Arterial access system

Abstract

An arterial access system includes a catheter assembly having an arterial catheter and an access port. A blood extraction device is coupled to the access port, where the blood extraction device includes a catheter tube, a housing movably receiving the catheter tube and having 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 a first position and a second position, the distal end of the catheter tube can be disposed through the distal tip of the arterial catheter. A collection device is positioned proximal to the housing and in fluid communication with the catheter tube such that the collection device directly collects a sample of arterial blood through the catheter tube when the catheter tube is in the second position.

Description

Technical Field

[0001] The utility model relates to an arterial access system and a use method thereof. The method is used for directly collecting arterial blood by utilizing a blood extraction device with an indwelling arterial catheter. Background Art

[0002] Arterial catheterization is an important procedure commonly used in hospital settings, both in severely injured patients and those undergoing surgery. Arterial catheters are used to continuously monitor and measure blood pressure, heart rate, and pulse contour to allow for immediate identification of abnormal hemodynamic events and initiation of appropriate treatment. Arterial catheters are also used to provide samples for blood gas analysis without the morbidity associated with repeated arterial punctures. In use, arterial catheters are typically inserted into the radial artery at the wrist, but may also be inserted into the brachial artery at the elbow, the femoral artery in the groin, the dorsalis pedis artery in the foot, or the ulnar artery in the wrist.

[0003] It has been recognized that the use of current arterial catheters and associated arterial blood gas and blood sampling systems can be complicated, have many workflow steps that could be simplified, and can result in difficult flushing of venous lines and interruptions to hemodynamic monitoring. For example, current systems used with arterial catheters require that a large volume of blood be drawn from the patient and into a large, complex fluid extension set prior to sampling, the system then samples from the extension set, pushes the large volume of blood back into the patient, and then flushes the large fluid path volume to clear the blood from the extension set.

[0004] Therefore, there is a need for an arterial access system that facilitates improved arterial line blood collection for arterial blood gas sampling and continuous pressure monitoring that overcomes the above limitations of existing systems and devices. The system would be able to collect blood samples from within a patient's artery while eliminating the complexity and complications associated with current systems and methods. Utility Model Content

[0005] The present invention provides an arterial access system, which includes a catheter assembly having an indwelling arterial catheter and a near-patient access port. The arterial access system also includes a blood extraction device connected to the near-patient access port, the blood extraction device also including: a catheter tube; a housing, the housing defining an internal volume configured to movably receive the catheter tube, and having a proximal end portion and a distal end portion that can be connected to the catheter assembly; and a propulsion member, the propulsion member is configured to move relative to the housing to move the catheter tube between a first position and a second position, in which the catheter tube is disposed in the housing, and in the second position, the distal end portion of the catheter tube is disposed to exceed the distal end portion of the housing, so that at least a first portion of the catheter tube can be disposed in the indwelling arterial catheter or pass through its distal end. The arterial access system also includes a collection device, which is connected to the proximal end portion of the housing and is in fluid communication with the catheter tube. When the catheter tube is in the second position, the collection device directly collects a sample of arterial blood through the catheter tube.

[0006] In some embodiments, the blood withdrawal device includes a secondary conduit coupled to the advancement member and extending proximally from the advancement member and out of a proximal end portion of the housing, the secondary conduit fluidly connecting the catheter tube and the collection device.

[0007] In some embodiments, the blood extraction device includes a coupler connected to the proximal end of the secondary conduit, and wherein the collection device is connected to the secondary conduit via the coupler.

[0008] In some embodiments, the collection device is a vacuum-assisted collection device.

[0009] In some embodiments, the collection device is a non-vacuum assisted collection device.

[0010] In some embodiments, the coupler includes a vent feature configured to vent the non-vacuum assisted collection device.

[0011] In some embodiments, the collection device is a diagnostic test cartridge that is directly coupled to the housing, and wherein the diagnostic test cartridge collects the microsample of arterial blood directly through the catheter tubing.

[0012] In some embodiments, the catheter assembly includes a catheter adapter and a connector, wherein the catheter adapter is coupled to the proximal end of the arterial catheter and has an adapter port, and the connector is connected to the adapter port via an extension tube, wherein the proximal patient access port is disposed at the proximal end of the connector.

[0013] In some embodiments, the connector includes a side port positioned distal to the proximal patient access port, and wherein the arterial access system further includes an extension kit coupled to the side port and fluidly coupled to the arterial catheter, the extension kit providing arterial blood from the arterial catheter to a hemodynamic monitoring system coupled to the arterial catheter.

[0014] In some embodiments, the distal end portion of the housing includes a lock configured to couple the housing to the proximal patient access port.

