Arterial blood protection device for arterial blood drawing and related methods

Abstract

An arterial catheter system may include a catheter assembly, which may include a catheter adapter. The arterial catheter system may include an arterial catheter extending from a distal end of the catheter adapter. An arterial catheter system may include a needle assembly that may include a needle hub and an introducer needle. An arterial catheter system may include an arterial blood protection device coupled to a catheter assembly. The arterial catheter system may include fluid pathways within the arterial catheter, the catheter adapter, and the arterial blood protection device. A first fluid resistance within a portion of the fluid pathway within the arterial blood protection device may be greater than a second fluid resistance within the fluid pathway distal to the portion of the fluid pathway.

Description

Technical Field

[0001] The present disclosure generally relates to the technical field of medical devices, and in particular, to an arterial catheter system configured for drawing or collecting blood and related devices and methods. Background Art

[0002] Catheters are often used to inject fluids into a patient's vascular system. For example, catheters can be used to infuse saline solutions, various medications, or total parenteral nutrition. Catheters can also be used to draw blood from a patient.

[0003] The catheter may include an over-the-needle intravenous ("IV") catheter. In this case, the catheter may be mounted on an introducer needle having a sharp distal tip. The catheter and introducer needle may be assembled such that the distal tip of the introducer needle extends beyond the distal tip of the catheter, and the bevel of the needle faces upward away from the patient's skin. The catheter and introducer needle are typically inserted through the skin at a shallow angle into the patient's vasculature.

[0004] To verify proper placement of the introducer needle and / or catheter in the blood vessel, the clinician typically confirms the presence of a "flashback" of blood in the flashback chamber of the catheter assembly that includes the catheter. Once needle placement has been confirmed, the clinician can temporarily occlude blood flow in the vasculature and remove the needle, leaving the catheter in place for future blood draws or infusions.

[0005] In order to draw blood from a patient or collect a blood sample, a blood collection container may be used. A blood collection container may include a syringe or test tube with a rubber stopper on one end. In some cases, the blood collection container has all or part of the air removed from the test tube so that the pressure inside the blood collection container is lower than the ambient pressure. Such a blood collection container is often referred to as an internal vacuum or vacuum tube. Commonly used blood collection containers are Blood collection tubes available from Becton Dickinson.

[0006] The blood collection container may be coupled to the catheter. When the blood collection container is coupled to the catheter, the pressure in the vein is higher than the pressure in the blood collection container, which pushes blood into the blood collection container, thereby filling the blood collection container with blood. As the blood collection container fills, the vacuum within the blood collection container decreases until the pressure in the blood collection container is equalized with the pressure in the vein, and blood stops flowing.

[0007] Unfortunately, as blood is drawn into the blood collection container, the red blood cells are in a state of high shear stress and are susceptible to hemolysis due to the high initial pressure differential between the vein and the blood collection container. Hemolysis may cause the blood sample to be rejected and discarded. The high initial pressure differential may also lead to catheter tip collapse, vein collapse, or other complications that prevent or limit the blood from filling the blood collection container. As the blood collection container fills, the pressure differential between the vein and the blood collection container decreases, and the filling of the blood collection tube by the blood slows down significantly. The risk of hemolysis is much higher in arterial blood draws compared to venous blood draws due to the higher pressure in the artery.

[0008] The subject matter claimed herein is not limited to embodiments that solve any disadvantages or that operate only in environments such as those described above. Rather, this background is merely provided to illustrate one exemplary technology area where some implementations described herein may be practiced. Summary of the invention

[0009] The present disclosure generally relates to an arterial catheter system configured for drawing or collecting blood and related devices and methods. In some embodiments, the arterial catheter system may include a catheter assembly, which may include a catheter adapter and an arterial catheter. In some embodiments, the catheter adapter may include a distal end and a proximal end. In some embodiments, the arterial catheter may extend from the distal end of the catheter adapter.

[0010] In some embodiments, the arterial catheter system may include a needle assembly, which may include a needle hub and an introducer needle extending from the needle hub. In some embodiments, the arterial catheter system may include an arterial blood protection device coupled to the catheter assembly. In some embodiments, the arterial catheter system may include a fluid pathway within the arterial catheter, the catheter adapter, and the arterial blood protection device.

[0011] In some embodiments, a first fluid resistance within a portion of the fluid pathway located within the arterial blood protection device may be greater than a second fluid resistance within the fluid pathway located distal to the portion of the fluid pathway. In some embodiments, the first fluid resistance within the portion of the fluid pathway may help reduce the flow rate of arterial blood within the portion of the fluid pathway, such that the maximum shear stress is reduced and the risk of hemolysis of the arterial blood to be collected is reduced.

[0012] In some embodiments, the arterial blood containment device may include a distal end, which may include a Luer adapter. In some embodiments, the arterial blood containment device may include a proximal end, which may include a blood collection device. In some embodiments, the arterial blood containment device may include an extension tube extending between the distal end and the proximal end. In some embodiments, the portion of the fluid pathway may be disposed within the extension tube.

[0013] In some embodiments, the extension tube may include a distal end and a proximal end. In some embodiments, the distal end of the extension tube may be integrated with a Luer adapter. In some embodiments, the proximal end of the extension tube may be integrated with a blood collection device. In some embodiments, the Luer adapter may be a first Luer adapter. In some embodiments, the blood collection device may include a second Luer adapter. In some embodiments, the arterial catheter system may include a third Luer adapter connected to the second Luer adapter. In some embodiments, the extension tube may include a distal end and a proximal end. In some embodiments, the distal end of the extension tube may be integrated with the first Luer adapter. In some embodiments, the proximal end of the extension tube may be integrated with the third Luer adapter. In some embodiments, the geometric factor G of the portion of the fluid pathway f The geometric factor G of another part of the fluid path can be f In some embodiments, the extension tube may have no more than one lumen extending therethrough.

[0014] In some embodiments, the arterial blood protection device may include a compact connector, which may include a spiral tube. In some embodiments, the portion of the fluid pathway may be disposed within the spiral tube. In some embodiments, the catheter adapter may include a side port disposed between the distal end of the catheter adapter and the proximal end of the catheter adapter. In some embodiments, the catheter assembly may include another extension tube extending from the side port. In some embodiments, the distal end of the other extension tube may be integrated with the side port. In some embodiments, the proximal end of the other extension tube may be integrated with a Y-shaped adapter. In some embodiments, the compact connector may be coupled to the Y-shaped adapter. In some embodiments, the geometric factor G of the portion of the fluid pathway is f The geometric factor G of another part of the fluid passage f In some embodiments, the helical tube may have no more than one lumen extending therethrough.

