Catheter systems for arterial blood extraction and related methods

Abstract

An arterial catheter system may include a catheter assembly that may include a catheter hub and an arterial catheter. An arterial catheter system may include a needle assembly that may include a needle hub and an introducer needle. The arterial catheter system may include an extension tube coupled to the catheter assembly and a fluid pathway extending through the arterial catheter, the catheter hub, and the extension tube. A first fluid resistance within a portion of the fluid passage within the extension tube may be greater than a second fluid resistance within the fluid passage distal or proximal to the portion of the fluid passage. The extension tube may have a length L and an inner diameter D. The geometry factor Gf of the portion of the fluid pathway may be equal to L / D4 and may be selected to reduce hemolysis during blood drawing from the artery.

Description

Technical Field

[0001] The present disclosure relates generally to medical devices. In some aspects, the present disclosure relates to catheter systems and related methods. Background Art

[0002] Catheters are commonly 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 peripheral 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 so that the distal tip of the introducer needle extends beyond the distal tip of the catheter, with the bevel of the needle facing 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 puncture needle and / or catheter in the blood vessel, the clinician typically confirms the presence of "flashback" of blood in the flashback chamber of the catheter assembly. Once needle placement is confirmed, the clinician can temporarily occlude flow in the vasculature and remove the needle, leaving the catheter in place for future blood draws or fluid infusions.

[0005] In order to draw blood from a patient or collect a blood sample, a blood collection container may be used. The blood collection container may include a syringe or test tube with a rubber stopper at one end. In some cases, the blood collection container has had all or part of the air removed from the test tube so that the pressure within the blood collection container is less than ambient pressure. Such blood collection containers are often referred to as internal vacuum or vacuum tubes. A commonly used blood collection container is the VACUTAINER available from Becton Dickinson (注册商标) Blood collection tube.

[0006] The blood collection container can 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, causing the blood collection container to fill with blood. As the blood collection container fills, the vacuum within the blood collection container decreases until the pressure within the blood collection container equals the pressure within the vein and the flow of blood stops.

[0007] Unfortunately, when 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 can cause the blood sample to be rejected and discarded. The high initial pressure differential can also cause catheter tip collapse, vein collapse, or other complications that prevent or limit 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 with blood slows significantly.

[0008] The subject matter claimed herein is not limited to embodiments that solve any disadvantages or that operate only in environments such as described above. Rather, this background is merely provided to illustrate one example 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, and related devices, systems and methods. In some embodiments, the arterial catheter system may include a catheter assembly, which may include a catheter hub. In some embodiments, the catheter hub 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 hub. In some embodiments, the arterial catheter may be shorter and / or more rigid than an intravenous catheter (e.g., a peripheral intravenous catheter).

[0010] In some embodiments, the arterial catheter system may include a needle assembly, which may include a needle hub and an introducer needle. In some embodiments, the arterial catheter system may include an extension tube, which is coupled to the catheter assembly and has a distal end and a proximal end. In some embodiments, the arterial catheter system may include a fluid passage extending through the arterial catheter, the catheter hub, and the extension tube.

[0011] In some embodiments, the geometric factor G of a portion of the fluid passage in the extension tube f Can be equal to L / D 4 , where L is the length of the extension tube and D is the inner diameter of the portion of the fluid path within the extension tube. In some embodiments, the geometric factor G of the portion of the fluid path within the extension tube 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 on arterial blood drawn from the artery and thereby reduce the risk of hemolysis of the arterial blood.

[0012] In some embodiments, the fluid resistance may be a first fluid resistance. In some embodiments, the first fluid resistance of a portion of the fluid pathway within the extension tube may be greater than a second fluid resistance within the fluid pathway distal or proximal to the portion of the fluid pathway. In some embodiments, the second fluid resistance may be defined in a manner similar to the first fluid resistance.

[0013] In some embodiments, the first fluid resistance, which may be lower than the second fluid resistance, may promote a reduction in the flow rate of arterial blood within the portion of the fluid pathway within the extension tube, such that the maximum shear stress is reduced within the portion of the fluid pathway and the risk of hemolysis of the arterial blood to be collected is reduced. In these embodiments, the geometric factor G of the portion of the fluid pathway may be determined as f The length L and the inner diameter D of the extension tube may be selected to increase the first fluid resistance and reduce the flow rate within this portion of the fluid pathway so that the risk of hemolysis is reduced but the flow rate is still sufficient for blood collection.