[0015] A method for directly sampling arterial blood via an indwelling arterial catheter of a catheter assembly is also provided. The method includes coupling a blood extraction device to a proximal patient access port of the catheter assembly, wherein the blood extraction device includes a catheter tube, a housing, and a propulsion member, the housing having a proximal end portion and a distal end portion and defining an internal volume configured to movably receive the catheter tube, the propulsion member being configured to move relative to the housing to move the catheter tube between a first position and a second position, in which the catheter tube is disposed within the housing, and in which the distal end of the catheter tube is disposed beyond the distal end portion of the housing and past the distal end of the indwelling arterial catheter. The method also includes connecting a collection device at the proximal end portion of the housing, moving the propulsion member along the housing to propel the catheter tube to the second position, and collecting a sample of arterial blood directly in the collection device when the catheter tube is in the second position.

[0016] In some embodiments, connecting the collection device includes connecting the collection device to a proximal end of a secondary conduit that fluidly connects the collection device to the catheter tube, the secondary conduit extending from the proximal end portion of the housing.

[0017] In some embodiments, connecting the collection device includes connecting the collection device to a coupler attached to the proximal end of the secondary catheter.

[0018] In some embodiments, connecting the collection device includes connecting a vacuum-assisted collection device to the proximal end of the secondary catheter.

[0019] In some embodiments, connecting the collection device includes connecting a non-vacuum assisted collection device to the proximal end of the secondary catheter.

[0020] In some embodiments, the method includes venting the non-vacuum assisted collection device via a vent included on the coupler to facilitate collection of a sample of arterial blood, wherein arterial blood pressure induces flow of arterial blood to the vented non-vacuum assisted collection device.

[0021] In some embodiments, the method includes dispensing at least a portion of the sample of arterial blood to a point-of-care (POC) testing device, including a blood diagnostic test cartridge or a blood analyzer test instrument.

[0022] In some embodiments, connecting the collection device includes connecting a blood diagnostic test cartridge directly to the housing, and wherein directly collecting the sample of arterial blood includes collecting a micro-sample of arterial blood directly in the blood diagnostic test cartridge through a catheter tube.

[0023] In some embodiments, coupling the blood extraction device to the proximal patient access port includes coupling the blood extraction device to a connector of a catheter assembly, the connector including a proximal end having the proximal patient access port, a distal end of a catheter adapter connected to the catheter assembly via an extension tube (wherein the catheter adapter receives an indwelling arterial catheter), and a side port positioned between the proximal and distal ends of the connector.

[0024] In some embodiments, the method includes connecting an extension kit to a side port fluidly connected to an indwelling arterial catheter, connecting a hemodynamic monitoring system to the extension kit, and providing a flow rate of arterial blood to the hemodynamic monitoring system via the indwelling arterial catheter and the extension kit, wherein the flow rate of arterial blood is provided to the hemodynamic monitoring system while a sample of the arterial blood is collected in a collection device. BRIEF DESCRIPTION OF THE DRAWINGS

[0025] Figure 1 is a perspective view of an arterial access system according to one aspect of the present disclosure, wherein a syringe is connected to a blood extraction device of the arterial access system;

[0026] Figure 2 According to one aspect of the present disclosure, Figure 1 A perspective view of a blood extraction device for use with an arterial access system;

[0027] Figure 3 yes Figure 2 An exploded view of a blood extraction device;

[0028] Figure 4 yes Figure 2 A side view of a blood extraction device showing the catheter in a first retracted position;

[0029] Figure 5 yes Figure 2 A side view of a blood extraction device showing the catheter in a second extended position;

[0030] Figure 6 is a perspective view of an arterial access system according to one aspect of the present disclosure, wherein a vacuum blood collector is connected to a blood extraction device of the arterial access system;

[0031] Figure 7 is a perspective view of an arterial access system according to one aspect of the present disclosure, wherein a diagnostic cassette is connected to a blood extraction device of the arterial access system; and

[0032] Figure 8 is a perspective view of an arterial access system according to one aspect of the present disclosure. DETAILED DESCRIPTION

[0033] This application claims priority to U.S. Provisional Application No. 63 / 452,012, filed on March 14, 2023, entitled “ARTERIAL ACCESS SYSTEM AND METHOD FOR DIRECTLY PERFORMING ARTERIAL BLOOD SAMPLING,” the entire disclosure of which is incorporated herein by reference.

[0034] The following description is provided to enable those skilled in the art to make and use the described embodiments intended for implementing the present invention. However, various modifications, equivalents, variations and substitutions will be apparent to those skilled in the art. Any and all of these modifications, variations, equivalents and substitutions are intended to fall within the spirit and scope of the present invention.

[0035] As used in this specification, the words "proximal" and "distal" refer to the direction closer to and away from the user who brings the device into contact with the patient, respectively. Thus, for example, the end of the device that first contacts the patient's body would be the distal end, and the opposite end of the device (e.g., the end of the device that is manipulated by the user) would be the proximal end of the device.

[0036] Spatial or directional terms, such as "left", "right", "inner", "outer", "above", "below", etc., should not be considered limiting as the invention can assume various alternative orientations.