[0015] In some embodiments, the arterial blood protection device may include a female Luer adapter coupled to a catheter assembly. In some embodiments, the arterial blood protection device may include a blood collection device, which may include a distal end. In some embodiments, the distal end of the blood collection device may include a male Luer adapter coupled to a female Luer adapter. In some embodiments, the male Luer adapter may include a distal opening. In some embodiments, the arterial blood protection device may include a cannula in fluid communication with the male Luer adapter. In some embodiments, the cannula may include a distal end and a sharp proximal end. In some embodiments, an elongated neck may be disposed between the male Luer adapter and the sharp proximal end. In some embodiments, the portion of the fluid pathway extends from the distal opening through the sharp proximal end. In some embodiments, the geometric factor G of the portion of the fluid pathway isf The geometric factor G of another part of the fluid path can be f different.

[0016] In some embodiments, a blood collection method may include inserting an arterial catheter of an arterial catheter system into an artery of a patient. In some embodiments, the arterial catheter system may include a catheter assembly. In some embodiments, the catheter assembly may include a catheter adapter, which may include a distal end and a proximal end. In some embodiments, the catheter assembly may include an arterial catheter extending from the distal end of the catheter adapter.

[0017] In some embodiments, the arterial catheter system may include a needle assembly, which may include a needle hub and an introducer needle extending from the needle hub. In some embodiments, the arterial catheter system may include an arterial blood protection device coupled to the catheter assembly. In some embodiments, the arterial catheter system may include a fluid pathway located within the arterial catheter, the catheter adapter, and the arterial blood protection device. In some embodiments, a first fluid resistance within a portion of the fluid pathway located within the arterial blood protection device may be greater than a second fluid resistance within the fluid pathway located distal to the portion of the fluid pathway.

[0018] In some embodiments, the blood collection method may include collecting arterial blood in a specific blood collection device, which may be coupled to the catheter assembly, whereby the arterial blood flows through the portion of the fluid pathway and enters the specific blood collection device.

[0019] In some embodiments, a method of manufacturing an arterial catheter system may include coupling a catheter assembly to a needle assembly. In some embodiments, a method of manufacturing may include coupling an arterial blood protection device to the catheter assembly such that the arterial blood protection device is in fluid communication with the catheter assembly and a portion of the fluid pathway is within the arterial catheter, the catheter adapter, and the arterial blood protection device.

[0020] In some embodiments, the manufacturing method may include selecting a length L of a portion of the fluid pathway located within the blood protection device and an inner diameter D of the portion of the fluid pathway located within the blood protection device so that a first fluid resistance within the portion of the fluid pathway is greater than a second fluid resistance distal to the portion of the fluid pathway within the fluid pathway.

[0021] It should be understood that the foregoing general description and the following detailed description are exemplary and explanatory, and not limiting of the claimed invention. It should be understood that the various embodiments are not limited to the arrangements and means shown in the accompanying drawings. It should also be understood that the embodiments may be combined, or other embodiments may be utilized, and structural changes may be made without departing from the scope of the various embodiments of the invention, unless so required. Therefore, the following detailed description should not be construed as limiting. BRIEF DESCRIPTION OF THE DRAWINGS

[0022] Example embodiments will be described and explained with additional specificity and detail through the use of the accompanying drawings in which:

[0023] Figure 1A is an upper perspective view of an exemplary arterial blood protection device according to some embodiments;

[0024] Figure 1B According to some embodiments Figure 1A A cross-sectional view of an arterial blood protection device;

[0025] Figure 1C is coupled to an exemplary arterial catheter assembly according to some embodiments Figure 1A An upper perspective view of an arterial blood protection device;

[0026] Figure 2A is an upper perspective view of another exemplary arterial blood protection device according to some embodiments;

[0027] Figure 2B According to some embodiments Figure 2B A cross-sectional view of an arterial blood protection device;

[0028] Figure 2C is connected to Figure 1C Arterial catheter set Figure 2A An upper perspective view of an arterial blood protection device;

[0029] Figure 3A is an upper perspective view of an exemplary arterial catheter system according to some embodiments;

[0030] Figure 3B is an upper perspective view of an example portion of an arterial catheter system according to some embodiments;

[0031] Figure 4A is an upper perspective view of an exemplary arterial catheter system according to some embodiments, showing an exemplary compact connector;

[0032] Figure 4B According to some embodiments Figure 4A a cross-sectional view of a portion of the ductus arteriosus system;

[0033] Figure 5A is an upper perspective view of an exemplary arterial blood protection device according to some embodiments;

[0034] Figure 5B According to some embodiments Figure 5A A cross-sectional view of an arterial blood protection device;

[0035] Figure 5C According to some embodiments Figure 5A an upper perspective view of a portion of an arterial blood containment device;

[0036] Figure 5D is connected to Figure 5A a cross-sectional view of a portion of the remainder of the arterial blood protection device;

[0037] Fig. 6A is an upper perspective view of an exemplary arterial catheter system according to some embodiments;

[0038] Figure 6B According to some embodiments Figure 3A A cross-sectional view of an arterial catheter system showing an exemplary needle assembly removed. DETAILED DESCRIPTION

[0039] Now refer to Figures 1A-1C In some embodiments, the arterial blood protection device 10 may include a distal end 12, which may include a Luer adapter 14 configured to be coupled to a catheter adapter or other suitable vascular access device. In some embodiments, the arterial blood protection device 10 may be configured to reduce the maximum shear stress acting on the arterial blood drawn from the artery into the arterial catheter system and thereby reduce the risk of hemolysis of the arterial blood, thereby providing an improved blood sample. In some embodiments, the arterial blood protection device 10 may include a proximal end 16, which may include a blood collection device 18. In some embodiments, the blood collection device 18 may include or correspond to a blood collection container. In some embodiments, the blood collection container may include a syringe, a vacuum blood collection tube (or vacuum tube), a small sample collection device, or any other container configured to collect blood from a patient via a pressure differential.

[0040] In some embodiments, the blood collection device 18 may include a needle assembly 19, which may include a needle 20 configured to receive a blood collection container. In these and other embodiments, the blood collection container may include a vacuum blood collection tube. In these embodiments, the blood collection container may be deprived of all or part of the air so that the pressure within the blood collection container is lower than the ambient pressure.

