Arterial blood shielding device for arterial blood sampling and related methods

Abstract

An arterial catheter system may include a catheter assembly that may include a catheter adapter. An arterial catheter system may include an arterial catheter extending from the distal end of the catheter adapter. An arterial catheter system may include a needle assembly that may include a needle hub and an introduction needle. An arterial catheter system may include an arterial blood shielding device coupled to the catheter assembly. An arterial catheter system may include an arterial catheter, a catheter adapter, and a fluid path within the arterial blood shielding device. A first fluid resistance in the portion of the fluid path within the arterial blood shielding device may be greater than a second fluid resistance in the fluid path distal to that portion of the fluid path.

Description

[Technical Field]

[0001] This disclosure generally relates to arterial catheter systems configured for blood collection or blood collection, as well as related devices and methods. [Background technology]

[0002] Catheters are commonly used to inject fluids into a patient's vascular system. For example, catheters can be used to inject saline solution, 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 introduction needle having a sharp distal tip. The catheter and introduction needle may be assembled such that the distal tip of the introduction needle extends beyond the distal tip of the catheter, and the bevel of the needle is oriented away from the patient's skin. The catheter and introduction needle are typically inserted into the patient's vascular system at a shallow angle from the skin.

[0004] To verify proper placement of the induction needle and / or catheter within the blood vessel, clinicians typically check for a “flashback” of blood within the flashback chamber of the catheter assembly, including the catheter. Once needle placement is confirmed, clinicians can temporarily interrupt vascular flow to withdraw the induction needle and leave the catheter in place for future blood draws or fluid infusions.

[0005] A blood collection container may be used for collecting blood from a patient or for taking blood samples. A blood collection container may include a syringe or a test tube with a rubber stopper at one end. The blood collection container may also be designed to remove all or part of the air from the test tube so that the pressure inside the container is lower than the ambient pressure. Such blood collection containers are often called internal vacuum or vacuum tubes. A commonly used blood collection container is the Vacutainer® blood collection tube, available from Becton Dickinson & Company.

[0006] The blood collection container can be coupled to a catheter. When the blood collection container is coupled to the catheter, the pressure within the vein is higher than the pressure within the blood collection container, forcing blood into the blood collection container to fill it. The vacuum within the blood collection container decreases as the blood collection container is filled until the pressure within the blood collection container equals the pressure within the vein and blood flow stops.

[0007] Unfortunately, when blood is drawn into the blood collection container, red blood cells are in a high shear stress state and are prone to hemolysis due to the high initial pressure difference between the vein and the blood collection container. Hemolysis can result in the rejection and discard of the blood sample. The high initial pressure difference can also cause complications such as the collapse of the catheter tip and the collapse of the vein, which may prevent or limit the filling of the blood collection container with blood. As the blood collection container is filled, the pressure difference between the vein and the blood collection container decreases, and the blood filling of the blood collection tube becomes significantly slower. Due to the higher pressure within the artery compared to venous blood collection, the risk of hemolysis is much higher in arterial blood collection.

[0008] The subject matter claimed herein is not limited to embodiments that solve any disadvantages as described above or to embodiments that operate only in the environments as described above. Rather, this background art is provided only to illustrate an example of a technical area in which some of the embodiments described herein may be implemented.

Prior Art Documents

Patent Documents

[0009]

Patent Document 1

Patent Document 2

Patent Document 3

Patent Document 4

Patent Document 5

[0010] In some embodiments, the arterial catheter system may include a catheter assembly that 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.

[0011] In some embodiments, the arterial catheter system may include a needle assembly that may include a needle hub and an introduction needle extending from the needle hub. In some embodiments, the arterial catheter system may include an arterial blood shielding device coupled to the catheter assembly. In some embodiments, the arterial catheter system may include an arterial catheter, a catheter adapter, and a fluid pathway within the arterial blood shielding device.

[0012] In some embodiments, the first fluid resistance in a portion of the fluid path within the arterial blood shielding device may be greater than the second fluid resistance in the distal portion of the fluid path. In some embodiments, the first fluid resistance in a portion of the fluid path may facilitate a decrease in the flow velocity of arterial blood within the portion of the fluid path, such that the maximum shear stress is reduced and the risk of hemolysis of the collected arterial blood is reduced.

[0013] In some embodiments, the arterial blood shielding device may include a distal end that may include a Luer adapter. In some embodiments, the arterial blood shielding device may include a proximal end that may include a blood collection device. In some embodiments, the arterial blood shielding device may include an extension tube extending between the distal and proximal ends. In some embodiments, a portion of the fluid path may be located within the extension tube.

[0014] 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 coupled 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 a first Luer adapter. In some embodiments, the proximal end of the extension tube may be integrated with a third Luer adapter. In some embodiments, the geometric coefficient G of the portion of the fluid path f This is the geometric coefficient G of another part of the fluid path. f This may differ. In some embodiments, the extension tube may have only one lumen extending through it.

[0015] In some embodiments, the arterial blood shielding device may include a compact connector which may include a spiral tube. In some embodiments, a portion of the fluid path may be located within the spiral tube. In some embodiments, the catheter adapter may include a side port located between the distal end 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 the Y adapter. In some embodiments, the compact connector may be coupled to the Y adapter. In some embodiments, the geometric coefficient G of the portion of the fluid path f This is the geometric coefficient G of another part of the fluid path. f This is different. In some embodiments, the spiral tube may have only one lumen extending through it.

[0016] In some embodiments, the arterial blood shielding device may include a female Luer adapter coupled to a catheter assembly. In some embodiments, the arterial blood shielding 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 the female Luer adapter. In some embodiments, the male Luer adapter may include a distal opening. In some embodiments, the arterial blood shielding device may include a cannula which is 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 positioned between the male Luer adapter and the sharp proximal end. In some embodiments, a portion of the fluid path extends from the distal opening through the sharp proximal end. In some embodiments, the geometric coefficient G of the portion of the fluid path f This is the geometric coefficient G of another part of the fluid path. f This may differ from the case.