[0037] For the purpose of the following description, the terms "upper", "lower", "right", "left", "vertical", "horizontal", "top", "bottom", "lateral", "longitudinal" and their derivatives should be related to the orientation of the utility model in the drawings. However, it should be understood that the utility model can take various alternative changes unless explicitly stated to the contrary. It should also be understood that the specific devices shown in the drawings and described in the following description are only exemplary aspects of the utility model.

[0038] The terms "first", "second", etc. do not refer to any particular sequence or chronological order, but rather to different conditions, properties or elements.

[0039] As used herein, "at least one" is synonymous with "one or more". For example, the phrase "at least one of A, B, and C" refers to 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.

[0040] The utility model relates to an arterial access system with a blood extraction device (alternatively, "line extraction device") and a method for using the arterial blood extraction device to advance a blood extraction catheter into an indwelling arterial catheter and then extracting a blood sample from a patient.

[0041] Reference Figure 1 , a non-limiting embodiment of an arterial access system 10 is shown for facilitating improved arterial line blood collection for arterial blood gas sampling and continuous pressure monitoring. The arterial access system 10 may include a catheter assembly 12 having 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 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 the proximal end 20 of the catheter adapter 14. The catheter 16 may be formed of any suitable material and may have any useful length, as known to those skilled in the art. The catheter 16 extends from the distal end 18 of the catheter adapter 14 and can be configured as an arterial catheter that is placed within an artery of a patient, wherein the distal end or tip 26 of the catheter 16 is appropriately positioned within the artery 28 so that blood can be drawn from the patient. In some embodiments, the catheter 16 can be inserted into the artery so that the distal tip 26 (the opening therein) faces upstream and into the arterial blood flow.

[0042] In some non-limiting embodiments or aspects, catheter assembly 12 may include a first fluid conduit 30 extending from port 22. The first fluid conduit 30 may be formed by any suitable material known to those skilled in the art, and may have a distal end 32 and a proximal end 34. The distal end 32 of the first fluid conduit 30 is coupled to port 22, and the proximal end 34 of the first fluid conduit 30 may be coupled to a connector 36. The connector 36 may be a T-connector (e.g., a side port is arranged at a 90 degree angle relative to the longitudinal axis of the connector 36), a Y-connector (e.g., a side port is arranged at a 25, 60 or 75 degree angle relative to the longitudinal axis of the connector 36), or any other type of connector known in the art. The connector 36 includes a second lumen 38 running through it, which has any number of branches suitable for connector types, such as branches extending between the distal end and the proximal end of the connector 36 and branches arranged to the ports 44 of the connector 36.

[0043] In some non-limiting embodiments or aspects, catheter assembly 12 can include a needleless access connector 46 that is coupled to the proximal end 42 of connector 36, wherein needleless access connector 46 provides the access port leading to catheter assembly 12. As an example, needleless access connector 46 can be constructed as a split diaphragm connector or a self-healing diaphragm connector. In the illustrated embodiment, the access port provided by needleless access connector 46 is a near patient access port near the insertion site of catheter 16, but it should be appreciated that the access port can be arranged at other alternative positions near the insertion site, and this alternative position allows blood to be drawn from the catheter tube to be advanced into the indwelling arterial catheter 16 and to advance beyond the distal end of the indwelling arterial catheter. For example, the access port provided for blood to be drawn from the catheter tube to be advanced into the indwelling arterial catheter 16 can be located on another connector, for example, the proximal connector on the extension kit (as described below) of catheter assembly 12.

[0044] In some non-limiting embodiments or aspects, the catheter assembly 12 may also include an extension kit 48 coupled to the port 44 of the connector 36. The extension kit 48 may include a second fluid conduit 50 coupled to the port 44 at an end 52 of the conduit 50 and a Luer connector 54 at an opposite end 56, wherein a clamp 57 is disposed on the second fluid conduit 50 to allow occlusion thereof. The extension kit 48 may be used to provide a fluid path from the catheter assembly 12 to a hemodynamic monitoring device 58 that monitors a patient's blood pressure, heart rate, and / or pulse profile based on arterial blood drawn through the catheter assembly 12. Although Figure 1The non-limiting embodiment of shows the needleless access connector 46 disposed at the connector 36 , but those skilled in the art will appreciate that a suitable needleless access connector may also be disposed at the Luer connector 54 of the extension set 48 .

[0045] The arterial access system 10 also includes a blood extraction device 60 (alternatively, a "line extraction device") that can be operated to obtain a blood sample from a patient, such as to enable blood gas analysis. Figure 1 shown and in Figure 2-5 , according to one non-limiting embodiment, the blood extraction device 60 includes at least a 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 movable within the housing 62 to provide a portion of the catheter tube 66 from a first or retracted position ( Figure 4 ) to a second or advanced position outside of housing 62 ( Figure 5 ) is advanced so that its distal end can be guided into the catheter assembly 12. Once a portion of the catheter tube 66 has been guided into the catheter assembly 12 and out of the distal tip 26 of the indwelling catheter 16, the catheter tube 66 can enable the collection of a blood sample.