[0041] In some embodiments, needle assembly 19 may include one or more threads that may be configured to couple to a retainer 22 of blood collection device 18, which may be generally cylindrical and configured to hold a blood collection container. In some embodiments, retainer 22 may be integrally formed with needle assembly 19 or coupled to needle assembly 19 via bonding or other suitable methods. In some embodiments, retainer 22 may surround needle 20. In some embodiments, needle assembly 19 and retainer 22 may include or correspond to a Luer lock access device, such as LUER-LOK TM Access device, which is available from Becton Dickinson, Inc. In some embodiments, the holder 22 may include or correspond to the blood collection tube holder described in U.S. Patent Application No. 17 / 075,420, filed on October 20, 2020, entitled "Blood Collection System with User-Adjustable Pressure Management and Related Methods," the entire contents of which are incorporated by reference.

[0042] In some embodiments, the Luer adapter 14 may be a first Luer adapter. In some embodiments, the arterial blood protection device 10 may include a second Luer adapter 24. In some embodiments, the blood collection device 18 may include a second Luer adapter 24. In some embodiments, the needle 20 may be integrated with the second Luer adapter 24. In some embodiments, the proximal end of the needle 20 may be enclosed within an elastomeric sheath 26. In some embodiments, the elastomeric sheath 26 may include an open distal end 28 and a closed proximal end 30. In some embodiments, in response to the blood collection container pushing the elastomeric sheath 26 distally, the needle 20 may penetrate the elastomeric sheath 26, and the needle 20 may be inserted into the cavity of the blood collection container.

[0043] In some embodiments, the arterial blood protection device 10 may include an extension tube 32 that may extend between the distal end 12 of the arterial blood protection device 10 and the proximal end 16 of the arterial blood protection device 10. In some embodiments, the extension tube 32 may be rigid or semi-rigid, which may reduce the likelihood of kinking. In some embodiments, the extension tube 32 may be flexible such that it is configured to bend. In some embodiments, the extension tube 32 may be constructed of plastic. In some embodiments, the extension tube 32 may include no more than one lumen extending therethrough.

[0044] In some embodiments, the arterial blood protection device 10 may include a third Luer adapter 34 that may be coupled to the second Luer adapter 24. In some embodiments, the extension tube 32 may include a distal end 36 and a proximal end 38. In some embodiments, the distal end 36 may be coupled to or integrated with the first Luer adapter. In some embodiments, the proximal end of the extension tube 32 may be coupled to or integrated with the third Luer adapter 34. In other embodiments, the proximal end of the extension tube 32 may be coupled to or integrated with the blood collection device 18, and the arterial catheter system may not include the third Luer adapter 34.

[0045] In some embodiments, the arterial blood protection device 10 may function as, for example, Figure 1C In some embodiments, the arterial catheter system may include an arterial catheter assembly 37, which may include a catheter adapter 39 and an arterial catheter 40. In some embodiments, the arterial catheter 40 may be fixed in the catheter adapter 39 and may extend distally from the catheter adapter 39. In some embodiments, the catheter adapter 39 may include a distal end 42, a proximal end 44, and an inner cavity extending through the distal end 42 and the proximal end 44. In some embodiments, an introducer needle 45 may extend from a needle shield through the arterial catheter 40.

[0046] In some embodiments, the arterial catheter assembly 37 can be integral. In more detail, in some embodiments, another extension tube 46 can extend from the side port 48 of the catheter adapter 39. In some embodiments, the proximal end of another extension tube 46 can include a fourth Luer adapter 50, which can be coupled to the first Luer adapter. In some embodiments, the arterial catheter assembly 37 can be straight and / or the first Luer adapter can be coupled to the proximal end 44 of the catheter adapter 39. In some embodiments, one or more of the first Luer adapter, the second Luer adapter 24, the third Luer adapter 34, and the fourth Luer adapter 50 can include a sliding or threaded or clamped male Luer adapter, a sliding or threaded female Luer adapter, a needleless connector, a blunt cannula, or other suitable access devices.

[0047] In some embodiments, the arterial catheter 40 may include an arterial catheter. In some embodiments, the arterial catheter 40 may be shorter and / or more rigid than a venous catheter (e.g., a peripheral venous catheter). In some embodiments, the arterial blood protection device 10 may be coupled to the arterial catheter assembly 37 in any suitable manner. In some embodiments, the fluid pathway of the arterial catheter system may include one or more of the following: an arterial catheter 40, a catheter adapter 39, another extension tube 46, a fourth Luer adapter 50, a first Luer adapter, an extension tube 32, a third Luer adapter 34, a second Luer adapter 24, and a blood collection device 18. In some embodiments, the arterial blood protection device 10 may reduce the flow rate of blood in the fluid pathway of the arterial catheter system, which may in turn reduce the shear rate for hemolysis management. In some embodiments, the arterial catheter assembly 37 may be replaced with other types of vascular access devices, such as venous puncture devices, disposable infusion devices, blood collection access devices, or blood collection containers.

[0048] In some embodiments, the geometric factor G of the portion of the fluid passageway located within the extension tube 32 is f Can be equal to L / D 4 , where L is the length of the extension tube 32 and D is the inner diameter of the portion of the fluid passageway located within the extension tube 32. In these embodiments, the portion of the fluid passageway can be cylindrical along the entire length L, and the inner diameter D can be constant along the length L. According to some embodiments, the length L corresponds to the entire length of the extension tube 32. In some embodiments, the geometric factor G of the portion of the fluid passageway located within the extension tube 32 f can be defined such that the fluid resistance in In some embodiments, the geometric factor G of the portion of the fluid path is f It may be selected to reduce the maximum shear stress acting on arterial blood drawn from the artery and thereby reduce the risk of hemolysis of the arterial blood.

[0049] Blood cells are subject to shear stress as they flow through a fluid path. The maximum shear stress is along the walls of the fluid path or is the wall shear stress. The wall shear stress acting on blood cells is considered to be the main cause of mechanical damage to blood cells. For a cylindrical fluid path, the wall shear stress is usually expressed as:

[0050]

[0051] Where ΔP is the pressure drop along a path of length L and inner radius r. k is the contraction exponent.

[0052] To fill a collection tube of a certain volume V at a flow rate Q, the time required can be simply estimated using the following equation:

[0053]

[0054] Where μ is the dynamic viscosity of the fluid. Hemolysis is usually related to the wall shear stress and the time that blood cells are subjected to the wall shear stress. According to the literature, it is generally believed that the hemolysis index can be approximated by the following function:

[0055] HI(%)=A*t α *τ β

[0056] where A, α, and β are coefficients.

