Arterial catheter system

Abstract

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

Description

Technical Field

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

[0002] Catheters are commonly used to inject fluids into a patient's vasculature. For example, a catheter can be used to infuse a saline solution, various medications, or total parenteral nutrition. A catheter can also be used to draw blood from a patient.

[0003] The catheter can include a stylet-based intravenous (“IV”) catheter. In such a case, the catheter can be mounted on a guide needle having a sharp distal end. The catheter and the guide needle can be assembled such that the distal end of the guide needle extends beyond the distal end of the catheter, and the bevel of the needle faces upward away from the patient's skin. The catheter and the guide needle are typically inserted into the patient's vasculature through the skin at a relatively small angle.

[0004] To verify the correct placement of the guide needle and / or catheter in a blood vessel, a clinician typically confirms the presence of blood “flashback” in a flashback chamber of a catheter assembly that includes the catheter. Once the placement of the needle has been confirmed, the clinician can temporarily occlude blood flow in the vasculature and remove the needle, leaving the catheter in place for future blood drawing or infusion.

[0005] To draw blood from a patient or collect a blood sample, a blood collection container can be used. The blood collection container can include a syringe or a 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, such that the pressure inside the blood collection container is lower than the ambient pressure. Such a blood collection container is commonly referred to as an internal vacuum or vacuum tube. A commonly used blood collection container is a blood collection tube, which is available from Becton Dickinson and Company.

[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 the blood into the blood collection container, thereby filling the blood collection container with blood. As the blood collection container fills, the vacuum inside the blood collection container decreases until the pressure in the blood collection container balances the pressure in the vein, and the blood stops flowing.

[0007] Unfortunately, when blood is drawn into a blood collection container, red blood cells in the blood are under a high shear stress state due to the high initial pressure difference between the vein and the blood collection container and are prone to hemolysis. Hemolysis may cause the blood sample to be rejected and discarded. The high initial pressure difference may also cause other complications such as collapse of the catheter tip, collapse of the vein, or prevention or limitation of blood filling the blood collection container. As the blood collection container fills, the pressure difference between the vein and the blood collection container decreases, and the filling of the blood collection tube with blood significantly slows down. Compared with venous blood drawing, the risk of hemolysis in arterial blood drawing is much higher because the pressure in the artery is higher.

[0008] The subject matter claimed herein is not limited to embodiments that solve any disadvantages or operate only in environments such as those described above. Instead, this background is only provided to illustrate an exemplary technical field in which some implementations described herein may be practiced. Summary of the Utility Model

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

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

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

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

[0013] In some embodiments, the extension tube may include a distal end and a proximal end. In some embodiments, the distal end of the extension tube may be integrated with a luer adapter. In some embodiments, the proximal end of the extension tube may be integrated with a blood collection device. In some embodiments, the luer adapter may be a first luer adapter. In some embodiments, the blood collection device may include a second luer adapter. In some embodiments, the arterial catheter system may include a third luer adapter 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 the first luer adapter. In some embodiments, the proximal end of the extension tube may be integrated with the third luer adapter. In some embodiments, the geometric factor G of the portion of the fluid passageway f may be different from the geometric factor G of another portion of the fluid passageway f . In some embodiments, the extension tube may have no more than one lumen extending therethrough.

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

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

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

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

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

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

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

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

[0022] The exemplary embodiments will be described and explained with additional features and details by using the drawings, in which:

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

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

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

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

[0027] Figure 2B is according to some embodiments Figure 2B cross-sectional view of the arterial blood protection device;

[0028] Figure 2C is according to some embodiments coupled to Figure 1C of the arterial catheter assembly Figure 2A top perspective view of the arterial blood protection device;

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

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

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

[0032] Figure 4B is according to some embodiments Figure 4A cross-sectional view of a portion of the arterial catheter system;

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

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

[0035] Figure 5C is a top perspective view of a portion of an arterial blood protection device in accordance with some embodiments; Figure 5A of an arterial blood protection device;

[0036] Figure 5D is a cross-sectional view of the remaining portion of an arterial blood protection device coupled to; Figure 5A of an arterial blood protection device in accordance with some embodiments;

[0037] Figure 6A is a top perspective view of an exemplary arterial catheter system in accordance with some embodiments;

[0038] Figure 6B is in accordance with some embodiments; Figure 3A cross-sectional view of an arterial catheter system of, showing the exemplary needle assembly removed. DETAILED DESCRIPTION

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

[0040] In some embodiments, the blood collection device 18 may include a needle assembly 19 that 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, such that the pressure within the blood collection container is lower than ambient pressure.

