Blood extraction device

Abstract

A blood extraction device includes a catheter tube, a housing configured to movably receive the catheter tube, and an advancement member movably coupled to the housing to move the catheter tube between a first position and a second position, the distal end of the catheter tube is disposed beyond the distal end of the housing and through the distal tip of the indwelling arterial catheter. An auxiliary catheter is coupled to and proximally extends from the advancement member, wherein an acquisition device is coupled to the auxiliary catheter for fluid communication with the catheter body. The blood extraction device is configured such that a fluid path formed by the catheter body and the auxiliary catheter has a controlled geometric factor defined as a ratio of a length of the fluid path to an inner diameter of the fluid path. The blood extraction device can facilitate improved arterial line blood collection for arterial blood gas sampling and continuous pressure monitoring.

Description

Technical Field

[0001] The present disclosure relates to a blood extraction device which utilizes an indwelling arterial catheter to perform direct arterial blood collection. Background Art

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

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

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

[0005] The present invention provides a blood extraction device that can be used with an indwelling arterial catheter for arterial blood collection. The blood extraction device includes: a catheter body; a housing having a proximal end portion and a distal end portion and defining an internal volume configured to movably receive the catheter body; and a propulsion member, the propulsion member being movably connected to the housing and configured to move relative to the housing to move the catheter body between a first position and a second position, in which the catheter body is disposed within the housing, and in which the distal end of the catheter body is disposed outside the distal end portion of the housing and beyond the distal end of the indwelling arterial catheter. The blood extraction device also includes: an auxiliary catheter, the auxiliary catheter being connected to the propulsion member and extending proximally from the propulsion member and extending through the proximal end portion of the housing, the auxiliary catheter being in fluid communication with the catheter body; and a collection device, the collection device being connected to the proximal end of the auxiliary catheter so as to be in fluid communication with the auxiliary catheter and the catheter body. The fluid path formed by the catheter body and the auxiliary catheter has a controlled geometric factor G f , the controlled geometry factor is defined as the ratio of the length L of the fluid path to the inner diameter D of the fluid path.

[0006] In some embodiments, the blood extraction device includes a coupler connected to the proximal end of the secondary conduit, and wherein the collection device is connected to the coupler.

[0007] In some embodiments, the collection device is a vacuum-assisted collection device.

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

[0009] In some embodiments, the coupler includes a vent feature configured to selectively vent the non-vacuum assisted collection device.

[0010] In some embodiments, for a non-vacuum assisted collection device, the fluid path has a geometric factor G of f Equal to or greater than 35 / D min 3 For vacuum-assisted collection devices, the geometry factor is equal to or greater than 220 / D min 3 .

[0011] In some embodiments, for an auxiliary conduit having a constant inner diameter, the geometric factor G f is defined as:

[0012]

[0013] In some embodiments, for an auxiliary conduit having multiple segments with lengths L1, L2, L3 and inner diameters D1, D2, D3, the geometric factor Gf is defined as:

[0014]

[0015] In some embodiments, for an auxiliary conduit having a varying inner diameter over its length, the geometric factor G f is defined as:

[0016]

[0017] In some embodiments, the housing and / or advancement member are configured such that when the catheter tube is moved to the second position, the distal end of the catheter tube protrudes less than 10 mm beyond the distal tip of the indwelling arterial catheter.

[0018] In some embodiments, the housing and / or advancement member are configured such that when the catheter tube is moved to the second position, the distal end of the catheter tube protrudes between 3 mm and 10 mm beyond the distal tip of the indwelling arterial catheter.

[0019] In some embodiments, the housing has a length of 103 mm to 110 mm or 122 mm to 129 mm.

[0020] In some embodiments, a spacer is included, the spacer being located within the interior volume of the housing and proximal to the advancement member, the spacer limiting movement of the advancement member along the housing.

[0021] A method of manufacturing an arterial blood extraction device is also provided, which is operable to collect an arterial blood sample. The method includes: providing a catheter tube; accommodating the catheter tube within an internal volume of a housing having a proximal end portion and a distal end portion, so that the catheter tube can move within the housing; and connecting a propulsion member to the catheter tube and the housing, wherein the propulsion member is movable relative to the housing to cause corresponding movement of the catheter tube between a first position and a second position, in which the catheter tube is disposed within the housing, and in which the distal end of the catheter tube is disposed outside the distal end portion of the housing. The method also includes: connecting an auxiliary catheter to the propulsion member to extend proximally from the propulsion member and extend through the proximal end portion of the housing, the auxiliary catheter being in fluid communication with the catheter tube; and connecting a collection device at the proximal end of the auxiliary catheter, the collection device including one of a vacuum-assisted collection device and a non-vacuum-assisted collection device. The method also includes: configuring the catheter tube and the auxiliary catheter to jointly provide a vacuum-assisted collection device having a geometric factor G f The geometric factor is defined as the ratio of the length L of the fluid path to the inner diameter D of the fluid path, wherein when the collection device is a vacuum-assisted collection device, the geometric factor G fhas a first value or a first value range, when the collection device is a non-vacuum assisted collection device, the geometric factor G f Having a second value or a second range of values.

