Arterial access system and method for direct arterial blood collection

Abstract

The arterial access system includes an arterial catheter and a catheter assembly having an access port. A blood collection device is coupled to the access port, and the blood collection device includes a catheter tube, a housing having a distal end portion that movably receives the catheter tube and can be coupled to the catheter assembly, and a forward member configured to move the catheter tube between a first position and a second position so that the distal end of the catheter tube is positioned distal to the arterial catheter. A collection device is located proximal to the housing and is in fluid communication with the catheter tube so that, with the catheter tube in the second position, the collection device directly collects a sample of arterial blood through the catheter tube.

Description

Technical Field

[0001] The present invention is directed to an arterial access system and method of use for direct arterial blood sampling using a blood sampling device equipped with an indwelling arterial catheter.

Background Art

[0002] Cross - reference to related applications This application claims priority to U.S. Provisional Application No. 63 / 452,012, titled "Arterial Access System and Method for Direct Arterial Blood Collection," filed on March 14, 2023, the entire disclosure of which is incorporated herein by reference.

[0003] Arterial catheter insertion is a very important procedure widely performed in hospital settings for critically ill trauma patients and perioperative patients. Arterial catheters are used to continuously monitor and measure blood pressure, heart rate, and pulse wave shape, enabling immediate recognition of abnormal hemodynamic events and initiation of appropriate treatment. Arterial catheters are also used to provide specimens for blood gas analysis without the risk of complications associated with repeated arterial punctures. In use, an arterial catheter is typically inserted into the radial artery at the wrist joint, but can 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 at the wrist joint.

[0004] It has been recognized that the use of current arterial catheters and related arterial blood gas and blood sampling systems is complex, with a number of procedural steps that can be simplified, and that it may cause difficulties in cleaning the drip line and interruption of hemodynamic monitoring. For example, in current systems used with arterial catheters, a large amount of clearing blood needs to be aspirated from the patient before sampling and fed into a large and complex fluid extension set. Thereafter, the system samples from the extension set, returns a large amount of blood to the patient, and further washes a large amount of fluid in the flow path to remove the blood in the extension set.

[0005] Therefore, there is a need for an arterial access system to facilitate improved arterial line blood collection for arterial blood gas sampling and continuous pressure monitoring, overcoming the aforementioned limitations of existing systems and devices. This system will enable the acquisition of blood samples from within a patient's artery while eliminating the complexity and complications associated with current systems and approaches. [Overview of the project]

[0006] Provided herein is an arterial access system comprising an indwelling arterial catheter and a catheter assembly having a patient-near-patient access port. The arterial access system also comprises a blood collection device connected to the patient-near-patient access port, the blood collection device further comprising a catheter tube and a housing that defines an internal volume configured to movably receive the catheter tube and have a proximal end portion and a distal end portion that can be coupled to the catheter assembly, and a forward member configured to move relative to the housing to move the catheter tube between a first position in which the catheter tube is positioned within the housing and a second position in which the distal end portion of the catheter tube is positioned beyond the distal end portion of the housing, thereby allowing at least a portion of the catheter tube to be positioned within the indwelling arterial catheter or beyond its distal end. The arterial access system further comprises a collection device coupled to the proximal end portion of the housing and 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.

[0007] In some embodiments, the blood collection device includes a secondary catheter coupled to an advancing member, extending proximal therefrom and outward from the proximal end portion of the housing, the secondary catheter fluidly connecting the catheter tube and the collection device.

[0008] In some embodiments, the blood collection device includes a coupler connected to the proximal end of a secondary catheter, and the collection device is connected to the secondary catheter via the coupler.

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

[0010] In some embodiments, the sampling device is a non-vacuum-assisted collection device.

[0011] In some embodiments, the coupler includes an exhaust feature configured to exhaust a non-vacuum-assisted collection device.

[0012] In some embodiments, the collection device is a diagnostic test cartridge directly coupled to a housing, which directly collects a microsample of arterial blood via a catheter tube.

[0013] In some embodiments, the catheter assembly includes a catheter adapter coupled to the proximal end of an arterial catheter and having an adapter port, and a connector connected to the adapter port via an extension tube, with a patient-near-access port provided at the proximal end of the connector.

[0014] In some embodiments, the connector includes a side port located distal to the patient-proximal access port, and the arterial access system further includes an extension set connected to the side port and fluid-connected to an arterial catheter, the extension set supplying arterial blood from the arterial catheter to a hemodynamic monitoring system connected thereto.

[0015] In some embodiments, the distal end portion of the housing includes a lock configured to connect the housing to a patient-proximal access port.

[0016] A method is also provided for directly sampling arterial blood via an indwelling arterial catheter of a catheter assembly. This method involves connecting a blood collection device to a patient-near-access port of a catheter assembly, the blood collection device comprising a catheter tube, a housing having a proximal and distal end portion and defining an internal volume configured to movably receive the catheter tube, and a forwarding member configured to move the catheter tube between a first position in which the catheter tube is located within the housing and a second position in which it is located beyond the distal end portion of the catheter tube, through the distal tip of the indwelling arterial catheter. This method also includes connecting a collection device at the proximal end portion of the housing, moving the forwarding member along the housing to advance the catheter tube to the second position, and directly collecting a sample of arterial blood into the collection device with the catheter tube in the second position.

