plunger assembly 104 distally to the distal end 114 of the syringe barrel 102 to dispense the blood sample into a sample container, as shown. Figure 13C As shown.

[0113] According to further embodiments of this disclosure, the structure of the plunger assembly 104 of the blood-drawing syringe 100 can be modified to enable controlled collection of blood samples and ensure that the maximum vacuum pressure within the syringe is controlled at a desired level during blood draw (e.g., such that the maximum vacuum pressure is similar to Vacutainer pressure). That is, the structure of the plunger rod 124 and / or the stopper 126 can be modified to help control / reduce the maximum vacuum pressure within the syringe during blood draw.

[0114] refer to Figure 14The image shows a plunger assembly 104, wherein each of the plunger rod 124 and the stopper 126 has a configuration that helps to reduce the maximum vacuum pressure within the syringe 100 during blood draw. Specifically, the plunger rod 124 includes an elongated (air) chamber 190 formed in its body 128 (at the distal end 132 of the body 128), while the stopper 126 includes a channel 192 formed therein, which extends longitudinally through the stopper 126—the channel 192 being located at the center of the stopper 126 so as to align with the elongated chamber 190 in the plunger rod 124.

[0115] refer to Figure 15 In relation to Figure 14 In another embodiment similar to the plunger assembly 104, instead of the plunger rod 124 defining the air chamber, the plug 126 may define the (air) chamber 194. That is, while the plunger rod 124 (i.e., its body 128) still defines an elongated chamber 190 therein, the plug 126 is configured to include a protrusion 196 that extends proximally from it and into the chamber 190 of the plunger rod 124. The protrusion 196 includes a hollow projection with a closed proximal end that defines the chamber 194 of the plunger assembly 104.

[0116] In some embodiments, and for Figure 14 and Figure 15 In any of the embodiments described, the vent plug 198 may be secured within a channel (192 or chamber 194) formed in the plug 126. The vent plug 198 may be secured at the distal end of the channel / chamber to form part of the distal side of the plug 126. The vent plug 198 may be made of a material that is breathable but does not allow fluid (e.g., blood) to permeate through it. Thus, the vent plug 198 allows air to move within the syringe barrel 102 to reduce the maximum vacuum pressure in the syringe 100 during blood draw, while preventing blood from entering and remaining in the chamber 190 of the plunger rod 124 (or the chamber 194 of the plug 126).

[0117] As described above, various embodiments (including) Figures 3A to 3CAs described in the embodiments, the maximum vacuum pressure provided in the syringe 100 during blood draw can be set / controlled by positioning the stopper 126 at the desired initial position, i.e., setting the initial volume V1 according to P2 = P1 * V1 / V2. Knowing the desired P2 value, the initial volume V1 can be selected to ensure that P2 is set to the desired value, wherein the air chamber 190 in the plunger rod 124 (or the air chamber 194 in the stopper 126) contributes to the total initial volume V1. Therefore, knowing the relationship between pressure and volume, a pre-set initial volume V1 in the syringe 100 ensures that the maximum vacuum pressure within the syringe 100 is controlled at the desired level during blood draw. In some embodiments, the maximum vacuum pressure P2 can be controlled such that it matches the maximum vacuum pressure set / provided in a vacuum blood collection tube (i.e., a vacuumtainer) of similar draw volume, as described in detail above.

[0118] Now for reference Figure 16 and Figure 17 The image shows a plunger assembly 104, wherein a stopper 126 has a structure that helps reduce the maximum vacuum pressure within the syringe 100 during blood draw. Specifically, the stopper 126 has an elongated structure in which a proximal set of annular flanges or ribs 140a are longitudinally separated from a distal annular flange or rib 140b by an interrib gap 200. The proximal ribs 140a are configured as annular flanges that form a tight seal with the cylindrical outer wall 106 of the syringe barrel 102. The distal ribs 140b are configured as annular flanges that include a plurality of channels 202 formed therein, the channels 202 being arranged circumferentially around the ribs 140b.

[0119] According to embodiments of this disclosure, since the stopper 126 has an elongated structure, wherein the proximal rib 140a is separated from the distal rib 140b by an interrib gap 200, a cavitation 204 is formed in the region / volume defined between the syringe barrel 102 and the interrib gap region of the stopper 126. This cavitation 204 is fluidly connected to the proximal portion of the chamber 110 in the syringe barrel 102 through a channel 202 formed in the distal rib 140b.

[0120] In some embodiments, a venting material 206 may be provided in each of the plurality of channels 202 formed in the distal rib 140b. The venting material 206 may be made of a material that is breathable but does not allow fluid (e.g., blood) to permeate through it, thereby allowing air to move within the syringe barrel 102 to reduce the maximum vacuum pressure in the syringe 100 during blood draw, while preventing blood from entering and stagnating in the cavitation 204.