[0022] In some embodiments, for non-vacuum assisted collection devices, the geometric factor G f Equal to or greater than 35 / D min 3 , for vacuum-assisted collection devices, the geometric factor G f Equal to or greater than 220 / D min 3 .

[0023] In some embodiments, the housing and / or advancement member are configured such that when the catheter tube is moved to the second position, the distal end of the catheter tube protrudes less than 10 mm beyond the distal tip of the indwelling arterial catheter.

[0024] In some embodiments, for an auxiliary conduit having a constant inner diameter, the geometric factor G f is defined as:

[0025]

[0026] In some embodiments, for an auxiliary conduit having multiple segments with lengths L1, L2, L3 and inner diameters D1, D2, D3, the geometric factor G f is defined as:

[0027]

[0028] In some embodiments, for an auxiliary conduit having a varying inner diameter over its length, the geometric factor G f is defined as:

[0029]

[0030] In some embodiments, the method of manufacturing an arterial blood extraction device includes configuring the housing to have a length of 103 mm to 110 mm or 122 mm to 129 mm.

[0031] In some embodiments, the housing is configured and / or the advancement member is coupled to the housing such that when the catheter tube is moved to the second position, the distal end of the catheter tube protrudes less than 10 mm beyond the distal end portion of the housing. BRIEF DESCRIPTION OF THE DRAWINGS

[0032] Figure 1 is a perspective view of an arterial access system according to one aspect of the present disclosure, wherein a syringe is connected to a blood extraction device of the arterial access system;

[0033] Figure 2 According to one aspect of the present disclosure, Figure 1 A perspective view of a blood extraction device for use with an arterial access system;

[0034] Figure 3 yes Figure 2 An exploded view of a blood extraction device;

[0035] Figure 4 yes Figure 2 A side view of a blood extraction device showing the catheter in a retracted first position;

[0036] Figure 5 yes Figure 2 A side view of a blood extraction device showing the catheter in an extended second position;

[0037] Figure 6 is a perspective view of an arterial access system according to one aspect of the present disclosure, wherein a vacuum blood collector is connected to a blood extraction device of the arterial access system;

[0038] Figure 7 is a perspective view of an arterial access system according to one aspect of the present disclosure, wherein a diagnostic cassette is connected to a blood extraction device of the arterial access system; and

[0039] Figure 8 is a perspective view of an arterial access system according to one aspect of the present disclosure. DETAILED DESCRIPTION

[0040] This application claims priority to U.S. Provisional Application No. 63 / 452,025, filed on March 14, 2023, entitled “LINE EXTRACTION DEVICE FOR DIRECT ARTERIAL BLOOD SAMPLING,” the entire disclosure of which is incorporated herein by reference.

[0041] The following description is provided to enable those skilled in the art to make and use the described embodiments intended for carrying out the present disclosure. However, various modifications, equivalents, variations and substitutions will be apparent to those skilled in the art. Any and all of these modifications, variations, equivalents and substitutions are intended to fall within the spirit and scope of the present disclosure.

[0042] As used in this specification, the words "proximal" and "distal" refer to directions closer to and farther from a user who places the device in contact with a patient, respectively. Thus, for example, the end of the device that first contacts the patient's body would be the distal end, and the opposite end of the device (e.g., the end of the device that is manipulated by the user) would be the proximal end of the device.

[0043] Spatial or directional terms, such as "left", "right", "inner", "outer", "upper", "lower", etc., are not to be considered limiting as the disclosure may assume various alternative orientations.

[0044] For the purpose of the following description, the terms "upper", "lower", "right", "left", "vertical", "horizontal", "top", "bottom", "lateral", "longitudinal" and their derivatives shall relate to the orientation of the present disclosure in the accompanying drawings. However, it should be understood that the present disclosure may take various alternative variations unless expressly stated to the contrary. It should also be understood that the specific devices shown in the drawings and described in the following specification are merely exemplary aspects of the present disclosure.

[0045] The terms "first", "second", etc. do not refer to any particular sequence or chronological order, but rather to different conditions, properties or elements.

[0046] As used herein, "at least one" is synonymous with "one or more". For example, the phrase "at least one of A, B, and C" refers to any one of A, B, or C, or any combination of any two or more of A, B, or C. For example, "at least one of A, B, and C" includes one or more of A alone; or one or more of B alone; or one or more of C alone; or one or more of A and one or more of B; or one or more of A and one or more of C; or one or more of B and one or more of C; or one or more of all of A, B, and C.

[0047] The present disclosure relates to an arterial access system having a blood extraction device (or "line extraction device") and a method of using the arterial blood extraction device to advance a blood extraction catheter tube into an indwelling arterial catheter and subsequently extract a blood sample from a patient.