[0017] In some embodiments, connecting the collection device involves connecting the collection device to the proximal end of a secondary catheter that fluidly connects the collection device to a catheter tube, the secondary catheter extending from the proximal end portion of the housing.

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

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

[0020] In some embodiments, connecting a collection device includes connecting a non-vacuum-assisted collection device to the proximal end of a secondary catheter.

[0021] In some embodiments, the method includes causing arterial blood to flow into an evacuated non-vacuum assisted collection device that draws arterial blood inflow by evacuating the non-vacuum assisted collection device through an exhaust port included in a coupler to facilitate collection of a sample of arterial blood using arterial blood pressure.

[0022] In some embodiments, the method includes dispensing at least a portion of the arterial blood sample to a point-of-care (POC) testing device, the POC testing device including a blood diagnostic test cartridge or a blood analyzer test instrument.

[0023] In some embodiments, connecting the collection device includes directly connecting a blood diagnostic test cartridge to the housing, and directly collecting a sample of arterial blood includes directly collecting a microsample of arterial blood within the blood diagnostic test cartridge via a catheter tube.

[0024] In some embodiments, coupling the blood collection device to a patient-proximate access port includes coupling the blood collection device to a connector of a catheter assembly including a proximal end having a patient-proximate access port, a distal end where the catheter adapter of the catheter assembly receives an indwelling arterial catheter, and a side port disposed between the proximal and distal ends of the connector, the blood collection device being connected via an extension tube to the catheter adapter.

[0025] In some embodiments, the method includes connecting an extension set to a side port in fluid connection with an indwelling arterial catheter, connecting a hemodynamic monitoring system to the extension set, and providing arterial blood flow through the indwelling arterial catheter and the extension set to the hemodynamic monitoring system, the arterial blood flow being provided to the hemodynamic monitoring system simultaneously with collection of a sample of arterial blood within the collection device.

Brief Description of the Drawings

[0026] [Figure 1]FIG. 1 is a perspective view showing an example of an arterial access system according to an aspect of the present disclosure, in which a syringe is connected to a blood sampling device of the arterial access system. [Figure 2] FIG. 2 is a perspective view of a blood sampling device that can be used in the arterial access system of FIG. 1 according to an aspect of the present disclosure. [Figure 3] FIG. 3 is an exploded view of the blood sampling of FIG. 2. [Figure 4] FIG. 4 is a side view of the blood sampling device of FIG. 2 showing the catheter tube in the first storage position. [Figure 5] FIG. 5 is a side view of the blood sampling device of FIG. 2, showing the state where the catheter tube is in the second position which is the extended position. [Figure 6] FIG. 6 is a perspective view of an arterial access system in which a vacutainer is connected to the blood sampling device according to an aspect of the present disclosure. [Figure 7] FIG. 7 is a perspective view of an arterial access system having a diagnostic cartridge connected to the blood sampling device according to an aspect of the present disclosure. [Figure 8] FIG. 8 is a perspective view of an arterial access system according to an aspect of the present disclosure.

MODE FOR CARRYING OUT THE INVENTION

[0027] The following description is provided to enable one of ordinary skill in the art to make and use the described embodiments contemplated for carrying out the present invention. However, various modifications, equivalents, variations, and alternatives will be readily apparent to one of ordinary skill in the art. Any and all such modifications, variations, equivalents, and alternatives are intended to fall within the spirit and scope of the present invention.

[0028] In this specification, the terms “proximal” and “distal” refer to the directions closer to and further away from the user when positioning the device to come into contact with the patient, respectively. Therefore, for example, the end of the device that first comes into contact with the patient's body is the distal end, and the opposite end of the device (for example, the end of the device that the user operates) is the proximal end.

[0029] Spatial or directional terms such as "left," "right," "inner," "outer," "above," and "below" should not be considered limiting, as the present invention may envision a variety of alternative orientations.

[0030] Hereafter, for explanatory purposes, “top,” “bottom,” “right,” “left,” “vertical,” “horizontal,” “top,” “bottom,” “horizontal,” “vertical,” and their derivatives will be used in relation to the present invention as oriented in the drawings. However, it will be understood that the present invention may presuppose various alternative modifications unless explicitly specified otherwise. It should also be understood that the specific devices shown in the accompanying drawings and described below are merely exemplary embodiments of the present invention.

[0031] The terms “first,” “second,” and similar terms are not intended to refer to any particular order or time sequence, but rather to different conditions, characteristics, or elements.

[0032] As used herein, “at least one of” is synonymous with “one or more of.” For example, the phrase “at least one of A, B, and C” means any one of A, B, or C, or any combination of any two or more of A, B, or C. For example, “at least one of A, B, and C” includes one or more A's, or one or more B's, or one or more C's, or one or more A's and one or more B's, or one or more A's and one or more C's, or one or more of all A, B, and C.

[0033] The present invention relates to an arterial access system equipped with a blood collection device (or "line blood collection device"), and to a method for advancing a blood collection catheter tube into an indwelling arterial catheter using the arterial blood collection device, and subsequently collecting a blood sample from a patient.