[0046] According to an embodiment, the size of catheter tube 66 is arranged to enable it to be introduced into the fluid path of catheter assembly 12 (that is, the lumen of catheter 16, the lumen 24 of catheter adapter 14 and the first fluid conduit 30), and is used to advance through this fluid path. Therefore, catheter tube 66 can have the outer diameter (for example, between No. 10 and No. 30 specifications) of the minimum lumen of the fluid path less than catheter assembly. Catheter tube 66 can have the length that is enough to place the distal end 70 of catheter tube 66 in the desired position in the fluid path of arterial access system 10. Therefore, in one embodiment, catheter tube 66 can have the length that is enough to provide its distal end 70 to be pushed out from housing 62 and pass through catheter assembly (that is, by connector 36, fluid conduit 30, catheter adapter 14 and catheter 16), and always push out the distal end 26 of catheter 16.

[0047] In some embodiments, and to accommodate the positioning of the catheter tube 66 within the catheter 16 and its advancement beyond the distal tip 26 of the catheter 16, the distal end 26 of the catheter 16 may include a fenestration formed therein. The fenestration at the distal end 26 of the catheter 16 serves to maintain fluid continuity from the artery and through the catheter 16 to the hemodynamic monitoring device 58 connected to the proximal end of the extension set 48, i.e., the fenestration prevents the catheter tube 66 from clogging the catheter 16 at its distal tip 26 and cutting off accurate pressure monitoring. Thus, the fenestration in the catheter 16 provides the ability to continue monitoring arterial pressure during the sampling process performed by the blood extraction device 60 as the catheter tube 66 is advanced.

[0048] According to aspects of the present disclosure, it is recognized that the use of a blood extraction device 60 with an indwelling arterial catheter 16 can be different from the use of a blood extraction device with an indwelling peripheral venous (IV) catheter. That is, unlike a peripheral IV catheter used in a vein, an arterial catheter has an opening and a distal end facing upstream and entering the upcoming arterial blood flow. Arterial blood flow is also generally at a higher flow rate and pressure, and therefore, some challenges and complications encountered by peripheral IV catheters do not occur in arterial catheters, such as thrombosis downstream of the catheter end in the venous side, which makes it difficult to aspirate and line aspiration during the stay of the peripheral IV catheter. Therefore, the use of a blood extraction device 60 with an indwelling arterial catheter 16 includes different requirements, optimization goals, and design considerations. For example, according to some non-limiting embodiments of the present disclosure, the blood extraction device 60 can be configured to extend the distal end 70 of the catheter tube 66 beyond the distal end 26 of the indwelling arterial catheter 16 by a distance less than 10 mm, and preferably between 3 mm and 10 mm, because such a distance can be sufficient to obtain a high-quality arterial blood sample due to the reasons provided above. In other embodiments, the blood extraction device 60 may be configured such that the distal end 70 of the catheter tube 66 extends beyond the distal tip 26 of the indwelling arterial catheter 16 by a distance of 20 cm, 30 cm, or more, according to other non-limiting embodiments.

[0049] like Figure 2-5 As shown, the housing 62 of the blood extraction device 60 can be an elongated member having a proximal end 72 and a distal end 74 and defining an interior volume 76. In some embodiments, the housing 62 can be formed from a pair of housing portions 78a, 78b coupled together to define the interior volume 76. The housing 62 can include one or more features or surface finishes on its exterior surface that can be configured to increase the ergonomics of the blood extraction device 60, which in some cases can allow a user to manipulate the blood extraction device 60 with a single hand (i.e., one-handed use).

[0050] The coupling device 64 of the blood extraction device 60 is disposed at the distal end 74 of the housing 62, and the coupling device 64 provides a reversible coupling of the blood extraction device 60 to the catheter assembly 12, for example via Figure 1 The needleless access connector 46 is shown. In some embodiments, the coupling device 64 is configured as a locking member 80, which includes a blunt cannula 82 and a locking arm 84 for coupling to the needleless access connector 46 of the catheter assembly 12, wherein the blunt cannula 82 and the locking arm 84 form three points of contact with the needleless access connector 46. However, those skilled in the art will understand that any connection or coupling, such as a Luer piece, can be used as long as the distal end 70 of the catheter tube 66 can pass through the coupling device 64 to reach the catheter assembly 12.

[0051] The advancement member 68 of the blood extraction 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 housing 62, and the second portion 88 is movably disposed within the interior volume 76 of the housing 62. The advancement member 68 and the housing 62 are arranged so that a connecting portion (not shown) of the advancement member 68 that joins the first portion 86 and the second portion 88 is located within a slot 92 formed in the upper surface 90 of the housing 62, the slot 92 extending generally between the proximal end 72 and the distal end 74 of the housing 62. When the first portion 86 and the second portion 88 are coupled together, movement of the first portion 86 along the upper surface 90 of the housing 62 results in corresponding movement of the second portion 88 within the interior volume 76.