[0048] Reference Figure 1, shows 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. The arterial access system 10 may include a catheter assembly 12 having a catheter adapter 14 and an associated catheter 16. The catheter adapter 14 may include a distal end 18 and a proximal end 20. In some embodiments, the catheter adapter 14 may include an additional adapter port 22, which may be disposed between the distal end 18 and the proximal end 20, or disposed at the proximal end 20. The catheter adapter 14 may include a first lumen 24 extending through the distal end 18 and the proximal end 20, and the first lumen 24 may be sealed at the proximal end 20 of the catheter adapter 14. The catheter 16 extends from the distal end 18 of the catheter adapter 14 and may be configured as an arterial catheter that is disposed in an artery of a patient, with the distal end or tip 26 of the catheter 16 appropriately positioned within the artery 28 to enable blood to be drawn from the patient. In some embodiments, catheter 16 may be inserted into an artery so that distal tip 26 (the opening therein) faces upstream and into the arterial blood flow. Catheter 16 may be formed of any suitable material and may have any useful length, as known to those skilled in the art.

[0049] 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 by any suitable material known to those skilled in the art, and may have a distal end 32 and a proximal end 34. The distal end 32 of the first fluid conduit 30 is coupled to the port 22, and the proximal end 34 of the first fluid conduit 30 may be coupled to a connector 36. The connector 36 may be a T-connector (e.g., a side port is arranged at a 90 degree angle relative to the longitudinal axis of the connector 36), a Y-connector (e.g., a side port is arranged at a 25 degree, 60 degree or 75 degree angle relative to the longitudinal axis of the connector 36), or any other type of connector known in the art. The connector 36 includes a second lumen 38 running through it, which has any number of branches suitable for 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 to the port 44 of the connector 36.

[0050] In some non-limiting embodiments or aspects, catheter assembly 12 can include a needleless access connector 46 that is coupled to the proximal end 42 of connector 36, wherein needleless access connector 46 provides an access port leading to catheter assembly 12. As an example, needleless access connector 46 can be configured as a split-type diaphragm connector or a self-healing diaphragm connector. In the illustrated embodiment, the access port provided by needleless access connector 46 is a near-patient access port near the insertion site of catheter 16, but it should be appreciated that the access port can be arranged at other alternative positions near the insertion site, which allows blood extraction catheter tubing to be advanced into the indwelling arterial catheter 16 and is pushed out from its distal end. For example, the access port provided for blood extraction catheter tubing to be advanced into the indwelling arterial catheter 16 can be located on another connector, for example, the proximal connector on the extension kit (as described below) of catheter assembly 12.

[0051] In some non-limiting embodiments or aspects, the catheter assembly 12 may also include an extension kit 48 coupled to the port 44 of the connector 36. The extension kit 48 may include a second fluid conduit 50 coupled to the port 44 at an end 52 of the second fluid conduit 50 and a Luer connector 54 at an opposite end 56, wherein a clamp 57 is disposed on the second fluid conduit 50, the clamp allowing occlusion of the second fluid conduit. The extension kit 48 may be used to provide a fluid path from the catheter assembly 12 to a hemodynamic monitoring device 58 that monitors the patient's blood pressure, heart rate, and / or pulse curve based on arterial blood drawn through the catheter assembly 12. Although Figure 1 The non-limiting embodiment of shows the needleless access connector 46 disposed at the connector 36 , but those skilled in the art will appreciate that a suitable needleless access connector may also be disposed at the Luer connector 54 of the extension set 48 .

[0052] The arterial access system 10 also includes a blood extraction device 60 (optionally, a "line extraction device") that can be operated to obtain a blood sample from a patient, such as to enable blood gas analysis. Figure 1 As shown and Figure 2-5 As shown in more detail, according to one non-limiting embodiment, the blood extraction device 60 includes at least a housing 62, a coupling device 64, a catheter tube 66, and an advancement member 68. As will be described in further detail below, the catheter tube 66 is movable within the housing 62 to provide a portion of the catheter tube 66 from a first position or a retracted position ( Figure 3 ) to a second or advanced position outside the housing 62 ( Figure 4) is advanced so that its distal end can be guided into the catheter assembly 12. Once a portion of the catheter tube 66 has been guided into the catheter assembly 12 and out of the distal end 26 of the indwelling catheter 16, the catheter tube 66 can be used to collect a blood sample.

[0053] According to an embodiment, the size of catheter body 66 is designed to enable it to be introduced into the fluid path of catheter assembly 12 (that is, introduced into the inner chamber of catheter 16, the inner chamber 24 of catheter adapter 14 and the first fluid conduit 30) and for passing it to advance. Therefore, catheter body 66 can have the outer diameter of the minimum inner chamber less than the fluid path of catheter assembly (for example, between No. 10 specifications and No. 30 specifications). Catheter body 66 can have enough lengths so that the distal end 70 of catheter body 66 is placed in the desired position in the fluid path of arterial access system 10. Therefore, in one embodiment, catheter body 66 can have enough lengths so that its distal end 70 is pushed out from housing 62 and passes catheter assembly (that is, passes connector 36, fluid conduit 30, catheter adapter 14 and catheter 16), always surpassing the distal end 26 of catheter 16 to come out.