[0034] Referring to Figure 1, a non-limiting embodiment of an arterial access system 10 for facilitating improved arterial line blood collection for arterial blood gas sampling and continuous pressure monitoring is shown. The arterial access system 10 may include a catheter assembly 12 comprising 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 located between the distal end 18 and the proximal end 20, or located at the proximal end 20. The catheter adapter 14 may include a first lumen 24 penetrating the distal end 18 and the proximal end 20, the first lumen 24 may be sealed at the proximal end 20 of the catheter adapter 14. The catheter 16 may be formed from any suitable material known to those skilled in the art and may be of any useful length. The catheter 16 extends from the distal end 18 of the catheter adapter 14 and may be configured as an arterial catheter placed in the patient's artery, with the distal end or tip 26 of the catheter 16 appropriately positioned within the artery 28 to enable blood collection from the patient. In some embodiments, the catheter 16 may be inserted into the artery with its distal tip 26 (the opening therein) facing upstream and entering the arterial blood flow.

[0035] In some non-limiting embodiments or aspects, the catheter assembly 12 may include a first fluid conduit 30 extending from the port 22. The first fluid conduit 30 may be formed of any suitable material well 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 may be connected to the port 22, and the proximal end 34 of the first fluid conduit 30 may be connected to a connector 36. The connector 36 may be a T-connector (for example, one side port positioned at a 90-degree angle to the longitudinal axis of the connector 36), a Y-connector (for example, one side port positioned at a 25-degree, 60-degree, or 75-degree angle to the longitudinal axis of the connector 36), or any other type of connector well known to those skilled in the art. The connector 36 includes a second lumen 38 having any number of branches suitable for the type of connector, such as a branch extending between the distal and proximal ends of the connector 36 and a branch provided to the port 44 of the connector 36.

[0036] In some non-limiting embodiments or aspects, the catheter assembly 12 includes a needleless access connector 46 coupled to the proximal end 42 of the connector 36, the needleless access connector 46 providing an access port to the catheter assembly 12. The needleless access connector 46 may be configured, for example, as a split septum connector or a self-healing septum connector. In the illustrated embodiment, the access port provided by the needleless access connector 46 is a patient-proximal access port close to the insertion site of the catheter 16. However, it is understood that the access port may be located at other alternative locations close enough to the insertion site to allow the blood collection catheter tube to enter the indwelling arterial catheter 16 and protrude beyond its distal end. For example, the access port for inserting the blood collection catheter tube into the indwelling arterial catheter 16 may be located on another connector, such as the proximal connector on an extension set (described later) of the catheter assembly 12.

[0037] In some non-limiting embodiments or aspects, the catheter assembly 12 may include an extension set 48 connected to a port 44 of the connector 36. The extension set 48 includes a second fluid conduit 50, the port 44 connected to one end 52 of the second fluid conduit 50 and a Luer connector 54 at the opposite end 56, the second fluid conduit 50 being provided with a clamp 57 that can be occluded. The extension set 48 can be used to provide a fluid pathway from the catheter assembly 12 to a hemodynamic monitoring device 58 that monitors the patient's blood pressure, heart rate, and / or pulse waveform based on arterial blood collected through the catheter assembly 12. The non-limiting embodiment in Figure 1 shows a needleless access connector 46 located on the connector 36, but those skilled in the art will understand that a suitable needleless access connector may also be located on the Luer 54 of the extension set 48.

[0038] The arterial access system 10 further includes a blood collection device 60 (or “line blood collection device”) that can be operated to collect a blood sample from a patient, and this blood sample can be used for, for example, blood gas analysis. According to a non-limiting embodiment, as shown in Figure 1 and in more detail in Figures 2-5, the blood collection device 60 includes at least a housing 62, a coupling device 64, a catheter tube 66, and an advancing member 68. As will be described in more detail below, the catheter tube 66 is movable within the housing 62 to advance a portion of the catheter tube 66 from a first or retracted position within the housing 62 (Figure 3) to a second or advanced position outside the housing 62 (Figure 4) so ​​that the distal end of the catheter tube 66 can be fed into the catheter assembly 12. Once the portion of the catheter tube 66 is guided into the catheter assembly 12, passes the distal tip 26 of the indwelling catheter 16 and protrudes outward, the catheter tube 66 can enable the collection of a blood sample.

[0039] According to one embodiment, the catheter tube 66 is designed to be sized to allow introduction into and advancement through the fluid pathways of the catheter assembly 12 (i.e., the lumen of the catheter 16, the lumen 24 of the catheter adapter 14, and the first fluid conduit 30). Thus, the catheter tube 66 may have an outer diameter smaller than the smallest lumen in the fluid pathway of the catheter assembly (e.g., between 10 gauge and 30 gauge). The catheter tube 66 may be long enough to position its distal end 70 at a desired location in the fluid pathway of the arterial access system 10. Thus, in one embodiment, the catheter tube 66 may be long enough to allow its distal end 70 to protrude from the housing 62 and further pass through the catheter assembly (i.e., the connector 36, the fluid conduit 30, the catheter adapter 14, and the catheter 16), and finally be led out completely beyond the distal tip 26 of the catheter 16.