[0121] As described above, the maximum vacuum pressure provided in the syringe 100 during blood draw can be set / controlled by positioning the stopper 126 in the desired initial position, i.e., setting the initial volume V1 according to P2 = P1 * V1 / V2. Knowing the desired P2 value, the initial volume V1 can be selected to ensure that P2 is set to the desired value, where the cavitation 204 provided by the elongated stopper 126 contributes to the overall initial volume V1. Therefore, knowing the relationship between pressure and volume, a pre-set initial volume V1 in the syringe 100 ensures that the maximum vacuum pressure within the syringe 100 is controlled at the desired level during blood draw. In some embodiments, the maximum vacuum pressure P2 can be controlled such that it matches the maximum vacuum pressure set / provided in a vacuum blood collection tube (i.e., a vacuumtainer) of similar draw volume, as described in detail above.

[0122] Now for reference Figure 18 and Figure 19 The image shows a plunger assembly 104 having a structure that helps reduce the maximum vacuum pressure within the syringe 100 during blood draw. Specifically, the plunger assembly 104 is configured to include a proximal stopper 126a and a distal stopper 126b, wherein each of the stoppers 126a and 126b is secured to the plunger rod 124 by a first flange member 138a and a second flange member 138b, respectively. Figure 18 As shown, flange members 138a and 138b are longitudinally spaced on the body 128 of the plunger rod 124, such that the proximal plug 126a and the distal plug 126b are also longitudinally spaced when fixed to the plunger rod 124. The proximal plug 126a includes annular flanges or ribs 140a configured to form a tight seal with the cylindrical outer wall 106 of the syringe barrel 102. The distal plug 126b includes one or more annular flanges or ribs 140b configured to include a plurality of channels 208 formed therein, these channels being arranged circumferentially around the one or more ribs 140b, as previously described... Figures 16 to 17 The embodiment described is for the distal rib 140.

[0123] According to embodiments of this disclosure, since the proximal plug 126a and the distal plug 126b are longitudinally spaced apart on the plunger rod 124, a cavitation 210 is formed in the area / volume defined between the syringe barrel 102 and the plugs 126a, 126b. This cavitation 210 is fluidly connected to the proximal portion of the chamber 100 in the syringe barrel 102 via a channel 208 formed in the distal rib 140b.

[0124] In some embodiments, a venting material 212 may be provided in each of the plurality of channels 208 formed in one or more ribs 140b of the distal plug 126b. The venting material 212 may be made of a material that is breathable but does not allow fluids (e.g., blood) to permeate through it, so as to allow air to move within the syringe barrel 102, thereby reducing the maximum vacuum pressure in the syringe 100 during blood draw, while preventing blood from entering and stagnating in the cavities 210.

[0125] As described above, the maximum vacuum pressure provided in the syringe 100 during blood draw can be set / controlled by positioning the stopper 126 in the desired initial position, i.e., setting the initial volume V1 according to P2 = P1 * V1 / V2. Knowing the desired P2 value, the initial volume V1 can be selected to ensure that P2 is set to the desired value, where the cavitation 210 provided by the spaced-apart stoppers 126a and 126b contributes to the overall initial volume V1. Therefore, knowing the relationship between pressure and volume, a pre-set initial volume V1 in the syringe 100 ensures that the maximum vacuum pressure within the syringe 100 is controlled at the desired level during blood draw. In some embodiments, the maximum vacuum pressure P2 can be controlled such that it matches the maximum vacuum pressure set / provided in a vacuum blood collection tube (i.e., a vacuumtainer) of similar draw volume, as described in detail above.

[0126] Therefore, it is advantageous that embodiments of this disclosure provide a blood-drawing syringe and an optional adapter for use with a VAD to collect blood samples. In some embodiments, the blood-drawing syringe is configured to pre-set / pre-construct its stopper in the desired position before the blood-drawing sequence begins, providing a pre-defined volume for controlling the vacuum pressure within the syringe during blood draw (e.g., by limiting the vacuum pressure to the vacuum level of the Vacutainer). In other embodiments, the plunger assembly of the blood-drawing syringe may be configured to provide additional cavitation for controlling the vacuum pressure within the syringe during blood draw (e.g., by limiting the vacuum pressure to the vacuum level of the Vacutainer). In yet another embodiment, an adapter is connected to the blood-drawing syringe to provide a pre-defined volume for controlling the vacuum pressure within the syringe during blood draw. In yet another embodiment, the adapter may operate to configure the blood-drawing syringe as a vacuum blood collection tube for use with a standard lancet kit, which is typically used with multiple vacuum blood collection tubes. The blood-drawing syringe and / or associated adapter eliminate the effect of syringe aspiration rate on hemolysis, thereby making the blood-drawing syringe more user-friendly and standardizing the blood-drawing procedure.