[0017] In some embodiments, the blood collection method may include inserting an arterial catheter of an arterial catheter system into a patient's artery. 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.

[0018] In some embodiments, the arterial catheter system may include a needle assembly that may include a needle hub and an introduction needle extending from the needle hub. In some embodiments, the arterial catheter system may include an arterial blood shielding device coupled to the catheter assembly. In some embodiments, the arterial catheter system comprises an arterial catheter, a catheter adapter, and a fluid path within the arterial blood shielding device. In some embodiments, a first fluid resistance in a portion of the fluid path within the arterial blood shielding device may be greater than a second fluid resistance in the fluid path distal to the portion of the fluid path.

[0019] In some embodiments, the blood collection method may include collecting arterial blood into a specific blood collection device that can be coupled to a catheter assembly, thereby causing the arterial blood to flow into the specific blood collection device through a portion of a fluid pathway.

[0020] In some embodiments, a method for manufacturing an arterial catheter system may include coupling a catheter assembly to a needle assembly. In some embodiments, a manufacturing method may include coupling an arterial blood shield device to a catheter assembly such that the arterial blood shield device is in fluid communication with the catheter assembly, and portions of the fluid pathway are located within the arterial catheter, catheter hub, and arterial blood shield device.

[0021] In some embodiments, the manufacturing method may include selecting the length L of the fluid path portion in the blood shield device and the inner diameter D of the fluid path portion in the blood shield device such that the first fluid resistance in the portion of the fluid path is greater than the second fluid resistance in the distal portion of the fluid path.

[0022] It should be understood that both the above-mentioned general description and the following detailed description are illustrative and for illustrative purposes only, and do not limit the claimed invention. It should be understood that various embodiments are not limited to the arrangements and instrumentalities shown in the drawings. It should also be understood that embodiments may be combined, or other embodiments may be used, and structural modifications may be made without departing from the scope of the various embodiments of the invention, unless otherwise claimed. Accordingly, the following detailed description should not be interpreted as restrictive. [Brief explanation of the drawing]

[0023] Exemplary embodiments are described and explained in more specific and detail with reference to the accompanying drawings. [Figure 1A] Figure 1A is a top perspective view of an exemplary arterial blood shielding device according to several embodiments. [Figure 1B] Figure 1B is a cross-sectional view of the arterial blood shielding device of Figure 1A according to several embodiments. [Figure 1C] Figure 1C is a top perspective view of the arterial blood shielding device of Figure 1A coupled to an exemplary arterial catheter assembly, according to several embodiments. [Figure 2A] Figure 2A is a top perspective view of another exemplary arterial blood shielding device according to several embodiments. [Figure 2B] Figure 2B is a cross-sectional view of the arterial blood shielding device of Figure 2B according to several embodiments. [Figure 2C]Figure 2C is a top perspective view of the arterial blood shield device of Figure 2A coupled to the arterial catheter assembly of Figure 1C, according to several embodiments. [Figure 3A] Figure 3A is a top perspective view of an exemplary arterial catheter system according to several embodiments. [Figure 3B] Figure 3B is a top perspective view of an exemplary portion of an arterial catheter system according to several embodiments. [Figure 4A] Figure 4A is a top perspective view of an exemplary arterial catheter system, showing an exemplary compact connector according to several embodiments. [Figure 4B] Figure 4B is a cross-sectional view of some of the arterial catheter systems of Figure 4A, according to several embodiments. [Figure 5A] Figure 5A is a top perspective view of an exemplary arterial blood shielding device according to several embodiments. [Figure 5B] Figure 5B is a cross-sectional view of the arterial blood shielding device of Figure 5A according to several embodiments. [Figure 5C] Figure 5C is a top perspective view of some of the arterial blood shielding devices of Figure 5A, according to several embodiments. [Figure 5D] Figure 5D is a cross-sectional view of the portion of the arterial blood shield device shown in Figure 5A that is coupled to the rest of the device, according to several embodiments. [Figure 6A] Figure 6A is a top perspective view of an exemplary arterial catheter system according to several embodiments. [Figure 6B] Figure 6B is a cross-sectional view of the arterial catheter system of Figure 3A, showing an exemplary needle assembly removed according to several embodiments. [Modes for carrying out the invention]

[0024] Referring here to Figures 1A-1C, in some embodiments, the arterial blood shielding device 10 may include a distal end 12, which may include a Luer adapter 14 configured to connect to a catheter adapter or another suitable vascular access device. In some embodiments, the arterial blood shielding device 10 may be configured to reduce the maximum shear stress on arterial blood drawn from the artery into the arterial catheter system, thereby reducing the risk of hemolysis of arterial blood and providing an improved blood sample. In some embodiments, the arterial blood shielding 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 the patient via a pressure difference.

[0025] 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 remove all or part of the air so that the pressure inside the blood collection container is lower than the ambient pressure.

[0026] In some embodiments, the needle assembly 19 may include one or more threads that can be configured to connect to a holder 22 of a blood collection device 18, and the blood collection device 18 may be generally cylindrical and configured to hold a blood collection container. In some embodiments, the holder 22 may be formed integrally with the needle assembly 19 or may be attached to the needle assembly 19 by joining or another suitable method. In some embodiments, the holder 22 may surround the needle 20. In some embodiments, the needle assembly 19 and the holder 22 may include or correspond to a Luer Lock access device, such as a Vacutainer® Luer Lock® access device available from Becton Dickinson & Company. In some embodiments, the holder 22 may include or correspond to a blood collection tube holder 127 described in Patent Document 1, filed October 20, 2020, entitled “Blood Collection System and Related Method with User-Adjustable Pressure Control,” which is incorporated by reference in its entirety.