[0040] In some embodiments, the distal end 26 of the catheter 16 may include fenestrations formed inside it, in order to position the catheter tube 66 within the catheter 16 and further advance it beyond the distal end 26 of the catheter 16. The fenestrations at the distal end 26 of the catheter 16 serve to maintain fluid continuity from the artery through the catheter 16 to the hemodynamic monitoring device 58 connected to the proximal end of the extension set 48; that is, the fenestrations prevent the catheter tube 66 from becoming occluded at the distal end 26 of the catheter 16, thereby interrupting accurate pressure monitoring. Thus, the fenestrations within the catheter 16 provide the ability to continue monitoring arterial pressure during the sampling procedure performed by the blood collection device 60 as the catheter tube 66 advances.

[0041] According to aspects of this disclosure, it is recognized that the use of a blood collection device 60 with an indwelling arterial catheter 16 may differ from the use of a blood collection device with an indwelling peripheral venous catheter. That is, unlike peripheral venous catheters used intravenously, arterial catheters have their distal end and opening oriented upstream, i.e., in the direction of the incoming arterial blood flow. Because arterial blood flow typically has higher flow rates and pressures, some of the challenges and complications seen with peripheral venous catheters (PIVs), such as thrombus formation in the vein downstream of the catheter tip making aspiration or line collection difficult during the retention period, do not occur with arterial catheters. Therefore, the use of a blood collection device 60 with an indwelling arterial catheter 16 involves different requirements, optimization goals, and design considerations. For example, according to some non-limiting embodiments of this disclosure, the blood collection device 60 may be configured such that the distal end 70 of the catheter tube 66 protrudes less than 10 mm, preferably in the range of 3 to 10 mm, from the distal tip 26 of the indwelling arterial catheter 16. For the reasons stated above, this distance is sufficient to collect a good quality arterial blood sample. In other embodiments, the blood collection device 60 may be configured to extend the distal end 70 of the catheter tube 66 beyond the distal tip 26 of the indwelling arterial catheter 16 to a distance of 20 cm, 30 cm, or even more.

[0042] As shown in Figures 2-5, the housing 62 of the blood collection device 60 may be an elongated member having a proximal end 72 and a distal end 74 that defines an internal volume 76. In some embodiments, the housing 62 may be formed from a pair of housing portions 78a, 78b joined together to define the internal volume 76. The housing 62 may have one or more features or surface finishes on its outer surface to improve the ergonomic characteristics of the blood collection device 60, in which case the user can operate the blood collection device 60 with one hand (i.e., use it with one hand).

[0043] The coupling device 64 of the blood collection device 60 is provided at the distal end 74 of the housing 62 and provides reversible coupling of the blood collection device 60 to the catheter assembly 12, such as via a needleless access connector 46, as shown in Figure 1. In some embodiments, the coupling device 64 is configured as a lock 80 including a blunt-end cannula 82 and a locking arm 84 for coupling to the needleless access connector 46 of the catheter assembly 12, with the blunt-end cannula 82 and locking arm 84 forming three contact points thereto. However, those skilled in the art will understand that any connection or coupling, such as a Luer, can be used, as long as the distal end 70 of the catheter tube 66 passes through the coupling device 64 and reaches the catheter assembly 12.

[0044] The forward member 68 of the blood collection device 60 includes a first portion 86 and a second portion 88. The first portion 86 is movably positioned along the upper surface 90 of the housing 62, and the second portion 88 is movably positioned within the internal volume 76 of the housing 62. The arrangement of the forward member 68 and the housing 62 is configured such that a coupling portion (not shown) connecting the first portion 86 and the second portion 88 of the forward member 68 fits into a slot 92 formed in the upper surface 90 of the housing 62, the slot 92 generally extending 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, the movement of the first portion 86 along the upper surface 90 of the housing 62 results in the corresponding movement of the second portion 88 within the internal volume 76.

[0045] As shown in Figures 2-5, the first portion 86 of the forward member 68 may be configured as a tab or tab having a contact surface 94a that can be engaged by the user and a lower surface 94b that contacts the outer surface 90 of the housing 62. In such an embodiment, the upper surface 90 of the housing 62 may be provided with a track 96 consisting of, for example, a set of ribs, protrusions, projections, grooves and / or similar, such that the lower surface 94b of the tab or projection moves along the track 96 when the user operates the forward member 68. In this way, the user can engage the first portion 86 of the forward member 68 and move the forward member 68 relative to the housing 62.

[0046] As shown in Figures 2-5, the second portion 88 is provided with a through-opening 98 configured to grasp or hold a portion of the catheter tube 66. Because a portion of the catheter tube 66 is held within the opening 98 of the second portion 94, when the advancing member 68 moves relative to the housing 62, the catheter tube 66 also undergoes a corresponding movement relative to the housing 62. In this way, the distal end 70 of the catheter tube 66 can be selectively moved in and out of the internal volume 76 of the housing 62 as needed. For example, when a blood collection device 60 is connected to the catheter assembly 12 and an arterial blood sample is to be collected, the distal end 70 of the catheter tube 66 can be advanced from the housing 62.