[0127] Although several embodiments of a system constructed for blood collection have been described in the above detailed description, modifications and changes can be made to these embodiments by those skilled in the art without departing from the scope and spirit of the present invention. That is, it should be recognized that features of each system in each embodiment can be incorporated into systems of other embodiments. Therefore, the foregoing description is intended to be illustrative and not restrictive. The present invention described above is defined by the appended claims, and all modifications to the present invention falling within the equivalent meaning and scope of the claims are included within the scope of the claims.

Claims

1. A blood-drawing syringe, the blood-drawing syringe being connectable to a vascular access device for blood drawing, characterized in that, The blood-drawing syringe includes: A syringe barrel having a distal end and a proximal end and defining a chamber therein, and a fluid connector component located at the distal end of the syringe barrel; and A plunger assembly including a plunger rod and a plug, the plunger rod having a proximal end and a distal end, the plug being positioned at the distal end of the plunger rod and capable of being inserted into the proximal end of a syringe barrel, wherein the plunger assembly is movable within the syringe barrel to move the plug between a starting position and a stopping position, providing a first volume in a chamber between the plug and the distal end of the syringe barrel when the plug is in the starting position, and providing a second volume in a chamber between the plug and the distal end of the syringe barrel when the plug is in the stopping position, the second volume being greater than the first volume; The syringe barrel includes: A first mark is provided on the syringe barrel, the first mark indicating the starting position of the stopper; and A second mark is provided on the syringe barrel, the second mark indicating the stop position of the plug; and wherein, during blood draw, the plunger assembly moves proximally within the syringe barrel to move the plug from the starting position to the stop position, the size of the first volume limiting the vacuum pressure within the syringe barrel during blood draw.

2. The blood-drawing syringe according to claim 1, characterized in that, The first marker includes: A first sub-mark is provided on the syringe barrel, the first sub-mark indicating the first starting position of the stopper; and A second sub-mark is provided on the syringe barrel, the second sub-mark indicating the second starting position of the stopper.

3. The blood-drawing syringe according to claim 1, characterized in that, The blood-drawing syringe also includes a clamp that is attached to the plunger rod in such a position that, when the clamp is against the proximal end of the syringe barrel, the plunger is located at the starting position and aligned with the first mark.

4. The blood-drawing syringe according to claim 3, characterized in that, The clamp is configured to be removed from the plunger rod so that the plunger assembly can be fully advanced distally into the syringe barrel.

5. The blood-drawing syringe according to claim 1, characterized in that, The blood-drawing syringe also includes a stopcock valve disposed within the syringe barrel and positioned at or near the fluid connector component at the distal end of the syringe barrel. The stopcock valve is actuable between an open position and a closed position to control fluid flow into the chamber of the syringe barrel.

6. The blood-drawing syringe according to claim 1, characterized in that, The first mark and the second mark include one or more of lines, symbols, pictures, icons, letter descriptors or number descriptors.

7. The blood-drawing syringe according to claim 1, characterized in that, The longitudinal positioning of the first and second marks on the syringe barrel, which respectively indicate the starting and stopping positions of the stopper, is selected to set the first and second volumes, thereby setting the maximum required vacuum pressure in the syringe barrel during the blood draw.

8. The blood-drawing syringe according to claim 7, characterized in that, The maximum required vacuum pressure is the following vacuum pressure: the vacuum pressure is equal to or less than the vacuum pressure in a vacuum blood collection tube having the same extraction volume as the blood collection syringe.

9. A blood-drawing syringe, the blood-drawing syringe being connectable to a vascular access device for blood drawing, characterized in that, The blood-drawing syringe includes: A syringe barrel having a distal end and a proximal end and defining a chamber therein, and a fluid connector component located at the distal end of the syringe barrel; and A plunger assembly includes a plunger rod and a plug, the plunger rod having a proximal end and a distal end, the plug being positioned at the distal end of the plunger rod and capable of being inserted into the proximal end of a syringe barrel, wherein the plunger assembly is movable within the syringe barrel to move the plug between a starting position and a stopping position, providing a first volume in a chamber between the plug and the distal end of the syringe barrel when the plug is in the starting position, and providing a second volume in a chamber between the plug and the distal end of the syringe barrel when the plug is in the stopping position, the second volume being larger than the first volume; The plunger rod includes a stop arm, which is fixed at or near the distal end of the plunger rod. The stop arm includes: The proximal end is fixed to the plunger rod; and The free distal end has a snap formed thereon, the snap being configured to engage with the proximal end of the syringe barrel when the plunger assembly is in the initial position; The stop arm is at an initial angle when engaged with the proximal end of the syringe barrel, and the stop arm is configured to rotate to a second angle when disengaged from the proximal end of the syringe barrel.

