Line insertion device for direct arterial blood sampling

Abstract

An arterial blood sampling device for performing arterial blood sampling comprises a catheter tube, a housing configured to movably accommodate the catheter tube, and a propulsion member movably coupled to the housing for moving the catheter tube between a first position and a second position, wherein the distal end of the catheter tube is positioned beyond the distal end of the housing and past the distal end of the indwelling arterial catheter when in the second position. A secondary catheter is coupled to the propulsion member and extends proximal therefrom, and a sampling device is coupled to the secondary catheter and arranged to fluidly connect with the catheter tube. The blood sampling device is configured such that the fluid passage formed by the catheter tube and the secondary catheter has a predetermined geometric coefficient, which is defined as the ratio of the length of the fluid passage to the inner diameter of the fluid passage.

Description

[Technical Field]

[0001] This invention relates to a blood collection device for direct arterial blood collection using an indwelling arterial catheter.

[0002] Cross-reference of related applications This application claims priority to U.S. Provisional Application No. 63 / 452,025, filed on 14 March 2023, entitled “Line Insertion Device for Direct Arterial Blood Collection,” the entire disclosure of which is incorporated herein by reference. [Background technology]

[0003] Arterial catheter insertion is a critically important procedure widely performed in hospital settings for critically injured 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 samples for blood gas analysis without the risk of complications associated with repeated arterial punctures. While typically inserted into the radial artery at the wrist, arterial catheters can also be inserted into the brachial artery at the elbow, the femoral artery at the groin, the dorsal pedis artery at the foot, or the ulnar artery at the wrist.

[0004] The current use of arterial catheters and associated arterial blood gas and blood sampling systems is complex, and it is recognized that there are numerous procedures that could be simplified, potentially leading to difficulties in cleaning the infusion line and interruptions in hemodynamic monitoring. For example, current systems used with arterial catheters require aspirating a large volume of clearing blood from the patient before sampling and sending it to a large, complex fluid extension set. The system then samples from the extension set, returns a large volume of blood to the patient, and further flushes the fluid in the flow path to remove the blood from within the extension set. [Overview of the Initiative] [Problems that the invention aims to solve]

[0005] Therefore, there is a need for arterial access systems and devices that overcome the aforementioned limitations of existing systems and devices and improve arterial line blood collection for arterial blood gas sampling and continuous blood pressure monitoring. These systems and devices will enable the collection of blood samples from within a patient's arteries, eliminating the complexity and difficulties associated with current systems and methods. [Means for solving the problem]

[0006] This specification provides a blood collection device that can be used in conjunction with an indwelling arterial catheter for arterial blood collection. The blood collection device comprises a catheter tube, a housing having a proximal and distal end and defining an internal space configured to movably accommodate the catheter tube, and a forward member movably coupled to the housing and configured to move the catheter tube relative to the housing, the forward member configured to move 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 of the housing and beyond the distal end of the indwelling arterial catheter. The blood collection device further includes a secondary catheter coupled to the forward member and extending proximal from the forward member and projecting outward from the proximal end of the housing, the secondary catheter being in fluid communication with the catheter tube, and a collection device coupled to the proximal end of the secondary catheter and configured to be in fluid communication with the secondary catheter and the catheter tube. The fluid passage formed by the catheter tube and the secondary catheter has a controlled geometric coefficient Gf, defined as the ratio of the length L of the fluid passage to the inner diameter D of the fluid passage.

[0007] 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 coupler.

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

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

[0010] In some embodiments, the coupler includes an exhaust mechanism configured to selectively exhaust the non-vacuum assisted collection device.

[0011] In some embodiments, the fluid passage has a geometric coefficient Gf, and in the non-vacuum assisted collection device, it is 35 / D min 3 Above, in the vacuum assisted collection device, it is 220 / D min 3 The above is the case.

[0012] In some embodiments, for a secondary catheter having a constant inner diameter, the geometric coefficient Gf is defined as in the following formula (1).

[0013]

Number

[0014] In some embodiments, for a secondary catheter having a plurality of sections with lengths L1, L2, L3 and inner diameters D1, D2, D3, the geometric coefficient Gf is defined as in the following formula (2).

[0015]

Number

[0016] In some embodiments, for a secondary catheter whose inner diameter changes over its entire length, the geometric coefficient Gf is defined as in the following formula (3).