[0047] As described above, when advancing the distal end 70 of the catheter tube 66 out of the housing 62 into the catheter assembly 12, the blood collection device 60 can be configured such that the distal end 70 of the catheter tube 66 protrudes less than 10 mm, preferably about 3 mm to 10 mm, beyond the distal tip 26 of the indwelling arterial catheter 16. This distance is sufficient for collecting a good arterial blood sample for the reasons mentioned above. By advancing the catheter tube 66 by this distance, it is possible to shorten the length of the catheter tube and the housing 62 and / or limit the relative movement of the advancing member 68 relative to the housing 62. In some embodiments, the housing 62 may be configured to have a length LIntro of 103 to 110 mm, relating to the need for the extended length of the catheter tube 66 to be shorter than the length typically required for the use of a blood collection device with a peripheral IV catheter. In some embodiments, the housing 62 may be configured to have a length LIntro of 122 to 129 mm. In other embodiments, the spacer 100 (shown as a dashed line in Figure 2) may be located within the internal volume 76 of the housing 62 at a position close to the forward member 68 (i.e., at the proximal end 72 of the housing 62), and the spacer 100 functions to restrict the movement path of the forward member 68 to a smaller path than that typically required for the use of a blood collection device with a peripheral IV catheter, in relation to the required length of the catheter tube 66.

[0048] As further shown in Figures 2-5, the blood collection device 60 includes a secondary catheter 102 provided at the proximal end 72 of the housing 62. The secondary catheter 102 has a proximal end 104 and a distal end 106 that define a lumen 108. A portion of the secondary catheter 102 is positioned within a through-opening 110 formed in the proximal end 72 of the housing 62 and extends through the through-opening 110. Thus, the proximal end 104 is at least partially positioned outside the housing 62, the distal end 106 is at least partially positioned inside the housing 62, and the distal end 106 is coupled to a second portion 88 of the forward member 68. In some embodiments, the secondary catheter 102 may have a larger diameter than the catheter tube 66, thereby serving to limit, reduce, and / or substantially prevent hemolysis that occurs as blood flows through the catheter 66 and the secondary catheter 102, as will be described in more detail below. As described later, once the blood collection device 60 is attached to a syringe, vacuum container, etc., the secondary catheter 102 establishes fluid communication between the reservoir, supply source, pump, etc. and the catheter tube 66.

[0049] According to embodiments of this disclosure, the proximal end 104 of the secondary catheter 102 is connected to and / or encompasses a coupler 114 configured to mate with a collection device 116 which is used in conjunction with (or considered to be part of) a blood collection device 60. This allows for the collection of an arterial blood sample for subsequent analysis (e.g., blood gas analysis of the sample). According to some embodiments, the coupler 114 may be configured as a Luer connector (i.e., a female Luer connector) configured to mate with a corresponding Luer connector (i.e., a male Luer connector) of the collection device 116. The coupler 114 physically and fluidly connects the secondary catheter 102 to the collection device 116. The collection device 116 may be either a vacuum-assisted collection device or a non-vacuum-assisted collection device, as described later, and examples include sampling syringes, vacuuminers®, Luer lock access devices (LLADs), point-of-care (POC) sampling devices, integrated POC cartridges, and blood culture collection systems. Non-limiting examples of vacuum-assisted or non-vacuum-assisted collection devices include Becton Dickinson's Vacutainer Arlock Access Device or Vacutainer Accustat Device. In some embodiments, an exhaust feature 118 may be provided that has the function of exhausting the vacuum-assisted or non-vacuum-assisted collection device 116 before blood collection. As shown in the illustrated embodiment, the exhaust feature 118 is provided on the coupler 114, but it is recognized that the exhaust feature 118 may be provided at any position in the sampling fluid path, although it is preferable to provide it near the proximal end 104 of the secondary catheter 102.

[0050] As shown in Figures 1-5, according to one aspect of the present disclosure, the collection device 116 connected to the blood collection device 60 (via a coupler 114) is provided as a syringe 116a. In some embodiments, the syringe 116a may be provided with the plunger 120 of the syringe 116a pre-installed in the advanced position. As the catheter tube 66 of the blood collection device 60 advances through the indwelling catheter 16 into the artery 28, the syringe plunger 120 can be retracted to draw an undiluted arterial blood sample into the syringe 116a. The syringe 116a may contain a blood preservative or stabilizer to maintain the quality of the sample. In other embodiments, the syringe 116a starts in the retracted position and is equipped with a selective exhaust feature (e.g., an exhaust port 118 on the coupler 114) so ​​that the syringe 116a can be exhausted after the catheter tube 66 has moved to a second position, which is the extended position. After the syringe 116a has been evacuated and sample collection and stabilization are complete, the syringe 116a is removed from the blood collection device 60, and the sample is dispensed into the POC blood diagnostic test cartridge 122 or supplied to other blood analysis testing equipment.

[0051] Referring here to Figure 6, an arterial access system 10 is shown in which the collection device 116 connected to the blood collection device 60 (via a coupler 114) is provided as an exhaust vacuum-type vacuum-tainer collection device 116b or a simplified / modified vacuum tube, which does not require a vacuum tube to drive the sampling volume collection. The vacuum-tainer 116b may contain a blood preservative or stabilizer to help maintain the quality of the sample. After the vacuum-tainer 116b is filled and the blood has stabilized, the vacuum-tainer 116b may be removed from the blood collection device 60, and the blood sample can then be dispensed into a POC blood diagnostic test cartridge 122 or supplied to other blood analysis testing equipment.