[0054] In some embodiments, and in order to accommodate the positioning of the catheter tube 66 within the catheter 16 and to advance it beyond the distal tip 26 of the catheter 16, the distal end 26 of the catheter 16 may include a fenestration formed therein. The fenestration at the distal end 26 of the catheter 16 is used 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 assembly 48, i.e., the fenestration prevents the catheter tube 66 from clogging the catheter at the distal tip 26 of the catheter 16 and prevents the catheter tube from cutting off accurate pressure monitoring. Thus, the fenestration in the catheter 16 provides the ability to continue to monitor arterial pressure as the catheter tube 66 is advanced during the sampling procedure performed by the blood extraction device 60.

[0055] According to aspects of the present disclosure, it should be recognized that the use of a blood extraction device 60 with an indwelling arterial catheter 16 can be different from the use of a blood extraction device with an indwelling peripheral IV catheter. That is, unlike a peripheral IV catheter used in a vein, an arterial catheter has a distal end and opening facing upstream and entering the oncoming arterial blood flow. Arterial blood flow is also typically at a higher flow rate and pressure, so some challenges and complications encountered by peripheral IV catheters do not occur in arterial catheters, such as thrombosis downstream of the end of the venous catheter, making it difficult to aspirate and line draw during PIV indwelling. Therefore, the use of a blood extraction device 60 with an indwelling arterial catheter 16 includes different requirements, optimization goals, and design considerations. For example, according to some non-limiting embodiments of the present disclosure, the blood extraction device 60 can be configured to extend the distal end 70 of the catheter body 66 beyond the distal end 26 of the indwelling arterial catheter 16 by a distance less than 10 mm, preferably extending beyond between 3 mm and 10 mm, because such a distance can be sufficient to obtain a high-quality arterial blood sample for the above reasons. In other embodiments, the blood extraction device 60 may be configured such that the distal end 70 of the catheter tube 66 extends beyond the distal tip 26 of the indwelling arterial catheter 16 by up to 20 cm, up to 30 cm, or greater according to other non-limiting embodiments.

[0056] like Figure 2-5 As shown, the housing 62 of the blood extraction device 60 can be an elongated member having a proximal end 72 and a distal end 74 and defining an interior volume 76. In some embodiments, the housing 62 can be formed from a pair of housing portions 78a, 78b coupled together to define the interior volume 76. The housing 62 can include one or more features or surface finishes on an outer surface thereof that can be arranged to increase the ergonomics of the blood extraction device 60, which in some cases can allow a user to manipulate the blood extraction device 60 with one hand (i.e., one-handed use).

[0057] The coupling device 64 of the blood extraction device 60 is disposed at the distal end 74 of the housing 62, and the coupling device 64 provides a reversible coupling of the blood extraction device 60 to the catheter assembly 12, for example via Figure 1 The needleless access connector 46 shown. In some embodiments, the coupling device 64 is configured as a locking member 80, which includes a blunt cannula 82 and a locking arm 84 for coupling to the needleless access connector 46 of the catheter assembly 12, and the blunt cannula 82 and the locking arm 84 form three points of contact with the needleless access connector. However, those skilled in the art will understand that any connection or coupling, such as a Luer piece, can be used as long as the distal end 70 of the catheter tube 66 can pass through the coupling device 64 to reach the catheter assembly 12.

[0058] The advancement member 68 of the blood extraction device 60 includes a first portion 86 and a second portion 88. The first portion 86 is movably disposed along an upper surface 90 of the housing 62, and the second portion 88 is movably disposed within the interior volume 76 of the housing 62. The advancement member 68 and the housing 62 are arranged so that a connecting portion (not shown) of the advancement member 68 that joins the first portion 86 and the second portion 88 is seated within a slot 92 formed in the upper surface 90 of the housing 62, the slot 92 extending generally between the proximal end 72 and the distal end 74 of the housing 62. When the first portion 86 and the second portion 88 are coupled together, movement of the first portion 86 along the upper surface 90 of the housing 62 results in corresponding movement of the second portion 88 within the interior volume 76.

[0059] like Figure 2-5 As shown, the first portion 86 of the advancement member 68 can be configured as a tab or protrusion having a contact surface 94a that can be engaged by a user and a lower side 94b that contacts the outer surface 90 of the housing 62. In such an embodiment, the upper surface 90 of the housing 62 may include a track 96, such as a set of ribs, ridges, bumps, grooves, and / or the like, along which the lower side 94b of the tab or protrusion advances when the advancement member 68 is engaged by the user. In this way, the user can engage the first portion 86 of the advancement member 68 and can move the advancement member 68 relative to the housing 62.