[0017]

Number

[0018] In some embodiments, the housing and / or the advancement member are configured such that when the catheter tube is moved to the second position, the distal end of the catheter tube protrudes 10 mm or less from the distal end of the indwelling arterial catheter.

[0019] In some embodiments, the housing and / or the advancement member are configured such that when the catheter tube is moved to the second position, the distal end of the catheter tube protrudes 3 to 10 mm from the distal end of the indwelling arterial catheter.

[0020] In some embodiments, the length of the housing is 103 to 110 mm, or 122 to 129 mm.

[0021] In some embodiments, it includes a spacer that is disposed within the internal space of the housing and is located proximal to the advancement member, and the spacer restricts the movement of the advancement member along the housing.

[0022] Also provided is a method for manufacturing an arterial blood sampling device that can be operated to collect arterial blood samples. The method provides a catheter tube, which is housed in an internal space of a housing having a proximal end and a distal end, so that the catheter tube is movable within the housing, and further connects a forward member to the catheter tube and the housing, so that the forward member is movable relative to the housing, so that the catheter tube causes corresponding movement between a first position in which the catheter tube is positioned within the housing and a second position (a position in which the distal end of the catheter tube is positioned beyond the distal end of the housing). The method further includes connecting a secondary catheter to the forward member, which extends proximal from the forward member and exits from the proximal end of the housing, the secondary catheter being in fluid communication with the catheter tube, and connecting a sampling device to the proximal end of the secondary catheter, the sampling device including either a vacuum-assisted sampling device or a non-vacuum-assisted sampling device. Furthermore, the method includes the step of configuring a catheter tube and a secondary catheter to provide a flow path having a geometric coefficient Gf defined as the ratio of the length L of the fluid passage to the inner diameter D of the fluid passage, wherein the geometric coefficient Gf has a first value or a range of the first value when the sampling device is a vacuum-assisted sampling device, and a second value or a range of the second value when the sampling device is a non-vacuum-assisted sampling device.

[0023] In some embodiments, the geometric coefficient Gf is 35 / D in non-vacuum-assisted sampling devices. min 3 In summary, with vacuum-assisted sampling devices, 220 / D min 3 That's all.

[0024] In some embodiments, the housing and / or the forward member is configured such that when the catheter tube is moved to a second position, the distal end of the catheter tube protrudes no more than 10 mm from the distal end of the indwelling arterial catheter.

[0025] In some embodiments, for a secondary catheter with a constant inner diameter, the geometric coefficient Gf is defined as shown in equation (4) below.

[0026]

number

[0027] In some embodiments, for a secondary catheter comprising multiple sections having lengths L1, L2, L3 and inner diameters D1, D2, D3, the geometric coefficient Gf is defined as shown in equation (5) below.

[0028]

number

[0029] In some embodiments, for a secondary catheter whose inner diameter changes along its entire length, the geometric coefficient Gf is defined as shown in equation (6) below.

[0030]

number

[0031] In some embodiments, the method for manufacturing an arterial blood collection device includes configuring the housing to have a length of 103 to 110 mm or 122 to 129 mm.

[0032] In some embodiments, the step of connecting the housing configuration and / or the forward member to the housing is performed such that when the catheter tube is moved to a second position, the distal end of the catheter tube protrudes no more than 10 mm from the distal end of the housing. [Brief explanation of the drawing]

[0033] [Figure 1] Figure 1 is a perspective view showing an example of an arterial access system according to an embodiment, in which a syringe is connected to the blood collection device of the arterial access system. [Figure 2] Figure 2 is a perspective view of a blood collection device, according to an embodiment, that can be used with the arterial access system shown in Figure 1. [Figure 3] Figure 3 is an exploded view of the blood collection device shown in Figure 2. [Figure 4] Figure 4 is a side view of the blood collection device shown in Figure 2, illustrating the catheter tube in its first storage position. [Figure 5] Figure 5 is a side view of the blood collection device shown in Figure 2, illustrating the catheter tube in its extended position, the second position. [Figure 6] Figure 6 is a perspective view of an arterial access system according to an embodiment, in which a vacuum blood collection tube is connected to the blood collection device. [Figure 7] Figure 7 is a perspective view of the arterial access system with a diagnostic cartridge connected to the blood collection device. [Figure 8] Figure 8 is a perspective view of an arterial access system according to an embodiment. [Modes for carrying out the invention]

[0034] The following description is provided to enable those skilled in the art to create and use the described embodiments intended for carrying out the invention. However, various modifications, equivalents, variations, and substitutes will be readily apparent to those skilled in the art. Any and all such modifications, variations, equivalents, and substitutes are intended to fall within the spirit and scope of the invention.