[0052] Referring here to Figure 7, the arterial access system 10 is shown, and the collection device 116 connected to the blood collection device 60 is provided as an onboard POC diagnostic cartridge 116c (e.g., an iStat test cartridge from Abbott Laboratories). The diagnostic cartridge 116c may be detachably coupled to the blood collection device 60 (i.e., coupled to the housing 62) for direct collection of a microsample of arterial blood. When using the diagnostic cartridge 116c, the system must selectively evacuate the microchannels of the cartridge to prevent filling until the distal end 70 of the catheter tube 66 is directly positioned in the artery 28 and undiluted blood is collected. Once the diagnostic cartridge 116c is filled, it can be removed from the blood collection device 60 and inserted into the POC blood testing instrument and analyzer.

[0053] As described above, arterial blood samples can be directly collected by using a collection device 116 equipped with a blood collection device 60 and a catheter assembly 12. According to embodiments of this disclosure, arterial blood collection can be performed by connecting a vacuum-assisted blood sample collection device 116 (e.g., a Luer lock access device (LLAD) equipped with a vacuum syringe or a vacuum retainer connected thereto) or by a non-vacuum-assisted blood sample collection device 116 (e.g., an exhaust syringe or other exhaust chamber). When a non-vacuum-assisted blood sample collection device 116 is used in conjunction with the blood collection device 60, arterial pressure acts to fill the exhaust blood collection device chamber, and the blood flow is driven by a constant arterial pressure. In the case of vacuum-assisted blood collection, the pressure gradient across the flow path of the blood collection device (i.e., the flow path via the catheter tube 66 and secondary catheter 102) is large, so hemolysis due to shear force may affect the collection of arterial blood samples.

[0054] Regarding the effect of hemolysis due to shear, the maximum shear stress in tubular fluid passages (such as catheter tube 66 and secondary catheter 102) is determined by the flow rate and the minimum hydraulic diameter of the tube. The fluid flow in the tubular fluid passage can be analyzed using Poiseuille's equation (1) below.

[0055]

number

[0056] In equation (7), ΔP represents the change in pressure gradient along the length of the fluid path, D and L represent the inner diameter and length of the fluid path, respectively, μ represents the viscosity of the fluid, and Rf = 128 μL / πD 4 This represents fluid resistance. Since μ is the viscosity of the fluid and not part of the geometric shape of the extension tube, if we define a geometric coefficient Gf, then Rf (fluid resistance) can be expressed as Rf = (128 μL / π) * Gf, where Gf = L / D 4 That is the case.

[0057] In some embodiments, the optimized fluid path has multiple sections, each with a length of (L1, L2, L3, ...) and an inner diameter of (D1, D2, D3, ...), in which case the geometric coefficient Gf is defined as shown in equation (2) below.

[0058]

number

[0059] In some embodiments, the optimized fluid path may have an inner diameter that changes over the length of the tube, in which case the geometric coefficient Gf is defined as shown in equation (3) below.

[0060]

number

[0061] In some embodiments, the optimized fluid path may have a cross-section with a non-circular inner diameter profile. The geometric coefficients can be determined by measuring the flow rate (Q) at a given pressure difference (ΔP) for a fluid with a known viscosity (μ), as shown in equation (4) below.

[0062]

number

[0063] In the case of arterial blood sampling, the Gf value of the optimized fluid pathway differs between sampling with a syringe and sampling with an exhaust chamber and vacuum retainer; therefore, the Gf value of the optimized fluid pathway can be a higher value between sampling with a syringe and sampling with a vacuum retainer. Alternatively, the Gf value of the optimized fluid pathway may be a lower value between sampling with a syringe and sampling with a vacuum retainer, and if a higher Gf value is required, an accessory in the form of an extension set or connector can be attached to the Luer. In another alternative embodiment, the proximal end of the extension tube (i.e., the secondary catheter 102) may consist of two ports, each providing a different Gf value.

[0064] In the case of blood collection using a syringe or an exhaust chamber, the arterial pressure is constant, so blood is collected at a constant flow rate. The maximum shear stress is constant according to equation (5) below.

[0065]

number

[0066] Here, D min This is the minimum diameter of the fluid passage defined by the catheter tube 66 and the secondary catheter 102.

[0067] Based on the above, the Gf value of the optimized fluid passage (i.e., catheter tube 66 and secondary catheter 102) can be selected according to the blood collection method. In the case of blood collection using a vacuum-assisted vacuumer, the Gf value of the optimized fluid passage may be selected to be equal to or less than the maximum shear stress of a typical vacuum-assisted push-button blood collection set in order to reduce the maximum shear stress, and according to an aspect of this disclosure, the Gf value may be 220 / D min 3 It is desirable that the above be true. In the case of blood collection by syringe or other exhaust chamber (i.e., non-vacuum-assisted collection device), the Gf value of the optimized fluid path can be selected to be equal to or less than the average maximum shear stress of a typical vacuum-assisted push-button blood collection set in order to reduce the maximum shear stress, and according to aspects of this disclosure, the Gf value is 35 / D min 3 The above is desirable.