[0014] In some embodiments, the extension tube may be a first extension tube, and the arterial catheter system may include a second extension tube in fluid communication with the fluid passage. In some embodiments, the fluid resistance in the second extension tube may be a second fluid resistance. In some embodiments, the geometric factor G of the first extension tube is f The geometric factor G of the second extension tube may be different from f In some embodiments, blood may be collected through the first extension tube, and the geometric factor G of the first extension tube is f It may be larger than a specific portion of the fluid path, and the blood for collection does not flow through the specific portion. In some embodiments, the arterial catheter system may include a blood pressure monitoring port between the first extension tube and the second extension tube and / or a blood collection port at the proximal end of the first extension tube, which is proximal to the second extension tube.

[0015] In some embodiments, the extension tube may include no more than one lumen extending therethrough. In some embodiments, the catheter hub may include a side port disposed between a distal end of the catheter hub and a proximal end of the catheter hub. In some embodiments, the distal end of the extension tube may be integral with the side port. In some embodiments, the arterial catheter system may include an adapter integral with the proximal end of the extension tube. In some embodiments, the adapter may include a blood collection port, which may include a female Luer interface.

[0016] In some embodiments, the second extension tube may include a distal end and a proximal end. In some embodiments, the arterial catheter system may include a distal adapter and a proximal adapter. In some embodiments, the catheter hub may include a side port arranged between the distal end of the catheter hub and the proximal end of the catheter hub. In some embodiments, the distal end of the second extension tube may be integral with the side port. In some embodiments, the proximal end of the second extension tube may be integrated into the distal adapter. In some embodiments, the distal end of the first extension tube may be coupled to the distal adapter. In some embodiments, the proximal end of the first extension tube may be coupled to the proximal adapter. In some embodiments, the distal adapter may include a blood pressure monitoring port. In some embodiments, the proximal adapter may include a blood collection port. In some embodiments, the second extension tube may include no more than one lumen extending therethrough.

[0017] In some embodiments, the distal end of the second extension tube can be integral with the side port. In some embodiments, the arterial catheter system can include a distal adapter integrated with the proximal end of the second extension tube and the distal end of the first extension tube. In some embodiments, the arterial catheter system can include a proximal adapter integral with the proximal end of the first extension tube. In some embodiments, the first extension tube can include a spiral shape. In some embodiments, the proximal adapter can include a blood collection port.

[0018] In some embodiments, the distal end of the first extension tube can be integral with the side port. In some embodiments, the proximal end of the first extension tube can be integrated into the distal adapter. In some embodiments, the distal end of the second extension tube can be coupled to the distal adapter. In some embodiments, the proximal end of the second extension tube can be coupled to the proximal adapter. In some embodiments, the first extension tube can be shorter than the second extension tube. In some embodiments, the distal adapter can include a blood collection port.

[0019] In some embodiments, a method of blood collection may include inserting an arterial catheter of an arterial catheter system into an artery of a patient. In some embodiments, the method of blood collection may include collecting arterial blood in a blood collection device coupled to a catheter assembly, whereby the arterial blood flows through the portion of the fluid pathway and enters the blood collection device. In some embodiments, the blood collection device may include a vacuum tube. In some embodiments, collecting arterial blood in a blood collection device coupled to a catheter assembly may include inserting a secondary catheter through a distal adapter, a first extension tube, an arterial catheter, and into an artery.

[0020] In some embodiments, a method of manufacturing an arterial catheter system may include coupling a catheter assembly to a needle assembly. In some embodiments, the catheter assembly may include a catheter hub and an arterial catheter extending distally from the catheter hub. In some embodiments, the manufacturing method may include coupling an extension tube to the catheter assembly so that the extension tube is in fluid communication with the catheter assembly, and a fluid path extends through the arterial catheter, the catheter hub, and the extension tube.

[0021] In some embodiments, the manufacturing method may include selecting the length L of the extension tube and the inner diameter D of the extension tube so that a first fluid resistance in a portion of the fluid path is greater than a second fluid resistance in the fluid path distally or proximally of the portion of the fluid path. In some embodiments, the geometric factor G of the portion of the fluid path in the extension tube is f Equal to L / D 4 .