[0041] In some embodiments, the needle assembly 19 may include one or more threads that may be configured to couple to a holder 22 of the blood collection device 18, which may be generally cylindrical and may be configured to hold a blood collection container. In some embodiments, the holder 22 may be integrally formed with the needle assembly 19 or coupled to the needle assembly 19 via adhesion or other suitable methods. 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 LUER-LOK TM an access device that may be purchased from Becton, Dickinson and Company. In some embodiments, the holder 22 may include or correspond to the blood collection tube holder described in U.S. Patent Application No. 17 / 075,420, titled "Blood Collection Systems and Related Methods with User-Regulated Pressure Management," filed on October 20, 2020, the entire content of which is incorporated herein by reference.

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

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

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

[0045] In some embodiments, the arterial blood protection device 10 may act as, for example, Figure 1C a flow resistor in the fluid path of an arterial catheter system or other vascular access system as shown. In some embodiments, the arterial catheter system may include an arterial catheter assembly 37 that may include a catheter adapter 39 and an arterial catheter 40. In some embodiments, the arterial catheter 40 may be secured within the catheter adapter 39 and may extend distally from the catheter adapter 39. In some embodiments, the catheter adapter 39 may include a distal end 42, a proximal end 44, and a lumen extending through the distal end 42 and the proximal end 44. In some embodiments, the guide needle 45 may extend through the arterial catheter 40 from the needle shield.

[0046] In some embodiments, the arterial catheter assembly 37 may be integral. More specifically, in some embodiments, another extension tube 46 may extend from a side port 48 of the catheter adapter 39. In some embodiments, the proximal end of the another extension tube 46 may include a fourth Luer adapter 50 that may be coupled to the first Luer adapter. In some embodiments, the arterial catheter assembly 37 may be straight 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-on or threaded or clamping male Luer adapter, a slip-on or threaded female Luer adapter, a needleless connector, a blunt cannula, or other suitable access device.

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

[0048] In some embodiments, the geometric factor G of a portion of the fluid path that is 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 that is within the extension tube 32. In these embodiments, this 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 entire length of the extension tube 32. In some embodiments, the geometric factor G of a portion of the fluid path that is within the extension tube 32 f may be defined such that the fluid resistance where In some embodiments, the geometric factor G of this portion of the fluid path f may be selected to reduce the maximum shear stress acting on the arterial blood withdrawn from the artery and thereby reduce the risk of arterial blood hemolysis.

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

[0050]

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

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

[0053]

[0054] where μ is the dynamic viscosity of the fluid. Hemolysis is generally related to both the wall shear stress and the time for blood cells to withstand the wall shear stress. According to the literature, it is generally believed that the hemolysis index can be approximated as the following function:

[0055] HI(%) = A * t α * τ β

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

[0057] In principle, the hemolysis index is related to the pressure gradient and the characteristic dimension of the cross-section:

[0058]

[0059] The fluid flow rate in a specific extension tube with a cylindrical fluid passage therethrough can be analyzed using the Poiseuille equation:

[0060]

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

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

[0063]

[0064] In some embodiments, if the extension tube 32 can have an inner diameter that varies with the length of the extension tube, the geometric factor is:

[0065]

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

[0067]

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

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

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

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

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

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

[0074] Now referring to Figure 2A - 2C , an arterial blood protection device 52 is shown in accordance with some embodiments. In some embodiments, the arterial blood protection device 52 can be similar or identical to the arterial blood protection device 10 Figure 1A - 1C in one or more of the included features and / or operations. In some embodiments, the proximal end of the extension tube 32 can be integrated with the blood collection device 18. In some embodiments, the arterial blood protection device 52 can include a clamp 54, and the clamp can be disposed on the extension tube 32. In some embodiments, the clamp 54 can be configured to move between a clamped position and a released position or between a greater clamped position and a lesser clamped position. In some embodiments, in response to the clamp 54 being in the clamped position, the clamp 54 can prevent or reduce the fluid flow through the extension tube 32.