[0052] like Figure 2-5 As shown, the first portion 86 of the advancement member 68 can be configured as a tab or protrusion having a contact surface 94a that can be engaged by a user and an underside 94b that contacts the outer surface 90 of the housing 62. In such an embodiment, the upper surface 90 of the housing 62 can include a track 96, such as a set of ribs, ridges, bumps, grooves, and / or the like, along which the underside 94b of the tab or protrusion is advanced when the advancement member 68 is engaged by the user. In this way, the user can engage the first portion 86 of the advancement member 68 and can move the advancement member 68 relative to the housing 62.

[0053] like Figure 2-5As shown, the second portion 88 includes an opening 98 extending therethrough that is configured to grip or retain a portion of the catheter tube 66. Since the portion of the catheter tube 66 is retained within the opening 98 of the second portion 94, movement of the advancement member 68 relative to the housing 62 results in corresponding movement of the catheter tube 66 relative to the housing 62. In this manner, the distal end 70 of the catheter tube 66 can be selectively moved out of or back into the interior volume 76 of the housing 62 as desired, such as by pushing the distal end 70 of the catheter tube 66 out of the housing 62 when the blood extraction device 60 has been coupled to the catheter assembly 12 and the collection of an arterial blood sample is to be performed.

[0054] As described above, when the distal end 70 of the catheter tube 66 is pushed out of the housing 62 and into the catheter assembly 12, the blood extraction device 60 can be configured to extend the distal end 70 of the catheter tube 66 beyond the distal tip 26 of the indwelling arterial catheter 16 by a distance less than 10 mm, preferably between 3 mm and 10 mm, which is sufficient to obtain a high-quality arterial blood sample for the reasons provided above. The advancement of the catheter tube 66 by this distance allows the length of the catheter tube and the housing 62 to be reduced and / or the movement of the advancement member 68 relative to the housing 62 to be limited. In some embodiments, the housing 62 can be configured to have a length L between 103-110 mm. Intro , which is related to the need for the extended length of the catheter tube 66 to be less than the length generally required for using a blood extraction device with a peripheral IV catheter. In some embodiments, the housing 62 can be configured to have a length L between 122-129 mm. Intro In other embodiments, the spacer 100 (in Figure 2 The spacer 100 (shown in phantom in the figure) can be disposed within the internal volume 76 of the housing 62, at a position proximal to the advancement member 68 (i.e., at the proximal end 72 of the housing 62), and is used to limit the travel path of the advancement member 68, which is related to the need for the extended length of the catheter tube 66 to be less than the length typically required for using a blood extraction device with a peripheral IV catheter.

[0055] like Figure 2-5As further shown, the blood draw collection device 60 includes a secondary conduit 102 disposed at the proximal end 72 of the housing 62. The secondary conduit 102 has a proximal end portion 104 and a distal end portion 106 and defines an inner cavity 108. A portion of the secondary conduit 102 is disposed within and extends through an opening 110 formed within the proximal end 72 of the housing 62. Thus, the proximal end portion 104 is at least partially disposed outside the housing 62 and the distal end portion 106 is at least partially disposed within the housing 62, wherein the distal end portion 106 is coupled to the second portion 88 of the push member 68. In some embodiments, the secondary conduit 102 may have a larger diameter than the catheter tube 66, which may be used to limit, reduce and / or substantially prevent hemolysis of a certain amount of blood when the certain amount of blood flows through the catheter tube 66 and the secondary conduit 102, as explained in more detail below. In this manner, when the blood drawing device 60 is coupled to a syringe, evacuated container, etc., the secondary conduit 102 establishes fluid communication between the reservoir, source, pump, etc. and the conduit tube 66, as further explained below.

[0056] According to embodiments of the present disclosure, the proximal end portion 104 of the secondary conduit 102 is coupled to and / or otherwise includes a coupler 114 configured to mate with a collection device 116 that can be used with (or considered to be a part of) the blood extraction device 60 to collect an arterial blood sample for subsequent analysis, such as blood gas analysis of the sample. According to some embodiments, the coupler 114 can be configured as a Luer connector (i.e., a female Luer connector) that is configured to mate with a corresponding Luer connector (i.e., a male Luer connector) of the collection device 116. The coupler 114 physically and fluidically couples the secondary conduit 102 to the collection device 116, which can be any suitable vacuum or non-vacuum assisted blood sample collection device 116, such as a sampling syringe, a vacutainer, a Luer lock access device (LLAD), a point-of-care (POC) sampling device, an integrated POC cartridge, a blood culture collection system, etc., as further described below. Non-limiting examples of vacuum or non-vacuum assisted blood sample collection devices may include Becton Dickinson Vacutainer ○R -Luer-Lok TM Access device or Accustat TM In some embodiments, a vent feature 118 may be provided for venting the vacuum or non-vacuum assisted collection device 116 prior to blood collection. As shown in the illustrated embodiment, the vent feature 118 may be disposed on the coupler 114, but it should be appreciated that the vent feature 118 may be disposed anywhere along the sampling fluid path, although preferably near the proximal end portion 104 of the secondary conduit 102.