[0022] It should be understood that the summary description above and the detailed description below are examples and illustrative, rather than limitations 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 various embodiments can be combined with each other, or other embodiments can be utilized, and unless so stated, structural changes can be made without departing from the scope of the various embodiments of the present invention. Therefore, the following detailed description should not be understood to be restrictive. BRIEF DESCRIPTION OF THE DRAWINGS

[0023] Example embodiments will be described and explained with additional specificity and detail through the use of the accompanying drawings, in which:

[0024] Figure 1A is an upper perspective view of an exemplary arterial catheter system according to some embodiments, showing an exemplary adapter;

[0025] Figure 1B is a cross-sectional view of an arterial catheter system showing an exemplary needle assembly removed, according to some embodiments;

[0026] Figure 1C An exemplary extension tube according to some embodiments is along Figure 1A A cross-sectional view taken along line 1C-1C;

[0027] Figure 2 is an upper perspective view of the arterial catheter system of FIG. 1 , showing another exemplary adapter, according to some embodiments;

[0028] Figure 3 is an upper perspective view of an arterial catheter system according to some embodiments, showing two exemplary extension tubes;

[0029] Figure 4is an upper perspective view of an arterial catheter system according to some embodiments, showing an exemplary helical or coiled extension tube;

[0030] Figure 5 is an upper perspective view of an arterial catheter system according to some embodiments, showing two exemplary extension tubes having different lengths, with the needle assembly removed;

[0031] Figure 6 is an upper perspective view of an arterial catheter system showing two example extension tubes of different lengths and an example secondary catheter, according to some embodiments. DETAILED DESCRIPTION

[0032] Referring now to FIGS. 1-2 , an arterial catheter system 10 is shown according to some embodiments. In some embodiments, the arterial catheter system 10 may be configured to reduce the maximum shear stress on arterial blood drawn from an artery into the arterial catheter system 10, and thereby reduce the risk of hemolysis of the arterial blood, thereby providing an improved blood sample. In some embodiments, the arterial catheter system 10 may include a catheter assembly 12, which may include a catheter hub 14. In some embodiments, the catheter hub 14 may include a distal end 16 and a proximal end 18. In some embodiments, the catheter assembly 12 may include an arterial catheter 20 extending from the distal end 16 of the catheter hub 14. In some embodiments, the arterial catheter 20 may be shorter and / or more rigid than an intravenous catheter, such as a peripheral intravenous catheter.

[0033] In some embodiments, the arterial catheter system 10 may include a needle assembly 22, which may include a needle hub 24 and an introducer needle 26. In some embodiments, the arterial catheter system 10 may include an extension tube 28 coupled to the catheter assembly 12 and having a distal end 30 and a proximal end 32. In some embodiments, the arterial catheter system 10 may include a fluid passage 34 extending through at least the arterial catheter 20, the catheter hub 14, and the extension tube 28.

[0034] In some embodiments, the geometric factor G of the portion 36 of the fluid passage 34 located within the extension tube 28 is f Can be equal to L / D 4 , where L is the length of extension tube 28 and D is the inner diameter of the portion of fluid passage 34 located within extension tube 28. In these embodiments, portion 36 of fluid passage 34 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 extension tube 28 or the length from a to b. In some embodiments, the geometric factor G of portion 36 of fluid passage 34 within extension tube 28 is f can be defined such that the fluid resistance in In some embodiments, the geometric factor G of the portion 36 of the fluid passage 34 isf It may be selected to reduce the maximum shear stress on arterial blood drawn from the artery, thereby reducing the risk of hemolysis of the arterial blood.

[0035] In some embodiments, the arterial catheter 20 may be a 20G arterial catheter. In these embodiments, the length L and the inner diameter D may be selected such that the geometric factor G of the portion of the fluid path within the extension tube 28 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 36 of the fluid passage 34 in the extension tube 28 is f is 3.41E+06(1 / in 3 )+ / -10%.

[0036] 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 such that the geometric factor G of the portion of the fluid path within the extension tube 28 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 36 of the fluid passage 34 in the extension tube 28 is f is 2.88E+06(1 / in 3 )+ / -10%.