[0057] In principle, the hemolysis index is related to the pressure gradient and the characteristic cross-sectional dimensions:

[0058]

[0059] The flow of fluid in a particular extended tube having a cylindrical fluid passage therethrough can be analyzed using the Poiseuille equation:

[0060]

[0061] where ΔP is the change in pressure gradient over a specific extension tube length, D and L are the inner diameter and length of the cylindrical fluid passage through the specific extension tube, μ is the fluid viscosity, and is the fluid resistance. The specific extension tube may include or correspond to extension tube 32. Because μ is the fluid viscosity and not part of the extension tube geometry, the geometric factor G is defined as follows f , so that R f (Fluid resistance) is in

[0062] In some embodiments, if the extension tube 32 may include multiple sections having lengths (L1, L2, L3) and inner diameters (D1, D2, D3), the geometric factor is:

[0063]

[0064] In some embodiments, if the extension tube 32 may have an inner diameter that varies along the length of the extension tube, the geometry factor is:

[0065]

[0066] In some embodiments, the extension tube 32 may have a non-circular cross-section. In this case, the geometric factor may be determined by measuring the flow rate (Q) at a given pressure (ΔP) using a fluid of known viscosity (μ):

[0067]

[0068] In some embodiments, the fluid resistance may be a first fluid resistance. In some embodiments, the first fluid resistance of the portion of the fluid pathway within the extension tube may be greater than a second fluid resistance within the fluid pathway distal to the portion of the fluid pathway. For example, the first fluid resistance may be greater than a specific fluid resistance within the lumen of the catheter adapter 39, where arterial blood may travel before reaching the extension tube 32 and the arterial blood protection device 10, through which blood may be collected.

[0069] In some embodiments, the arterial catheter 40 may be a 20G arterial catheter. In these embodiments, the length L and the inner diameter D may be selected so that the geometric factor G of the portion of the fluid passageway located within the extension tube 32 is f is 3.41E+06(1 / in 3 ) or higher. In some embodiments, the length L and the inner diameter D of the 20G arterial catheter can be selected so that the geometric factor G of the portion of the fluid passage located within the extension tube 32 is f is 3.41E+06(1 / in 3 )+ / -10%.

[0070] In some embodiments, the arterial catheter 20 may be an 18G arterial catheter. In these embodiments, the length L and the inner diameter D may be selected so that the geometric factor G of the portion of the fluid passageway located within the extension tube 32 is f is 2.88E+06(1 / in 3 ) or higher. In some embodiments, the length L and the inner diameter D of the 18G arterial catheter can be selected so that the geometric factor G of the portion of the fluid passage located within the extension tube 32 is f is 2.88E+06(1 / in 3 )+ / -10%.

[0071] In some embodiments, the arterial catheter 20 may be a 22G arterial catheter. In these embodiments, the length L and the inner diameter D may be selected so that the geometric factor G of the portion of the fluid passageway located within the extension tube 32 is f is 1.05E+07(1 / in 3 ) or higher. In some embodiments, the length L and the inner diameter D of the 24G arterial catheter can be selected so that the geometric factor G of the portion of the fluid passage located within the extension tube 32 is fis 1.05E+07(1 / in 3 )+ / -10%.

[0072] In some embodiments, the arterial catheter 20 may be a 24G arterial catheter. In these embodiments, the length L and the inner diameter D may be selected so that the geometric factor G of the portion of the fluid passageway located within the extension tube 32 is f is 3.20E+07(1 / in 3 ) or higher. In some embodiments, the length L and the inner diameter D of the 24G arterial catheter can be selected so that the geometric factor G of the portion of the fluid passage located within the extension tube 32 is f is 3.20E+07(1 / in 3 )+ / -10%.

[0073] In some embodiments, the fluid pathway of the arterial catheter system may include the entire blood collection pathway through which blood flows during the blood collection process, and the fluid pathway may include one or more of the needle assembly 19, the extension tube 32, and the arterial catheter assembly 37 (which may include another extension tube 46). System geometry factor G of the fluid pathway of the arterial catheter system fs It can be determined in a similar manner as described previously.

[0074] Now refer to Figures 2A-2C , shows an arterial blood protection device 52 according to some embodiments. In some embodiments, the arterial blood protection device 52 can be similar to Figures 1A-1C In some embodiments, the arterial blood protection device 52 may be similar to or identical to the arterial blood protection device 10 of the present invention. In some embodiments, the proximal end of the extension tube 32 may be integrated with the blood collection device 18. In some embodiments, the arterial blood protection device 52 may include a clamp 54 that may be disposed on the extension tube 32. In some embodiments, the clamp 54 may be configured to move between a clamped position and an unclamped position or between a larger clamped position and a smaller clamped position. In some embodiments, in response to the clamp 54 being in the clamped position, the clamp 54 may prevent or reduce fluid flow through the extension tube 32.

[0075] In some embodiments, the clinician can adjust the flow resistance within the arterial catheter system by manually changing the fluid properties of the arterial catheter system via the clamp 54. In some embodiments, in response to the clamp 54 being in the clamped position, the flow resistance within the arterial catheter system can be increased and the blood flow through the extension tube 32 can be reduced. In these embodiments, the risk of hemolysis can be reduced. In some embodiments, to reduce the flow resistance within the arterial catheter system after the blood collection container is nearly full, the clinician can move the clamp to the loosened position, which can allow for faster blood collection when the risk of hemolysis is reduced.

[0076] In some embodiments, the clamp 54 may include a sliding clamp that may include a gradually narrowing slot. In these and other embodiments, the extension tube 32 may be flexible and compliant. In some embodiments, the clinician may adjust the inner diameter of the extension tube 32 by adjusting the depth of the extension tube 32 within the slot of the sliding clamp. The clinician may in turn adjust the flow resistance within the arterial blood protection device 52. In some embodiments, the clamp 54 may include a roller clamp, a sliding clamp, a pinch clamp, or other suitable types of clamps.

[0077] Now refer to Figure 3A , shows an arterial catheter assembly 118 according to some embodiments. In some embodiments, the arterial catheter assembly 118 may include an arterial blood protection device 120, which may be integrated with the arterial catheter assembly 37. More specifically, in some embodiments, the distal end 12 of the arterial blood protection device 120 may be integrated with the adapter 122 of the arterial catheter assembly 37, for example Figure 3A As shown, or integrated with the catheter adapter 39 itself. In these and other embodiments, the arterial blood protection device 120 may not be removable from the arterial catheter assembly 118. In some embodiments, the distal end of the extension tube 32 can be integrated with the adapter 122 or the catheter adapter 39. In some embodiments, the adapter 122 can include a Y-shaped adapter, a T-shaped adapter, or other suitable adapter. In some embodiments, the other extension tube 46 can be shorter than the extension tube 52 so that the adapter 122 provides a port for blood collection or sampling near the patient. In some embodiments, the arterial blood protection device 120 can be similar or identical to one or more of the following in terms of one or more of the included features and / or operations: Figures 1A-1C The arterial blood protection device 10 and Figures 2A-2C Arterial blood protection device 52.