[0057] like Figure 1-5 As shown, according to one aspect of the present invention, the collection device 116 connected to the blood extraction device 60 (via the coupling 114) is provided as a syringe 116a. In some embodiments, the syringe 116a may be pre-attached with a plunger 120 of the syringe 116a in an advanced position. When the catheter tube 66 of the blood extraction device 60 is advanced through the indwelling catheter 16 and into the artery 28, the plunger 120 of the syringe may be retracted to draw an undiluted arterial blood sample into the syringe 116a. The syringe 116a may contain a blood preservative / stabilizer therein to help maintain the quality of the sample. In other embodiments, the syringe 116a may start in a retracted position and have a selective exhaust feature (e.g., an exhaust member 118 on the coupling 114), and the syringe 116a may be exhausted via the exhaust feature after the catheter tube 66 has moved to the second, advanced position. After any venting of syringe 116a and subsequent sample collection and stabilization, syringe 116a may be removed from blood drawing device 60 and the sample may then be dispensed into a POC blood diagnostic test cartridge 122 or provided to another blood analyzer testing instrument.

[0058] Reference now Figure 6 , an arterial access system 10 is shown, wherein a collection device 116 connected to a blood extraction device 60 (via a connector 114) is configured as a vacuum blood collector collection device 116b, or a simplified / improved vacuum blood collector that is vented without the need for a vacuum tube to drive the sample volume collection. The vacuum blood collector 116b may contain a blood preservative / stabilizer therein to help maintain the quality of the sample. After the vacuum blood collector 116b is filled and the blood is stabilized, the vacuum blood collector 116b may be removed from the blood extraction device 60, and the blood sample may then be dispensed onto a POC diagnostic test cartridge 122 or provided to another blood analyzer test instrument.

[0059] Reference now Figure 7 , arterial access system 10 is shown, wherein, the collection device 116 connected to blood extraction device 60 is provided as an onboard POC diagnostic box 116c (e.g., iStat test box from Abbott). Diagnostic box 116c can be removably coupled to blood extraction device 60 (i.e., coupled to housing 62), for directly collecting the micro-sample of arterial blood. Utilizing diagnostic box 116c, system needs to carry out the selective exhaust of the fluid path of box microfluidic to prevent filling, until the distal end 70 of catheter tube 66 is directly in artery 28 for undiluted blood sampling. After having filled diagnostic box 116c, diagnostic box 116c can be removed from blood extraction device 60 and inserted into POC blood testing instrument and analyzer.

[0060] As noted above, the use of the blood drawing device 60 and the collection device 116 with the catheter assembly 12 enables direct collection of a sample of arterial blood. According to aspects of the present disclosure, arterial blood drawing can be performed by connecting a vacuum-assisted blood sample collection device 116 (e.g., a vacuum syringe or LLAD with a vacuum blood collector connected thereto) or by a non-vacuum-assisted blood sample collection device 116 (e.g., a vented syringe or other vented chamber). When a non-vacuum-assisted blood sample collection device 116 is used with the blood drawing device 60, arterial pressure is used to fill the vented collection device chamber, where blood flow is driven by a constant arterial pressure. In the case of vacuum-assisted blood drawing, the pressure gradient across the fluid path of the blood drawing device (i.e., across the catheter tube 66 and the secondary catheter 102) is much higher, and therefore shear-driven hemolysis may affect the collection of arterial blood samples.

[0061] With respect to the effect of shear-driven hemolysis, the maximum shear stress in a tubular fluid path (such as catheter tube 66 and secondary catheter 102) is determined by the flow rate and the minimum hydraulic diameter of the tube. Fluid flow through a tubular fluid path can be analyzed using Poisson's equation:

[0062]

[0063] where ΔP is the change in pressure gradient across the length of the fluid path, D and L are the inner diameter and length of the fluid path, respectively, μ is the viscosity of the fluid, and R f =128μL / πD 4 is the fluid resistance. Since μ is the viscosity of the fluid and not part of the extended tube geometry, the geometric factor G f is defined so that R f (fluid resistance) is R f =(128μL / π)*G f , where G f =L / D 4 .