[0037] 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 such that the geometric factor G of the portion of the fluid path within the extension tube 28 is f is 1.05E+07(1 / in 3 ) or higher. In some embodiments, the length L and the inner diameter D of the 22G arterial catheter can be selected so that the geometric factor G of the portion 36 of the fluid passage 34 in the extension tube 28 is f is 1.05E+07(1 / in 3 )+ / -10%.

[0038] 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 such that the geometric factor G of the portion of the fluid path within the extension tube 28 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 36 of the fluid passage 34 in the extension tube 28 is f is 3.20E+07(1 / in3 )+ / -10%.

[0039] In some embodiments, the fluid resistance may be a first fluid resistance. In some embodiments, the first fluid resistance of the portion 36 of the fluid passage 34 within the extension tube 28 may be greater than a second fluid resistance within the fluid passage 34 distal to the portion 36 of the fluid passage 34. For example, the first fluid resistance may be greater than a specific fluid resistance within the lumen 38 of the catheter hub 14, where arterial blood may travel before reaching the extension tube 28 and the adapter 40, which may be coupled to a blood collection device for blood collection.

[0040] Blood cells are subject to shear stress when flowing in a fluid path. The maximum shear stress is along the walls of the fluid path, or wall shear stress. Wall shear stress on blood cells is considered to be the main source of mechanical damage to blood cells. For a cylindrical fluid path, wall shear stress is usually expressed as:

[0041]

[0042] Where ΔP is the pressure drop along a path of length L and inner radius r. k is the contraction exponent.

[0043] The time required to fill a collection tube of a certain volume V at a flow rate Q can be simply estimated as follows:

[0044]

[0045] where μ is the dynamic viscosity of the fluid. Hemolysis is usually related to the wall shear stress and the time the blood cells are exposed to the wall shear stress. From the literature, it is widely believed that the hemolysis index can be approximated as the following function:

[0046] HI(%)=A*t α *τ β

[0047] where A, α, and β are coefficients.

[0048] In principle, the hemolysis index is related to the pressure gradient and the characteristic cross-sectional dimensions:

[0049]

[0050] The flow of fluid in a particular extended tube with a cylindrical fluid passage can be analyzed using the Poiseuille equation:

[0051]

[0052] where ΔP is the change in pressure gradient across the length of the extension tube, D and L are the inner diameter and length, respectively, of the cylindrical fluid passage through the particular extension tube, μ is the viscosity of the fluid, and is the fluid resistance. The specific extension tube may include or correspond to the extension tube 28. Since μ is the viscosity of the fluid and not part of the extension tube geometry, the geometric factor G f is defined so that R f (fluid resistance) is in

[0053] In some embodiments, the extension tube 28 may have multiple sections with lengths (L1, L2, L3) and inner diameters (D1, D2, D3), then the geometric factor is:

[0054]

[0055] In some embodiments, the extension tube 28 may have an inner diameter that varies over the length of the extension tube, and the geometry factor is then:

[0056]

[0057] In some embodiments, the extension tube 28 may have a non-circular cross-section. In this case, the geometric factor may be determined by measuring the flow rate (Q) of a fluid with a known viscosity (μ) at a given pressure (ΔP):

[0058]

[0059] In some embodiments, the first fluid resistance, which may be lower than the second fluid resistance, may promote a reduced flow rate of arterial blood within the portion 36 of the fluid passage 34 within the extension tube 28, such that the maximum shear stress is reduced within the portion 36 of the fluid passage 34, and there is a reduced risk of hemolysis of the arterial blood to be collected. In these embodiments, the geometric factor G of the portion 36 of the fluid passage 34 may be determined as f The length L and the inner diameter D of the extension tube 28 may be selected to increase the first fluid resistance and reduce the flow rate within the portion 36 of the fluid pathway so that the risk of hemolysis is reduced but the flow rate is still sufficient for blood collection.