[0027] In some embodiments, the Luer adapter 14 may be a first Luer adapter. In some embodiments, the arterial blood shielding 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 elastomer sheath 26. In some embodiments, the elastomer 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 distally the elastomer sheath 26, the needle 20 may penetrate the elastomer sheath 26 and be inserted into the cavity of the blood collection container.

[0028] In some embodiments, the arterial blood shield device 10 may include an extension tube 32 that can extend between the distal end 12 and the proximal end 16 of the arterial blood shield device 10. In some embodiments, the extension tube 32 may be rigid or semi-rigid, which may reduce the possibility of twisting. In some embodiments, the extension tube 32 may be flexible so as to be bent. In some embodiments, the extension tube 32 may be made of plastic. In some embodiments, the extension tube 32 may include only one lumen extending through it.

[0029] In some embodiments, the arterial blood shielding device 10 may include a third Luer adapter 34 which can be coupled to a 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.

[0030] In some embodiments, the arterial blood shield device 10 may function as a flow resistance in the fluid path of an arterial catheter system or another vascular access system, for example, as shown in 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 within the catheter adapter 39 or 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 a lumen extending through the distal end 42 and the proximal end 44. In some embodiments, an introduction needle 45 may extend from the needle shield through the arterial catheter 40.

[0031] In some embodiments, the arterial catheter assembly 37 may be integrated. More specifically, in some embodiments, another extension tube 46 may extend from the side port 48 of the catheter adapter 39. In some embodiments, the proximal end of the other extension tube 46 may include a fourth Luer adapter 50 which can be coupled to the first Luer adapter. In some embodiments, the arterial catheter assembly 37 may be linear, and / or the first Luer adapter may 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 may include a slip or threaded or clipped male Luer adapter, a slip or threaded female Luer adapter, a needleless connector, a blunt cannula, or another suitable access device.

[0032] 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 an intravenous catheter such as a peripheral intravenous catheter. In some embodiments, the arterial blood shield device 10 may be coupled to the arterial catheter assembly 37 in any number of suitable ways. In some embodiments, the fluid path of the arterial catheter system may include one or more of the arterial catheter 40, catheter adapter 39, another extension tube 46, fourth luer adapter 50, first luer adapter, extension tube 32, third luer adapter 34, second luer adapter 24, and blood sampling device 18. In some embodiments, the arterial blood shield device 10 may reduce the blood flow rate within the fluid path 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 another type of vascular access device such as, for example, a venipuncture device, an infusion disposable, a blood sampling access device, or a blood sampling container.

[0033] In some embodiments, the geometric coefficient G of the portion of the fluid path within the extension tube 32 f may 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 path within the extension tube 32. In these embodiments, the portion of the fluid path may be cylindrical along the entire length L and the inner diameter D may be constant along the length L. According to some embodiments, the length L corresponds to the total length of the extension tube 32. In some embodiments, the geometric coefficient G of the portion of the fluid path within the extension tube 32 f may be defined such that it is

[0034]

Number

[0035] Here,

[0036]

number

[0037] In some embodiments, the geometric coefficient G of the fluid path portion. f This may be selected to reduce the maximum shear stress on arterial blood drawn from an artery, thereby reducing the risk of hemolysis of the arterial blood.

[0038] Blood cells experience shear stress as they flow through a fluid pathway. The maximum shear stress occurs along the walls of the fluid pathway, or wall shear stress. Wall shear stress in blood cells is considered the primary cause of mechanical damage to blood cells. In the case of a cylindrical fluid pathway, wall shear stress is typically expressed as follows:

[0039]

number

[0040] Here, ΔP is the pressure drop along a path of length L and internal radius r, and k is the contraction index.

[0041] The time required to fill a collection tube V of a specific capacity with a flow rate Q can be easily calculated using the following formula.

[0042]

number

[0043] Here, μ is the dynamic viscosity of the fluid. Hemolysis is typically related to both the wall shear stress and the time that blood cells are exposed to the wall shear stress. From the literature, it has been widely considered that the hemolysis index can be approached as the following function: HI(%)=A*t α *τ β In the formula, A, α, and β are coefficients.

[0044] In principle, the hemolysis index is related to the pressure gradient and cross-sectional dimensions:

[0045]

number

[0046] The fluid flow in a specific extension tube through a cylindrical fluid path can be analyzed using Poiseuille's equations.

[0047]

number

[0048] Here, ΔP is the change in pressure gradient over a specific length of extension tube, D and L are the inner diameter and length of the cylindrical fluid path through the specific extension tube, respectively, and μ is the viscosity of the fluid.

[0049]

number

[0050] μ is the fluid resistance. A particular extension tube may include or correspond to extension tube 32. μ is the viscosity of the fluid and is not part of the geometry of the extension tube, therefore the geometric coefficient G is... f R f (Fluid resistance)

[0051]

number

[0052] It is defined as such, and here,

[0053]

number

[0054] That is the case.

[0055] In some embodiments, the extension tube 32 may have multiple sections having lengths (L1, L2, L3) and inner diameters (D1, D2, D3), with geometric coefficients as follows:

[0056]

number

[0057] In some embodiments, the extension tube 32 may have an inner diameter that varies over the length of the extension tube, with geometric coefficients as follows:

[0058]

number

[0059] In some embodiments, the extension tube 32 may have a non-circular cross-section. In this case, the geometric coefficient can be determined by measuring the flow rate (Q) at a given pressure difference (ΔP) for a fluid with a known viscosity (μ):

[0060]

number

[0061] In some embodiments, the fluid resistance may be a first fluid resistance. In some embodiments, the first fluid resistance in a portion of the fluid path within the extension tube may be greater than a second fluid resistance in the fluid path distal to that portion of the fluid path. For example, the first fluid resistance may be greater than a specific fluid resistance in the lumen of the catheter adapter 39, and arterial blood may move before reaching the extension tube 32 and arterial blood shielding device 10 from which the blood can be collected.