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

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

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

[0078] Now referring Figure 3B , a portion 124 of an arterial catheter assembly is shown in accordance with some embodiments. In some embodiments, the portion 124 of the arterial catheter assembly can include an arterial blood protection device 126 that can be coupled to or integrated with an instrument delivery device 127 that can deliver a probe, catheter, or guidewire through a particular arterial catheter assembly (e.g., as Figure 3A shown). In some embodiments, the arterial blood protection device 126 can be similar or identical to one or more of the following in one or more included features and / or operations: Figure 1A - 1C the arterial blood protection device 10 of Figure 2A - 2C and the arterial blood protection device 52 of

[0079] In some embodiments, the instrument delivery device 127 can include any suitable instrument delivery device. In some embodiments, the instrument delivery device 127 can be further described in U.S. Patent No. 11,969,247, titled "Extension for Receiving a Probe or Venous Catheter," issued on April 30, 2024, U.S. Patent Application No. 16 / 388,650, titled "Instrument Delivery Device with a Rotating Element," filed on April 18, 2019, and U.S. Patent No. 11,173,277, titled "Multi-Diameter Catheters and Related Devices and Methods," issued on November 16, 2021, U.S. Patent No. 11,406,795, titled "Delivery Device for a Vascular Access Instrument," filed on August 9, 2022, U.S. Patent No. 11,337,628, titled "Spring-Biased Delivery Device for a Vascular Access Instrument," issued on May 24, 2022, U.S. Patent No. 11,547,832, titled "Catheter Delivery Device and Related Systems and Methods," issued on January 10, 2023, and U.S. Patent No. 11,504,503, titled "Vascular Access Instrument with a Fluid Permeable Structure and Related Devices and Methods," issued on November 22, 2022, the entire contents of which are incorporated by reference.

[0080] Now referring to Figure 4A - 4B , an arterial catheter system 410 is shown in accordance with some embodiments. In some embodiments, the arterial catheter system 410 can be configured to reduce the maximum shear stress acting on arterial blood drawn into the arterial catheter system 410 from an artery and thereby reduce the risk of arterial blood hemolysis, thereby providing an improved blood sample. In some embodiments, the arterial catheter system 410 can be similar or identical to an arterial catheter system of one or more of Figure 1C , Figure 3A and Figure 3B in one or more included features and / or operations.

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

[0082] In some embodiments, the arterial catheter system 410 may include a needle assembly 422, which may include a needle hub 424 and a guide needle 426. In some embodiments, the arterial catheter system 410 may include a tube 428 that is coupled to the arterial catheter assembly 412 and has a distal end 430 and a proximal end 432. In some embodiments, the arterial catheter system 410 may include a fluid passageway 434 that extends at least through the arterial catheter 420, the catheter adapter 414, and the tube 428.

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

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

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

[0086]

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

[0088] To fill a collection tube of a certain volume V at a flow rate Q, the required time can be simply evaluated by the following equation:

[0089]

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

[0091] HI(%) = A * t α * τ β

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

[0093] In principle, the hemolysis index is related to the pressure gradient and the characteristic dimension of the cross-section:

[0094]

[0095] The fluid flow rate in a specific tube with a cylindrical fluid passage therethrough can be analyzed using the Poiseuille equation:

[0096]

[0097] where ΔP is the change in the pressure gradient along the length of the tube, D and L are the inner diameter and length of the cylindrical fluid passage through the specific tube respectively, μ is the viscosity of the fluid, and is the fluid resistance. The specific tube can include or correspond to tube 428. Since μ is the viscosity of the fluid and not part of the tube geometry, the geometric factor G f is defined such that R f (fluid resistance) is where

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

[0099]

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

[0101]

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

[0103]

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

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

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

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

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

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

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

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

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

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

[0114] In some embodiments, the outer diameter of the collar 539 may be greater than the outer diameter of the elongated neck 535. In some embodiments, the blood protection 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 end 534 may be disposed at the center of the cylindrical body 542 to facilitate piercing of the seal of the blood collection container in response to insertion of the blood collection container into the proximal opening 544 of the cylindrical body 542.

[0115] In some embodiments, the outer diameter of the cylindrical body 542 may be greater than the outer diameter of the elongated neck 535. In some embodiments, the elongated neck 535 may be disposed 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 elastomeric sheath 531 may be coupled to the inner surface of the holder 541.

[0116] Now referring Figure 5C - 5D , in some embodiments, the blood protection device 520 may include a female Luer adapter 546 disposed 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 protection device 520 may include an extension 550 that a user may couple to the holder 541 to provide the elongated neck 535 and an 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 a portion of the elongated neck 535. In some embodiments, the male Luer adapter 548 may be similar or identical to the male Luer adapter 526 in one or more features and / or operations.

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

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

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

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

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

[0122]

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

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

[0125]

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

[0127]

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

[0129]

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

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

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

[0133] All of the examples and conditional language recited herein are intended for pedagogical purposes to aid the reader in understanding the present invention and the concepts contributed by the inventor to further the art and are to be construed as not being limited to such specifically recited examples and conditions. Although embodiments of the present invention have been described in detail, it should be understood that various changes, substitutions, and alterations can be made hereto without departing from the spirit and scope of the present invention.

Claims

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

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

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

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

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

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

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

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

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

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

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

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

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