[0078] Now refer to Figure 3B , showing a portion 124 of an arterial catheter assembly according to some embodiments. In some embodiments, portion 124 of an arterial catheter assembly may include an arterial blood protection device 126, which may be coupled to or integrated with an instrument delivery device 127 that may deliver a stylet, catheter, or guidewire through a particular arterial catheter assembly (e.g., Figure 3A In some embodiments, the arterial blood protection device 126 may be similar or identical to one or more of the following in terms of one or more of the included features and / or operations: Figures 1A-1C The arterial blood protection device 10 and Figures 2A-2C Arterial blood protection device 52.

[0079] In some embodiments, the instrument delivery device 127 may include any suitable instrument delivery device. In some embodiments, the instrument delivery device 127 may be in accordance with U.S. Patent No. 11,969,247, entitled “Extension for accommodating a stylet or intravenous catheter”, issued on April 30, 2024, U.S. Patent Application No. 16 / 388,650, entitled “Instrument delivery device with a rotating element”, filed on April 18, 2019, and U.S. Patent No. 11,173,277, entitled “Multiple diameter catheters and related devices and methods”, issued on November 16, 2021, and U.S. Patent No. 11,173,277, entitled “Delivery device for vascular access device”, filed on August 9, 2022. No. 11,406,795, entitled “Spring-Biased Delivery Device for Vascular Access Device,” issued on May 24, 2022, U.S. Patent No. 11,337,628, entitled “Catheter Delivery Device and Related Systems and Methods,” issued on January 10, 2023, and U.S. Patent No. 11,504,503, entitled “Vascular Access Device with Fluid-Permeable Structure and Related Devices and Methods,” issued on November 22, 2022, are further described, all of which are incorporated by reference.

[0080] Now refer to Figure 4A-4B , shows an arterial catheter system 410 according to some embodiments. In some embodiments, the arterial catheter system 410 can be configured to reduce the maximum shear stress acting on the arterial blood drawn from the artery into the arterial catheter system 410 and thereby reduce the risk of hemolysis of the arterial blood, thereby providing an improved blood sample. In some embodiments, the arterial catheter system 410 can be similar to Figure 1C , Figure 3A and Figure 3B The ductus arteriosus systems of one or more of the agents are similar or identical.

[0081] In some embodiments, the arterial catheter system 410 may include an arterial catheter assembly 412, which may include a catheter adapter 414. In some embodiments, the catheter adapter 414 may include a distal end 416 and a proximal end 418. In some embodiments, the arterial catheter assembly 412 may include an arterial catheter 420 extending from the distal end 416 of the catheter adapter 414. In some embodiments, the arterial catheter 420 may be shorter and / or more rigid than an intravenous catheter (e.g., a peripheral intravenous catheter).

[0082] In some embodiments, arterial catheter system 410 may include needle assembly 422, which may include needle hub 424 and introducer needle 426. In some embodiments, arterial catheter system 410 may include tube 428 coupled to arterial catheter assembly 412 and having distal end 430 and proximal end 432. In some embodiments, arterial catheter system 410 may include fluid passage 434 extending through at least arterial catheter 420, catheter adapter 414, and tube 428.

[0083] In some embodiments, the geometric factor G of the portion 436 of the fluid passage 434 located within the tube 428 is f Can be equal to L / D 4 , where L is the length of tube 428 and D is the inner diameter of the portion of fluid passage 434 located within tube 428. In these embodiments, portion 436 of fluid passage 434 can be cylindrical along the entire length L, and the inner diameter D can be constant along the length L. According to some embodiments, length L corresponds to the entire length of tube 428. In some embodiments, the geometric factor G of portion 436 of fluid passage 434 located within tube 428 is f can be defined such that the fluid resistance in In some embodiments, the geometric factor G of the portion 436 of the fluid passage 434 is f It may be selected to reduce the maximum shear stress acting on arterial blood drawn from the artery and thereby reduce the risk of hemolysis of the arterial blood.

[0084] In some embodiments, the fluid resistance may be a first fluid resistance. In some embodiments, the first fluid resistance of portion 436 of fluid pathway 434 within tube 428 may be greater than a second fluid resistance within fluid pathway 434 distal to portion 436 of fluid pathway 434. For example, the first fluid resistance may be greater than a specific fluid resistance within lumen 438 of catheter adapter 414, where arterial blood may travel before reaching tube 428 and adapter 440, which may be coupled to a blood collection device for blood collection.

[0085] As mentioned above, blood cells are subject to shear stress as they flow through a fluid path. The maximum shear stress is along the wall of the fluid path, or wall shear stress. The wall shear stress acting on blood cells is considered to be the main cause of mechanical damage to blood cells. For a cylindrical fluid path, the wall shear stress is usually expressed as:

[0086]

[0087] Where ΔP is the pressure drop along a path of length L and inner radius r. k is the contraction exponent.

[0088] The time required to fill a collection tube of a certain volume V at a flow rate Q can be simply estimated using the following equation:

[0089]

[0090] Where μ is the dynamic viscosity of the fluid. Hemolysis is usually related to the wall shear stress and the time that blood cells are subjected to the wall shear stress. According to the literature, it is generally believed that the hemolysis index can be approximated by the following function:

[0091] HI(%)=A*t α *τ β

[0092] where A, α, and β are coefficients.

[0093] In principle, the hemolysis index is related to the pressure gradient and the characteristic cross-sectional dimensions:

[0094]

[0095] The flow of fluid in a particular tube having a cylindrical fluid passage through it can be analyzed using the Poiseuille equation:

[0096]

[0097] where ΔP is the change in pressure gradient over the length of the tube, D and L are the inner diameter and length of the cylindrical fluid passage through the particular tube, μ is the viscosity of the fluid, and is the fluid resistance. This particular tube may include or correspond to tube 428. Because μ is the viscosity of the fluid and not part of the tube geometry, the geometric factor G f is defined so that R f (Fluid resistance) is in

[0098] In some embodiments, if the tube 428 may have multiple sections with lengths (L1, L2, L3) and inner diameters (D1, D2, D3), the geometry factor is:

[0099]

[0100] In some embodiments, if the tube 428 may have an inner diameter that varies along the length of the tube, then the geometry factor is:

[0101]

[0102] In some embodiments, tube 428 may have a non-circular cross-section. In this case, the geometry factor may be determined by measuring the flow rate (Q) at a given pressure (ΔP) with a fluid of known viscosity (μ):

[0103]

[0104] In some embodiments, the first fluid resistance, which may be lower than the second fluid resistance, may help reduce the flow rate of arterial blood within the portion 436 of the fluid passage 434 located within the tube 428, so that the maximum shear stress within the portion 436 of the fluid passage 434 is reduced and the risk of hemolysis of the arterial blood to be collected is reduced. In these embodiments, the length L and the inner diameter D of the tube 428 may be selected to increase the first fluid resistance and reduce the flow rate within the portion 436 of the fluid passage, so that the risk of hemolysis is reduced, but the flow rate is still sufficient for blood collection, and the length L and the inner diameter D may determine the geometric factor G of the portion 436 of the fluid passage 434. f .