[0062] In some embodiments, the arterial catheter 40 may be a 20G arterial catheter. In these embodiments, the length L and inner diameter D are geometric coefficients G of the portion of the fluid path within the extension tube 32.f 3.41E+06(1 / in 3 ) may be selected to be greater than or equal to. In some embodiments, the length L and inner diameter D of the 20G arterial catheter are the geometric coefficient G of the portion of the fluid path in the extension tube 32. f 3.41E+06(1 / in 3 It may be chosen to be + / - 10%.

[0063] In some embodiments, the arterial catheter 20 may be an 18G arterial catheter. In these embodiments, the length L and inner diameter D are geometric coefficients G of the portion of the fluid path within the extension tube 32. f 2.88E+06(1 / in 3 ) may be selected to be greater than or equal to. In some embodiments, the length L and inner diameter D of the 18G arterial catheter are the geometric coefficient G of the portion of the fluid path in the extension tube 32. f 2.88E+06(1 / in 3 It may be chosen to be + / - 10%.

[0064] In some embodiments, the arterial catheter 20 may be a 22G arterial catheter. In these embodiments, the length L and inner diameter D are geometric coefficients G of the portion of the fluid path within the extension tube 32. f 1.05E+07(1 / in 3 ) may be selected to be greater than or equal to. In some embodiments, the length L and inner diameter D of the 24G arterial catheter are the geometric coefficient G of the portion of the fluid path in the extension tube 32. f 1.05E+07(1 / in 3 It may be chosen to be + / - 10%.

[0065] In some embodiments, the arterial catheter 20 may be a 24G arterial catheter. In these embodiments, the length L and inner diameter D are geometric coefficients G of the portion of the fluid path within the extension tube 32. f 3.20E+07(1 / in 3) may be selected to be greater than or equal to. In some embodiments, the length L and inner diameter D of the 24G arterial catheter are the geometric coefficient G of the portion of the fluid path in the extension tube 32. f 3.20E+07(1 / in 3 It may be chosen to be + / - 10%.

[0066] In some embodiments, the fluid pathway of an arterial catheter system, which may include one or more of the needle assembly 19, extension tube 32, and arterial catheter assembly 37 (which may include another extension tube 46), may include the entire blood collection pathway through which blood flows during blood collection. System geometric coefficient G of the fluid pathway of the arterial catheter system. fs This can be determined in the same way as described above.

[0067] Referring here to Figures 2A-2C, arterial blood shielding devices 52 according to several embodiments are shown. In some embodiments, the arterial blood shielding device 52 may be similar to or identical to the arterial blood shielding device 10 in Figures 1A-1C in terms of one or more included features and / or operation. 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 shielding device 52 may include a clamp 54 which may be positioned 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 more clamped position and a less clamped position. In some embodiments, the clamp 54 may prevent or reduce the flow of fluid through the extension tube 32 in response to the clamp 54 being in the clamped position.

[0068] In some embodiments, the clinician may adjust the fluid resistance within the arterial catheter system by manually changing the fluid properties of the arterial catheter system via the clamp 54. In some embodiments, the flow resistance within the arterial catheter system may increase and blood flow through the extension tube 32 may decrease in response to the clamp 54 being in the clamped position. In these embodiments, the risk of hemolysis may be reduced. In some embodiments, the clinician may move the clamp to the unclamped position to reduce the flow resistance within the arterial catheter system after the blood collection container is nearing fullness, which may allow for faster blood collection when the risk of hemolysis is reduced.

[0069] In some embodiments, the clamp 54 may include a slide clamp, which may include a gradually narrowing slot. In these and other embodiments, the extension tube 32 may be flexible and pliable. In some embodiments, the clinician can adjust the inner diameter of the extension tube 32 by adjusting the depth of the extension tube 32 in the slot of the slide clamp. The clinician can then adjust the flow resistance within the arterial blood shield device 52. In some embodiments, the clamp 54 may include a roller clamp, a slide clamp, a pinch clamp, or another suitable type of clamp.

[0070] Referring here to Figure 3A, an arterial catheter assembly 118 according to several embodiments is shown. In some embodiments, the arterial catheter assembly 118 may include an arterial blood shield 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 shield device 120 may be integrated with the adapter 122 of the arterial catheter assembly 37, for example, as shown in Figure 3A, or with the catheter adapter 39 itself. In these and other embodiments, the arterial blood shield device 120 may not be detachable from the arterial catheter assembly 118. In some embodiments, the distal end of the extension tube 32 may be integrated with the adapter 122 or the catheter adapter 39. In some embodiments, the adapter 122 may include a Y-adapter, a T-adapter, or another suitable adapter. In some embodiments, another extension tube 46 may be shorter than the extension tube 52 so that the adapter 122 provides a port for blood collection or sampling from a nearby patient. In some embodiments, the arterial blood shield device 120 may be similar to or identical to one or more of the following with respect to one or more included features and / or operation: arterial blood shield device 10 of Figures 1A-1C and arterial blood shield device 52 of Figures 2A-2C.

[0071] Referring here to Figure 3B, a portion 124 of an arterial catheter assembly is shown according to several embodiments. In some embodiments, the portion 124 of the arterial catheter assembly may include an arterial blood shield device 126 which may be coupled to or integrated with the instrument delivery device 127, which can deliver a probe, catheter, or guidewire through a particular arterial catheter assembly (for example, as shown in Figure 3A). In some embodiments, the arterial blood shield device 126 may be similar to or identical to one or more of the following with respect to one or more included features and / or operation: arterial blood shield device 10 in Figures 1A-1C and arterial blood shield device 52 in Figures 2A-2C.