[0060] like Figure 2-5 As shown, the second portion 88 includes an opening 98 extending therethrough that is configured to grip or retain a portion of the catheter tubing 66. Because a portion of the catheter tubing 66 is retained within the opening 98 of the second portion 94, movement of the advancement member 68 relative to the housing 62 results in corresponding movement of the catheter tubing 66 relative to the housing 62. In this manner, the distal end 70 of the catheter tubing 66 can be selectively moved out of or back into the interior volume 76 of the housing 62 as desired, such as by pushing the distal end 70 of the catheter tubing 66 out of the housing 62 when the blood extraction device 60 has been coupled to the catheter assembly 12 and the collection of an arterial blood sample is to be performed.

[0061] As described above, when the distal end 70 of the catheter tube 66 is pushed out of the housing 62 and into the catheter assembly 12, the blood extraction device 60 can be configured to extend the distal end 70 of the catheter tube 66 beyond the distal end 26 of the indwelling arterial catheter 16 by a distance less than 10 mm, preferably between 3 mm and 10 mm, because such a distance is sufficient to obtain a high-quality arterial blood sample for the reasons described above. By advancing the catheter tube 66 by this distance, the length of the catheter tube and the housing 62 is allowed to be reduced and / or the movement of the advancement member 68 relative to the housing 62 is limited. In some embodiments, the introducer 62 can be configured to have a length L between 103 mm and 110 mm. Intro , which is related to the need for the extended length of the catheter tube 66 to be less than the length typically required for using a blood extraction device with a peripheral IV catheter. In some embodiments, the housing 62 can be configured to have a length L between 122 mm and 129 mm. Intro In other embodiments, the spacer 100 (in Figure 2 The spacer 100 (shown in phantom in the figure) can be disposed within the internal volume 76 of the housing 62 at a position proximal to the advancement member 68 (i.e., at the proximal end 72 of the housing 62), and serves to limit the travel path of the advancement member 68, which is related to the need for the extended length of the catheter tube 66 to be less than the length typically required for use with a blood extraction device with a peripheral IV catheter.

[0062] like Figure 2-5 As further shown, the blood extraction device 60 includes an auxiliary conduit 102 disposed at the proximal end 72 of the housing 62. The auxiliary conduit 102 has a proximal end portion 104 and a distal end portion 106 and defines an inner cavity 108. A portion of the auxiliary conduit 102 is disposed within and extends through an opening 110 formed in the proximal end 72 of the housing 62. Thus, the proximal end portion 104 is at least partially disposed outside the housing 62, the distal end portion 106 is at least partially disposed within the housing 62, and the distal end portion 106 is coupled to the second portion 88 of the advancement member 68. In some embodiments, the auxiliary conduit 102 can have a larger diameter than the catheter tube 66, which can serve to limit, reduce and / or substantially prevent hemolysis of a volume of blood as the volume of blood flows through the catheter tube 66 and the auxiliary conduit 102, as explained in more detail below. In this manner, when the blood drawing device 60 is coupled to a syringe, evacuated container, or the like, the auxiliary conduit 102 establishes fluid communication between the reservoir, source, pump, or the like and the conduit tube 66, as further explained below.

[0063] According to embodiments of the present disclosure, the proximal end portion 104 of the auxiliary conduit 102 is coupled to and / or otherwise includes a coupler 114 configured to mate with a collection device 116 that can be used with (or considered to be a part of) the blood extraction device 60 to collect an arterial blood sample for subsequent analysis, such as blood gas analysis of the sample. According to some embodiments, the coupler 114 can be configured as a Luer connector (i.e., a female Luer connector) that is configured to mate with a corresponding Luer connector (i.e., a male Luer connector) of the collection device 116. The coupler 114 physically and fluidically couples the auxiliary conduit 102 to the collection device 116, which, as further described below, can be any suitable vacuum-assisted or non-vacuum-assisted blood sample collection device 116, such as a sampling syringe, a vacuum blood collection device, a Luer lock access device (LLAD), a point of care (POC) sampling device, an integrated POC cartridge, a blood culture collection system, or the like. Non-limiting examples of vacuum or non-vacuum assisted blood sample collection devices may include Becton Dickinson and Company's Luer-Lok TM Access device or Accustat TM In some embodiments, a vent feature 118 may be provided that serves to ventilate the vacuum-assisted or non-vacuum-assisted collection device 116 prior to blood collection. As shown in the illustrated embodiment, the vent feature 118 may be disposed on the coupler 114, but it should be appreciated that the vent feature 118 may be disposed anywhere along the sampling fluid path, although it may preferably be disposed near the proximal end portion 104 of the secondary conduit 102.