[0064] In some embodiments, the optimized fluid path may have multiple segments with lengths (L1, L2, L3, ...) and inner diameters (D1, D2, D3, ...), and the geometric factors are:

[0065]

[0066] In some embodiments, the optimized fluid path may have an inner diameter that varies over the length of the tube, with the geometric factor being:

[0067]

[0068] In some embodiments, the optimized fluid path may have a cross-section with a non-circular inner diameter profile. The geometric factor can be determined by measuring the flow rate (Q) of a fluid with a known viscosity (μ) at a given pressure (ΔP):

[0069]

[0070] Since in the case of arterial blood collection, the G of the optimized fluid path f The values ​​are different for syringe draws or vented chamber and evacuated blood collection, so the G of the optimized fluid path is f The value may be the higher value between syringe draw and vacuum blood collection. Alternatively, the G of the optimized fluid path f The value can be the lower value between syringe draw and vacutainer draw and is used when a higher G f In the case of a value of G, an accessory in the form of an extension kit or connector can be connected to the Luer piece. In another alternative embodiment, the proximal end of the extension tube (i.e., the secondary catheter 102) can be composed of two ports, each of which provides a different G f value.

[0071] In the case of syringe draw or vented chambers, blood draw occurs at a constant flow rate due to a constant driving arterial pressure. The maximum shear stress is constant where:

[0072]

[0073] Where D min is the minimum diameter of the fluid path defined by the conduit tube 66 and the secondary conduit 102 .

[0074] Based on the above, the G of the optimized fluid path (ie, the catheter tube 66 and the secondary catheter 102) can be selected according to the blood drawing method. f According to aspects of the present disclosure, in the case of vacuum-assisted evacuation, the G of the optimized fluid path can be selected. f value to reduce the maximum shear stress to be equal to or less than the maximum shear stress of a typical vacuum-assisted button blood collection kit (where G f Value equal to or greater than 220 / D min 3 is desirable). According to aspects of the present invention, in the case of syringe extraction or other vented chambers (ie, non-vacuum assisted devices), the G of the optimized fluid channel f The value may again be selected to reduce the maximum shear stress to be equal to or less than the average maximum shear stress of a typical vacuum-assisted button blood collection kit (where G f Value greater than 35 / D min3 is expected).

[0075] It should be appreciated that the aspects of the present disclosure are not limited to Figure 1-7 The particular blood extraction device 60 shown and described in the drawings, and blood extraction devices having other suitable configurations may also include aspects of the present disclosure. Figure 8 , an arterial access system 128 is shown, which includes a blood extraction device 130 according to another embodiment of the present disclosure. The blood extraction device 130 includes a housing 132 having a proximal end 134 and a distal end 136, and a propulsion member 138 slidably received within the housing 132 (i.e., within the interior volume 140 of the housing 132). In the illustrated embodiment, the propulsion member 138 is configured as one or more telescopic cylinders 138a, which are configured in a telescopic relationship with the housing 132 so that the propulsion member 138 can be slidably received completely or nearly completely within the interior volume 140 of the housing 132. The propulsion member 138 also includes a proximal end 142 and a distal end 144, and in a non-limiting embodiment, the propulsion member 138 can have a variable diameter along its length. As one example, the distal end 144 of the advancement member 138 can have a larger diameter than other portions of the advancement member 138, so that when the advancement member 138 is retracted, one or more features on the housing 132 can interact with the enlarged portion of the advancement member 138 to prevent the advancement member 138 from being completely pulled out of the housing 132. As another example, the distal end 144 of the advancement member 138 can have a smaller diameter than other portions of the advancement member 138 to maintain the advancement member 138 in a position in a pre-blood-drawing state so that the operator's hands are freed to manipulate additional components (e.g., a vacuum blood collection tube).

[0076] The blood extraction device 130 also includes a catheter tube 146 having a proximal end 148 and a distal end 150. The catheter tube 146 is received within the interior volume 140 of the housing 132 and can be advanced and / or retracted relative to the housing 132 by displacement of the advancement member 138 relative to the housing 132. In some embodiments, the catheter tube 146 can be coupled to the advancement member 138 via a fitting 152 disposed at the distal end 144 of the advancement member 138, such that displacement of the advancement member 138 relative to the housing 132 causes a corresponding displacement of the catheter tube 146. In a non-limiting embodiment, the catheter tube 146 can be advanced from a first position in which the distal end 150 of the catheter tube 146 is located within the housing 132 to a second position in which the distal end 150 of the catheter tube 146 is located distally of the housing 132 (and also distally of the catheter 16), as previously described with reference to the blood extraction device 60 and its operation.

[0077] The blood extraction device also includes a coupling device 154 located thereon, which can be connected to Figure 1-7 That is, the coupling device 154 is configured as a locking member 80, which includes a blunt cannula 82 and a locking arm 84 for connecting to the needleless access connector 46 of the catheter assembly 12, wherein the blunt cannula 82 and the locking arm 84 form three points of contact with the needleless access connector 46. However, it should be understood that alternative embodiments of the blood extraction device 130 may include another type of coupling device 154 to secure the blood extraction device 130 to the catheter assembly 12, including a Luer connector, a clamp, a blunt plastic cannula, a blunt metal cannula, a hybrid Luer (e.g., with a cannula) friction fit, etc.