[0072] In some embodiments, the instrument delivery device 127 may include any suitable instrument delivery device. In some embodiments, the instrument delivery device 127 is Patent Document 2, entitled “Extension for housing a probe or intravenous catheter,” granted April 30, 2024; Patent Document 3, entitled “Instrument delivery device with a rotating element,” filed April 18, 2019; Patent Document 4, entitled “Multi-diameter catheter and related devices and methods,” granted November 16, 2021; Patent Document 5, entitled “Delivery device for vascular access instruments,” filed August 9, 2022; Patent Document 6, entitled “Syringe-based delivery device for vascular access instruments,” granted May 24, 2022; Patent Document 7, entitled “Catheter delivery device and related systems and methods,” granted January 10, 2023; and Patent Document 8, entitled “Vascular access instruments and related devices and methods having a fluid permeable structure,” granted November 22, 2022, which are incorporated in their entirety by reference.

[0073] Referring here to Figures 4A–4B, several embodiments of the arterial catheter system 410 are shown. In some embodiments, the arterial catheter system 410 may be configured to reduce the maximum shear stress on arterial blood drawn from the artery into the arterial catheter system 410, thereby reducing the risk of hemolysis of arterial blood and providing an improved blood sample. In some embodiments, the arterial catheter system 410 may be similar to or identical to one or more arterial catheter systems from Figures 1C, 3A, and 3B in terms of one or more included features and / or operation.

[0074] 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 than an intravenous catheter, such as a peripheral intravenous catheter, and / or may be more rigid.

[0075] In some embodiments, the arterial catheter system 410 may include a needle assembly 422 which may include a needle hub 424 and an introduction needle 426. In some embodiments, the arterial catheter system 410 may include a tube 428 coupled to the arterial catheter assembly 412 and having a distal end 430 and a proximal end 432. In some embodiments, the arterial catheter system 410 may include at least an arterial catheter 420, a catheter adapter 414, and a fluid path 434 extending through the tube 428.

[0076] In some embodiments, the geometric coefficient G of portion 436 of the fluid path 434 within the tube 428 f L / D 4G may be equal to the length of the tube 428, and D is the inner diameter of the portion of the fluid path 434 within the tube 428. In these embodiments, the portion 436 of the fluid path 434 may be cylindrical along its entire length L, and the inner diameter D may be constant along the length L. According to some embodiments, the length L corresponds to the total length of the tube 428. In some embodiments, the geometric coefficient G of the portion 436 of the fluid path 434 within the tube 428 is... f fluid resistance

[0077]

number

[0078] It can be defined in such a way. Here,

[0079]

number

[0080] In some embodiments, the geometric coefficient G of portion 436 of the fluid path 434 f This may be selected to reduce the maximum shear stress on arterial blood drawn from an artery, thereby reducing the risk of hemolysis of the arterial blood.

[0081] In some embodiments, the fluid resistance may be a first fluid resistance. In some embodiments, the first fluid resistance in portion 436 of the fluid path 434 within the tube 428 may be greater than a second fluid resistance in the fluid path 434 distal to portion 436 of the fluid path 434. For example, the first fluid resistance may be greater than a specific fluid resistance in the lumen 438 of the catheter adapter 414, and arterial blood may move before reaching the tube 428 and adapter 440 which can be coupled to a blood collection device for blood collection.

[0082] As mentioned earlier, blood cells experience shear stress as they flow through a fluid pathway. The maximum shear stress is along the walls of the fluid pathway, or wall shear stress. Wall shear stress in blood cells is considered the main cause of mechanical damage to blood cells. In the case of a cylindrical fluid pathway, wall shear stress is typically expressed as follows:

[0083]

number

[0084] Here, ΔP is the pressure drop along a path of length L and internal radius r, and k is the contraction index.

[0085] The time required to fill a collection tube V of a specific capacity with a flow rate Q can be easily calculated using the following formula.

[0086]

number

[0087] Here, μ is the dynamic viscosity of the fluid. Hemolysis is typically related to both the wall shear stress and the time that blood cells are exposed to the wall shear stress. From the literature, it has been widely considered that the hemolysis index can be approached as the following function: HI(%)=A*t α *τ β In the formula, A, α, and β are coefficients.

[0088] In principle, the hemolysis index is related to the pressure gradient and cross-sectional dimensions:

[0089]

number

[0090] The fluid flow in a particular tube through a cylindrical fluid path can be analyzed using Poiseuille's equations:

[0091]

number

[0092] Here, ΔP is the change in pressure gradient over a specific length of extension tube, D and L are the inner diameter and length of the cylindrical fluid path through the specific extension tube, respectively, and μ is the viscosity of the fluid.

[0093]

number

[0094] μ is the fluid resistance. A particular tube may include or correspond to tube 428. μ is the viscosity of the fluid and is not part of the tube shape, therefore the geometric coefficient G is not included. f R f (Fluid resistance)

[0095]

number

[0096] It is defined as such, and here,

[0097]

number

[0098] That is the case.

[0099] In some embodiments, there may be multiple sections having lengths (L1, L2, L3) and inner diameters (D1, D2, D3), and then the geometric coefficients are:

[0100]

number

[0101] In some embodiments, the tube 428 may have an inner diameter that varies over the length of the tube, and then the geometric coefficient is,

[0102]

number

[0103] In some embodiments, the tube 428 may have a non-circular cross-section. In this case, the geometric coefficient can be determined by measuring the flow rate (Q) at a given pressure (ΔP) with a fluid of known viscosity (μ).

[0104]

number

[0105] In some embodiments, the first fluid resistance, which may be lower than the second fluid resistance, may promote a reduced flow velocity of arterial blood in portion 436 of the fluid path 434 within tube 428, such that the maximum shear stress is reduced within portion 436 of the fluid path 434, thereby reducing the risk of hemolysis of the collected arterial blood. In these embodiments, the geometric coefficient G of portion 436 of the fluid path 434 is f The length L and inner diameter D of the tube 428, which can be determined, may be selected to increase the first fluid resistance and decrease the flow rate in portion 436 of the fluid path, thereby reducing the risk of hemolysis, while the flow rate remains suitable for blood collection.