[0064] like Figure 1-5As shown, according to one aspect of the present disclosure, the collection device 116 connected to the blood extraction device 60 (via the connector 114) is provided as a syringe 116a. In some embodiments, the syringe 116a can be pre-attached, wherein the plunger 120 of the syringe 116a is in the advanced position. When the catheter tube 66 of the blood extraction device 60 advances through the indwelling catheter 16 and enters the artery 28, the plunger 120 of the syringe can be retracted to draw the undiluted arterial blood sample into the syringe 116a. The syringe 116a can contain a blood preservative / stabilizer to help maintain the quality of the sample. In other embodiments, the syringe 116a can start in a retracted position and have a selective ventilation feature (e.g., a vent 118 on the connector 114), and the syringe 116a can be ventilated via the selective ventilation feature after the catheter tube 66 has moved to the second, advanced position. After any venting of the syringe 116a and subsequent sample collection and stabilization, the syringe 116a may be detached from the blood drawing device 60 and the sample may then be dispensed into a POC blood diagnostic test cartridge 122 or provided to another blood analyzer testing instrument.

[0065] Reference now Figure 6 , an arterial access system 10 is shown in which a collection device 116 connected to a blood extraction device 60 (via a connector 114) is configured as a vacuum blood collector collection device 116b, or a simplified / improved vented vacuum blood collector that does not require a vacuum tube to drive the sample volume collection. A blood preservative / stabilizer may be included in the vacuum blood collector 116b to help maintain the quality of the sample. After the vacuum blood collector 116b is filled and the blood is stabilized, the vacuum blood collector 116b may be removed from the blood extraction device 60, and the blood sample may then be dispensed onto a POC diagnostic test cartridge 122 or provided to another blood analyzer test instrument.

[0066] Reference now Figure 7 , an arterial access system 10 is shown, wherein a collection device 116 connected to a blood extraction device 60 is provided as a loaded POC diagnostic cassette 116c (e.g., an iStat test cassette from Abbott Labratories). The diagnostic cassette 116c can be removably coupled to the blood extraction device 60 (i.e., coupled to the housing 62) for direct collection of micro-samples of arterial blood. Utilizing the diagnostic cassette 116c, the system requires selective ventilation of the cassette microfluidic path to prevent filling until the distal end 70 of the catheter tubing 66 directly performs undiluted blood sampling in the artery 28. After filling the diagnostic cassette 116c, it can be removed from the blood extraction device 60 and inserted into a POC blood testing instrument and analyzer.

[0067] As described above, the use of the blood extraction device 60 and the collection device 116 with the catheter assembly 12 enables direct collection of an arterial blood sample. According to aspects of the present disclosure, arterial blood extraction can be performed by connecting a vacuum-assisted blood sample collection device 116 (e.g., a vacuum syringe or LLAD connected to a vacuum blood collector) or by a non-vacuum-assisted blood sample collection device 116 (e.g., a vented syringe or other vented chamber). When a non-vacuum-assisted blood sample collection device 116 is used with the blood extraction device 60, arterial pressure acts to fill the vented collection device chamber, where blood flow is driven by a constant arterial pressure. In the case of vacuum-assisted blood extraction, the pressure gradient across the fluid path of the blood extraction device (i.e., the catheter tube 66 and the auxiliary catheter 102) is much higher, so shear-driven hemolysis may affect the collection of an arterial blood sample.

[0068] Regarding the effects of shear-driven hemolysis, the maximum shear stress in the tubular fluid pathway (e.g., catheter tubing 66 and auxiliary catheter 102) is determined by the flow rate and the minimum hydraulic diameter of the tubing. The fluid flow in the tubular fluid pathway therethrough can be analyzed using the Poiseuille equation:

[0069]

[0070] where ΔP is the change in pressure gradient across the length of the fluid path, D and L are the inner diameter and length of the fluid path, respectively, μ is the viscosity of the fluid, and R f =128μL / πD 4 is the fluid resistance. Since μ is the viscosity of the fluid and not part of the extended tube geometry, the geometric factor G f is defined so that R f (fluid resistance) is R f =(128μL / π)*G f , where G f =L / D 4 .

[0071] In some embodiments, the optimized fluid path may have multiple segments with lengths (L1, L2, L3, ...) and inner diameters (D1, D2, D3, ...), and the geometric factors are:

[0072]

[0073] In some embodiments, the optimized fluid path may have an inner diameter that varies over the length of the tube, with the geometric factor being:

[0074]

[0075] In some embodiments, the optimized fluid passage may have a cross-section having a non-circular inner diameter profile. The geometric factor may be determined by measuring the flow rate (Q) of a fluid of known viscosity (μ) at a given pressure (ΔP):

[0076]

[0077] Since in the case of arterial blood collection, for syringe drawing or venting chamber and vacuum blood collection, the G of the optimized fluid path f The values ​​will be different, so the G of the optimized fluid path f The value may be the higher value between syringe draw and vacuum blood collection. Alternatively, the G of the optimized fluid path f The value can be the lower value between syringe draw and vacutainer draw and is used when a higher G f In the case of a value of G, an accessory in the form of an extension kit or connector can be connected to the Luer piece. In another alternative embodiment, the proximal end of the extension tube (i.e., the auxiliary catheter 102) can be composed of two ports, each of which provides a different G f value.