[0060] In some embodiments, the extension tube 28 may include no more than one lumen 42 extending therethrough. In these embodiments, a single lumen is sufficient for the extension tube 28 in the arterial catheter system 10, since arterial catheters are rarely used for infusions, and an extension tube with a higher fluid resistance for infusions will significantly reduce the infusion rate. In some embodiments, the extension tube 28 may include more than one lumen. In some embodiments, the catheter hub 14 may include a side port 44 disposed between the distal end 16 of the catheter hub 14 and the proximal end 18 of the catheter hub 14. In some embodiments, the distal end 30 of the extension tube 28 may be coupled to the side port 44 or be integral with the side port 44. In some embodiments, the arterial catheter system 10 may include an adapter 40 coupled to the proximal end 32 of the extension tube 28 or be integral with the proximal end 32 of the extension tube 28. In some embodiments, the adapter 40 may include a blood collection port 48, which may include a female Luer interface. In some embodiments, a blood collection device may be coupled to the blood collection port 48. In some embodiments, a blood collection set may be coupled to the blood collection port 48 via a needleless access connector disposed between the blood collection set and the blood collection port 48 and / or directly coupled to both.

[0061] like Figure 2 As shown, in some embodiments, the adapter 40 may include a Y-shaped connector, which may include a blood collection port 49 configured to be connected to a blood collection device and / or a blood pressure monitoring port 50 configured to be connected to an arterial pressure monitor. In some embodiments, the blood collection port 49 and / or the blood pressure monitoring port 50 may include a female Luer interface. In some embodiments, a needleless connector 51 may be connected to the blood collection port 49 and / or the blood collection device may be connected to the needleless connector 51. In some embodiments, the blood collection device may be connected to the blood collection port 49 via the needleless connector 51 disposed between the blood collection device and the blood collection port 49 and / or directly connect both. In some embodiments, the arterial pressure monitor may be connected to the blood pressure monitoring port 50.

[0062] In some embodiments, the blood collection device 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. In some embodiments, the blood collection device may include a Luer lock access device, such as the VACUTAINER available from Becton Dickinson (注册商标) LUER-LOK (商标)Access Device. In some embodiments, the Luer lock access device may include a blood collection tube holder, such as further described in U.S. Patent Application No. 17 / 075,420, filed on October 20, 2020, entitled “BLOOD COLLECTION SYSTEM WITH USER-ADJUSTED PRESSURE MANAGEMENT AND RELATED METHODS,” the entire contents of which are incorporated herein by reference.

[0063] In some embodiments, the blood collection set may include a device delivery device configured to deliver the second catheter through the catheter assembly. In some embodiments, the instrument delivery device may be further described in the following patents, namely, U.S. Patent No. 11,969,247, entitled “EXTENSION HOUSING A PROBE OR INTRAVENOUS CATHETER”, filed on April 30, 2024; U.S. Patent Application No. 16 / 388,650, entitled “INSTRUMENT DELIVERY DEVICE HAVING AROTARY ELEMENT”, filed on April 18, 2019; U.S. Patent No. 11,173,277, entitled “MULTI-DIAMETER CATHETER AND RELATED DEVICES AND METHODS”, filed on November 16, 2021; and U.S. Patent No. 11,173,277, entitled “DELIVERY DEVICE FOR AVASCULAR ACCESS No. 11,406,795, entitled “SYRINGE-BASED DELIVERY DEVICE FOR A VASCULAR ACCESS INSTRUMENT”, issued on May 24, 2022; No. 11,337,628, entitled “SYRINGE-BASED DELIVERY DEVICE FOR A VASCULAR ACCESS INSTRUMENT”, issued on May 24, 2022; No. 11,547,832, entitled “CATHETER DELIVERY DEVICE AND RELATED SYSTEMS AND METHODS”, issued on January 10, 2023; and No. 11,547,832, entitled “VASCULAR ACCESS INSTRUMENT HAVING A FLUID PERMEABLE STRUCTURE AND RELATED DEVICES No. 11,504,503 to "Vascular access devices having fluid permeable structures and related apparatus and methods," the entirety of which is incorporated herein by reference.

[0064] See now Figure 3In some embodiments, the extension tube 28 may be a first extension tube, and the arterial catheter system 10 may include a second extension tube 54 in fluid communication with the fluid passage 34. In some embodiments, the fluid resistance within the second extension tube 54 may be a second fluid resistance. In some embodiments, the geometric factor G of the first extension tube f The geometric factor G of the second extension tube 54 may be different from f In some embodiments, the first fluid resistance of the portion 36 of the fluid passage 34 located within the extension tube 28 (e.g., see Figure 1B ) can be lower than the second fluid resistance.