[0106] In some embodiments, the arterial catheter 420 may be a 20G arterial catheter. In these embodiments, the length L and inner diameter D are geometric coefficients G of portion 436 of the fluid path 434 within the tube 428. f 3.33E+06(1 / in 3 ) may be selected to be greater than or equal to . In these embodiments, the length L and inner diameter D are geometric coefficients G of portion 436 of the fluid path 434 in the tube 428. f 3.41E+06(1 / in 3) may be selected to be greater than or equal to. In some embodiments, the length L and inner diameter D are geometric coefficients G of portion 436 of the fluid path 434 in the tube 428. f 3.33E+06(1 / in 3 ) or greater may be selected.

[0107] In some embodiments, the arterial catheter 20 may be an 18G arterial catheter. In these embodiments, the length L and inner diameter D are geometric coefficients G of the portion of the fluid path within the tube 428. f 2.88E+06(1 / in 3 ) or greater may be selected.

[0108] In some embodiments, the arterial catheter 20 may be a 22G arterial catheter. In these embodiments, the length L and inner diameter D are geometric coefficients G of the portion of the fluid path within the tube 428. f 1.05E+07(1 / in 3 ) or greater may be selected.

[0109] In some embodiments, the arterial catheter 20 may be a 24G arterial catheter. In these embodiments, the length L and inner diameter D are geometric coefficients G of the portion of the fluid path within the tube 428. f 3.20E+07(1 / in 3 ) or greater may be selected.

[0110] In some embodiments, the tube 428 may include only one lumen 442 extending through it. In these embodiments, since the arterial catheter is rarely used for injections where an extension tube with higher fluid resistance could significantly reduce the injection rate, a single lumen may suffice for the tube 428 in the arterial catheter system 410. In some embodiments, the catheter adapter 414 may include a side port 444 located between the distal end 416 of the catheter adapter 414 and the proximal end 418 of the catheter adapter 414. In some embodiments, the extension tube 454 may include a distal end coupled to or integrated with the side port 444. In some embodiments, the extension tube 454 may include a proximal end coupled to or integrated with the adapter 456, where the adapter 456 may be a Y-adapter or another suitable adapter. In some embodiments, the adapter 456 may include at least two ports, one for blood collection and the other for pressure monitoring. In some embodiments, the needleless access connector 457 may be coupled to one or more ports of the adapter 456.

[0111] In some embodiments, the compact connector 458 may include a tube 428 therein. In some embodiments, the tube 428 may have a spiral or coil shape, which may facilitate a compact device for easy use by clinicians. In some embodiments, the tube 428 may be flexible, rigid, or semi-rigid. In some embodiments, the tube 428 may be made of plastic or another suitable material. In some embodiments, the proximal end 460 of the compact connector 458 may include a female Luer or another suitable adapter for coupling to a blood collection device. In some embodiments, the proximal end 460 may include a partition 461 configured to compress in response to coupling the proximal end 460 to a blood collection device. In some embodiments, in response to compression of the partition 461, the blood collection device may be in fluid communication with a fluid path 434. In some embodiments, the distal end 462 of the compact connector 458 may be coupled to or integrated with an adapter 456.

[0112] Referring here to Figures 5A and 5B, several embodiments of the blood shield device 520 are shown. In some embodiments, the blood shield device 520 may include a distal end 522 and a proximal end 524. In some embodiments, the distal end 522 of the blood shield device 520 may include a male Luer adapter 526 which may include a distal opening 528. In some embodiments, the blood shield device 520 may include a cannula 530 that is 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 made of metal or another suitable material configured to puncture the seal of a blood collection container, such as a blood collection tube. In some embodiments, the elastomer sheath 531 may have a sharp proximal tip 534 that can be compressed distally by the blood collection container in response to the blood collection container being inserted into the blood shield device 520.

[0113] In some embodiments, the blood shield device 520 may include an elongated neck 535 positioned between a male Luer adapter 526 and a sharp proximal tip 534. In some embodiments, the fluid path of the arterial catheter system may include a portion 536 within the blood shield device 520, the portion 536 extending from a distal opening 528 through a sharp proximal tip 534. In some embodiments, the diameter 537 of the portion 536 of the fluid path is constant. In some embodiments, the total length 538 of the portion 536 of the fluid path is represented by L, and the diameter 537 of the portion 536 of the fluid path is represented by D.

[0114] In some embodiments, the male Luer adapter 526 of the blood shield device 520 may include a collar 539 that can extend around a projection 540 of the male Luer adapter 526. In some embodiments, the distal opening 528 may be located within the most distal portion of the projection 540. In some embodiments, the inner surface of the collar 539 may be screwed in to form a Luer lock fit with the corresponding female Luer adapter. In other embodiments, the inner surface of the collar 539 may be smooth to form a slip fit with the corresponding female Luer adapter. In some embodiments, the portion 536 of the fluid path may be entirely formed by a cannula 530 that extends through the collar 539 and can form the projection 540 and the distal opening 528.

[0115] In some embodiments, the outer diameter of the collar 539 may be larger than the outer diameter of the elongated neck 535. In some embodiments, the blood shield device 520 may include a holder 541 configured to receive a blood collection container, such as a blood collection tube. In some embodiments, the holder 541 may include a cylindrical body 542. In some embodiments, a sharp proximal tip 534 may be located in the center of the cylindrical body 542 to facilitate puncturing the seal of the blood collection container in response to the insertion of the blood collection container into the proximal opening 544 of the cylindrical body 542.

[0116] In some embodiments, the outer diameter of the cylindrical body 542 may be larger than the outer diameter of the elongated neck 535. In some embodiments, the elongated neck 535 may be positioned between the holder 541 and the collar 539. In some embodiments, the distal end 532 of the cannula 530 may be integrated and fixed within the elongated neck 535. In some embodiments, the elastomer sheath 531 may be bonded to the inner surface of the holder 541.