[0078] In the case of syringe withdrawal or venting chamber, blood withdrawal occurs at a constant flow rate because the driving arterial pressure is constant. The maximum shear stress is constant where:

[0079]

[0080] Among them, D min is the minimum diameter of the fluid passage defined by the catheter tube 66 and the auxiliary catheter 102.

[0081] Based on the above, the G of the optimized fluid path (i.e., the catheter tube 66 and the auxiliary catheter 102) can be selected according to the blood extraction method. f The G of the optimized fluid path in the case of vacuum-assisted vacutainer extraction f The value may be selected to reduce the maximum shear stress to be equal to or less than the maximum shear stress of a typical vacuum-assisted button blood collection kit, wherein according to aspects of the present disclosure, G f Value equal to or greater than 220 / D min 3 is desirable. In the case of syringe draws or other vented chambers (i.e., non-vacuum assisted devices), the G of the optimized fluid path f The value can be selected to reduce the maximum shear stress to be equal to or less than the average maximum shear stress of a typical vacuum-assisted button blood collection kit, wherein according to aspects of the present disclosure, G f Value equal to or greater than 35 / D min 3is expected.

[0082] It should be appreciated that the aspects of the present disclosure are not limited to Figure 1-7 The particular blood extraction device 60 shown and described herein, and blood extraction devices with other suitable configurations may also incorporate aspects of the present disclosure. Figure 8 , an arterial access system 128 is shown, which includes a blood extraction device 130 according to another embodiment of the present disclosure. The blood extraction device 130 includes: a housing 132, the housing having a proximal end 134 and a distal end 136; and a propulsion member 138, the propulsion member 138 being slidably received within the housing 132 (i.e., received within the interior volume 140 of the housing 132). In the illustrated embodiment, the propulsion member 138 is configured as one or more telescopic columns 138a, which are arranged in a telescopic relationship with the housing 132 so that the propulsion member 138 can be slidably received completely or nearly completely within the interior volume 140 of the housing 132. The propulsion member 138 also includes a proximal end 142 and a distal end 144, and in a non-limiting embodiment, the propulsion member 138 can have a variable diameter along its length. As one example, the diameter of the distal end 144 of the pusher member 138 can be larger than the diameter of the rest of the pusher member 138 so that when the pusher member 138 is retracted, one or more features on the housing 132 can interact with the enlarged portion of the pusher member 138 to prevent the pusher member 138 from being pulled completely out of the housing 132. As another example, the diameter of the distal end 144 of the pusher member 138 can be smaller than the diameter of the rest of the pusher member 138 to hold the pusher member 138 in place in the forward state of blood extraction so that the operator's hands are freed to manipulate additional components (e.g., a vacuum blood collection tube).

[0083] The blood withdrawal device 130 also includes a catheter tube 146 having a proximal end 148 and a distal end 150. The catheter tube 146 is received within the interior volume 140 of the housing 132 and can be advanced and / or retracted relative to the housing 132 by displacement of the advancement member 138 relative to the housing 132. In some embodiments, the catheter tube 146 can be coupled to the advancement member 138 via a fitting 152 disposed at the distal end 144 of the advancement member 138, such that displacement of the advancement member 138 relative to the housing 132 causes a corresponding displacement of the catheter tube 146. In a non-limiting embodiment, the catheter tube 146 can be advanced from a first position, in which the distal end 150 of the catheter tube 146 is within the housing 132, to a second position, in which the distal end 150 of the catheter tube 146 is located distally of the housing 132 (and also distally of the catheter 16), as previously described with respect to the blood withdrawal device 60 and its operation.

[0084] The blood extraction device also includes a coupling device 154 located thereon, which can be connected to Figure 1-7 That is, the coupling device 154 is configured as a locking member 80 that includes a blunt-tipped cannula 82 and a locking arm 84 for connecting to the needleless access connector 46 of the catheter assembly 12, wherein the blunt-tipped cannula 82 and the locking arm 84 form three points of contact with the needleless access connector. However, it should be understood that alternative embodiments of the blood extraction device 130 may include another type of coupling device 154 to secure the blood extraction device 130 to the catheter assembly 12, including a Luer connector, a clamp, a blunt plastic cannula, a blunt metal cannula, a hybrid Luer (e.g., with a cannula), a friction fit, or the like.