10. The blood-drawing syringe according to claim 9, characterized in that, When the plunger assembly is in the initial position, the stop arm prevents the plunger assembly from being pushed further distally into the syringe barrel.

11. The blood-drawing syringe according to claim 9, characterized in that, As the plunger assembly moves proximally, the latch disengages from the proximal end of the syringe barrel.

12. The blood-drawing syringe according to claim 9, characterized in that, When the stop arm rotates to the second angle, the plunger assembly can be advanced distally into the syringe barrel until the plug contacts the distal end of the syringe barrel.

13. The blood-drawing syringe according to claim 9, characterized in that, When the stop arm rotates to the second angle, it rotates toward or away from the plunger rod.

14. The blood-drawing syringe according to claim 9, characterized in that, During blood draw, the plunger assembly moves proximally within the syringe barrel to move the plug from the starting position to the stopping position, the size of the first volume limiting the vacuum pressure within the syringe barrel during the blood draw.

15. A system for drawing blood, characterized in that, The system includes: Vascular access device, the vascular access device comprising: The catheter includes a distal end and a proximal end; A catheter adapter including a distal adapter and a proximal adapter port, and defining a lumen therein, wherein the proximal end of the catheter is secured to the distal adapter; and An extension kit extending from the catheter adapter and in fluid communication with the catheter through the lumen of the catheter adapter, the extension kit including an extension tube having a distal end coupled to the catheter adapter and a proximal end having a connector thereon; and A syringe connected to the vascular access device, the syringe comprising: A syringe barrel having a distal end and a proximal end and defining a chamber therein, and a fluid connector component located at the distal end of the syringe barrel, the fluid connector component being configured to engage with the connector to fluidly connect the syringe to the vascular access device; and A plunger assembly includes a plunger rod and a plug, the plunger rod having a proximal end and a distal end, the plug being positioned at the distal end of the plunger rod and capable of being inserted into the proximal end of a syringe barrel, wherein the plunger assembly is movable within the syringe barrel between a starting position and a stopping position, providing a first volume in a chamber between the plug and the distal end of the syringe barrel when the plug is in the starting position, and providing a second volume in a chamber between the plug and the distal end of the syringe barrel when the plug is in the stopping position, the second volume being larger than the first volume; The syringe is configured to pre-set the plunger assembly within the syringe barrel before blood is drawn, wherein the plunger is positioned at the initial position to limit the vacuum pressure within the syringe barrel during blood drawing.

16. The system according to claim 15, characterized in that, The syringe barrel includes: A first mark is provided on the syringe barrel, the first mark indicating the starting position of the stopper; and A second mark is provided on the syringe barrel, the second mark indicating the stop position of the stopper; During blood draw, the plunger assembly moves proximally within the syringe barrel to move the plug from the starting position to the stopping position, and the size of the first volume limits the vacuum pressure within the syringe barrel during blood draw.

17. The system according to claim 16, characterized in that, The syringe also includes a clamp that is attached to the plunger rod in a position where, when the clamp is against the proximal end of the syringe barrel, the plug is located at the starting position and aligned with the first mark, and wherein the clamp is removable from the plunger rod to allow the plunger assembly to be fully advanced distally into the syringe barrel.

18. The system according to claim 15, characterized in that, The syringe also includes a stopcock valve disposed within the syringe barrel and positioned at or near the fluid connector component at the distal end of the syringe barrel. The stopcock valve is actuable between an open position and a closed position to control fluid flow into the chamber of the syringe barrel.

19. The system according to claim 15, characterized in that, The plunger rod includes a stop arm, which is fixed at or adjacent to the distal end of the plunger rod, and the stop arm includes: The proximal end is fixed to the plunger rod; and The free distal end has a snap formed thereon, the snap being configured to engage with the proximal end of the syringe barrel when the plunger assembly is in the initial position; The stop arm is at an initial angle when engaged with the proximal end of the syringe barrel, and the stop arm is configured to rotate to a second angle when disengaged from the proximal end of the syringe barrel.

20. The system according to claim 19, characterized in that, When the plunger assembly is in the initial position, the stop arm prevents the plunger assembly from being further advanced distally into the syringe barrel, and when the stop arm rotates to the second angle, the plunger assembly is able to be advanced distally into the syringe barrel until the plug contacts the distal end of the syringe barrel, wherein the stop arm rotates to the second angle as the plunger assembly moves proximally from the initial position toward the stop position.

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