[0117] Referring here to Figures 5C-5D, in some embodiments, the blood shield device 520 may include a female Luer adapter 546 positioned at the proximal end of the elongated neck 535. In some embodiments, the distal end of the holder 541 may include a male Luer adapter 548. In some embodiments, the female Luer adapter 546 may be coupled to the male Luer adapter 548. Thus, in some embodiments, the blood shield device 520 may include an extension 550 that can be coupled to the holder 541 to provide the elongated neck 535 and increased L, which may reduce the risk of hemolysis. In these and other embodiments, D may correspond to the inner diameter of the cannula 530. In some embodiments, the inner diameter of the elongated neck 535 may be equal to D along all or part of the elongated neck 535. In some embodiments, the male Luer adapter 548 may be similar to or identical to the male Luer adapter 526 with respect to one or more features and / or operation.

[0118] Referring here to Figures 6A-6B, several embodiments of the arterial catheter system 552 are shown. In some embodiments, the arterial catheter system 552 may be similar to or identical to one or more arterial catheter systems from Figures 1C, 3A, 3B, 4A, and 4B in terms of one or more included features and / or operation. 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 shielding device 520 that can reduce the risk of hemolysis.

[0119] In some embodiments, the 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 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.

[0120] In some embodiments, the male Luer adapter 526 of the blood shield device 520 may be coupled to a female Luer adapter 556. In some embodiments, the positions of the arterial catheter system 552 and / or the female Luer adapter 556 may vary. In some embodiments, the arterial catheter system 552 may include an extension tube 66, which may 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 is located between the distal end 560 and the proximal end 562 of the catheter adapter 558 and can be in fluid communication with the lumen 564. In some embodiments, the proximal end 562 of the catheter adapter 558 may include a female Luer adapter 556, and the blood shield device 520 may be coupled to the proximal end 562 of the catheter adapter 558.

[0121] In some embodiments, the partition 570 may be located within the lumen 564 of the catheter adapter 558. In some embodiments, when the arterial catheter system 552 is inserted into the patient's vascular system, the introduction needle 572 of the needle assembly 574 may extend through the partition 570 and the arterial catheter 554. In some embodiments, the needle assembly 574 may be removed from the arterial catheter system 552 in response to the insertion of the arterial catheter 554 into the vascular system. In some embodiments, the introduction needle 572 may include a sharp distal tip 76 and may extend from the needle hub 578 of the needle assembly 574, which may be coupled to the proximal end 562 of the catheter adapter 558.

[0122] Typically, the maximum shear stress during blood collection via arterial catheter 554 is much higher than the maximum shear stress during blood collection using another type of catheter, namely a venous catheter. The fluid flow in a particular cannula with a cylindrical fluid path can be analyzed using Poiseuille's equations:

[0123]

number

[0124] Here, ΔP is the change in pressure gradient over the length of the fluid path, D and L are the inner diameter and length of the cylindrical fluid path through a particular cannula, respectively, μ is the viscosity of the fluid, and

[0125]

number

[0126] μ is fluid resistance. A particular cannula may include or correspond to cannula 530, and a cylindrical fluid path may include or correspond to part 536. μ is the viscosity of the fluid and is not part of the geometry of the extension tube, therefore R f (Fluid resistance) is Gf The geometric coefficient G is such that f It is defined as,

[0127]

number

[0128] And here,

[0129]

number

[0130] That is the case.

[0131] In some embodiments, the fluid path portion 536 may have multiple sections having lengths (L1, L2, L3) and inner diameters (D1, D2, D3), and then the geometric coefficients are

[0132]

number

[0133] In some embodiments, portion 536 of the fluid path may have an inner diameter that varies over the length of the fluid path, and then the geometric coefficient is

[0134]

number

[0135] In some embodiments, portion 536 of the fluid path may have a non-circular cross-section. The geometric coefficient can be determined by measuring the flow rate (Q) at a given pressure (ΔP) with a fluid of known viscosity (μ):

[0136]

number

[0137] In some embodiments, the diameter of the fluid path portion 536 may be larger than the minimum inner diameter of the arterial catheter 554. In some embodiments, D 4 / L is less than or equal to a predetermined value, which may be based at least in part on the gauge of the arterial catheter 554. In some embodiments, the predetermined value may correspond to a value below which the risk of hemolysis is determined.

[0138] In some embodiments, fluid resistance within portion 536 of the fluid path may facilitate a decrease in the flow velocity of arterial blood within portion 536 of the fluid path 534 in the cannula 530, such that the maximum shear stress is reduced and the risk of hemolysis of the collected arterial blood is reduced. In these embodiments, the geometric coefficient G of portion 536 of the fluid path f The length L and inner diameter D of the cannula 530, which can be determined, may be selected to increase fluid resistance and decrease the flow rate in portion 536 of the fluid path, thereby reducing the risk of hemolysis, while the flow rate remains suitable for blood collection.

[0139] In some embodiments, the fluid resistance in portion 536 of the fluid path may be a first fluid resistance. In some embodiments, the first fluid resistance in portion of the fluid path in the extension tube may be greater than a second fluid resistance in the fluid path distal to portion 536 of the fluid path. For example, the first fluid resistance may be greater than a specific fluid resistance in the lumen of the catheter adapter 564, and arterial blood may move before reaching the extension tube 32 and arterial blood shielding device 10 from which the blood can be collected.

[0140] All examples and conditional statements set forth herein are intended for educational purposes to facilitate the Art and to help the reader understand the Invention and the concepts provided by the Inventors, and should be construed as not being limited to the examples and conditions specifically listed herein. While embodiments of the Invention are described in detail, it should be understood that various changes, substitutions, and modifications can be made herein without departing from the spirit and scope of the Invention.