[0085] According to aspects of the present disclosure, the secondary catheter 102 can be guided through the telescopic column 138a of the advancement member 138, wherein the secondary catheter 102 provides a fluid connection between the catheter tube 146 and the coupling 114 disposed at the proximal end portion 104 of the secondary catheter 102, wherein the coupling 114 is configured to cooperate with the collection device 116. Figure 8 The syringe 116a is shown in FIG. 1 , but the collection device 116 may be configured as Figure 1-7 1, wherein the collection device 116 is attached to a blood drawing device 130 to provide an arterial access system for facilitating improved arterial line blood collection for arterial blood gas sampling. That is, the blood drawing device 130 can accommodate any of a variety of different vacuum-assisted or non-vacuum-assisted blood collection devices 116 for use therewith to collect a blood sample, wherein the blood drawing device can be configured to prevent hemolysis during sample collection, for example by controlling the dimensions of the device, including the geometric factor G of the device (i.e., the fluid passage therein). f .

[0086] Advantageously, embodiments of the present disclosure thus provide an arterial access system for facilitating improved arterial line blood collection for arterial blood gas sampling and continuous pressure monitoring. The arterial access system includes a catheter assembly having a blood extraction device attached thereto, which can be used to collect an arterial blood sample directly from a patient via an indwelling arterial catheter, wherein the blood sample is used for blood gas analysis. At the same time, the arterial access system provides continuous blood pressure monitoring by using an extension kit that can be attached to the catheter assembly, and provides arterial blood to a hemodynamic monitoring system connected thereto. The blood extraction device can be adapted for use with any of a variety of different vacuum-assisted or non-vacuum-assisted blood collection devices for collection of blood samples, wherein the blood extraction device can be configured to prevent hemolysis during sample collection.

[0087] Although for the purpose of illustration, the present disclosure is described in detail based on what is currently considered to be the most practical and preferred embodiments or aspects, it should be understood that such details are only for this purpose, and the present disclosure is not limited to the disclosed embodiments or aspects, but on the contrary, it is intended to cover modifications and equivalent arrangements that fall within the spirit and scope of the appended claims. For example, it should be understood that the present disclosure contemplates that, to the extent possible, one or more features of any embodiment can be combined with one or more features of any other embodiment.

Claims

1. A blood extraction device, which can be used together with an indwelling arterial catheter to collect arterial blood, characterized in that: The blood extraction device comprises: Catheter body; a housing having a proximal end portion and a distal end portion and defining an interior volume configured to movably receive the catheter tube; a pusher member movably coupled to the housing and configured to move relative to the housing to move the catheter tube between a first position in which the catheter tube is disposed within the housing and a second position in which a distal end of the catheter tube is disposed outside of the distal end portion of the housing and beyond a distal tip of the indwelling arterial catheter; an auxiliary conduit coupled to the advancement member and extending proximally from the advancement member and through the proximal end portion of the housing, the auxiliary conduit being in fluid communication with the catheter tube; and a collection device coupled to the proximal end of the auxiliary catheter so as to be in fluid communication with the auxiliary catheter and the catheter body; Wherein, the fluid path including the catheter body and the auxiliary catheter has a controlled geometric factor G f , the controlled geometry factor is defined as the ratio of the length L of the fluid path to the inner diameter D of the fluid path.

2. The blood extraction device according to claim 1, characterized in that: The blood extraction device includes a coupler connected to the proximal end of the auxiliary conduit, and wherein the collection device is connected to the coupler.

3. The blood extraction device according to claim 2, characterized in that: The collection device includes a vacuum-assisted collection device.

4. The blood extraction device according to claim 2, characterized in that: The collection device includes a non-vacuum assisted collection device.

5. The blood extraction device according to claim 4, characterized in that: The coupler includes a vent feature configured to selectively vent the non-vacuum assisted collection device.

6. The blood extraction device according to claim 2, characterized in that: For non-vacuum assisted collection devices, the controlled geometry factor G f Equal to or greater than 35 / D min 3 For vacuum-assisted collection devices, the controlled geometry factor is equal to or greater than 220 / D min 3 .

7. The blood extraction device according to claim 6, characterized in that: For the auxiliary conduit with a constant inner diameter, the controlled geometry factor Gf is defined as:

8. The blood extraction device according to claim 6, characterized in that: For the auxiliary conduit having multiple sections with lengths L1, L2, L3 and inner diameters D1, D2, D3, the controlled geometric factor G f is defined as:

9. The blood extraction device according to claim 6, characterized in that: For the auxiliary conduit having a varying inner diameter over its length, the controlled geometry factor G f is defined as:

10. The blood extraction device according to claim 1, characterized in that: 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 less than 10 mm beyond the distal tip of the indwelling arterial catheter.

11. The blood extraction device according to claim 1, characterized in that: 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 between 3 mm and 10 mm beyond the distal tip of the indwelling arterial catheter.

12. The blood extraction device according to claim 1, characterized in that: The housing has a length of 103 mm to 110 mm or 122 mm to 129 mm.

13. The blood extraction device according to claim 1, characterized in that: The blood withdrawal device includes a spacer located within the interior volume of the housing and proximal to the advancement member, the spacer limiting movement of the advancement member along the housing.

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