[0105] In some embodiments, the arterial catheter 420 can be a 20G arterial catheter. In these embodiments, the length L and the inner diameter D can be selected so that the geometric factor G of the portion 436 of the fluid passage 434 located within the tube 428 is f is 3.33E+06(1 / in 3 ) or higher. In these embodiments, the length L and the inner diameter D can be selected so that the geometric factor G of the portion 436 of the fluid passage 434 located within the tube 428 is f is 3.41E+06(1 / in 3 ) or higher. In some embodiments, the length L and the inner diameter D can be selected so that the geometric factor G of the portion 436 of the fluid passage 434 located within the tube 428 is f is 3.33E+06(1 / in 3 ) or higher.

[0106] In some embodiments, the arterial catheter 20 can be an 18G arterial catheter. In these embodiments, the length L and the inner diameter D can be selected so that the geometric factor G of the portion of the fluid passageway located within the tube 428 is f is 2.88E+06(1 / in 3 ) or higher.

[0107] In some embodiments, the arterial catheter 20 can be a 22G arterial catheter. In these embodiments, the length L and the inner diameter D can be selected so that the geometric factor G of the portion of the fluid passageway located within the tube 428 is f is 1.05E+07(1 / in 3 ) or higher.

[0108] In some embodiments, the arterial catheter 20 can be a 24G arterial catheter. In these embodiments, the length L and the inner diameter D can be selected so that the geometric factor G of the portion of the fluid passageway located within the tube 428 is f is 3.20E+07(1 / in 3 ) or higher.

[0109] In some embodiments, tube 428 may include no more than one lumen 442 extending therethrough. In these embodiments, a single lumen may be sufficient for tube 428 in arterial catheter system 410, because arterial catheters are rarely used for infusion, where an extension tube with a higher fluid resistance may significantly reduce the infusion rate. In some embodiments, catheter adapter 414 may include a side port 444 disposed between distal end 416 of catheter adapter 414 and proximal end 418 of catheter adapter 414. In some embodiments, extension tube 454 may include a distal end coupled to side port 444 or integrated with side port 444. In some embodiments, extension tube 454 may include a proximal end coupled to adapter 456 or integrated with adapter 456, which may be a Y-shaped adapter or other suitable adapter. In some embodiments, adapter 456 may include at least two ports, one for blood collection and the other for pressure monitoring. In some embodiments, needleless access connector 457 may be coupled to one or more ports of adapter 456.

[0110] In some embodiments, the compact connector 458 may include a tube 428 therein. In some embodiments, the tube 428 may include a spiral or coil shape, which may facilitate a compact device for use by a clinician. In some embodiments, the tube 428 may be flexible, rigid, or semi-rigid. In some embodiments, the tube 428 may be constructed of plastic or other suitable materials. In some embodiments, the proximal end 460 of the compact connector 458 may include a female Luer adapter or other suitable adapter for connecting to a blood collection device. In some embodiments, the proximal end 460 may include a diaphragm 461 configured to compress in response to the proximal end 460 being connected to the blood collection device. In some embodiments, in response to the compression of the diaphragm 461, the blood collection device may be in fluid communication with the fluid passage 434. In some embodiments, the distal end 462 of the compact connector 458 may be connected to the adapter 456 or integrated with the adapter 456.

[0111] Now refer to Figure 5A-5B, shows a blood protection device 520 according to some embodiments. In some embodiments, the blood protection device 520 may include a distal end 522 and a proximal end 524. In some embodiments, the distal end 522 of the blood protection device 520 may include a male Luer adapter 526, which may include a distal opening 528. In some embodiments, the blood protection device 520 may include a cannula 530 in fluid communication with the male Luer adapter 526. In some embodiments, the cannula 530 may include a distal end 532 and a sharp proximal tip 534. In some embodiments, the cannula 530 may be constructed of metal or other suitable materials configured to pierce a seal of a blood collection container (e.g., a blood collection tube). In some embodiments, an elastomeric sheath 531 and in response to inserting the blood collection container into the blood protection device 520, the sharp proximal tip 534 may pierce the elastomeric sheath 531, which may be compressed in a distal direction by the blood collection container.

[0112] In some embodiments, the blood protection device 520 can include an elongated neck 535 disposed between the male Luer adapter 526 and the sharp proximal tip 534. In some embodiments, the fluid pathway of the arterial catheter system can include a portion 536 within the blood protection device 520 that extends from the distal opening 528 through the sharp proximal tip 534. In some embodiments, a diameter 537 of the portion 536 of the fluid pathway is constant. In some embodiments, the entire length 538 of the portion 536 of the fluid pathway is represented by L, and the diameter 537 of the portion 536 of the fluid pathway is represented by D.

[0113] In some embodiments, the male Luer adapter 526 of the blood protection device 520 can include a collar 539 that can extend around the protrusion 540 of the male Luer adapter 526. In some embodiments, the distal opening 528 can be disposed within the distal-most portion of the protrusion 540. In some embodiments, the inner surface of the collar 539 can be threaded to form a Luer lock fit with a corresponding female Luer adapter. In other embodiments, the inner surface of the collar 539 can be smooth to form a sliding fit with a corresponding female Luer adapter. In some embodiments, the portion 536 of the fluid pathway can be formed entirely by the cannula 530, which can extend through the collar 539 and form the protrusion 540 and the distal opening 528.

[0114] In some embodiments, the outer diameter of the collar 539 can be greater than the outer diameter of the elongated neck 535. In some embodiments, the blood protection device 520 can include a retainer 541 configured to receive a blood collection container, such as a blood collection tube. In some embodiments, the retainer 541 can include a cylindrical body 542. In some embodiments, the sharp proximal tip 534 can be disposed at the center of the cylindrical body 542 to facilitate piercing a seal of the blood collection container in response to the blood collection container being inserted into the proximal opening 544 of the cylindrical body 542.