[0035] 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.

[0036] 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.

[0037] 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.

[0038] 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.

[0039] 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 A's, B's, and C's.

[0040] 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.

[0041] Referring to Figure 1, a non-limiting embodiment of an arterial access system 10 used to improve 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 that penetrates 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 extend from the distal end 18 of the catheter adapter 14 and be configured as an arterial catheter placed in the patient's artery. The distal end 26 of the catheter 16 is appropriately positioned in the artery 28 to allow blood collection from the patient. In some embodiments, the catheter 16 can be inserted into an artery so that its distal end 26 (the opening therein) faces upstream and enters the arterial blood flow. The catheter 16 may be formed from any suitable material known to those skilled in the art and may be of any useful length.

[0042] 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 with respect 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 with respect 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 inside, and the second lumen 38 has any number of branches suitable for the type of connector, such as branches extending between the distal end 40 and the proximal end 42 of the connector 36, and branches provided at the port 44 of the connector 36.

[0043] 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 the extension set (described later) of the catheter assembly 12.

[0044] 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 passage 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 connector 54 of the extension set 48.

[0045] 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 the 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 to 5, the blood collection 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 more detail below, the catheter tube 66 is movable within the housing 62 and allows a portion of the catheter tube 66 to be advanced from a first position (or retracted position) within the housing 62 (see Figure 3) to a second position (or extended position) outside the housing 62 (see Figure 4). This allows the distal end of the catheter tube 66 to be guided into the catheter assembly 12. Once a portion of the catheter tube 66 is guided into the catheter assembly 12 and passes the distal end 26 of the indwelling catheter 16 and protrudes outward, the catheter tube 66 may enable the collection of a blood sample.

[0046] According to one embodiment, the catheter tube 66 is designed to be sized to allow introduction into and advancement through the fluid passages 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). Therefore, the catheter tube 66 can have an outer diameter smaller than the smallest lumen in the fluid passage of the catheter assembly (e.g., between 10 gauge and 30 gauge). The catheter tube 66 can be long enough to position its distal end 70 in the fluid passage of the arterial access system 10 at a desired location. Therefore, in one embodiment, the catheter tube 66 can 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 end 26 of the catheter 16.

[0047] In some embodiments, the distal end 26 of the catheter 16 may include fenestrations formed inside in order to position the catheter tube 66 within the catheter 16 and to allow it to be advanced 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 in the catheter 16 allow for continued monitoring of arterial pressure even when the catheter tube 66 is advanced during a sampling procedure by the blood collection device 60.

[0048] According to the embodiments, 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 downstream vein 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 end 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 end 26 of the indwelling arterial catheter 16 to a distance of 20 cm, 30 cm, or even more.

[0049] As shown in Figures 2 to 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, defining an internal space 76. In some embodiments, the housing 62 may be formed from a pair of housing portions 78a, 78b joined together to define the internal space 76. The housing 62 may have one or more structural elements 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).

[0050] The coupling device 64 of the blood collection device 60 is located at the distal end 74 of the housing 62, and this coupling device 64 allows the blood collection device 60 to be reversibly coupled to the catheter assembly 12 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 can pass through the coupling device 64 and reach the catheter assembly 12.

[0051] 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 space 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 extends 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 space 76.

[0052] As shown in Figures 2 to 5, the first portion 86 of the forward member 68 may be configured as a tab having a user-operable contact surface 94a and a lower surface 94b that contacts the upper 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 having, for example, a set of ribs, ridges, projections, grooves, etc., so that when the user operates the forward member 68, the lower surface 94b of the tab or projection moves along the track 96. 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.

[0053] As shown in Figures 2 to 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 through-opening 98 of the second portion 88, 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 space 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.