[0065] In some embodiments, the first extension tube and / or the second extension tube 54 can be flexible, which can facilitate the use of the arterial catheter system 10. In other embodiments, the first extension tube and / or the second extension tube 54 can be rigid or semi-rigid. In some embodiments, the first extension tube and / or the second extension tube 54 can be made of plastic. In some embodiments, any suitable first lumen can replace the first extension tube and / or any suitable second lumen can replace the second extension tube 54.

[0066] In some embodiments, the second extension tube 54 may include a distal end 56 and a proximal end 58. In some embodiments, the arterial catheter system 10 may include a distal adapter 60 and a proximal adapter 62. In some embodiments, the catheter hub 14 may include a side port 44 disposed between the distal end 16 of the catheter hub 14 and the proximal end 18 of the catheter hub 14. In some embodiments, the distal end 56 of the second extension tube 54 may be coupled to or integral with the side port 44. In some embodiments, the proximal end 58 of the second extension tube 54 may be coupled to or integrated into the distal adapter 60. In some embodiments, the distal end 30 of the first extension tube may be coupled to the distal adapter 60. In some embodiments, the proximal end 32 of the first extension tube may be coupled to the proximal adapter 62. In some embodiments, the distal adapter 60 may include a blood pressure monitoring port 63.

[0067] In some embodiments, the proximal adapter 62 may include a blood collection port. In some embodiments, the blood collection port and / or the blood pressure monitoring port 63 may include a female Luer interface. In some embodiments, the first extension tube may be proximal to the second extension tube 54, and the blood collection port may be disposed at the proximal end 32 of the first extension tube.

[0068] In some embodiments, the arterial catheter system 10 may include a blood pressure monitoring port 63 between the first extension tube and the second extension tube 54, both of which may be coupled to or integral with the distal adapter 60. Thus, in some embodiments, arterial blood for pressure testing may pass through the second extension tube 54 instead of the first extension tube to provide an accurate arterial blood pressure reading.

[0069] See now Figure 4 In some embodiments, the distal end 56 of the second extension tube 54 can be coupled to or integrated with the side port 44. In some embodiments, the arterial catheter system 10 can include a distal adapter 64 that is coupled to or integrated with the proximal end 58 of the second extension tube 54 and the distal end 30 of the first extension tube (corresponding to the extension tube 28). In some embodiments, the arterial catheter system 10 can include a proximal adapter 66 that is coupled to or integrated with the proximal end 32 of the first extension tube. In some embodiments, the first extension tube can include a spiral shape, which can facilitate a compact device for easy use by a clinician. In some embodiments, the distal adapter 64 can include a blood pressure monitoring port 65. In some embodiments, the proximal adapter 66 can include a blood collection port 67. In some embodiments, the blood collection port 67 and / or the blood pressure monitoring port 65 can include a female Luer interface.

[0070] See now Figure 5 In some embodiments, the distal end 16 of the first extension tube (corresponding to the extension tube 28) can be coupled to or integrated with the side port 44. In some embodiments, the proximal end 18 of the first extension tube can be coupled to or integrated with the distal adapter 68. In some embodiments, the distal end 56 of the second extension tube 54 can be coupled to the distal adapter 68. In some embodiments, the proximal end 58 of the second extension tube 54 can be coupled to the proximal adapter 70. In some embodiments, the first extension tube can be shorter than the second extension tube 54. In some embodiments, the distal adapter 68 can include a blood collection port 71 and / or the proximal adapter 70 can include a blood pressure monitoring port. In some embodiments, the blood collection port 71 and / or the blood pressure monitoring port can include a female Luer interface. In some embodiments, the geometric factor G of the first extension tube f The geometric factor G of the second extension tube 54 may be higher than f , because the first extension tube can be used for blood collection.

[0071] Reference now Figure 6In some embodiments, the distal end 16 of the first extension tube (corresponding to the extension tube 28) can be connected to or integrated into the distal adapter 68. In some embodiments, the proximal end 18 of the first extension tube can be connected to or integrated into the proximal adapter 70. In some embodiments, the distal end 56 of the second extension tube 54 can be connected to the side port 44. In some embodiments, the proximal end 58 of the second extension tube 54 can be connected to the distal adapter 68. In some embodiments, the second extension tube 54 can be shorter than the first extension tube. In some embodiments, the proximal adapter 70 may include a blood collection port. In some embodiments, the third extension tube 74 can extend from the distal adapter 68. The blood pressure monitoring port 76 and / or the needleless connector 51 can be provided at the proximal end of the third extension tube 74. In some embodiments, the geometric factor G of the first extension tube f and the geometric factor G of the second extension tube 54 f The geometric factor G of the third extension tube 74 may be higher than f , because the first extension tube and the second extension tube 54 can be used for blood collection.