[0068] It is recognized that the embodiments of this disclosure are not limited to the specific blood collection device 60 shown and described in Figures 1-7, and other blood collection devices having suitable structures may also incorporate embodiments of this disclosure. Referring now to Figure 8, an arterial access system 128 is shown which includes a blood collection device 130 according to another embodiment of this disclosure. The blood collection device 130 includes a housing 132 having a proximal end 134 and a distal end 136, and a forward member 138 slidably housed within the housing 132 (i.e., within the internal space 140 of the housing 132). In the illustrated embodiment, the forward member 138 is provided as one or more telescopic cylinders 138a that are in a telescopic relationship with the housing 132, so that the forward member 138 can be slidably housed entirely or almost entirely within the internal space 140 of the housing 132. The forward member 138 also includes a proximal end 142 and a distal end 144, and in a non-limiting embodiment, the forward member 138 may have a variable diameter along its length. As an example, the distal end 144 of the forward member 138 may be configured to have a larger diameter than the rest of the forward member 138, so that when the forward member 138 is retracted, one or more features on the housing 132 interact with the enlarged portion of the forward member 138, preventing the forward member 138 from being completely withdrawn from the housing 132. As another example, the distal end 144 of the forward member 138 may be set to have a smaller diameter than the rest of the forward member 138. This holds the forward member 138 in place when it is in the advanced position for blood collection, freeing up one hand of the operator to manipulate additional components (e.g., a vacuuminer tube).

[0069] The blood collection device 130 further comprises a catheter tube 146 having a proximal end 148 and a distal end 150. The catheter tube 146 is housed within the internal space 140 of the housing 132 and can be advanced and / or retracted relative to the housing 132 by the displacement of the advance member 138 relative to the housing 132. In some embodiments, the catheter tube 146 may be connected to the advance member 138 via a joint 152 provided at the distal end 144 of the advance member 138, so that the catheter tube 146 displaces in response to the displacement of the advance member 138 relative to the housing 132. In some non-limiting embodiments, the catheter tube 146 can be advanced from a first position where the distal end 150 of the catheter tube 146 is located inside the housing 132 to a second position where the distal end 150 of the catheter tube 146 is located distal to the housing 132 (and distal to the catheter 16), as described above with respect to the blood collection device 60 and its operation.

[0070] The blood collection device also includes a coupling device 154 on it, which may be identical to the coupling device shown and described in the blood collection devices of Figures 1-7. That is, the coupling device 154 is configured as a lock 80 comprising a blunt-ended cannula 82 and a locking arm 84 for connection to the needleless access connector 46 of the catheter assembly 12, with the blunt-ended cannula 82 and the locking arm 84 forming three contact points thereto. However, alternative embodiments of the blood collection device 130 may include another type of coupling device 154 for securing the blood collection device 130 to the catheter assembly 12, including Luer connectors, clips, blunt-ended plastic cannulas, blunt-ended metal cannulas, hybrid Luer connectors (e.g., with cannulas), friction fittings, etc.

[0071] According to aspects of the present disclosure, the secondary catheter 102 is disposed through the telescopic cylinder 138a of the forward member 138, and the secondary catheter 102 provides a fluid connection between the catheter tube 146 and a coupler 114 provided on the proximal end 104 of the secondary catheter 102, the coupler 114 is configured to mate with a collection device 116. Although shown as a syringe 116a in Figure 8, the collection device 116 is configured as any of the collection devices 116 shown and described in Figures 1 to 7, and the blood collection device 116 is attached to a blood collection device 130 to provide an arterial access system for facilitating improved arterial line blood collection for arterial blood gas sampling. That is, the blood collection device 130 may be used with any of several different vacuum-assisted or non-vacuum-assisted blood collection devices 116 for blood sample collection, and the blood collection device may be configured to prevent hemolysis during sample collection by controlling the sizing of the device, including the geometric coefficient Gf of the device (i.e., the fluid path therein).

[0072] Benefitingly, embodiments of the present disclosure provide an arterial access system to improve arterial line blood collection for arterial blood gas sampling and continuous pressure monitoring. The arterial access system includes a catheter assembly to which a blood collection device is attached, which can be used to collect arterial blood samples directly from a patient via an indwelling arterial catheter, and such blood samples are used for blood gas analysis. The arterial access system, by using an extension set that can be attached to the catheter assembly, enables continuous blood pressure monitoring while simultaneously supplying arterial blood to a connected hemodynamic monitoring system. The blood collection device can accommodate the use of either a vacuum-assisted or non-vacuum-assisted blood collection device for blood sample collection and can be configured to prevent hemolysis during sample collection.

[0073] This disclosure has been described in detail for illustrative purposes based on what is currently considered to be the most practical and preferred embodiments or aspects, but such details are for that purpose only, and this disclosure is not limited to the disclosed embodiments or aspects, but rather intended to encompass modifications and equivalent arrangements that fall within the spirit and scope of the appended claims. For example, this disclosure is intended to be, wherever possible, to allow one or more features of any embodiment to be combined with one or more features of any other embodiment.