[0054] As described above, when the distal end 70 of the catheter tube 66 is projected from the housing 62 and advanced into the catheter assembly 12, the blood sampling device 60 can be configured to project the distal end 70 of the catheter tube 66 less than 10 mm, preferably about 3 mm or more and 10 mm or less, beyond the distal end 26 of the indwelling arterial catheter 16. This distance is sufficient to obtain a good arterial blood sample for the reasons described 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 with respect to the housing 62. In some embodiments, the inserter 62 is related to the requirement of requiring an extended length of the catheter tube 66 that is shorter than the extended length normally required for the use of a blood sampling device using a peripheral venous catheter, and has a length L Intro in the range of 103 to 110 mm. In some embodiments, the housing 62 may be configured such that the length L Intro is 122 to 129 mm. In other embodiments, a spacer 100 (shown in dashed lines in FIG. 2) may be provided within the internal space 76 of the housing 62 at a proximal position with respect to the advancing member 68 (i.e., the proximal end 72 of the housing 62). In this case, the spacer 100 serves to limit the movement path of the advancing member 68, thereby meeting the requirement that the extended length of the catheter tube 66 may be shorter than the length normally required when using a blood sampling device together with a peripheral venous catheter.

[0055] As further shown in Figures 2 to 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, defining 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 tube 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.

[0056] According to embodiments of the present 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 sampling devices include Becton Dickinson's Vacutainer Luer Lock Access Device or Vacutainer AccuStat Device. In some embodiments, an exhaust mechanism 118 may be provided that has the function of exhausting the vacuum-assisted or non-vacuum-assisted sampling device 116 before blood collection. As shown in the illustrated embodiment, the exhaust mechanism 118 is provided on the coupler 114, but it is recognized that the exhaust mechanism 118 may also be provided at any position in the sampling fluid passage. However, it is preferable to provide it near the proximal end 104 of the secondary catheter 102.

[0057] As shown in Figures 1 to 5, according to the embodiment, the collection device 116 connected to the blood collection device 60 (via the 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 from a retracted position and is equipped with a selective exhaust mechanism (e.g., an exhaust port 118 on the coupler 114) so ​​that the syringe 116a can be exhausted after the catheter tube 66 has been 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.

[0058] Referring to Figure 6, an arterial access system 10 is shown. In this arterial access system 10, the collection device 116 connected to the blood collection device 60 (via a coupler 114) may be configured as a vacuum collection device 116b, or as a simplified / improved vacuum collection device having a vent structure and not requiring a vacuum tube to drive the collection of the sample volume. The vacuum collection device 116b may contain a blood preservative or stabilizer to help maintain the quality of the sample. After the vacuum collection device 116b is filled and the blood has stabilized, the vacuum collection device 116b may be removed from the blood collection device 60. The blood sample can then be dispensed into a POC blood diagnostic test cartridge 122 or supplied to other blood analysis testing equipment.

[0059] Referring to Figure 7, an arterial access system 10 is shown in which a collection device 116 connected to a 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 is detachably connected to the blood collection device 60 (i.e., the housing 62) for direct collection of a small sample 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 a POC blood testing instrument and analyzer.

[0060] As described above, by using the collection device 116 equipped with the blood collection device 60 and catheter assembly 12, it is possible to directly collect an arterial blood sample. According to the embodiment, 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., a ventilated syringe or other ventilated chamber). When the vacuum-assisted blood sample collection device 116 is used in combination with the blood collection device 60, arterial pressure acts to fill the ventilated 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) becomes large, so hemolysis due to shear force may affect the collection of the arterial blood sample.

[0061] Regarding the effect of hemolysis due to shear, the maximum shear stress in the tubular fluid passage (e.g., catheter tube 66 and secondary catheter 102) is determined by the flow rate and the minimum effective diameter of the tube. The fluid flow in the tubular fluid passage can be analyzed using Poiseuille's equation (7) below.

[0062]

number

[0063] In equation (7), ΔP represents the change in pressure gradient along the length of the fluid passage, D and L represent the inner diameter and length of the fluid passage, respectively, μ represents the viscosity of the fluid, and R f = 128 μL / πD 4 μ represents fluid resistance. Since μ is the viscosity of the fluid and is not part of the geometric shape of the extension tube, defining a geometric coefficient Gf gives the fluid resistance R. f R f It can be expressed as =(128μL / π)*Gf, where Gf=L / D 4 That is the case.