[0072] Now refer to FIGS. 1 to Figure 6 In some embodiments, a method of collecting blood may include inserting an arterial catheter 20 of an arterial catheter system 10 into an artery of a patient. In some embodiments, the method of collecting blood may include collecting arterial blood in a blood collection device that may be coupled to a catheter assembly 12, whereby the arterial blood flows through a portion 36 of a fluid passage 34 (e.g., see Figure 1B ) and flows into a blood collection device. In some embodiments, the blood collection device may include a vacuum tube. Figure 5-6 In some embodiments, collecting arterial blood in a blood collection device coupled to the catheter assembly 12 may include inserting a secondary catheter through the distal adapter 68, the first extension tube, the arterial catheter 20, and into the artery. In some embodiments, the distal adapter 68 may provide proximal port access to the arterial catheter system 10, which may allow a shorter length of secondary catheter or other blood collection device to be inserted through the catheter assembly 12.

[0073] 1-6, in some embodiments, a method of manufacturing an arterial catheter system 10 may include coupling a catheter assembly 12 to a needle assembly 22. In some embodiments, the catheter assembly 12 may include a catheter hub 14 and an arterial catheter 20 extending distally from the catheter hub 14. In some embodiments, the manufacturing method may include coupling an extension tube 28 to the catheter assembly 12 such that the extension tube 28 is in fluid communication with the catheter assembly 12 and a fluid passage 34 extends through the arterial catheter 20, the catheter hub 14, and the extension tube 28.

[0074] In some embodiments, the manufacturing method may include selecting the length L of the extension tube 28 and the inner diameter D of the extension tube 28 so that a first fluid resistance within a portion of the fluid passage 34 is greater than a second fluid resistance within the fluid passage distally or proximally of the portion of the fluid passage. In some embodiments, the geometric factor G of the portion of the fluid passage within the extension tube is f Equal to L / D 4 .

[0075] All examples and conditional language described here are intended for teaching purposes, to help readers understand the present invention and the concepts contributed by the inventors to expand this area, and should be interpreted as not being limited to such specific 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, the arterial catheter system include: A catheter assembly, the catheter assembly comprising: a catheter hub comprising a distal end and a proximal end; an arterial catheter extending from a distal end of the catheter hub; A needle assembly, the needle assembly comprising: Needle hub; Guide needle; an extension tube coupled to the catheter assembly and having a distal end and a proximal end; and a fluid pathway extending through the arterial catheter, the catheter hub, and the extension tube, Wherein, a first fluid resistance in a portion of the fluid passage in the extension tube is greater than a second fluid resistance in a fluid passage distally or proximally of the portion of the fluid passage.

2. The arterial catheter system according to claim 1, in, The extension tube is a first extension tube, wherein the arterial catheter system includes a second extension tube in fluid communication with the fluid passage, wherein the geometric factor G of the portion of the fluid passage within the first extension tube is f The geometric factor G of another part of the fluid passage in the second extension tube is different from f , wherein the first extension tube is proximal to the second extension tube, and a blood collection port is arranged at the proximal end of the first extension tube.

3. The arterial catheter system according to claim 1, in, The extension tube includes no more than one lumen extending therethrough.

4. The arterial catheter system according to claim 1, in, The catheter hub further comprises a side port disposed between a distal end of the catheter hub and a proximal end of the catheter hub, wherein the distal end of the extension tube is integral with the side port, and the arterial catheter system further comprises an adapter integral with the proximal end of the extension tube, wherein the adapter comprises a blood collection port, wherein the blood collection port comprises a female Luer interface.

5. The arterial catheter system according to claim 1, in, The extension tube is a first extension tube, wherein the arterial catheter system further comprises a second extension tube having a distal end and a proximal end, wherein the arterial catheter system further comprises a distal adapter and a proximal adapter, wherein the catheter hub further comprises a side port arranged between the distal end of the catheter hub and the proximal end of the catheter hub, wherein the distal end of the second extension tube is integrated with the side port, wherein the proximal end of the second extension tube is integrated into the distal adapter, wherein the distal end of the first extension tube is connected to the distal adapter, wherein the proximal end of the first extension tube is connected to the proximal adapter.