Claims

1. Arterial access system, A catheter assembly comprising an arterial catheter and an access port, A blood collection device coupled to the access port and in fluid communication with the arterial catheter via the catheter assembly, Catheter tube and A housing having a proximal end portion and a distal end portion, wherein the distal end portion is connectable to the access port, and the housing defines an internal volume configured to movably receive the catheter tube, A forward member configured to move relative to the housing so as to move the catheter tube between a first position in which the catheter tube is positioned within the housing and a second position in which the distal end of the catheter tube is positioned beyond the distal end portion of the housing and beyond the distal tip of the arterial catheter, A blood collection device equipped with, A collection device is positioned proximal to the housing and is in fluid communication with the catheter tube, Equipped with, An arterial access system in which, with the catheter tube in the second position, the collection device is configured to directly collect a sample of arterial blood through the catheter tube.

2. The arterial access system according to claim 1, wherein the blood collection device includes a secondary catheter coupled to the forward member and extending proximal therefrom, and extending outward from the proximal end portion of the housing, the secondary catheter fluidly connecting the catheter tube and the collection device.

3. The arterial access system according to claim 2, wherein the blood collection device comprises a coupler connected to the proximal end of the secondary catheter, and the collection device is connected to the secondary catheter via the coupler.

4. The arterial access system according to claim 3, wherein the collection device comprises a vacuum-assisted collection device.

5. The arterial access system according to claim 3, wherein the collection device comprises a non-vacuum-assisted collection device.

6. The arterial access system according to claim 5, wherein the coupler comprises an exhaust feature configured to exhaust the vacuum or non-vacuum-assisted collection device.

7. The arterial access system according to claim 1, wherein the collection device comprises a diagnostic test cartridge directly coupled to the housing, the diagnostic test cartridge directly collects a microsample of arterial blood via the catheter tube.

8. The catheter assembly is A catheter adapter coupled to the proximal end of the arterial catheter, wherein the catheter adapter is equipped with an adapter port, The arterial access system according to claim 1, comprising a connector connected to the adapter port via an extension tube, wherein the access port is provided at the proximal end of the connector.

9. The arterial access system according to claim 8, wherein the connector comprises a side port located distal to the access port, and the arterial access system further comprises an extension set connected to the side port and fluidly connected to the arterial catheter, the extension set providing arterial blood from the arterial catheter to a hemodynamic monitoring system connected thereto.

10. The arterial access system according to claim 1, wherein the distal end portion of the housing is provided with a lock configured to connect the housing to the access port.

11. A method for directly sampling arterial blood via an indwelling arterial catheter of a catheter assembly, The blood collection device is connected to the access port of the catheter assembly, wherein the blood collection device is Catheter tube and A housing having a proximal end portion and a distal end portion, wherein the distal end portion is connectable to the access port, and the housing defines an internal volume configured to movably receive the catheter tube, A forward member configured to move relative to the housing so as to move the catheter tube between a first position in which the catheter tube is positioned within the housing and a second position in which the distal end of the catheter tube is positioned beyond the distal end portion of the housing and beyond the distal tip of the indwelling arterial catheter, To be equipped with, to be combined, Connecting the collection device at the proximal end portion of the housing, Moving the forward member along the housing to advance the catheter tube to the second position, A method comprising directly collecting a sample of arterial blood into the collection device using the catheter tube located at the second position.

12. The method according to claim 11, wherein connecting the collection device includes connecting the collection device to the proximal end of a secondary catheter that fluidly connects the collection device to the catheter tube, the secondary catheter extending from the proximal end portion of the housing.

13. The method according to claim 12, wherein connecting the collection device includes connecting the collection device to a coupler attached to the proximal end of a secondary catheter.

14. The method according to claim 13, wherein connecting the collection device includes connecting a vacuum-assisted collection device to the proximal end of the secondary catheter.

15. The method according to claim 13, wherein connecting the collection device includes connecting a non-vacuum-assisted collection device to the proximal end of the secondary catheter.

16. The method according to claim 15, further comprising evacuating the vacuum or non-vacuum-assisted collection device adjacent to the proximal end of the secondary catheter or through an exhaust port included on the coupler, thereby facilitating the collection of the arterial blood sample such that arterial blood pressure causes arterial blood to flow into the evacuated non-vacuum-assisted collection device.

17. The method according to claim 11, further comprising distributing at least a portion of the arterial blood sample to a point-of-care (POC) testing device, wherein the POC testing device comprises a blood diagnostic test cartridge or a blood analyzer testing instrument.

18. The method according to claim 11, wherein connecting the collection device includes directly connecting the blood diagnostic test cartridge to the housing, and directly collecting the sample of arterial blood includes directly collecting a microsample of arterial blood in the blood diagnostic test cartridge via the catheter tube.

19. Connecting the blood collection device to the access port includes connecting the blood collection device to the connector of the catheter assembly, The aforementioned connector is The proximal end, including the aforementioned access port, A distal end connected to the catheter adapter of the catheter assembly via an extension tube, wherein the catheter adapter accepts the indwelling arterial catheter, The method according to claim 11, further comprising a side port disposed between the proximal end and the distal end of the connector.

20. Connecting an extension set to the side port which is fluidly connected to the indwelling arterial catheter, Connecting the hemodynamic monitoring system to the extension set, To provide arterial blood flow to the hemodynamic monitoring system via the indwelling arterial catheter and the extension set, It further includes, The method according to claim 19, wherein the flow of arterial blood is provided to the hemodynamic monitoring system at the same time as the collection of the sample of arterial blood in the collection device.

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