[0078] According to aspects of the present disclosure, the secondary catheter 102 can be guided through the telescoping cylinder 138a of the advancement member 138, wherein the secondary catheter 102 provides a fluid connection between the catheter tube 146 and the coupling 114 disposed at the proximal end portion 104 of the secondary catheter 102, wherein the coupling 114 is configured to cooperate with the collection device 116. Figure 8 The syringe 116a is shown in FIG. 1 , but the collection device 116 may be configured as Figure 1-7 Any of the collection devices 116 shown and described in the drawings, wherein the collection device 116 is attached to the blood drawing device 130 to provide an arterial access system to facilitate improved arterial line blood collection for arterial blood gas sampling. That is, the blood drawing device 130 can accommodate any of a variety of different vacuum-assisted or non-vacuum-assisted blood collection devices 116 for use therewith to collect blood samples, wherein the blood drawing device can be configured, for example, by controlling the size of the device (including the device (i.e., the fluid path therein) The geometric factor G f ) to prevent hemolysis during sample collection.

[0079] Advantageously, embodiments of the present disclosure therefore provide an arterial access system that facilitates improved arterial line blood collection for arterial blood gas sampling and continuous pressure monitoring. The arterial access system includes a catheter assembly having a blood extraction device attached thereto, the blood extraction device being used to collect an arterial blood sample directly from a patient via an indwelling arterial catheter, wherein such blood sample is used for blood gas analysis. The arterial access system simultaneously provides continuous blood pressure monitoring and provides arterial blood to a hemodynamic monitoring system connected thereto by using an extension kit connectable to the catheter assembly. The blood extraction device can be adapted for use with any of a variety of different vacuum-assisted or non-vacuum-assisted blood collection devices for collecting blood samples, wherein the blood extraction device can be configured to prevent hemolysis during sample collection.

[0080] Although for the purpose of illustration, the present disclosure is described in detail based on what is currently considered to be the most practical and preferred embodiments or aspects, it should be understood that such details are only for this purpose, and the present disclosure is not limited to the disclosed embodiments or aspects, but on the contrary, it is intended to cover modifications and equivalent arrangements within the spirit and scope of the appended claims. For example, it should be understood that the present disclosure contemplates that, to the extent possible, one or more features of any embodiment can be combined with one or more features of any other embodiment.

Claims

1. An arterial access system, characterized in that: The arterial access system comprises: a catheter assembly comprising an arterial catheter and an access port; a blood extraction device coupled to the access port and in fluid communication with the arterial catheter via the catheter assembly, the blood extraction device comprising: catheter tube; a housing having a proximal end portion and a distal end portion, the distal end portion being coupleable to the access port, the housing defining an interior 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 arterial catheter; and a collection device positioned proximal to the housing and in fluid communication with the catheter tube; Wherein, when the catheter tube is in the second position, the collecting device is configured to directly collect a sample of arterial blood through the catheter tube.

2. The arterial access system according to claim 1, characterized in that: The blood withdrawal device includes a secondary conduit coupled to the advancement member and extending proximally therefrom and out of the proximal end portion of the housing, the secondary conduit fluidly connecting the catheter tube and the collection device.

3. The arterial access system according to claim 2, characterized in that: The blood extraction device includes a coupler connected to a proximal end of the secondary conduit, wherein the collection device is connected to the secondary conduit via the coupler.

4. The arterial access system according to claim 3, characterized in that: The collection device includes a vacuum-assisted collection device.

5. The arterial access system according to claim 3, characterized in that: The collection device includes a non-vacuum assisted collection device.

6. The arterial access system according to claim 5, characterized in that: The coupler includes a vent feature configured to vent a vacuum-assisted collection device or a non-vacuum-assisted collection device.

7. The arterial access system according to claim 1, characterized in that: The collection device includes a diagnostic test cartridge directly coupled to the housing, wherein the diagnostic test cartridge collects a micro-sample of arterial blood directly through the catheter tube.

8. The arterial access system according to claim 1, characterized in that: The catheter assembly comprises: a catheter adapter coupled to the proximal end of the arterial catheter, the catheter adapter comprising an adapter port; and A connector is connected to the adapter port via an extension tube, wherein the access port is provided at a proximal end of the connector.

9. The arterial access system according to claim 8, characterized in that: The connector includes a side port positioned distal to the access port, wherein the arterial access system further includes an extension kit connected to the side port and fluidly connected to the arterial catheter, the extension kit providing arterial blood from the arterial catheter to a hemodynamic monitoring system connected to the arterial catheter.

10. The arterial access system according to claim 1, characterized in that: The distal end portion of the housing includes a lock configured to couple the housing to the access port.

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