[0064] In some embodiments, the optimized fluid passage has multiple sections, each with a length of (L1, L2, L3, …) and an inner diameter of (D1, D2, D3, …). In this case, the geometric coefficient Gf is defined as shown in equation (8) below.

[0065]

number

[0066] In some embodiments, the optimized fluid passage may have an inner diameter that varies over the length of the tube, in which case the geometric coefficient Gf is defined as shown in equation (9) below.

[0067]

number

[0068] In some embodiments, the optimized fluid passage may have a cross-section with a non-circular inner diameter profile. The geometric coefficient Gf 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 (10) below.

[0069]

number

[0070] In the case of arterial blood sampling, the Gf value of the optimized fluid passage differs between sampling with a syringe or a ventilated chamber and sampling with a vacuum retainer; therefore, the Gf value of the optimized fluid passage can be higher for sampling with a syringe or vacuum retainer. Alternatively, the Gf value of the optimized fluid passage can be lower for sampling with a syringe or vacuum retainer, and if a higher Gf value is required, accessories such as extension sets or connectors can be attached to the Luer. In another alternative embodiment, the proximal end of the extension tube (i.e., secondary catheter 102) may consist of two ports, each providing a different Gf value.

[0071] In the case of blood collection using a syringe or a ventilated chamber, the arterial pressure is constant, so blood is collected at a constant flow rate. The maximum shear stress is constant under the following conditions of equation (11).

[0072]

number

[0073] Here, D min This is the minimum diameter of the fluid passage defined by the catheter tube 66 and the secondary catheter 102.

[0074] 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 vacuum tanker, 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. In this case, the Gf value is 220 / D min 3The above is desirable. For blood collection by syringe or other ventilated chambers (i.e., non-vacuum-assisted collection devices), the Gf value of the optimized fluid passage 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. In this case, the Gf value is 35 / D min 3 The above is desirable.

[0075] It is recognized that the disclosures herein are not limited to the specific blood collection device 60 shown and described in Figures 1 to 7, and that other blood collection devices having suitable structures may also incorporate embodiments. Referring to Figure 8, an arterial access system 128 is shown that includes a blood collection device 130 according to another embodiment of the 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. This allows one or more mechanisms on the housing 132 to interact with the enlarged portion of the forward member 138 when the forward member 138 is retracted, 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 vacuum tube).

[0076] 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.

[0077] The blood collection device further includes a coupling device 154 which may be identical to the coupling device shown and described in the blood collection devices shown in Figures 1 to 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.

[0078] According to the embodiment, 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 at 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 may consist of any form of collection device 116 shown and described in Figures 1 to 7. The collection device 116 is attached to a blood collection device 130 and provides an arterial access system to improve arterial line blood collection for arterial blood gas sampling. That is, the blood collection device 130 can be used in combination with any of the various vacuum-assisted or non-vacuum-assisted blood sample collection devices 116 for blood sample collection, and the blood collection device can be configured to prevent hemolysis during sample collection, for example, by controlling the size of the device (including the geometric coefficient Gf of the device, i.e., the fluid passages within the device).

[0079] Beneficially, embodiments of the present disclosure provide an arterial access system for improving 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.

[0080] 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. A blood collection device that can be used with an indwelling arterial catheter for arterial blood collection, wherein the blood collection device is Catheter tube and A housing having a proximal end and a distal end, defining an internal space configured to movably receive the catheter tube, A forward member is movably coupled to the housing and is 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 of the catheter tube is positioned beyond the distal end of the housing and beyond the distal end of the indwelling arterial catheter. A secondary catheter connected to the forward member, extending proximal to the forward member, and extending outward through the proximal end of the housing, which is fluidly connected to the catheter tube, A sampling device is coupled to the proximal end of the secondary catheter so as to be fluidly connected to the secondary catheter and the catheter tube, Equipped with, A blood collection device wherein the fluid passage, comprising the catheter tube and the secondary catheter, has a predetermined geometric coefficient Gf defined as the ratio of the length L of the fluid passage to the inner diameter D of the fluid passage.

2. The blood collection device comprises a coupler that is coupled to the proximal end of the secondary catheter. The blood collection device according to claim 1, wherein the collection device is coupled to the coupler.

3. The blood collection device according to claim 2, wherein the collection device comprises a vacuum-assisted collection device.