[0115] In some embodiments, the outer diameter of the cylindrical body 542 can be greater than the outer diameter of the elongated neck 535. In some embodiments, the elongated neck 535 can be disposed between the retainer 541 and the collar 539. In some embodiments, the distal end 532 of the cannula 530 can be integrated and fixed within the elongated neck 535. In some embodiments, the elastomeric sheath 531 can be coupled to the inner surface of the retainer 541.

[0116] Now refer to Figure 5C-5D In some embodiments, the blood protection device 520 can include a female Luer adapter 546 disposed at the proximal end of the elongated neck 535. In some embodiments, the distal end of the retainer 541 can include a male Luer adapter 548. In some embodiments, the female Luer adapter 546 can be coupled to the male Luer adapter 548. Thus, in some embodiments, the blood protection device 520 can include an extension 550 that a user can couple to the retainer 541 to provide the elongated neck 535 and an increased L, which can reduce the risk of hemolysis. In these and other embodiments, D can correspond to the inner diameter of the cannula 530. In some embodiments, the inner diameter of the elongated neck 535 can be equal to D along all or a portion of the elongated neck 535. In some embodiments, the male Luer adapter 548 can be similar or identical to the male Luer adapter 526 in one or more features and / or operations.

[0117] Now refer to Figure 6A-6B , shows an arterial catheter system 552 according to some embodiments. In some embodiments, the arterial catheter system 552 can be similar to the arterial catheter system 552 in terms of one or more of the features and / or operations included. Figure 1C , Figure 3A , Figure 3B , Figure 4A and Figure 4B In some embodiments, the arterial catheter system 552 may include an arterial catheter 554 and a female Luer adapter 556 coupled to the arterial catheter 554. In some embodiments, the arterial catheter system 552 may include a blood protection device 520 that may reduce the risk of hemolysis.

[0118] In some embodiments, the arterial catheter system 552 may include a catheter adapter 558, which may include a distal end 560, a proximal end 562, and a lumen 564 extending through the distal end 560 of the catheter adapter 558 and the proximal end 562 of the catheter adapter 558. In some embodiments, the arterial catheter 554 may extend distally from the distal end 560 of the catheter adapter 558.

[0119] In some embodiments, the male Luer adapter 526 of the blood protection device 520 can be coupled to the female Luer adapter 556. In some embodiments, the position of the arterial catheter system 552 and / or the female Luer adapter 556 can vary. In some embodiments, the arterial catheter system 552 can include an extension tube 66, which can include a distal end integrated with a side port 568 of the catheter adapter 558 and a proximal end integrated with the female Luer adapter 556. In some embodiments, the side port 568 can be disposed between the distal end 560 and the proximal end 562 of the catheter adapter 558 and in fluid communication with the lumen 564. In some embodiments, the proximal end 562 of the catheter adapter 558 can include the female Luer adapter 556, and the blood protection device 520 can be coupled to the proximal end 562 of the catheter adapter 558.

[0120] In some embodiments, the septum 570 can be disposed within the lumen 564 of the catheter adapter 558. In some embodiments, when the arterial catheter system 552 is inserted into the vasculature of the patient, the introducer needle 572 of the needle assembly 574 can extend through the septum 570 and the arterial catheter 554. In some embodiments, the needle assembly 574 can be removed from the arterial catheter system 552 in response to the arterial catheter 554 being inserted into the vasculature. In some embodiments, the introducer needle 572 can include a sharp distal tip 76 and can extend from a needle hub 578 of the needle assembly 574, which can be coupled to the proximal end 562 of the catheter adapter 558.

[0121] Typically, the maximum shear stress during blood collection through an arterial catheter 554 is much higher than the maximum shear stress during blood collection using other types of catheters (i.e., venous catheters). The fluid flow in a particular cannula having a cylindrical fluid passage can be analyzed using the Poiseuille equation:

[0122]

[0123] where ΔP is the change in pressure gradient over the length of the fluid pathway, D and L are the inner diameter and length of the cylindrical fluid pathway through the particular cannula, μ is the fluid viscosity, and is the fluid resistance. The specific cannula may include or correspond to cannula 530, and the cylindrical fluid passage may include or correspond to portion 536. Because μ is the fluid viscosity and not part of the extension tube geometry, the geometric factor G f is defined so that R f (Fluid resistance) is in

[0124] In some embodiments, the portion 536 of the fluid passageway may have multiple portions with lengths (L1, L2, L3) and inner diameters (D1, D2, D3), then the geometry factor is:

[0125]

[0126] In some embodiments, the portion 536 of the fluid passage may have an inner diameter that varies with the length of the fluid passage, then the geometry factor is:

[0127]

[0128] In some embodiments, portion 536 of the fluid passage may have a non-circular cross-section. In this case, the geometry factor may be determined by measuring the flow rate (Q) at a given pressure (ΔP) using a fluid of known viscosity (μ):

[0129]

[0130] In some embodiments, the diameter of the portion 536 of the fluid passageway can be greater than the minimum inner diameter of the arterial conduit 554. 4 / L is equal to or less than a predetermined value, which can be based at least in part on the specifications of arterial catheter 554. In some embodiments, the predetermined value can correspond to a value at which the risk of hemolysis is determined to be low.

[0131] In some embodiments, the fluid resistance within the portion 536 of the fluid pathway can help reduce the flow rate of arterial blood within the portion 536 of the fluid pathway 534 located within the cannula 530, so that the maximum shear stress is reduced and the risk of hemolysis of the arterial blood to be collected is reduced. In these embodiments, the length L and the inner diameter D of the cannula 530 can be selected to increase the fluid resistance and reduce the flow rate within the portion 536 of the fluid pathway so that the risk of hemolysis is reduced, but the flow rate is still sufficient for blood collection, and the length L and the inner diameter D can determine the geometric factor G of the portion 536 of the fluid pathway. f .

[0132] In some embodiments, the fluid resistance within the portion 536 of the fluid pathway may be a first fluid resistance. In some embodiments, the first fluid resistance of the portion of the fluid pathway located within the extension tube may be greater than a second fluid resistance within the fluid pathway located distal to the portion 536 of the fluid pathway. For example, the first fluid resistance may be greater than a specific fluid resistance within the lumen of the catheter adapter 564, where arterial blood may travel before reaching the extension tube 32 and the arterial blood protection device 10, through which blood may be collected.

[0133] All examples and conditional language cited herein are intended for teaching purposes to help readers understand the present invention and the concepts contributed by the inventors to advance the art, and should be interpreted as not being limited to such specifically cited examples and conditions. Although embodiments of the present invention have been described in detail, it should be understood that various changes, substitutions and modifications may be made thereto without departing from the spirit and scope of the present invention.