Claims

1. An arterial catheter system, A catheter assembly, A catheter adapter having a distal end and a proximal end, An arterial catheter extending from the distal end of the catheter adapter, A catheter assembly comprising, A needle assembly, Needle hub and, The introduction needle, A needle assembly comprising, An arterial blood shielding device coupled to the catheter assembly, The arterial catheter, the catheter adapter, and the fluid pathway within the arterial blood shield device, Equipped with, An arterial catheter system in which the first fluid resistance in a portion of the fluid path within the arterial blood shield device is greater than the second fluid resistance in the fluid path distal to the portion of the fluid path.

2. The arterial blood shielding device is The distal end is equipped with a Luer adapter, The proximal end equipped with a blood collection device, The arterial catheter system according to claim 1, comprising: an extension tube extending between the distal end and the proximal end, wherein the portion of the fluid path is disposed within the extension tube.

3. The arterial catheter system according to claim 2, wherein the extension tube comprises a distal end and a proximal end, the distal end of the extension tube being integrated with the Luer adapter, and the proximal end of the extension tube being integrated with the blood collection device.

4. The arterial catheter system according to claim 2, wherein the Luer adapter is a first Luer adapter, and the blood collection device comprises a second Luer adapter further comprising a third Luer adapter coupled to the second Luer adapter, and the extension tube comprises a distal end and a proximal end, the distal end of the extension tube being integrated with the first Luer adapter, and the proximal end of the extension tube being integrated with the third Luer adapter.

5. The geometric coefficient G of the portion of the fluid path f However, the geometric coefficient G of another part of the fluid path f An arterial catheter system according to claim 2, which is different from the arterial catheter system described in claim 2.

6. The arterial catheter system according to claim 2, wherein the extension tube has only one lumen extending through it.

7. The arterial catheter system according to claim 1, wherein the arterial blood shielding device comprises a compact connector, the compact connector comprises a spiral tube, and the portion of the fluid path is disposed within the spiral tube.

8. The arterial catheter system according to claim 7, wherein the catheter adapter further comprises a side port located between the distal end of the catheter adapter and the proximal end of the catheter adapter, the catheter assembly further comprises another extension tube extending from the side port, the distal end of the other extension tube being integrated with the side port, the proximal end of the other extension tube being integrated with a Y-adapter, and the compact connector being coupled to the Y-adapter.

9. The geometric coefficient G of the portion of the fluid path f However, the geometric coefficient G of another part of the fluid path f An arterial catheter system according to claim 7, which is different from the arterial catheter system described in claim 7.

10. The arterial catheter system according to claim 7, wherein the spiral tube has only one lumen extending through it.

11. The arterial blood shielding device is A female Luer adapter attached to the catheter assembly, It is a blood collection device, A distal end comprising a male luer adapter coupled to the female luer adapter, wherein the male luer adapter has a distal opening, A cannula that communicates fluid with the male luer adapter, the cannula having a distal end and a sharp proximal end, A long, slender neck is positioned between the male lure adapter and the sharp proximal tip, A blood collection device equipped with, Equipped with, The arterial catheter system according to claim 1, wherein the portion of the fluid path extends from the distal opening through the sharp proximal tip.

12. The geometric coefficient G of the portion of the fluid path f However, the geometric coefficient G of another part of the fluid path f An arterial catheter system according to claim 11, which is different from the arterial catheter system described in claim 11.

13. A method of blood collection, The arterial catheter of an arterial catheter system is inserted into the artery of a patient, and the arterial catheter system is A catheter assembly, A catheter adapter having a distal end and a proximal end, An arterial catheter extending from the distal end of the catheter adapter, A catheter assembly comprising, A needle assembly, Needle hub and, The introduction needle, A needle assembly comprising, An arterial blood shielding device coupled to the catheter assembly, A fluid path within the arterial catheter, catheter adapter, and arterial blood shield device, wherein the first fluid resistance in the portion of the fluid path within the arterial blood shield device is greater than the second fluid resistance in the fluid path distal to the portion of the fluid path, It is equipped with the ability to insert, The collection of arterial blood into a blood collection device coupled to the catheter assembly, wherein the arterial blood flows into the blood collection device through the portion of the fluid pathway, A voting method that includes this.

14. The arterial blood shielding device is The distal end is equipped with a Luer adapter, The proximal end equipped with a blood collection device, An extension tube extending between the distal end and the proximal end, wherein the portion of the fluid path is disposed within the extension tube, The method according to claim 13, comprising:

15. The method according to claim 13, wherein the arterial blood shielding device comprises a compact connector, the compact connector comprises a spiral tube, and the portion of the fluid path is disposed within the spiral tube.

16. The blood shielding device is A female Luer adapter connected to the arterial catheter, It is a blood collection device, A distal end comprising a male luer adapter coupled to the female luer adapter, wherein the male luer adapter has a distal opening, A cannula that communicates fluid with the male luer adapter, the cannula having a distal end and a sharp proximal end, A long, slender neck is positioned between the male lure adapter and the sharp proximal tip, A blood collection device equipped with, Equipped with, The method according to claim 13, wherein the portion of the fluid path extends from the distal opening through the sharp proximal tip.

17. A method for manufacturing an arterial catheter system having a fluid pathway therein, The method of connecting a catheter assembly to a needle assembly, wherein the catheter assembly comprises a catheter hub and an arterial catheter extending distally from the catheter hub. The arterial blood shield device is coupled to the catheter assembly such that the arterial blood shield device is in fluid communication with the catheter assembly, and the fluid pathway is located within the arterial catheter, the catheter hub, and the arterial blood shield device. The selection of the length L of the portion of the fluid path within the arterial blood shield device, and the inner diameter D of the portion of the fluid path within the arterial blood shield device, wherein the first fluid resistance within the portion of the fluid path is greater than the second fluid resistance within the fluid path distal to the portion of the fluid path. Methods that include...

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