4. The blood collection device according to claim 2, wherein the collection device comprises a non-vacuum-assisted collection device.

5. The blood collection device according to claim 4, wherein the coupler comprises an exhaust mechanism configured to selectively exhaust the non-vacuum-assisted blood collection device.

6. The geometric coefficient Gf is 35 / D in a non-vacuum-assisted sampling device. min 3 The above is true, and in the vacuum-assisted sampling device, 220 / D min 3 The blood collection device according to claim 2.

7. In the secondary catheter having a constant inner diameter, the geometric coefficient Gf is defined by the following formula, as described in claim 6, for the blood collection device. [Math 1]

8. The blood collection device according to claim 6, wherein the secondary catheter has a plurality of sections having lengths L1, L2, L3 and inner diameters D1, D2, D3, the geometric coefficient Gf is defined by the following formula. [Math 2]

9. In the secondary catheter, the inner diameter changes along its entire length, the geometric coefficient Gf is defined by the following equation, according to claim 6, for the blood collection device. [Math 3]

10. The blood collection device according to claim 1, wherein the housing and / or the forward member is configured such that when the catheter tube is moved to the second position, the distal end of the catheter tube protrudes 10 mm or less from the distal end of the indwelling arterial catheter.

11. The blood collection device according to claim 1, wherein the housing and / or the forward member is configured such that when the catheter tube is moved to the second position, the distal end of the catheter tube protrudes 3 to 10 mm from the distal end of the indwelling arterial catheter.

12. The blood collection device according to claim 1, wherein the length of the housing is 103 to 110 mm or 122 to 129 mm.

13. The housing includes a spacer located within the internal space and proximal to the forward member, The blood collection device according to claim 1, wherein the spacer restricts the movement of the forward member along the housing.

14. A method for manufacturing an arterial blood collection device capable of collecting arterial blood samples, The steps include providing a catheter tube and A step of housing the catheter tube within the internal space of a housing having a proximal end and a distal end, wherein the catheter tube is movable within the housing, A step of connecting a forward member to the catheter tube and the housing, wherein the forward member is movable relative to the housing, and the movement of the forward member causes a corresponding movement 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 of the housing. A step of connecting a secondary catheter to the forward member, wherein the secondary catheter extends proximal to the forward member, exits from the proximal end of the housing, and is fluidly connected to the catheter tube; A step of attaching a collection device to the proximal end of the secondary catheter, wherein the collection device comprises either a vacuum-assisted collection device or a non-vacuum-assisted collection device, A step of forming the catheter tube and the secondary catheter so that they together form a fluid passage, wherein the fluid passage has a geometric coefficient Gf defined as the ratio of the length L of the fluid passage to the inner diameter D of the fluid passage, and the geometric coefficient Gf has a first value or a range of the first value when the sampling device is a vacuum-assisted sampling device, and a second value or a range of the second value when the sampling device is a non-vacuum-assisted sampling device, A method for manufacturing an arterial blood collection device.

15. The geometric coefficient Gf is 35 / D in the non-vacuum-assisted sampling device. min 3 The above is true, and in the vacuum-assisted sampling device, 220 / D min 3 The manufacturing method according to claim 14.

16. The manufacturing method according to claim 14, wherein the housing and / or the forward member is configured such that when the catheter tube is moved to the second position, the distal end of the catheter tube protrudes 10 mm or less from the distal end of the indwelling arterial catheter.

17. In the secondary catheter having a constant inner diameter, the geometric coefficient Gf is defined by the following formula, as described in claim 14. [Math 4]

18. The manufacturing method according to claim 14, wherein the secondary catheter has a plurality of sections having lengths L1, L2, L3 and inner diameters D1, D2, D3, the geometric coefficient Gf is defined by the following formula. [Math 5]

19. In the secondary catheter, the inner diameter changes along its entire length, the geometric coefficient Gf is defined by the following formula, as described in claim 14. [Math 6]

20. The manufacturing method according to claim 14, further comprising the step of configuring the housing to have a length of 103 to 110 mm or 122 to 129 mm.

21. The manufacturing method according to claim 20, comprising the steps of configuring the housing such that when the catheter tube is moved to the second position, the distal end of the catheter tube extends 10 mm or less beyond the distal end of the housing, and / or connecting the forward member to the housing.

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