Claims

1. An arterial catheter system, characterized in that: The arterial catheter system comprises: A catheter assembly, the catheter assembly comprising: a catheter adapter, the catheter adapter comprising a distal end and a proximal end; an arterial catheter extending from the distal end of the catheter adapter; A needle assembly, the needle assembly comprising: Needle holder; Guide needle; an arterial blood protection device coupled to the catheter assembly; and a fluid pathway within the arterial catheter, the catheter adapter, and the arterial blood protection device; wherein a first fluid resistance in a portion of the fluid pathway located within the arterial blood protection device is greater than a second fluid resistance in the fluid pathway located distal to the portion of the fluid pathway.

2. The arterial catheter system according to claim 1, characterized in that: The arterial blood protection device comprises: a distal end, the distal end of the arterial blood protection device comprising a Luer adapter; a proximal end, the proximal end of the arterial blood protection device comprising a blood collection device; and An extension tube extends between the distal end of the arterial blood protection device and the proximal end of the arterial blood protection device, wherein the portion of the fluid passage is disposed within the extension tube.

3. The arterial catheter system according to claim 2, characterized in that: The extension tube includes a distal end and a proximal end, wherein the distal end of the extension tube is integrated with the Luer adapter, and wherein the proximal end of the extension tube is integrated with the blood collection device.

4. The arterial catheter system according to claim 2, characterized in that: The Luer adapter is a first Luer adapter, wherein the blood collection device includes a second Luer adapter, and the arterial catheter system also includes a third Luer adapter connected to the second Luer adapter, wherein the extension tube includes a distal end and a proximal end, wherein the distal end of the extension tube is integrated with the first Luer adapter, and wherein the proximal end of the extension tube is integrated with the third Luer adapter.

5. The arterial catheter system according to claim 2, characterized in that: The geometric factor G of the portion of the fluid passage f The geometric factor G of another part of the fluid passage f different.

6. The arterial catheter system according to claim 2, characterized in that: The extension tube has no more than one lumen extending therethrough.

7. The arterial catheter system according to claim 1, characterized in that: The arterial blood protection device comprises a compact connector, wherein the compact connector comprises a coiled tube, wherein the portion of the fluid pathway is disposed within the coiled tube.

8. The arterial catheter system according to claim 7, characterized in that: The catheter adapter also includes a side port disposed between the distal end of the catheter adapter and the proximal end of the catheter adapter, wherein the catheter assembly also includes another extension tube extending from the side port, wherein the distal end of the other extension tube is integrated with the side port, wherein the proximal end of the other extension tube is integrated with a Y-shaped adapter, and wherein the compact connector is connected to the Y-shaped adapter.

9. The arterial catheter system according to claim 7, characterized in that: The geometric factor G of the portion of the fluid passage f The geometric factor G of another part of the fluid passage f different.

10. The arterial catheter system according to claim 7, characterized in that: The helical tube has no more than one lumen extending therethrough.

11. The arterial catheter system according to claim 1, characterized in that: The arterial blood protection device comprises: a female Luer adapter coupled to the catheter assembly; A blood collection device, comprising: a distal end, the distal end of the blood collection set comprising a male Luer adapter coupled to the female Luer adapter, the male Luer adapter comprising a distal opening; a cannula in fluid communication with the male Luer adapter, wherein the cannula comprises a distal end and a sharpened proximal tip; and an elongated neck disposed between the male Luer adapter and the sharpened proximal tip, wherein the portion of the fluid pathway extends from the distal opening through the sharpened proximal tip.

12. The arterial catheter system according to claim 11, characterized in that: The geometric factor G of the portion of the fluid passage f The geometric factor G of another part of the fluid passage f different.

13. A blood collection method, characterized in that: The blood collection method comprises: An arterial catheter of an arterial catheter system is inserted into an artery of a patient, wherein the arterial catheter system comprises: A catheter assembly, the catheter assembly comprising: a catheter adapter, the catheter adapter comprising a distal end and a proximal end; an arterial catheter extending from the distal end of the catheter adapter; A needle assembly, the needle assembly comprising: Needle holder; Guide needle; an arterial blood protection device coupled to the catheter assembly; a fluid pathway within the arterial catheter, the catheter adapter, and the arterial blood protection device, wherein a first fluid resistance within a portion of the fluid pathway within the arterial blood protection device is greater than a second fluid resistance within the fluid pathway distal to the portion of the fluid pathway; and Arterial blood is collected in a blood collection set coupled to the catheter assembly, whereby the arterial blood flows through the portion of the fluid pathway and into the blood collection set.

14. The method according to claim 13, characterized in that The arterial blood protection device comprises: a distal end, the distal end of the arterial blood protection device comprising a Luer adapter; a proximal end, the proximal end of the arterial blood protection device comprising a blood collection device; and An extension tube extends between the distal end of the arterial blood protection device and the proximal end of the arterial blood protection device, wherein the portion of the fluid passage is disposed within the extension tube.

15. The method according to claim 13, characterized in that The arterial blood protection device comprises a compact connector, wherein the compact connector comprises a coiled tube, wherein the portion of the fluid pathway is disposed within the coiled tube.

16. The method according to claim 13, characterized in that The arterial blood protection device comprises: a female Luer adapter coupled to the arterial catheter; A blood collection device, comprising: a distal end, the distal end of the blood collection set comprising a male Luer adapter coupled to the female Luer adapter, the male Luer adapter comprising a distal opening; a cannula in fluid communication with the male Luer adapter, wherein the cannula comprises a distal end and a sharpened proximal tip; and an elongated neck disposed between the male Luer adapter and the sharpened proximal tip, wherein the portion of the fluid pathway extends from the distal opening through the sharpened proximal tip.

17. A method of manufacturing an arterial catheter system having a fluid passage therein, characterized in that: The method comprises: coupling a catheter assembly to the needle assembly, wherein the catheter assembly includes a catheter hub and an arterial catheter extending distally from the catheter hub; coupling an arterial blood protection device to the catheter assembly such that the arterial blood protection device is in fluid communication with the catheter assembly and the fluid pathway is within the arterial catheter, the catheter adapter, and the arterial blood protection device; and A length L of a portion of the fluid pathway located within the arterial blood protection device and an inner diameter D of the portion of the fluid pathway located within the arterial blood protection device are selected so that a first fluid resistance within the portion of the fluid pathway is greater than a second fluid resistance within the fluid pathway located distal to the portion of the fluid pathway.

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