6. The arterial catheter system according to claim 5, in, The distal adapter includes a blood pressure monitoring port, wherein the proximal adapter includes a blood collection port.

7. The arterial catheter system according to claim 5, in, The first extension tube includes no more than one lumen extending therethrough, wherein the second extension tube includes no more than one lumen extending therethrough.

8. The arterial catheter system according to claim 1, in, The extension tube is a first extension tube, wherein the arterial catheter system includes a second extension tube having a distal end and a proximal end, wherein the catheter hub also includes a side port arranged between the distal end of the catheter hub and the proximal end of the catheter hub, wherein the distal end of the second extension tube is formed integrally with the side port, wherein the arterial catheter system also includes a distal adapter formed integrally with the proximal end of the second extension tube and the distal end of the first extension tube, wherein the arterial catheter system also includes a proximal adapter formed integrally with the proximal end of the first extension tube, wherein the first extension tube includes a spiral shape, and wherein the proximal adapter includes a blood collection port.

9. The arterial catheter system according to claim 1, in, The extension tube is a first extension tube, wherein the arterial catheter system further comprises a second extension tube having a distal end and a proximal end, wherein the arterial catheter system further comprises a distal adapter and a proximal adapter, wherein the catheter hub further comprises a side port arranged between the distal end of the catheter hub and the proximal end of the catheter hub, wherein the distal end of the first extension tube is integrated with the side port, wherein the proximal end of the first extension tube is integrated into the distal adapter, wherein the distal end of the second extension tube is connected to the distal adapter, wherein the proximal end of the second extension tube is connected to the proximal adapter, wherein the first extension tube is shorter than the second extension tube, and wherein the distal adapter comprises a blood collection port.

10. A blood collection method, the method comprising: include: 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 hub comprising a distal end and a proximal end; an arterial catheter extending from a distal end of the catheter hub; A needle assembly, the needle assembly comprising: Needle hub; Guide needle; an extension tube coupled to the catheter assembly and having a distal end and a proximal end; and a fluid pathway extending through the arterial catheter, the catheter hub, and the extension tube, wherein a first fluid resistance within a portion of the fluid passage within the extension tube is greater than a second fluid resistance within the fluid passage distally or proximally of the portion of the fluid passage; and Arterial blood is collected in a blood collection device coupled to the catheter assembly, whereby the arterial blood flows through the portion of the fluid pathway and into the blood collection device.

11. The method according to claim 10, in, The blood collection device includes a vacuum tube.

12. The method according to claim 10, in, The extension tube is a first extension tube, wherein the arterial catheter system further comprises a second extension tube having a distal end and a proximal end, wherein the arterial catheter system further comprises a distal adapter and a proximal adapter, wherein the catheter hub further comprises a side port disposed between the distal end of the catheter hub and the proximal end of the catheter hub, wherein the distal end of the first extension tube is integral with the side port, wherein the proximal end of the first extension tube is integrated into the distal adapter, wherein the distal end of the second extension tube is coupled to the distal adapter, wherein the proximal end of the second extension tube is coupled to the proximal adapter, wherein the first extension tube is shorter than the second extension tube, and wherein the distal adapter comprises a blood collection port; Wherein, collecting arterial blood in a blood collection device coupled to the catheter assembly includes inserting a second catheter through the distal adapter, the first extension tube, the arterial catheter, and into the artery.

13. A method for manufacturing an arterial catheter system, the method include: 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 the extension tube to the catheter assembly such that the extension tube is in fluid communication with the catheter assembly and a fluid pathway extends through the arterial catheter, the catheter hub, and the extension tube; and The length L of the extension tube and the inner diameter D of the extension tube are selected so that a first fluid resistance within a portion of the fluid pathway is greater than a second fluid resistance within the fluid pathway distally or proximally of the portion of the fluid pathway.

14. The method according to claim 13, in, The catheter is a 20G catheter, wherein the length L and the inner diameter D are selected so that the geometric factor G of the portion of the fluid passage of the extension tube is f is 3.33E+06(1 / in 3 ) or higher.

Images